Hazard Communication Standard 29 CFR 1910.1200

CFR-2014-title29-vol6-sec1910-1200 (1).pdf

Hazard Communication (29 CFR 1910.1200, 1915.1200, 1917.28, 1918.90, 1926.59, and 1928.21)

Hazard Communication Standard 29 CFR 1910.1200

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Occupational Safety and Health Admin., Labor
of a currently effective determination
by the Assistant Secretary of Labor
that such program is compatible with
the requirements of this section. Such
determinations currently are in effect
only in the States of Alabama, Arkansas, California, Kansas, Kentucky,
Florida, Mississippi, New Hampshire,
New York, North Carolina, Texas, Tennessee, Oregon, Idaho, Arizona, Colorado, Louisiana, Nebraska, Washington, Maryland, North Dakota,
South Carolina, and Georgia.
[39 FR 23502, June 27, 1974, as amended at 43
FR 49746, Oct. 24, 1978; 43 FR 51759, Nov. 7,
1978; 49 FR 18295, Apr. 30, 1984; 58 FR 35309,
June 30, 1993. Redesignated at 61 FR 31430,
June 20, 1996]

§ 1910.1200 Hazard communication.
(a) Purpose. (1) The purpose of this
section is to ensure that the hazards of
all chemicals produced or imported are
classified, and that information concerning the classified hazards is transmitted to employers and employees.
The requirements of this section are
intended to be consistent with the provisions of the United Nations Globally
Harmonized System of Classification
and Labelling of Chemicals (GHS), Revision 3. The transmittal of information is to be accomplished by means of
comprehensive hazard communication
programs, which are to include container labeling and other forms of
warning, safety data sheets and employee training.
(2) This occupational safety and
health standard is intended to address
comprehensively
the
issue
of
classifying the potential hazards of
chemicals, and communicating information concerning hazards and appropriate protective measures to employees, and to preempt any legislative or
regulatory enactments of a state, or
political subdivision of a state, pertaining to this subject. Classifying the
potential hazards of chemicals and
communicating
information
concerning hazards and appropriate protective measures to employees, may include, for example, but is not limited
to, provisions for: developing and maintaining a written hazard communication program for the workplace, including lists of hazardous chemicals
present; labeling of containers of

§ 1910.1200

chemicals in the workplace, as well as
of containers of chemicals being
shipped to other workplaces; preparation and distribution of safety data
sheets to employees and downstream
employers; and development and implementation of employee training programs regarding hazards of chemicals
and protective measures. Under section
18 of the Act, no state or political subdivision of a state may adopt or enforce any requirement relating to the
issue addressed by this Federal standard, except pursuant to a Federally-approved state plan.
(b) Scope and application. (1) This section requires chemical manufacturers
or importers to classify the hazards of
chemicals which they produce or import, and all employers to provide information to their employees about the
hazardous chemicals to which they are
exposed, by means of a hazard communication program, labels and other
forms of warning, safety data sheets,
and information and training. In addition, this section requires distributors
to transmit the required information
to employers. (Employers who do not
produce or import chemicals need only
focus on those parts of this rule that
deal with establishing a workplace program and communicating information
to their workers.)
(2) This section applies to any chemical which is known to be present in
the workplace in such a manner that
employees may be exposed under normal conditions of use or in a foreseeable emergency.
(3) This section applies to laboratories only as follows:
(i) Employers shall ensure that labels
on incoming containers of hazardous
chemicals are not removed or defaced;
(ii) Employers shall maintain any
safety data sheets that are received
with incoming shipments of hazardous
chemicals, and ensure that they are
readily
accessible
during
each
workshift to laboratory employees
when they are in their work areas;
(iii) Employers shall ensure that laboratory employees are provided information and training in accordance
with paragraph (h) of this section, except for the location and availability of

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

the written hazard communication program under paragraph (h)(2)(iii) of this
section; and,
(iv) Laboratory employers that ship
hazardous chemicals are considered to
be either a chemical manufacturer or a
distributor under this rule, and thus
must ensure that any containers of
hazardous chemicals leaving the laboratory are labeled in accordance with
paragraph (f) of this section, and that a
safety data sheet is provided to distributors and other employers in accordance with paragraphs (g)(6) and
(g)(7) of this section.
(4) In work operations where employees only handle chemicals in sealed
containers which are not opened under
normal conditions of use (such as are
found in marine cargo handling,
warehousing, or retail sales), this section applies to these operations only as
follows:
(i) Employers shall ensure that labels
on incoming containers of hazardous
chemicals are not removed or defaced;
(ii) Employers shall maintain copies
of any safety data sheets that are received with incoming shipments of the
sealed containers of hazardous chemicals, shall obtain a safety data sheet as
soon as possible for sealed containers
of hazardous chemicals received without a safety data sheet if an employee
requests the safety data sheet, and
shall ensure that the safety data sheets
are readily accessible during each work
shift to employees when they are in
their work area(s); and,
(iii) Employers shall ensure that employees are provided with information
and training in accordance with paragraph (h) of this section (except for the
location and availability of the written
hazard communication program under
paragraph (h)(2)(iii) of this section), to
the extent necessary to protect them
in the event of a spill or leak of a hazardous chemical from a sealed container.
(5) This section does not require labeling of the following chemicals:
(i) Any pesticide as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.), when subject to the labeling
requirements of that Act and labeling
regulations issued under that Act by
the Environmental Protection Agency;

(ii) Any chemical substance or mixture as such terms are defined in the
Toxic Substances Control Act (15
U.S.C. 2601 et seq.), when subject to the
labeling requirements of that Act and
labeling regulations issued under that
Act by the Environmental Protection
Agency.
(iii) Any food, food additive, color additive, drug, cosmetic, or medical or
veterinary device or product, including
materials intended for use as ingredients in such products (e.g. flavors and
fragrances), as such terms are defined
in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the
Virus-Serum-Toxin Act of 1913 (21
U.S.C. 151 et seq.), and regulations
issued under those Acts, when they are
subject to the labeling requirements
under those Acts by either the Food
and Drug Administration or the Department of Agriculture;
(iv) Any distilled spirits (beverage alcohols), wine, or malt beverage intended for nonindustrial use, as such
terms are defined in the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) and regulations issued under that
Act, when subject to the labeling requirements of that Act and labeling
regulations issued under that Act by
the Bureau of Alcohol, Tobacco, Firearms and Explosives;
(v) Any consumer product or hazardous substance as those terms are defined in the Consumer Product Safety
Act (15 U.S.C. 2051 et seq.) and Federal
Hazardous Substances Act (15 U.S.C.
1261 et seq.) respectively, when subject
to a consumer product safety standard
or labeling requirement of those Acts,
or regulations issued under those Acts
by the Consumer Product Safety Commission; and,
(vi) Agricultural or vegetable seed
treated with pesticides and labeled in
accordance with the Federal Seed Act
(7 U.S.C. 1551 et seq.) and the labeling
regulations issued under that Act by
the Department of Agriculture.
(6) This section does not apply to: (i)
Any hazardous waste as such term is
defined by the Solid Waste Disposal
Act, as amended by the Resource Conservation and Recovery Act of 1976, as
amended (42 U.S.C. 6901 et seq.), when
subject to regulations issued under

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Occupational Safety and Health Admin., Labor
that Act by the Environmental Protection Agency;
(ii) Any hazardous substance as such
term is defined by the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA) (42
U.S.C. 9601 et seq.) when the hazardous
substance is the focus of remedial or
removal action being conducted under
CERCLA in accordance with Environmental Protection Agency regulations.
(iii) Tobacco or tobacco products;
(iv) Wood or wood products, including
lumber which will not be processed,
where the chemical manufacturer or
importer can establish that the only
hazard they pose to employees is the
potential for flammability or combustibility (wood or wood products which
have been treated with a hazardous
chemical covered by this standard, and
wood which may be subsequently sawed
or cut, generating dust, are not exempted);
(v) Articles (as that term is defined
in paragraph (c) of this section);
(vi) Food or alcoholic beverages
which are sold, used, or prepared in a
retail establishment (such as a grocery
store, restaurant, or drinking place),
and foods intended for personal consumption by employees while in the
workplace;
(vii) Any drug, as that term is defined in the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.),
when it is in solid, final form for direct
administration to the patient (e.g., tablets or pills); drugs which are packaged
by the chemical manufacturer for sale
to consumers in a retail establishment
(e.g., over-the-counter drugs); and
drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies);
(viii) Cosmetics which are packaged
for sale to consumers in a retail establishment, and cosmetics intended for
personal consumption by employees
while in the workplace;
(ix) Any consumer product or hazardous substance, as those terms are
defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and Federal Hazardous Substances Act (15
U.S.C. 1261 et seq.) respectively, where
the employer can show that it is used
in the workplace for the purpose intended by the chemical manufacturer

§ 1910.1200

or importer of the product, and the use
results in a duration and frequency of
exposure which is not greater than the
range of exposures that could reasonably be experienced by consumers when
used for the purpose intended;
(x) Nuisance particulates where the
chemical manufacturer or importer
can establish that they do not pose any
physical or health hazard covered
under this section;
(xi) Ionizing and nonionizing radiation; and,
(xii) Biological hazards.
(c) Definitions. Article means a manufactured item other than a fluid or particle: (i) which is formed to a specific
shape or design during manufacture;
(ii) which has end use function(s) dependent in whole or in part upon its
shape or design during end use; and (iii)
which under normal conditions of use
does not release more than very small
quantities, e.g., minute or trace
amounts of a hazardous chemical (as
determined under paragraph (d) of this
section), and does not pose a physical
hazard or health risk to employees.
Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.
Chemical means any substance, or
mixture of substances.
Chemical manufacturer means an employer with a workplace where chemical(s) are produced for use or distribution.
Chemical name means the scientific
designation of a chemical in accordance with the nomenclature system developed by the International Union of
Pure and Applied Chemistry (IUPAC)
or the Chemical Abstracts Service
(CAS) rules of nomenclature, or a name
that will clearly identify the chemical
for the purpose of conducting a hazard
classification.
Classification means to identify the
relevant data regarding the hazards of
a chemical; review those data to ascertain the hazards associated with the
chemical; and decide whether the
chemical will be classified as hazardous
according to the definition of hazardous chemical in this section. In addition, classification for health and
physical hazards includes the determination of the degree of hazard, where

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

appropriate, by comparing the data
with the criteria for health and physical hazards.
Commercial account means an arrangement whereby a retail distributor
sells hazardous chemicals to an employer, generally in large quantities
over time and/or at costs that are
below the regular retail price.
Common name means any designation
or identification such as code name,
code number, trade name, brand name
or generic name used to identify a
chemical other than by its chemical
name.
Container means any bag, barrel, bottle, box, can, cylinder, drum, reaction
vessel, storage tank, or the like that
contains a hazardous chemical. For
purposes of this section, pipes or piping
systems, and engines, fuel tanks, or
other operating systems in a vehicle,
are not considered to be containers.
Designated representative means any
individual or organization to whom an
employee gives written authorization
to exercise such employee’s rights
under this section. A recognized or certified collective bargaining agent shall
be treated automatically as a designated representative without regard
to written employee authorization.
Director means the Director, National
Institute for Occupational Safety and
Health, U.S. Department of Health and
Human Services, or designee.
Distributor means a business, other
than a chemical manufacturer or importer,
which
supplies
hazardous
chemicals to other distributors or to
employers.
Employee means a worker who may be
exposed to hazardous chemicals under
normal operating conditions or in foreseeable emergencies. Workers such as
office workers or bank tellers who encounter hazardous chemicals only in
non-routine, isolated instances are not
covered.
Employer means a person engaged in a
business where chemicals are either
used, distributed, or are produced for
use or distribution, including a contractor or subcontractor.
Exposure or exposed means that an
employee is subjected in the course of
employment to a chemical that is a
physical or health hazard, and includes
potential (e.g. accidental or possible)

exposure. ‘‘Subjected’’ in terms of
health hazards includes any route of
entry (e.g. inhalation, ingestion, skin
contact or absorption.)
Foreseeable emergency means any potential occurrence such as, but not limited to, equipment failure, rupture of
containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical
into the workplace.
Hazard category means the division of
criteria within each hazard class, e.g.,
oral acute toxicity and flammable liquids include four hazard categories.
These categories compare hazard severity within a hazard class and should
not be taken as a comparison of hazard
categories more generally.
Hazard class means the nature of the
physical or health hazards, e.g., flammable solid, carcinogen, oral acute toxicity.
Hazard not otherwise classified (HNOC)
means an adverse physical or health effect identified through evaluation of
scientific evidence during the classification process that does not meet the
specified criteria for the physical and
health hazard classes addressed in this
section. This does not extend coverage
to adverse physical and health effects
for which there is a hazard class addressed in this section, but the effect
either falls below the cut-off value/concentration limit of the hazard class or
is under a GHS hazard category that
has not been adopted by OSHA (e.g.,
acute toxicity Category 5).
Hazard statement means a statement
assigned to a hazard class and category
that describes the nature of the hazard(s) of a chemical, including, where
appropriate, the degree of hazard.
Hazardous chemical means any chemical which is classified as a physical
hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric
gas, or hazard not otherwise classified.
Health hazard means a chemical
which is classified as posing one of the
following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or
skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive
toxicity; specific target organ toxicity

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Occupational Safety and Health Admin., Labor
(single or repeated exposure); or aspiration hazard. The criteria for determining whether a chemical is classified
as a health hazard are detailed in Appendix A to § 1910.1200—Health Hazard
Criteria.
Immediate use means that the hazardous chemical will be under the control of and used only by the person who
transfers it from a labeled container
and only within the work shift in
which it is transferred.
Importer means the first business
with employees within the Customs
Territory of the United States which
receives hazardous chemicals produced
in other countries for the purpose of
supplying them to distributors or employers within the United States.
Label means an appropriate group of
written, printed or graphic information
elements concerning a hazardous chemical that is affixed to, printed on, or attached to the immediate container of a
hazardous chemical, or to the outside
packaging.
Label elements means the specified
pictogram, hazard statement, signal
word and precautionary statement for
each hazard class and category.
Mixture means a combination or a solution composed of two or more substances in which they do not react.
Physical hazard means a chemical
that is classified as posing one of the
following hazardous effects: explosive;
flammable (gases, aerosols, liquids, or
solids); oxidizer (liquid, solid or gas);
self-reactive; pyrophoric (liquid or
solid); self-heating; organic peroxide;
corrosive to metal; gas under pressure;
or in contact with water emits flammable gas. See Appendix B to
§ 1910.1200—Physical Hazard Criteria.
Pictogram means a composition that
may include a symbol plus other graphic elements, such as a border, background pattern, or color, that is intended to convey specific information
about the hazards of a chemical. Eight
pictograms are designated under this
standard for application to a hazard
category.
Precautionary statement means a
phrase that describes recommended
measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous

§ 1910.1200

chemical, or improper storage or handling.
Produce means to manufacture, process, formulate, blend, extract, generate, emit, or repackage.
Product identifier means the name or
number used for a hazardous chemical
on a label or in the SDS. It provides a
unique means by which the user can
identify the chemical. The product
identifier used shall permit cross-references to be made among the list of
hazardous chemicals required in the
written hazard communication program, the label and the SDS.
Pyrophoric gas means a chemical in a
gaseous state that will ignite spontaneously in air at a temperature of 130 degrees F (54.4 degrees C) or below.
Responsible party means someone who
can provide additional information on
the hazardous chemical and appropriate emergency procedures, if necessary.
Safety data sheet (SDS) means written
or printed material concerning a hazardous chemical that is prepared in accordance with paragraph (g) of this section.
Signal word means a word used to indicate the relative level of severity of
hazard and alert the reader to a potential hazard on the label. The signal
words used in this section are ‘‘danger’’
and ‘‘warning.’’ ‘‘Danger’’ is used for
the more severe hazards, while ‘‘warning’’ is used for the less severe.
Simple asphyxiant means a substance
or mixture that displaces oxygen in the
ambient atmosphere, and can thus
cause oxygen deprivation in those who
are exposed, leading to unconsciousness and death.
Specific chemical identity means the
chemical name, Chemical Abstracts
Service (CAS) Registry Number, or any
other information that reveals the precise chemical designation of the substance.
Substance means chemical elements
and their compounds in the natural
state or obtained by any production
process, including any additive necessary to preserve the stability of the
product and any impurities deriving
from the process used, but excluding
any solvent which may be separated
without affecting the stability of the
substance or changing its composition.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

Trade secret means any confidential
formula, pattern, process, device, information or compilation of information
that is used in an employer’s business,
and that gives the employer an opportunity to obtain an advantage over
competitors who do not know or use it.
Appendix E to § 1910.1200—Definition of
Trade Secret, sets out the criteria to
be used in evaluating trade secrets.
Use means to package, handle, react,
emit, extract, generate as a byproduct,
or transfer.
Work area means a room or defined
space in a workplace where hazardous
chemicals are produced or used, and
where employees are present.
Workplace means an establishment,
job site, or project, at one geographical
location containing one or more work
areas.
(d) Hazard classification. (1) Chemical
manufacturers and importers shall
evaluate chemicals produced in their
workplaces or imported by them to
classify the chemicals in accordance
with this section. For each chemical,
the chemical manufacturer or importer
shall determine the hazard classes,
and, where appropriate, the category of
each class that apply to the chemical
being classified. Employers are not required to classify chemicals unless
they choose not to rely on the classification performed by the chemical
manufacturer or importer for the
chemical to satisfy this requirement.
(2) Chemical manufacturers, importers or employers classifying chemicals
shall identify and consider the full
range of available scientific literature
and other evidence concerning the potential hazards. There is no requirement to test the chemical to determine
how to classify its hazards. Appendix A
to § 1910.1200 shall be consulted for classification of health hazards, and Appendix B to § 1910.1200 shall be consulted for the classification of physical
hazards.
(3) Mixtures. (i) Chemical manufacturers, importers, or employers evaluating chemicals shall follow the procedures described in Appendices A and B
to § 1910.1200 to classify the hazards of
the chemicals, including determinations regarding when mixtures of the
classified chemicals are covered by this
section.

(ii) When classifying mixtures they
produce or import, chemical manufacturers and importers of mixtures may
rely on the information provided on
the current safety data sheets of the
individual ingredients, except where
the chemical manufacturer or importer
knows, or in the exercise of reasonable
diligence should know, that the safety
data sheet misstates or omits information required by this section.
(e) Written hazard communication program. (1) Employers shall develop, implement, and maintain at each workplace, a written hazard communication
program which at least describes how
the criteria specified in paragraphs (f),
(g), and (h) of this section for labels
and other forms of warning, safety data
sheets, and employee information and
training will be met, and which also includes the following:
(i) A list of the hazardous chemicals
known to be present using a product
identifier that is referenced on the appropriate safety data sheet (the list
may be compiled for the workplace as a
whole or for individual work areas);
and,
(ii) The methods the employer will
use to inform employees of the hazards
of non-routine tasks (for example, the
cleaning of reactor vessels), and the
hazards associated with chemicals contained in unlabeled pipes in their work
areas.
(2) Multi-employer workplaces. Employers who produce, use, or store hazardous chemicals at a workplace in
such a way that the employees of other
employer(s) may be exposed (for example, employees of a construction contractor working on-site) shall additionally ensure that the hazard communication programs developed and implemented under this paragraph (e) include the following:
(i) The methods the employer will
use to provide the other employer(s)
on-site access to safety data sheets for
each hazardous chemical the other employer(s)’ employees may be exposed to
while working;
(ii) The methods the employer will
use to inform the other employer(s) of
any precautionary measures that need
to be taken to protect employees during the workplace’s normal operating

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Occupational Safety and Health Admin., Labor
conditions and in foreseeable emergencies; and,
(iii) The methods the employer will
use to inform the other employer(s) of
the labeling system used in the workplace.
(3) The employer may rely on an existing hazard communication program
to comply with these requirements,
provided that it meets the criteria established in this paragraph (e).
(4) The employer shall make the
written hazard communication program available, upon request, to employees, their designated representatives, the Assistant Secretary and the
Director, in accordance with the requirements of 29 CFR 1910.20 (e).
(5) Where employees must travel between workplaces during a workshift,
i.e., their work is carried out at more
than one geographical location, the
written hazard communication program may be kept at the primary
workplace facility.
(f) Labels and other forms of warning—
(1) Labels on shipped containers. The
chemical manufacturer, importer, or
distributor shall ensure that each container of hazardous chemicals leaving
the workplace is labeled, tagged, or
marked. Hazards not otherwise classified do not have to be addressed on the
container. Where the chemical manufacturer or importer is required to
label, tag or mark the following information shall be provided:
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s); and,
(vi) Name, address, and telephone
number of the chemical manufacturer,
importer, or other responsible party.
(2) The chemical manufacturer, importer, or distributor shall ensure that
the information provided under paragraphs (f)(1)(i) through (v) of this section is in accordance with Appendix C
to § 1910.1200, for each hazard class and
associated hazard category for the hazardous chemical, prominently displayed, and in English (other languages
may also be included if appropriate).
(3) The chemical manufacturer, importer, or distributor shall ensure that
the information provided under paragraphs (f)(1)(ii) through (iv) of this sec-

§ 1910.1200

tion is located together on the label,
tag, or mark.
(4) Solid materials. (i) For solid metal
(such as a steel beam or a metal casting), solid wood, or plastic items that
are not exempted as articles due to
their downstream use, or shipments of
whole grain, the required label may be
transmitted to the customer at the
time of the initial shipment, and need
not be included with subsequent shipments to the same employer unless the
information on the label changes;
(ii) The label may be transmitted
with the initial shipment itself, or with
the safety data sheet that is to be provided prior to or at the time of the first
shipment; and,
(iii) This exception to requiring labels on every container of hazardous
chemicals is only for the solid material
itself, and does not apply to hazardous
chemicals used in conjunction with, or
known to be present with, the material
and to which employees handling the
items in transit may be exposed (for
example, cutting fluids or pesticides in
grains).
(5) Chemical manufacturers, importers, or distributors shall ensure that
each container of hazardous chemicals
leaving the workplace is labeled,
tagged, or marked in accordance with
this section in a manner which does
not conflict with the requirements of
the Hazardous Materials Transportation Act (49 U.S.C. 1801 et seq.) and
regulations issued under that Act by
the Department of Transportation.
(6) Workplace labeling. Except as
provided in paragraphs (f)(7) and (f)(8)
of this section, the employer shall ensure that each container of hazardous
chemicals in the workplace is labeled,
tagged or marked with either:
(i) The information specified under
paragraphs (f)(1)(i) through (v) of this
section for labels on shipped containers; or,
(ii) Product identifier and words, pictures, symbols, or combination thereof,
which provide at least general information regarding the hazards of the
chemicals, and which, in conjunction
with the other information immediately available to employees under
the hazard communication program,

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.
(7) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels
to individual stationary process containers, as long as the alternative
method identifies the containers to
which it is applicable and conveys the
information required by paragraph
(f)(6) of this section to be on a label.
The employer shall ensure the written
materials are readily accessible to the
employees in their work area throughout each work shift.
(8) The employer is not required to
label portable containers into which
hazardous chemicals are transferred
from labeled containers, and which are
intended only for the immediate use of
the employee who performs the transfer. For purposes of this section, drugs
which are dispensed by a pharmacy to
a health care provider for direct administration to a patient are exempted
from labeling.
(9) The employer shall not remove or
deface existing labels on incoming containers of hazardous chemicals, unless
the container is immediately marked
with the required information.
(10) The employer shall ensure that
workplace labels or other forms of
warning are legible, in English, and
prominently displayed on the container, or readily available in the work
area throughout each work shift. Employers having employees who speak
other languages may add the information in their language to the material
presented, as long as the information is
presented in English as well.
(11) Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant
information regarding the hazards of a
chemical shall revise the labels for the
chemical within six months of becoming aware of the new information, and
shall ensure that labels on containers
of hazardous chemicals shipped after
that time contain the new information.
If the chemical is not currently produced or imported, the chemical manufacturer, importer, distributor, or employer shall add the information to the

label before the chemical is shipped or
introduced into the workplace again.
(g) Safety data sheets. (1) Chemical
manufacturers and importers shall obtain or develop a safety data sheet for
each hazardous chemical they produce
or import. Employers shall have a safety data sheet in the workplace for each
hazardous chemical which they use.
(2) The chemical manufacturer or importer preparing the safety data sheet
shall ensure that it is in English (although the employer may maintain
copies in other languages as well), and
includes at least the following section
numbers and headings, and associated
information under each heading, in the
order listed (See Appendix D to
§ 1910.1200—Safety Data Sheets, for the
specific content of each section of the
safety data sheet):
(i) Section 1, Identification;
(ii) Section 2, Hazard(s) identification;
(iii) Section 3, Composition/information on ingredients;
(iv) Section 4, First-aid measures;
(v) Section 5, Fire-fighting measures;
(vi) Section 6, Accidental release
measures;
(vii) Section 7, Handling and storage;
(viii) Section 8, Exposure controls/
personal protection;
(ix) Section 9, Physical and chemical
properties;
(x) Section 10, Stability and reactivity;
(xi) Section 11, Toxicological information;
(xii) Section 12, Ecological information;
(xiii) Section 13, Disposal considerations;
(xiv) Section 14, Transport information;
(xv) Section 15, Regulatory information; and
(xvi) Section 16, Other information,
including date of preparation or last
revision.
NOTE 1 TO PARAGRAPH (g)(2): To be consistent with the GHS, an SDS must also include the headings in paragraphs (g)(2)(xii)
through (g)(2)(xv) in order.
NOTE 2 TO PARAGRAPH (g)(2): OSHA will not
be enforcing information requirements in
sections 12 through 15, as these areas are not
under its jurisdiction.

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Occupational Safety and Health Admin., Labor
(3) If no relevant information is
found for any sub-heading within a section on the safety data sheet, the
chemical manufacturer, importer or
employer preparing the safety data
sheet shall mark it to indicate that no
applicable information was found.
(4) Where complex mixtures have
similar hazards and contents (i.e. the
chemical ingredients are essentially
the same, but the specific composition
varies from mixture to mixture), the
chemical manufacturer, importer or
employer may prepare one safety data
sheet to apply to all of these similar
mixtures.
(5) The chemical manufacturer, importer or employer preparing the safety data sheet shall ensure that the information provided accurately reflects
the scientific evidence used in making
the hazard classification. If the chemical manufacturer, importer or employer preparing the safety data sheet
becomes newly aware of any significant
information regarding the hazards of a
chemical, or ways to protect against
the hazards, this new information shall
be added to the safety data sheet within three months. If the chemical is not
currently being produced or imported,
the chemical manufacturer or importer
shall add the information to the safety
data sheet before the chemical is introduced into the workplace again.
(6)(i) Chemical manufacturers or importers shall ensure that distributors
and employers are provided an appropriate safety data sheet with their initial shipment, and with the first shipment after a safety data sheet is updated;
(ii) The chemical manufacturer or
importer shall either provide safety
data sheets with the shipped containers
or send them to the distributor or employer prior to or at the time of the
shipment;
(iii) If the safety data sheet is not
provided with a shipment that has been
labeled as a hazardous chemical, the
distributor or employer shall obtain
one from the chemical manufacturer or
importer as soon as possible; and,
(iv) The chemical manufacturer or
importer shall also provide distributors
or employers with a safety data sheet
upon request.

§ 1910.1200

(7)(i) Distributors shall ensure that
material data sheets, and updated information, are provided to other distributors and employers with their initial shipment and with the first shipment after a safety data sheet is updated;
(ii) The distributor shall either provide safety data sheets with the
shipped containers, or send them to the
other distributor or employer prior to
or at the time of the shipment;
(iii) Retail distributors selling hazardous chemicals to employers having
a commercial account shall provide a
safety data sheet to such employers
upon request, and shall post a sign or
otherwise inform them that a material
safety data sheet is available;
(iv) Wholesale distributors selling
hazardous chemicals to employers
over-the-counter may also provide
safety data sheets upon the request of
the employer at the time of the overthe-counter purchase, and shall post a
sign or otherwise inform such employers that a material safety data sheet is
available;
(v) If an employer without a commercial account purchases a hazardous
chemical from a retail distributor not
required to have safety data sheets on
file (i.e., the retail distributor does not
have commercial accounts and does not
use the materials), the retail distributor shall provide the employer,
upon request, with the name, address,
and telephone number of the chemical
manufacturer, importer, or distributor
from which a safety data sheet can be
obtained;
(vi) Wholesale distributors shall also
provide safety data sheets to employers
or other distributors upon request; and,
(vii) Chemical manufacturers, importers, and distributors need not provide safety data sheets to retail distributors that have informed them that
the retail distributor does not sell the
product to commercial accounts or
open the sealed container to use it in
their own workplaces.
(8) The employer shall maintain in
the workplace copies of the required
safety data sheets for each hazardous
chemical, and shall ensure that they
are readily accessible during each work
shift to employees when they are in
their work area(s). (Electronic access

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

and other alternatives to maintaining
paper copies of the safety data sheets
are permitted as long as no barriers to
immediate employee access in each
workplace are created by such options.)
(9) Where employees must travel between workplaces during a workshift,
i.e., their work is carried out at more
than one geographical location, the
safety data sheets may be kept at the
primary workplace facility. In this situation, the employer shall ensure that
employees can immediately obtain the
required information in an emergency.
(10) Safety data sheets may be kept
in any form, including operating procedures, and may be designed to cover
groups of hazardous chemicals in a
work area where it may be more appropriate to address the hazards of a process rather than individual hazardous
chemicals. However, the employer
shall ensure that in all cases the required information is provided for each
hazardous chemical, and is readily accessible during each work shift to employees when they are in their work
area(s).
(11) Safety data sheets shall also be
made readily available, upon request,
to designated representatives, the Assistant Secretary, and the Director, in
accordance with the requirements of
§ 1910.1020(e).
(h) Employee information and training.
(1) Employers shall provide employees
with effective information and training
on hazardous chemicals in their work
area at the time of their initial assignment, and whenever a new chemical
hazard the employees have not previously been trained about is introduced into their work area. Information and training may be designed to
cover categories of hazards (e.g., flammability, carcinogenicity) or specific
chemicals. Chemical-specific information must always be available through
labels and safety data sheets.
(2) Information. Employees shall be
informed of:
(i) The requirements of this section;
(ii) Any operations in their work area
where hazardous chemicals are present;
and,
(iii) The location and availability of
the written hazard communication program, including the required list(s) of

hazardous chemicals, and safety data
sheets required by this section.
(3) Training. Employee training shall
include at least:
(i) Methods and observations that
may be used to detect the presence or
release of a hazardous chemical in the
work area (such as monitoring conducted by the employer, continuous
monitoring devices, visual appearance
or odor of hazardous chemicals when
being released, etc.);
(ii) The physical, health, simple asphyxiation, combustible dust, and
pyrophoric gas hazards, as well as hazards not otherwise classified, of the
chemicals in the work area;
(iii) The measures employees can
take to protect themselves from these
hazards, including specific procedures
the employer has implemented to protect employees from exposure to hazardous chemicals, such as appropriate
work practices, emergency procedures,
and personal protective equipment to
be used; and,
(iv) The details of the hazard communication program developed by the employer, including an explanation of the
labels received on shipped containers
and the workplace labeling system
used by their employer; the safety data
sheet, including the order of information and how employees can obtain and
use the appropriate hazard information.
(i) Trade secrets. (1) The chemical
manufacturer, importer, or employer
may withhold the specific chemical
identity, including the chemical name,
other specific identification of a hazardous chemical, or the exact percentage (concentration) of the substance in
a mixture, from the safety data sheet,
provided that:
(i) The claim that the information
withheld is a trade secret can be supported;
(ii) Information contained in the
safety data sheet concerning the properties and effects of the hazardous
chemical is disclosed;
(iii) The safety data sheet indicates
that the specific chemical identity and/
or percentage of composition is being
withheld as a trade secret; and,
(iv) The specific chemical identity
and percentage is made available to
health professionals, employees, and

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Occupational Safety and Health Admin., Labor
designated representatives in accordance with the applicable provisions of
this paragraph (i).
(2) Where a treating physician or
nurse determines that a medical emergency exists and the specific chemical
identity and/or specific percentage of
composition of a hazardous chemical is
necessary for emergency or first-aid
treatment, the chemical manufacturer,
importer, or employer shall immediately disclose the specific chemical
identity or percentage composition of a
trade secret chemical to that treating
physician or nurse, regardless of the
existence of a written statement of
need or a confidentiality agreement.
The chemical manufacturer, importer,
or employer may require a written
statement of need and confidentiality
agreement, in accordance with the provisions of paragraphs (i)(3) and (4) of
this section, as soon as circumstances
permit.
(3) In non-emergency situations, a
chemical manufacturer, importer, or
employer shall, upon request, disclose
a specific chemical identity or percentage composition, otherwise permitted
to be withheld under paragraph (i)(1) of
this section, to a health professional
(i.e. physician, industrial hygienist,
toxicologist, epidemiologist, or occupational health nurse) providing medical
or other occupational health services
to exposed employee(s), and to employees or designated representatives, if:
(i) The request is in writing;
(ii) The request describes with reasonable detail one or more of the following occupational health needs for
the information:
(A) To assess the hazards of the
chemicals to which employees will be
exposed;
(B) To conduct or assess sampling of
the workplace atmosphere to determine employee exposure levels;
(C) To conduct pre-assignment or
periodic medical surveillance of exposed employees;
(D) To provide medical treatment to
exposed employees;
(E) To select or assess appropriate
personal protective equipment for exposed employees;
(F) To design or assess engineering
controls or other protective measures
for exposed employees; and,

§ 1910.1200

(G) To conduct studies to determine
the health effects of exposure.
(iii) The request explains in detail
why the disclosure of the specific
chemical identity or percentage composition is essential and that, in lieu
thereof, the disclosure of the following
information to the health professional,
employee, or designated representative, would not satisfy the purposes described in paragraph (i)(3)(ii) of this
section:
(A) The properties and effects of the
chemical;
(B) Measures for controlling workers’
exposure to the chemical;
(C) Methods of monitoring and analyzing worker exposure to the chemical; and,
(D) Methods of diagnosing and treating harmful exposures to the chemical;
(iv) The request includes a description of the procedures to be used to
maintain the confidentiality of the disclosed information; and,
(v) The health professional, and the
employer or contractor of the services
of the health professional (i.e. downstream employer, labor organization,
or individual employee), employee, or
designated representative, agree in a
written confidentiality agreement that
the health professional, employee, or
designated representative, will not use
the trade secret information for any
purpose other than the health need(s)
asserted and agree not to release the
information under any circumstances
other than to OSHA, as provided in
paragraph (i)(6) of this section, except
as authorized by the terms of the
agreement or by the chemical manufacturer, importer, or employer.
(4) The confidentiality agreement authorized by paragraph (i)(3)(iv) of this
section:
(i) May restrict the use of the information to the health purposes indicated in the written statement of need;
(ii) May provide for appropriate legal
remedies in the event of a breach of the
agreement, including stipulation of a
reasonable pre-estimate of likely damages; and,
(iii) May not include requirements
for the posting of a penalty bond.
(5) Nothing in this standard is meant
to preclude the parties from pursuing

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

non-contractual remedies to the extent
permitted by law.
(6) If the health professional, employee, or designated representative receiving the trade secret information
decides that there is a need to disclose
it to OSHA, the chemical manufacturer, importer, or employer who provided the information shall be informed by the health professional, employee, or designated representative
prior to, or at the same time as, such
disclosure.
(7) If the chemical manufacturer, importer, or employer denies a written request for disclosure of a specific chemical identity or percentage composition, the denial must:
(i) Be provided to the health professional, employee, or designated representative, within thirty days of the
request;
(ii) Be in writing;
(iii) Include evidence to support the
claim that the specific chemical identity or percent of composition is a
trade secret;
(iv) State the specific reasons why
the request is being denied; and,
(v) Explain in detail how alternative
information may satisfy the specific
medical or occupational health need
without revealing the trade secret.
(8) The health professional, employee, or designated representative
whose request for information is denied
under paragraph (i)(3) of this section
may refer the request and the written
denial of the request to OSHA for consideration.
(9) When a health professional, employee, or designated representative refers the denial to OSHA under paragraph (i)(8) of this section, OSHA shall
consider the evidence to determine if:
(i) The chemical manufacturer, importer, or employer has supported the
claim that the specific chemical identity or percentage composition is a
trade secret;
(ii) The health professional, employee, or designated representative
has supported the claim that there is a
medical or occupational health need
for the information; and,
(iii) The health professional, employee or designated representative has
demonstrated adequate means to protect the confidentiality.

(10)(i) If OSHA determines that the
specific chemical identity or percentage composition requested under paragraph (i)(3) of this section is not a
‘‘bona fide’’ trade secret, or that it is a
trade secret, but the requesting health
professional, employee, or designated
representative has a legitimate medical or occupational health need for the
information, has executed a written
confidentiality agreement, and has
shown adequate means to protect the
confidentiality of the information, the
chemical manufacturer, importer, or
employer will be subject to citation by
OSHA.
(ii) If a chemical manufacturer, importer, or employer demonstrates to
OSHA that the execution of a confidentiality agreement would not provide
sufficient protection against the potential harm from the unauthorized disclosure of a trade secret, the Assistant
Secretary may issue such orders or impose such additional limitations or
conditions upon the disclosure of the
requested chemical information as may
be appropriate to assure that the occupational health services are provided
without an undue risk of harm to the
chemical manufacturer, importer, or
employer.
(11) If a citation for a failure to release trade secret information is contested by the chemical manufacturer,
importer, or employer, the matter will
be adjudicated before the Occupational
Safety and Health Review Commission
in accordance with the Act’s enforcement scheme and the applicable Commission rules of procedure. In accordance with the Commission rules, when
a chemical manufacturer, importer, or
employer continues to withhold the information during the contest, the Administrative Law Judge may review
the citation and supporting documentation ‘‘in camera’’ or issue appropriate orders to protect the confidentiality of such matters.
(12) Notwithstanding the existence of
a trade secret claim, a chemical manufacturer, importer, or employer shall,
upon request, disclose to the Assistant
Secretary any information which this
section requires the chemical manufacturer, importer, or employer to make
available. Where there is a trade secret
claim, such claim shall be made no

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Occupational Safety and Health Admin., Labor
later than at the time the information
is provided to the Assistant Secretary
so that suitable determinations of
trade secret status can be made and
the necessary protections can be implemented.
(13) Nothing in this paragraph shall
be construed as requiring the disclosure under any circumstances of process information which is a trade secret.
(j) Effective dates. (1) Employers shall
train employees regarding the new
label elements and safety data sheets
format by December 1, 2013.
(2) Chemical manufacturers, importers, distributors, and employers shall
be in compliance with all modified provisions of this section no later than
June 1, 2015, except:
(i) After December 1, 2015, the distributor shall not ship containers labeled by the chemical manufacturer or
importer unless the label has been
modified to comply with paragraph
(f)(1) of this section.
(ii) All employers shall, as necessary,
update any alternative workplace labeling used under paragraph (f)(6) of
this section, update the hazard communication program required by paragraph (h)(1), and provide any additional
employee training in accordance with
paragraph (h)(3) for newly identified
physical or health hazards no later
than June 1, 2016.
(3) Chemical manufacturers, importers, distributors, and employers may
comply with either § 1910.1200 revised as
of October 1, 2011, or the current
version of this standard, or both during
the transition period.
APPENDIX A TO § 1910.1200—HEALTH HAZARD
CRITERIA (MANDATORY)
A.0

A.0.1.2 For many hazard classes, the criteria are semi-quantitative or qualitative
and expert judgment is required to interpret
the data for classification purposes.
A.0.2

A.0.3

CLASSIFICATION

A.0.1.1 The term ‘‘hazard classification’’
is used to indicate that only the intrinsic
hazardous properties of chemicals are considered. Hazard classification incorporates
three steps:
(a) Identification of relevant data regarding the hazards of a chemical;
(b) Subsequent review of those data to ascertain the hazards associated with the
chemical;
(c) Determination of whether the chemical
will be classified as hazardous and the degree
of hazard.

AVAILABLE DATA, TEST METHODS AND
TEST DATA QUALITY

A.0.2.1 There is no requirement for testing chemicals.
A.0.2.2 The
criteria
for
determining
health hazards are test method neutral, i.e.,
they do not specify particular test methods,
as long as the methods are scientifically
validated.
A.0.2.3 The term ‘‘scientifically validated’’ refers to the process by which the reliability and the relevance of a procedure are
established for a particular purpose. Any
test that determines hazardous properties,
which is conducted according to recognized
scientific principles, can be used for purposes
of a hazard determination for health hazards.
Test conditions need to be standardized so
that the results are reproducible with a
given substance, and the standardized test
yields ‘‘valid’’ data for defining the hazard
class of concern.
A.0.2.4 Existing test data are acceptable
for classifying chemicals, although expert
judgment also may be needed for classification purposes.
A.0.2.5 The effect of a chemical on biological systems is influenced, by the physicochemical properties of the substance and/or
ingredients of the mixture and the way in
which ingredient substances are biologically
available. A chemical need not be classified
when it can be shown by conclusive experimental data from scientifically validated
test methods that the chemical is not biologically available.
A.0.2.6 For classification purposes, epidemiological data and experience on the effects
of chemicals on humans (e.g., occupational
data, data from accident databases) shall be
taken into account in the evaluation of
human health hazards of a chemical.

GENERAL CLASSIFICATION
CONSIDERATIONS
A.0.1

§ 1910.1200

CLASSIFICATION BASED ON WEIGHT OF
EVIDENCE

A.0.3.1 For some hazard classes, classification results directly when the data satisfy the criteria. For others, classification of
a chemical shall be determined on the basis
of the total weight of evidence using expert
judgment. This means that all available information bearing on the classification of
hazard shall be considered together, including the results of valid in vitro tests, relevant
animal data, and human experience such as
epidemiological and clinical studies and
well-documented case reports and observations.
A.0.3.2 The quality and consistency of the
data shall be considered. Information on

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

chemicals related to the material being classified shall be considered as appropriate, as
well as site of action and mechanism or
mode of action study results. Both positive
and negative results shall be considered together in a single weight-of-evidence determination.
A.0.3.3 Positive effects which are consistent with the criteria for classification,
whether seen in humans or animals, shall
normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated
in order to resolve the question of classification. Reliable, good quality human data
shall generally have precedence over other
data. However, even well-designed and conducted epidemiological studies may lack a
sufficient number of subjects to detect relatively rare but still significant effects, or to
assess potentially confounding factors.
Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the
robustness, quality and statistical power of
both the human and animal data.
A.0.3.4 Route of exposure, mechanistic information, and metabolism studies are pertinent to determining the relevance of an effect in humans. When such information
raises doubt about relevance in humans, a
lower classification may be warranted. When
there is scientific evidence demonstrating
that the mechanism or mode of action is not
relevant to humans, the chemical should not
be classified.
A.0.3.5 Both positive and negative results
are considered together in the weight of evidence determination. However, a single positive study performed according to good scientific principles and with statistically and
biologically significant positive results may
justify classification.
A.0.4 CONSIDERATIONS FOR THE
CLASSIFICATION OF MIXTURES
A.0.4.1 For most hazard classes, the recommended process of classification of mixtures is based on the following sequence:
(a) Where test data are available for the
complete mixture, the classification of the
mixture will always be based on those data;
(b) Where test data are not available for
the mixture itself, the bridging principles
designated in each health hazard chapter of
this appendix shall be considered for classification of the mixture;
(c) If test data are not available for the
mixture itself, and the available information
is not sufficient to allow application of the
above-mentioned bridging principles, then
the method(s) described in each chapter for
estimating the hazards based on the information known will be applied to classify the

mixture (e.g., application of cut-off values/
concentration limits).
A.0.4.2 An exception to the above order or
precedence is made for Carcinogenicity,
Germ Cell Mutagenicity, and Reproductive
Toxicity. For these three hazard classes,
mixtures shall be classified based upon information on the ingredient substances, unless
on a case-by-case basis, justification can be
provided for classifying based upon the mixture as a whole. See chapters A.5, A.6, and
A.7 for further information on case-by-case
bases.
A.0.4.3 Use of cut-off values/concentration
limits.
A.0.4.3.1 When classifying an untested
mixture based on the hazards of its ingredients, cut-off values/concentration limits for
the classified ingredients of the mixture are
used for several hazard classes. While the
adopted cut-off values/concentration limits
adequately identify the hazard for most mixtures, there may be some that contain hazardous ingredients at lower concentrations
than the specified cut-off values/concentration limits that still pose an identifiable
hazard. There may also be cases where the
cut-off value/concentration limit is considerably lower than the established non-hazardous level for an ingredient.
A.0.4.3.2 If the classifier has information
that the hazard of an ingredient will be evident (i.e., it presents a health risk) below the
specified cut-off value/concentration limit,
the mixture containing that ingredient shall
be classified accordingly.
A.0.4.3.3 In exceptional cases, conclusive
data may demonstrate that the hazard of an
ingredient will not be evident (i.e., it does
not present a health risk) when present at a
level above the specified cut-off value/concentration limit(s). In these cases the mixture may be classified according to those
data. The data must exclude the possibility
that the ingredient will behave in the mixture in a manner that would increase the
hazard over that of the pure substance. Furthermore, the mixture must not contain ingredients that would affect that determination.
A.0.4.4 Synergistic or antagonistic effects.
When performing an assessment in accordance with these requirements, the evaluator
must take into account all available information about the potential occurrence of
synergistic effects among the ingredients of
the mixture. Lowering classification of a
mixture to a less hazardous category on the
basis of antagonistic effects may be done
only if the determination is supported by
sufficient data.

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Occupational Safety and Health Admin., Labor
A.0.5

BRIDGING PRINCIPLES FOR THE CLASSIFICATION OF MIXTURES WHERE TEST DATA
ARE NOT AVAILABLE FOR THE COMPLETE
MIXTURE

A.0.5.1 Where the mixture itself has not
been tested to determine its toxicity, but
there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards
of the mixture, these data shall be used in
accordance with the following bridging principles, subject to any specific provisions for
mixtures for each hazard class. These principles ensure that the classification process
uses the available data to the greatest extent possible in characterizing the hazards of
the mixture.
A.0.5.1.1 Dilution.
For mixtures classified in accordance with
A.1 through A.10 of this Appendix, if a tested
mixture is diluted with a diluent that has an
equivalent or lower toxicity classification
than the least toxic original ingredient, and
which is not expected to affect the toxicity
of other ingredients, then:
(a) The new diluted mixture shall be classified as equivalent to the original tested mixture; or
(b) For classification of acute toxicity in
accordance with A.1 of this Appendix, paragraph A.1.3.6 (the additivity formula) shall
be applied.
A.0.5.1.2 Batching.
For mixtures classified in accordance with
A.1 through A.10 of this Appendix, the toxicity of a tested production batch of a mixture can be assumed to be substantially
equivalent to that of another untested production batch of the same mixture, when
produced by or under the control of the same
chemical manufacturer, unless there is reason
to believe there is significant variation such
that the toxicity of the untested batch has
changed. If the latter occurs, a new classification is necessary.
A.0.5.1.3 Concentration of mixtures.
For mixtures classified in accordance with
A.1, A.2, A.3, A.8, A.9, or A.10 of this Appendix, if a tested mixture is classified in Category 1, and the concentration of the ingredients of the tested mixture that are in Category 1 is increased, the resulting untested
mixture shall be classified in Category 1.
A.0.5.1.4 Interpolation within one toxicity
category.
For mixtures classified in accordance with
A.1, A.2, A.3, A.8, A.9, or A.10 of this Appendix, for three mixtures (A, B and C) with
identical ingredients, where mixtures A and

§ 1910.1200

B have been tested and are in the same toxicity category, and where untested mixture
C has the same toxicologically active ingredients as mixtures A and B but has concentrations of toxicologically active ingredients intermediate to the concentrations in
mixtures A and B, then mixture C is assumed
to be in the same toxicity category as A and
B.
A.0.5.1.5 Substantially similar mixtures.
For mixtures classified in accordance with
A.1 through A.10 of this Appendix, given the
following set of conditions:
(a) Where there are two mixtures:
(i) A + B;
(ii) C + B;
(b) The concentration of ingredient B is essentially the same in both mixtures;
(c) The concentration of ingredient A in
mixture (i) equals that of ingredient C in
mixture (ii);
(d) And data on toxicity for A and C are
available and substantially equivalent; i.e.,
they are in the same hazard category and are
not expected to affect the toxicity of B; then
If mixture (i) or (ii) is already classified
based on test data, the other mixture can be
assigned the same hazard category.
A.0.5.1.6 Aerosols.
For mixtures classified in accordance with
A.1, A.2, A.3, A.4, A.8, or A.9 of this Appendix, an aerosol form of a mixture shall be
classified in the same hazard category as the
tested, non-aerosolized form of the mixture,
provided the added propellant does not affect
the toxicity of the mixture when spraying.
A.1

ACUTE TOXICITY
A.1.1

DEFINITION

Acute toxicity refers to those adverse effects
occurring following oral or dermal administration of a single dose of a substance, or
multiple doses given within 24 hours, or an
inhalation exposure of 4 hours.
A.1.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

A.1.2.1 Substances can be allocated to one
of four toxicity categories based on acute
toxicity by the oral, dermal or inhalation
route according to the numeric cut-off criteria as shown in Table A.1.1. Acute toxicity
values are expressed as (approximate) LD50
(oral, dermal) or LC50 (inhalation) values or
as acute toxicity estimates (ATE). See the
footnotes following Table A.1.1 for further
explanation on the application of these values.

TABLE A.1.1—ACUTE TOXICITY HAZARD CATEGORIES AND ACUTE TOXICITY ESTIMATE (ATE) VALUES
DEFINING THE RESPECTIVE CATEGORIES
Exposure route

Category 1

Category 2

Category 3

Category 4

Oral (mg/kg bodyweight)

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

TABLE A.1.1—ACUTE TOXICITY HAZARD CATEGORIES AND ACUTE TOXICITY ESTIMATE (ATE) VALUES
DEFINING THE RESPECTIVE CATEGORIES—Continued
Exposure route
see: Note (a) ...................
Note (b)
Dermal (mg/kg bodyweight)
see: Note (a) ...................
Note (b)
Inhalation—Gases (ppmV)
see: Note (a) ...................
Note (b)
Note (c)
Inhalation—Vapors (mg/l)
see: Note (a) ...................
Note (b)
Note (c)
Note (d)
Inhalation—Dusts and Mists (mg/l)
see: Note (a) ...................
Note (b)
Note (c)

Category 1

Category 2

Category 3

Category 4

≤5

>5 and ≤ 50 ................

>50 and ≤ 300 ............

>300 and ≤ 2000.

≤ 50

>50 and ≤ 200 ............

>200 and ≤ 1000 ........

>1000 and ≤ 2000.

≤ 100

>100 and ≤ 500 ..........

>500 and ≤ 2500 ........

>2500 and ≤ 20000.

≤ 0.5

>0.5 and ≤ 2.0 ............

>2.0 and ≤ 10.0 ..........

>10.0 and ≤ 20.0.

≤ 0.05

>0.05 and ≤ 0.5 ..........

>0.5 and ≤ 1.0 ............

>1.0 and ≤ 5.0.

Note: Gas concentrations are expressed in parts per million per volume (ppmV).
Notes to Table A.1.1:
(a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available;
(b) The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is derived using:
(i) the LD50/LC50 where available. Otherwise,
(ii) the appropriate conversion value from Table 1.2 that relates to the results of a range test, or
(iii) the appropriate conversion value from Table 1.2 that relates to a classification category;
(c) Inhalation cut-off values in the table are based on 4 hour testing exposures. Conversion of existing inhalation toxicity data
which has been generated according to 1 hour exposure is achieved by dividing by a factor of 2 for gases and vapors and 4 for
dusts and mists;
(d) For some substances the test atmosphere will be a vapor which consists of a combination of liquid and gaseous phases.
For other substances the test atmosphere may consist of a vapor which is nearly all the gaseous phase. In these latter cases,
classification is based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), Category
4 (20000 ppmV).
The terms ‘‘dust’’, ‘‘mist’’ and ‘‘vapor’’ are defined as follows:
(i) Dust: solid particles of a substance or mixture suspended in a gas (usually air);
(ii) Mist: liquid droplets of a substance or mixture suspended in a gas (usually air);
(iii) Vapor: the gaseous form of a substance or mixture released from its liquid or solid state.

A.1.2.3 The preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat, while the rat or
rabbit are preferred for evaluation of acute
dermal toxicity. Test data already generated
for the classification of chemicals under existing systems should be accepted when reclassifying these chemicals under the harmonized system. When experimental data for
acute toxicity are available in several animal species, scientific judgment should be
used in selecting the most appropriate LD50

value from among scientifically validated
tests.
A.1.3

CLASSIFICATION CRITERIA FOR
MIXTURES

A.1.3.1 The approach to classification of
mixtures for acute toxicity is tiered, and is
dependent upon the amount of information
available for the mixture itself and for its ingredients. The flow chart of Figure A.1.1 indicates the process that must be followed:

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Occupational Safety and Health Admin., Labor

A.1.3.2 Classification of mixtures for
acute toxicity may be carried out for each
route of exposure, but is only required for
one route of exposure as long as this route is
followed (estimated or tested) for all ingredients and there is no relevant evidence to suggest acute toxicity by multiple routes. When
there is relevant evidence of acute toxicity
by multiple routes of exposure, classification
is to be conducted for all appropriate routes
of exposure. All available information shall
be considered. The pictogram and signal
word used shall reflect the most severe hazard category; and all relevant hazard statements shall be used.
A.1.3.3 For purposes of classifying the
hazards of mixtures in the tiered approach:
(a) The ‘‘relevant ingredients’’ of a mixture
are those which are present in concentrations ≥1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume
for gases). If there is reason to suspect that
an ingredient present at a concentration <1%
will affect classification of the mixture for
acute toxicity, that ingredient shall also be
considered relevant. Consideration of ingredients present at a concentration <1% is particularly important when classifying untested mixtures which contain ingredients that
are classified in Category 1 and Category 2;
(b) Where a classified mixture is used as an
ingredient of another mixture, the actual or
derived acute toxicity estimate (ATE) for
that mixture is used when calculating the
classification of the new mixture using the
formulas in A.1.3.6.1 and A.1.3.6.2.4.
(c) If the converted acute toxicity point estimates for all ingredients of a mixture are

§ 1910.1200

within the same category, then the mixture
should be classified in that category.
(d) When only range data (or acute toxicity
hazard category information) are available
for ingredients in a mixture, they may be
converted to point estimates in accordance
with Table A.1.2 when calculating the classification of the new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
A.1.3.4 CLASSIFICATION OF MIXTURES WHERE
ACUTE TOXICITY TEST DATA ARE AVAILABLE
FOR THE COMPLETE MIXTURE
Where the mixture itself has been tested to
determine its acute toxicity, it is classified
according to the same criteria as those used
for substances, presented in Table A.1.1. If
test data for the mixture are not available,
the procedures presented below must be followed.
A.1.3.5 CLASSIFICATION OF MIXTURES WHERE
ACUTE TOXICITY TEST DATA ARE NOT
AVAILABLE FOR THE COMPLETE MIXTURE:
BRIDGING PRINCIPLES
A.1.3.5.1 Where the mixture itself has not
been tested to determine its acute toxicity,
but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards
of the mixture, these data will be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of
mixtures, Interpolation within one toxicity
category, Substantially similar mixtures,
and Aerosols.

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479

§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

A.1.3.6

CLASSIFICATION OF
ON
INGREDIENTS
OF
(ADDITIVITY FORMULA)

MIXTURES BASED
THE
MIXTURE

A.1.3.6.1 Data available for all ingredients.
The acute toxicity estimate (ATE) of ingredients is considered as follows:
(a) Include ingredients with a known acute
toxicity, which fall into any of the acute
toxicity categories, or have an oral or dermal LD50 greater than 2000 but less than or
equal to 5000 mg/kg body weight (or the
equivalent dose for inhalation);
(b) Ignore ingredients that are presumed
not acutely toxic (e.g., water, sugar);

Where:
Ci = concentration of ingredient i
n ingredients and i is running from 1 to n
ATEi = acute toxicity estimate of ingredient
i.
A.1.3.6.2 Data are not available for one or
more ingredients of the mixture.
A.1.3.6.2.1 Where an ATE is not available
for an individual ingredient of the mixture,
but available information provides a derived
conversion value, the formula in A.1.3.6.1
may be applied. This information may include evaluation of:
(a) Extrapolation between oral, dermal and
inhalation acute toxicity estimates. Such an
evaluation
requires
appropriate
pharmacodynamic
and
pharmacokinetic
data;
(b) Evidence from human exposure that indicates toxic effects but does not provide lethal dose data;
(c) Evidence from any other toxicity tests/
assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or
(d) Data from closely analogous substances
using structure/activity relationships.
A.1.3.6.2.2 This approach requires substantial supplemental technical information, and
a highly trained and experienced expert, to
reliably estimate acute toxicity. If sufficient
information is not available to reliably estimate acute toxicity, proceed to the provisions of A.1.3.6.2.3.

(c) Ignore ingredients if the data available
are from a limit dose test (at the upper
threshold for Category 4 for the appropriate
route of exposure as provided in Table A.1.1)
and do not show acute toxicity.
Ingredients that fall within the scope of
this paragraph are considered to be ingredients with a known acute toxicity estimate
(ATE). See note (b) to Table A.1.1 and paragraph A.1.3.3 for appropriate application of
available data to the equation below, and
paragraph A.1.3.6.2.4.
The ATE of the mixture is determined by
calculation from the ATE values for all relevant ingredients according to the following
formula below for oral, dermal or inhalation
toxicity:

A.1.3.6.2.3 In the event that an ingredient
with unknown acute toxicity is used in a
mixture at a concentration ≥1%, and the
mixture has not been classified based on
testing of the mixture as a whole, the mixture cannot be attributed a definitive acute
toxicity estimate. In this situation the mixture is classified based on the known ingredients only. (Note: A statement that × percent
of the mixture consists of ingredient(s) of
unknown toxicity is required on the label
and safety data sheet in such cases; see Appendix C to this section, Allocation of Label
Elements and Appendix D to this section,
Safety Data Sheets.)
Where an ingredient with unknown acute
toxicity is used in a mixture at a concentration ≥1%, and the mixture is not classified
based on testing of the mixture as a whole,
a statement that X% of the mixture consists
of ingredient(s) of unknown acute toxicity is
required on the label and safety data sheet in
such cases; see Appendix C to this section,
Allocation of Label Elements and Appendix
D to this section, Safety Data Sheets.)
A.1.3.6.2.4 If the total concentration of the
relevant ingredient(s) with unknown acute
toxicity is ≤10% then the formula presented
in A.1.3.6.1 must be used. If the total concentration of the relevant ingredient(s) with
unknown acute toxicity is >10%, the formula
presented in A.1.3.6.1 is corrected to adjust
for the percentage of the unknown ingredient(s) as follows:

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Occupational Safety and Health Admin., Labor

§ 1910.1200

TABLE A.1.2—CONVERSION FROM EXPERIMENTALLY OBTAINED ACUTE TOXICITY RANGE VALUES (OR
ACUTE TOXICITY HAZARD CATEGORIES) TO ACUTE TOXICITY POINT ESTIMATES FOR USE IN THE
FORMULAS FOR THE CLASSIFICATION OF MIXTURES
Classification category or experimentally obtained
acute
toxicity range estimate

Exposure routes
Oral (mg/kg bodyweight ) .............................................

Dermal (mg/kg bodyweight) ..........................................

Gases (ppmV) ...............................................................

Vapors (mg/l) ................................................................

Dust/mist (mg/l) .............................................................

Converted
acute toxicity
point estimate

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481

§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)
TABLE A.2.1—SKIN CORROSION CATEGORY AND SUB-CATEGORIES

Category 1: corrosive

Corrosive in ≥1 of 3 animals

Corrosive sub-categories

Exposure
1A ...........................................
1B ...........................................
1C ...........................................

A.2.2.2

IRRITATION

A.2.2.2.1 A single irritant category (Category 2) is presented in the Table A.2.2. The

≤3 min ....................................
>3 min ≤1 h ............................
>1 h ≤4 h ...............................

Observation
≤1 h.
≤14 days.
≤14 days.

major criterion for the irritant category is
that at least 2 tested animals have a mean
score of ≥2.3 ≤4.0.

TABLE A.2.2—SKIN IRRITATION CATEGORY
Criteria
Irritant (Category 2) ........

(1) Mean value of ≥2.3 ≤4.0 for erythema/eschar or for edema in at least 2 of 3 tested animals from
gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3
consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria
above.

A.2.2.2.2 Animal irritant responses within
a test can be quite variable, as they are with
corrosion. A separate irritant criterion accommodates cases when there is a significant irritant response but less than the
mean score criterion for a positive test. For
example, a substance might be designated as
an irritant if at least 1 of 3 tested animals
shows a very elevated mean score throughout the study, including lesions persisting at
the end of an observation period of normally
14 days. Other responses could also fulfil this
criterion. However, it should be ascertained
that the responses are the result of chemical
exposure. Addition of this criterion increases
the sensitivity of the classification system.
A.2.2.2.3 Reversibility of skin lesions is
another consideration in evaluating irritant
responses. When inflammation persists to
the end of the observation period in 2 or
more test animals, taking into consideration
alopecia (limited area), hyperkeratosis,
hyperplasia and scaling, then a chemical
should be considered to be an irritant.
A.2.3 CLASSIFICATION CRITERIA FOR
SUBSTANCES USING OTHER DATA ELEMENTS
A.2.3.1 Existing human and animal data
including information from single or repeated exposure should be the first line of
analysis, as they give information directly
relevant to effects on the skin. If a substance
is highly toxic by the dermal route, a skin
corrosion/irritation study may not be practicable since the amount of test substance to
be applied would considerably exceed the
toxic dose and, consequently, would result in

the death of the animals. When observations
are made of skin corrosion/irritation in
acute toxicity studies and are observed up
through the limit dose, these data may be
used for classification provided that the dilutions used and species tested are equivalent.
In vitro alternatives that have been scientifically validated shall be used to make classification decisions. Solid substances (powders) may become corrosive or irritant when
moistened or in contact with moist skin or
mucous membranes. Likewise, pH extremes
like ≤2 and ≥11.5 may indicate skin effects,
especially when associated with significant
buffering capacity. Generally, such substances are expected to produce significant
effects on the skin. In the absence of any
other information, a substance is considered
corrosive (Skin Category 1) if it has a pH ≤2
or a pH ≥11.5. However, if consideration of alkali/acid reserve suggests the substance or
mixture may not be corrosive despite the low
or high pH value, then further evaluation
may be necessary. In some cases enough information may be available from structurally related compounds to make classification decisions.
A.2.3.2 A tiered approach to the evaluation
of initial information shall be used (Figure
A.2.1) recognizing that all elements may not
be relevant in certain cases.
A.2.3.3 The tiered approach explains how
to organize information on a substance and
to make a weight-of-evidence decision about
hazard assessment and hazard classification.
A.2.3.4 All the above information that is
available on a substance shall be evaluated.
Although information might be gained from

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Occupational Safety and Health Admin., Labor
the evaluation of single parameters within a
tier, there is merit in considering the totality of existing information and making an
overall weight of evidence determination.
This is especially true when there is information available on some but not all param-

§ 1910.1200

eters. Emphasis shall be placed upon existing
human experience and data, followed by animal experience and testing data, followed by
other sources of information, but case-bycase determinations are necessary.

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§ 1910.1200

A.2.4

29 CFR Ch. XVII (7–1–13 Edition)

CLASSIFICATION CRITERIA FOR
MIXTURES

A.2.4.1 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
A.2.4.1.1 The mixture shall be classified
using the criteria for substances (See A.2.3).
A.2.4.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.2.4.2.1 Where the mixture itself has not
been tested to determine its skin corrosion/
irritation, but there are sufficient data on
both the individual ingredients and similar
tested mixtures to adequately characterize
the hazards of the mixture, these data will
be used in accordance with the following
bridging principles, as found in paragraph
A.0.5 of this Appendix: Dilution, Batching,
Concentration of mixtures, Interpolation
within one toxicity category, Substantially
similar mixtures, and Aerosols.
A.2.4.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.2.4.3.1 For purposes of classifying the
skin corrosion/irritation hazards of mixtures
in the tiered approach:
The ‘‘relevant ingredients’’ of a mixture
are those which are present in concentrations ≥1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume
for gases.) If the classifier has reason to suspect that an ingredient present at a con-

centration <1% will affect classification of
the mixture for skin corrosion/irritation,
that ingredient shall also be considered relevant.
A.2.4.3.2 In general, the approach to classification of mixtures as irritant or corrosive
to skin when data are available on the ingredients, but not on the mixture as a whole, is
based on the theory of additivity, such that
each corrosive or irritant ingredient contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor
of 10 is used for corrosive ingredients when
they are present at a concentration below
the concentration limit for classification
with Category 1, but are at a concentration
that will contribute to the classification of
the mixture as an irritant. The mixture is
classified as corrosive or irritant when the
sum of the concentrations of such ingredients exceeds a cut-off value/concentration
limit.
A.2.4.3.3 Table A.2.3 below provides the
cut-off value/concentration limits to be used
to determine if the mixture is considered to
be an irritant or a corrosive to the skin.
A.2.4.3.4 Particular care shall be taken
when classifying certain types of chemicals
such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The approach explained in A.2.4.3.1 and A.2.4.3.2
might not work given that many of such substances are corrosive or irritant at concentrations <1%. For mixtures containing
strong acids or bases the pH should be used
as classification criteria since pH will be a
better indicator of corrosion than the concentration limits of Table A.2.3. A mixture

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Occupational Safety and Health Admin., Labor
containing corrosive or irritant ingredients
that cannot be classified based on the
additivity approach shown in Table A.2.3,
due to chemical characteristics that make
this approach unworkable, should be classified as Skin Category 1 if it contains ≥1% of
a corrosive ingredient and as Skin Category
2 when it contains ≥3% of an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table A.2.3
does not apply is summarized in Table A.2.4
below.
A.2.4.3.5 On occasion, reliable data may
show that the skin corrosion/irritation of an

§ 1910.1200

ingredient will not be evident when present
at a level above the generic concentration
cut-off values mentioned in Tables A.2.3 and
A.2.4. In these cases the mixture could be
classified according to those data (See Use of
cut-off values/concentration limits, paragraph
A.0.4.3 of this Appendix).
A.2.4.3.6 If there are data showing that
(an) ingredient(s) may be corrosive or irritant at a concentration of <1% (corrosive) or
<3% (irritant), the mixture shall be classified
accordingly (See Use of cut-off values/concentration limits, paragraph A.0.4.3 of this Appendix).

TABLE A.2.3—CONCENTRATION OF INGREDIENTS OF A MIXTURE CLASSIFIED AS SKIN CATEGORY 1 OR
2 THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE AS HAZARDOUS TO SKIN
[Category 1 or 2]
Concentration triggering classification of a
mixture as:
Sum of ingredients classified as:

Skin Category 1 .........................................................................................................
Skin Category 2 .........................................................................................................
(10 × Skin Category 1) + Skin Category 2 ...............................................................

Skin corrosive

Skin irritant

Category 1

Category 2

≥5%
................................
................................

≥1% but <5%.
≥10%.
≥10%.

TABLE A.2.4—CONCENTRATION OF INGREDIENTS OF A MIXTURE FOR WHICH THE ADDITIVITY APPROACH DOES NOT APPLY, THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE AS HAZARDOUS TO SKIN
Ingredient:

Concentration:

Acid with pH ≤2 .........................................................................................................
Base with pH ≥11.5 ...................................................................................................
Other corrosive (Category 1) ingredients for which additivity does not apply ..........
Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases.

A.3

SERIOUS EYE DAMAGE/EYE
IRRITATION

A.3.1

DEFINITIONS AND GENERAL
CONSIDERATIONS

A.3.1.1 Serious eye damage is the production of tissue damage in the eye, or serious
physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible
within 21 days of application.
Eye irritation is the production of changes
in the eye following the application of test
substance to the anterior surface of the eye,
which are fully reversible within 21 days of
application.
A.3.1.2 Serious eye damage/eye irritation
shall be classified using a tiered approach as
detailed in Figure A.3.1. Emphasis shall be
placed upon existing human data (See
A.0.2.6), followed by animal data, followed by
other sources of information. Classification
results directly when the data satisfy the

≥1%
≥1%
≥1%
≥3%

Mixture
classified as:
Skin
Category
Category
Category
Category

1.
1.
1.
2.

criteria in this section. In case the criteria
cannot be directly applied, classification of a
substance or a mixture is made on the basis
of the total weight of evidence (See A.0.3.1).
This means that all available information
bearing on the determination of serious eye
damage/eye irritation is considered together,
including the results of appropriate scientifically validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations.
A.3.2 CLASSIFICATION CRITERIA FOR
SUBSTANCES USING ANIMAL TEST DATA
A.3.2.1 Irreversible effects on the eye/serious damage to eyes (Category 1).
A single hazard category is provided in
Table A.3.1, for substances that have the potential to seriously damage the eyes. Category 1, irreversible effects on the eye, includes the criteria listed below. These observations include animals with grade 4 cornea

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

lesions and other severe reactions (e.g. destruction of cornea) observed at any time
during the test, as well as persistent corneal
opacity, discoloration of the cornea by a dye
substance, adhesion, pannus, and interference with the function of the iris or other
effects that impair sight. In this context,
persistent lesions are considered those which

are not fully reversible within an observation period of normally 21 days. Category 1
also contains substances fulfilling the criteria of corneal opacity ≥3 and/or iritis >1.5
detected in a Draize eye test with rabbits,
because severe lesions like these usually do
not reverse within a 21-day observation period.

TABLE A.3.1—IRREVERSIBLE EYE EFFECTS
A substance is classified as Serious Eye Damage Category 1 (irreversible effects on the eye)
when it produces:
(a) at least in one tested animal, effects on the cornea, iris or conjunctiva that are not
expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or
(b) at least in 2 of 3 tested animals, a positive response of:
(i) corneal opacity ≥3; and/or
(ii) iritis >1.5;
calculated as the mean scores following grading at 24, 48 and 72 hours
after instillation of the substance.

A.3.2.2 Reversible effects on the eye (Category 2).

A single category is provided in Table A.3.2
for substances that have the potential to induce reversible eye irritation.

TABLE A.3.2—REVERSIBLE EYE EFFECTS
A substance is classified as Eye irritant Category 2A (irritating to eyes) when it produces in at
least in 2 of 3 tested animals a positive response of:
(i) corneal opacity ≥1; and/or
(ii) iritis ≥1; and/or
(iii) conjunctival redness ≥2; and/or
(iv) conjunctival edema (chemosis) ≥2
calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the substance, and which fully reverses within an observation period of normally 21 days.
An eye irritant is considered mildly irritating to eyes (Category 2B) when the effects listed
above are fully reversible within 7 days of observation.

A.3.2.3 For those chemicals where there is
pronounced variability among animal responses, this information may be taken into
account in determining the classification.
A.3.3 CLASSIFICATION CRITERIA FOR
SUBSTANCES USING OTHER DATA ELEMENTS
A.3.3.1 Existing human and animal data
should be the first line of analysis, as they
give information directly relevant to effects
on the eye. Possible skin corrosion shall be
evaluated prior to consideration of serious
eye damage/eye irritation in order to avoid
testing for local effects on eyes with skin
corrosive substances. In vitro alternatives
that have been scientifically validated and
accepted shall be used to make classification
decisions. Likewise, pH extremes like ≤2 and
≥11.5, may indicate serious eye damage, espe-

cially when associated with significant
buffering capacity. Generally, such substances are expected to produce significant
effects on the eyes. In the absence of any
other information, a mixture/substance is
considered to cause serious eye damage (Eye
Category 1) if it has a pH ≤2 or ≥11.5. However, if consideration of acid/alkaline reserve
suggests the substance may not have the potential to cause serious eye damage despite
the low or high pH value, then further evaluation may be necessary. In some cases
enough information may be available from
structurally related compounds to make
classification decisions.
A.3.3.2 A tiered approach to the evaluation of initial information shall be used

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Occupational Safety and Health Admin., Labor

ER26MR12.066

Although information might be gained from
the evaluation of single parameters within a
tier, consideration should be given to the totality of existing information and making an
overall weight-of-evidence determination.
This is especially true when there is conflict
in information available on some parameters.

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ER26MR12.065

where applicable, recognizing that all elements may not be relevant in certain cases
(Figure A.3.1).
A.3.3.3 The tiered approach explains how
to organize existing information on a substance and to make a weight-of-evidence decision, where appropriate, about hazard assessment and hazard classification.
A.3.3.4 All the above information that is
available on a substance shall be evaluated.

§ 1910.1200

§ 1910.1200
A.3.4

29 CFR Ch. XVII (7–1–13 Edition)

CLASSIFICATION CRITERIA FOR
MIXTURES

A.3.4.1 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
A.3.4.1.1 The mixture will be classified
using the criteria for substances.
A.3.4.1.2 Unlike other hazard classes,
there are alternative tests available for skin
corrosivity of certain types of chemicals
that can give an accurate result for classification purposes, as well as being simple and
relatively inexpensive to perform. When considering testing of the mixture, chemical
manufacturers are encouraged to use a tiered
weight of evidence strategy as included in
the criteria for classification of substances
for skin corrosion and serious eye damage
and eye irritation to help ensure an accurate
classification, as well as avoid unnecessary
animal testing. In the absence of any other
information, a mixture is considered to
cause serious eye damage (Eye Category 1) if
it has a pH ≤2 or ≥11.5. However, if consideration of acid/alkaline reserve suggests the
substance or mixture may not have the potential to cause serious eye damage despite
the low or high pH value, then further evaluation may be necessary.
A.3.4.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.3.4.2.1 Where the mixture itself has not
been tested to determine its skin corrosivity
or potential to cause serious eye damage or
eye irritation, but there are sufficient data
on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data
will be used in accordance with the following
bridging principles, as found in paragraph
A.0.5 of this Appendix: Dilution, Batching,
Concentration of mixtures, Interpolation
within one toxicity category, Substantially
similar mixtures, and Aerosols.
A.3.4.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.3.4.3.1 For purposes of classifying the
eye corrosion/irritation hazards of mixtures
in the tiered approach:
The ‘‘relevant ingredients’’ of a mixture
are those which are present in concentrations ≥1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume
for gases.) If the classifier has reason to suspect that an ingredient present at a concentration <1% will affect classification of
the mixture for eye corrosion/irritation, that
ingredient shall also be considered relevant.
A.3.4.3.2 In general, the approach to classification of mixtures as seriously damaging

to the eye or eye irritant when data are
available on the ingredients, but not on the
mixture as a whole, is based on the theory of
additivity, such that each corrosive or irritant ingredient contributes to the overall irritant or corrosive properties of the mixture
in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive ingredients when they are present at a
concentration below the concentration limit
for classification with Category 1, but are at
a concentration that will contribute to the
classification of the mixture as an irritant.
The mixture is classified as seriously damaging to the eye or eye irritant when the
sum of the concentrations of such ingredients exceeds a threshold cut-off value/concentration limit.
A.3.4.3.3 Table A.3.3 provides the cut-off
value/concentration limits to be used to determine if the mixture should be classified as
seriously damaging to the eye or an eye irritant.
A.3.4.3.4 Particular care must be taken
when classifying certain types of chemicals
such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The approach explained in A.3.4.3.1 and A.3.4.3.2
might not work given that many of such substances are corrosive or irritant at concentrations <1%. For mixtures containing
strong acids or bases, the pH should be used
as classification criteria (See A.3.4.1) since
pH will be a better indicator of serious eye
damage than the concentration limits of
Table A.3.3. A mixture containing corrosive
or irritant ingredients that cannot be classified based on the additivity approach applied
in Table A.3.3 due to chemical characteristics that make this approach unworkable,
should be classified as Eye Category 1 if it
contains ≥1% of a corrosive ingredient and as
Eye Category 2 when it contains ≥3% of an
irritant ingredient. Classification of mixtures with ingredients for which the approach in Table A.3.3 does not apply is summarized in Table A.3.4.
A.3.4.3.5 On occasion, reliable data may
show that the reversible/irreversible eye effects of an ingredient will not be evident
when present at a level above the generic
cut-off values/concentration limits mentioned in Tables A.3.3 and A.3.4. In these
cases the mixture could be classified according to those data (See also A.0.4.3 Use of cutoff values/concentration limits’’). On occasion,
when it is expected that the skin corrosion/
irritation or the reversible/irreversible eye
effects of an ingredient will not be evident
when present at a level above the generic
concentration/cut-off levels mentioned in
Tables A.3.3 and A.3.4, testing of the mixture
may be considered. In those cases, the tiered
weight of evidence strategy should be applied as referred to in section A.3.3, Figure
A.3.1 and explained in detail in this chapter.

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Occupational Safety and Health Admin., Labor
A.3.4.3.6 If there are data showing that
(an) ingredient(s) may be corrosive or irritant at a concentration of <1% (corrosive) or

§ 1910.1200

<3% (irritant), the mixture should be classified accordingly (See also paragraph A.0.4.3,
Use of cut-off values/concentration limits).

TABLE A.3.3—CONCENTRATION OF INGREDIENTS OF A MIXTURE CLASSIFIED AS SKIN CATEGORY 1
AND/OR EYE CATEGORY 1 OR 2 THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURES AS
HAZARDOUS TO THE EYE
Concentration triggering classification of a mixture as:
Sum of ingredients classified as:

Irreversible eye effects

Reversible eye effects

Category 1
Eye or Skin Category 1 .......................................................
Eye Category 2 ....................................................................
(10 × Eye Category 1) + Eye Category 2 ...........................
Skin Category 1 + Eye Category 1 .....................................
10 × (Skin Category 1 + Eye Category 1) + Eye Category
2.

Category 2

≥3%
................................................
................................................
≥3%
................................................

≥1% but <3%.
≥10%.
≥10%.
≥1% but <3%.
≥10%.

Note: A mixture may be classified as Eye Category 2B in cases when all relevant ingredients are classified as Eye Category
2B.

TABLE A.3.4—CONCENTRATION OF INGREDIENTS OF A MIXTURE FOR WHICH THE ADDITIVITY APPROACH DOES NOT APPLY, THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE AS HAZARDOUS TO THE EYE
Ingredient

Concentration

Acid with pH ≤2 ...........................................................................................................
Base with pH ≥11.5 .....................................................................................................
Other corrosive (Category 1) ingredients for which additivity does not apply ............
Other irritant (Category 2) ingredients for which additivity does not apply, including
acids and bases.

A.4
A.4.1

RESPIRATORY OR SKIN
SENSITIZATION
DEFINITIONS AND GENERAL
CONSIDERATIONS

A.4.1.1 Respiratory sensitizer means a
chemical that will lead to hypersensitivity
of the airways following inhalation of the
chemical.
Skin sensitizer means a chemical that will
lead to an allergic response following skin
contact.
A.4.1.2 For the purpose of this chapter,
sensitization includes two phases: the first
phase
is
induction
of
specialized
immunological memory in an individual by
exposure to an allergen. The second phase is
elicitation, i.e., production of a cell-mediated or antibody-mediated allergic response
by exposure of a sensitized individual to an
allergen.
A.4.1.3 For respiratory sensitization, the
pattern of induction followed by elicitation
phases is shared in common with skin sensitization. For skin sensitization, an induction phase is required in which the immune
system learns to react; clinical symptoms
can then arise when subsequent exposure is
sufficient to elicit a visible skin reaction
(elicitation phase). As a consequence, predictive tests usually follow this pattern in

≥1%
≥1%
≥1%
≥3%

Mixture
classified as:
Eye
Category
Category
Category
Category

1.
1.
1.
2.

which there is an induction phase, the response to which is measured by a standardized elicitation phase, typically involving a
patch test. The local lymph node assay is the
exception, directly measuring the induction
response. Evidence of skin sensitization in
humans normally is assessed by a diagnostic
patch test.
A.4.1.4 Usually, for both skin and respiratory sensitization, lower levels are necessary for elicitation than are required for
induction.
A.4.1.5 The hazard class ‘‘respiratory or
skin sensitization’’ is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization.
A.4.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

A.4.2.1

RESPIRATORY SENSITIZERS

A.4.2.1.1 Hazard Categories.
A.4.2.1.1.1 Effects seen in either humans
or animals will normally justify classification in a weight of evidence approach for respiratory sensitizers. Substances may be allocated to one of the two sub-categories 1A or
1B using a weight of evidence approach in accordance with the criteria given in Table
A.4.1 and on the basis of reliable and good

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

quality evidence from human cases or epidemiological studies and/or observations from
appropriate studies in experimental animals.

A.4.2.1.1.2 Where data are not sufficient
for sub-categorization, respiratory sensitizers shall be classified in Category 1.

TABLE A.4.1—HAZARD CATEGORY AND SUB-CATEGORIES FOR RESPIRATORY SENSITIZERS
Category 1

Respiratory sensitizer

Sub-category 1A .......................

Sub-category 1B .......................

A substance is classified as a respiratory sensitizer.
(a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or
(b) if there are positive results from an appropriate animal test.1
Substances showing a high frequency of occurrence in humans; or a probability of occurrence
of a high sensitization rate in humans based on animal or other tests.1 Severity of reaction
may also be considered.
Substances showing a low to moderate frequency of occurrence in humans; or a probability of
occurrence of a low to moderate sensitization rate in humans based on animal or other
tests.1 Severity of reaction may also be considered.

A.4.2.1.2 Human evidence.
A.4.2.1.2.1 Evidence that a substance can
lead to specific respiratory hypersensitivity
will normally be based on human experience.
In this context, hypersensitivity is normally
seen as asthma, but other hypersensitivity
reactions such as rhinitis/conjunctivitis and
alveolitis are also considered. The condition
will have the clinical character of an allergic
reaction. However, immunological mechanisms do not have to be demonstrated.
A.4.2.1.2.2 When considering the human
evidence, it is necessary that in addition to
the evidence from the cases, the following be
taken into account:
(a) The size of the population exposed;
(b) The extent of exposure.
A.4.2.1.2.3 The evidence referred to above
could be:
(a) Clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other
supportive evidence which may include:
(i) In vivo immunological test (e.g., skin
prick test);
(ii) In vitro immunological test (e.g., serological analysis);
(iii) Studies that may indicate other specific
hypersensitivity
reactions
where
immunological mechanisms of action have
not been proven, e.g., repeated low-level irritation, pharmacologically mediated effects;
(iv) A chemical structure related to substances known to cause respiratory hypersensitivity;
(b) Data from positive bronchial challenge
tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.
1 At this writing, recognized and validated
animal models for the testing of respiratory
hypersensitivity are not available. Under certain circumstances, data from animal studies
may provide valuable information in a weight of
evidence assessment.

A.4.2.1.2.4 Clinical history should include
both medical and occupational history to determine a relationship between exposure to a
specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the
home and workplace, the onset and progress
of the disease, family history and medical
history of the patient in question. The medical history should also include a note of
other allergic or airway disorders from childhood and smoking history.
A.4.2.1.2.5 The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on
their own. It is, however, recognized that in
practice many of the examinations listed
above will already have been carried out.
A.4.2.1.3 Animal studies.
A.4.2.1.3.1 Data from appropriate animal
studies 2 which may be indicative of the potential of a substance to cause sensitization
by inhalation in humans 3 may include:
(a) Measurements of Immunoglobulin E
(IgE) and other specific immunological parameters, for example in mice
(b) Specific pulmonary responses in guinea
pigs.
A.4.2.2
A.4.2.2.1

SKIN SENSITIZERS

Hazard categories.

2 At this writing, recognized and validated
animal models for the testing of respiratory
hypersensitivity are not available. Under certain circumstances, data from animal studies
may provide valuable information in a weight of
evidence assessment.
3 The mechanisms by which substances induce
symptoms of asthma are not yet fully known.
For preventive measures, these substances are
considered respiratory sensitizers. However, if
on the basis of the evidence, it can be demonstrated that these substances induce symptoms of asthma by irritation only in people with
bronchial hyperactivity, they should not be considered as respiratory sensitizers.

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Occupational Safety and Health Admin., Labor
A.4.2.2.1.1 Effects seen in either humans
or animals will normally justify classification in a weight of evidence approach for
skin sensitizers. Substances may be allocated to one of the two sub-categories 1A or
1B using a weight of evidence approach in accordance with the criteria given in Table
A.4.2 and on the basis of reliable and good
quality evidence from human cases or epide-

§ 1910.1200

miological studies and/or observations from
appropriate studies in experimental animals
according to the guidance values provided in
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A
and in A.4.2.2.2.2 and A.4.2.2.3.3 for sub-category 1B.
A.4.2.2.1.2 Where data are not sufficient
for sub-categorization, skin sensitizers shall
be classified in Category 1.

TABLE A.4.2—HAZARD CATEGORY AND SUB-CATEGORIES FOR SKIN SENSITIZERS
Category 1

Skin sensitizer

Sub-category 1A .......................

Sub-category 1B .......................

A substance is classified as a skin sensitizer.
(a) if there is evidence in humans that the substance can lead to sensitization by skin contact
in a substantial number of persons, or
(b) if there are positive results from an appropriate animal test.
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitization in humans.
Severity of reaction may also be considered.
Substances showing a low to moderate frequency of occurrence in humans and/or a low to
moderate potency in animals can be presumed to have the potential to produce sensitization
in humans. Severity of reaction may also be considered.

A.4.2.2.2 Human evidence.
A.4.2.2.2.1 Human evidence for sub-category 1A may include:
(a) Positive responses at ≤500 μg/cm2
(Human Repeat Insult Patch Test (HRIPT),
Human Maximization Test (HMT)—induction
threshold);
(b) Diagnostic patch test data where there
is a relatively high and substantial incidence
of reactions in a defined population in relation to relatively low exposure;
(c) Other epidemiological evidence where
there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure.
A.4.2.2.2.2 Human evidence for sub-category 1B may include:
(a) Positive responses at >500 μg/cm2
(HRIPT, HMT—induction threshold);
(b) Diagnostic patch test data where there
is a relatively low but substantial incidence

of reactions in a defined population in relation to relatively high exposure;
(c) Other epidemiological evidence where
there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure.
A.4.2.2.3 Animal studies
A.4.2.2.3.1 For Category 1, when an adjuvant type test method for skin sensitization
is used, a response of at least 30% of the animals is considered as positive. For a non-adjuvant Guinea pig test method a response of
at least 15% of the animals is considered
positive. For Category 1, a stimulation index
of three or more is considered a positive response in the local lymph node assay.4
A.4.2.2.3.2 Animal test results for sub-category 1A can include data with values indicated in Table A.4.3 below:

TABLE A.4.3—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1A
Assay

Criteria

Local lymph node assay .............................
Guinea pig maximization test ......................
Buehler assay .............................................

EC3 value ≤2%.
≥30% responding
≥60% responding
≥15% responding
≥60% responding

at
at
at
at

≤0.1% intradermal induction dose or
>0.1% to ≤1% intradermal induction dose.
≤0.2% topical induction dose or
>0.2% to ≤20% topical induction dose.

Note: EC3 refers to the estimated concentration of test chemical required to induce a stimulation index of 3 in the local lymph
node assay.

4 Test methods for skin sensitization are described in OECD Guideline 406 (the Guinea Pig
Maximization test and the Buehler guinea pig
test) and Guideline 429 (Local Lymph Node
Assay). Other methods may be used provided
that they are scientifically validated. The

Mouse Ear Swelling Test (MEST), appears to be
a reliable screening test to detect moderate to
strong sensitizers, and can be used, in accordance with professional judgment, as a first stage
in the assessment of skin sensitization potential.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

A.4.2.2.3.3 Animal test results for sub-category 1B can include data with values indicated in Table A.4.4 below:

TABLE A.4.4—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1B
Assay

Criteria

Local lymph node assay .............................
Guinea pig maximization test ......................
Buehler assay .............................................

EC3 value >2%.
≥30% to <60% responding at >0.1% to ≤1% intradermal induction dose or
≥30% responding at >1% intradermal induction dose.
≥15% to <60% responding at >0.2% to ≤20% topical induction dose or
≥15% responding at >20% topical induction dose.

Note: EC3 refers to the estimated concentration of test chemical required to induce a stimulation index of 3 in the local lymph
node assay.

A.4.2.2.4 Specific considerations.
A.4.2.2.4.1 For classification of a substance, evidence shall include one or more of
the following using a weight of evidence approach:
(a) Positive data from patch testing, normally obtained in more than one dermatology clinic;
(b) Epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic
symptoms are to be looked at with special
concern, even if the number of cases is small;
(c) Positive data from appropriate animal
studies;
(d) Positive data from experimental studies in man (See paragraph A.0.2.6 of this Appendix);
(e) Well documented episodes of allergic
contact dermatitis, normally obtained in
more than one dermatology clinic;
(f) Severity of reaction.
A.4.2.2.4.2 Evidence from animal studies is
usually much more reliable than evidence
from human exposure. However, in cases
where evidence is available from both
sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in
order to resolve the question of classification on a case-by-case basis. Normally,
human data are not generated in controlled
experiments with volunteers for the purpose
of hazard classification but rather as part of
risk assessment to confirm lack of effects
seen in animal tests. Consequently, positive
human data on skin sensitization are usually
derived from case-control or other, less defined studies. Evaluation of human data
must, therefore, be carried out with caution
as the frequency of cases reflect, in addition
to the inherent properties of the substances,
factors such as the exposure situation, bioavailability, individual predisposition and
preventive measures taken. Negative human
data should not normally be used to negate
positive results from animal studies. For
both animal and human data, consideration
should be given to the impact of vehicle.

A.4.2.2.4.3 If none of the above-mentioned
conditions are met, the substance need not
be classified as a skin sensitizer. However, a
combination of two or more indicators of
skin sensitization, as listed below, may alter
the decision. This shall be considered on a
case-by-case basis.
(a) Isolated episodes of allergic contact
dermatitis;
(b) Epidemiological studies of limited
power, e.g., where chance, bias or confounders have not been ruled out fully with
reasonable confidence;
(c) Data from animal tests, performed according to existing guidelines, which do not
meet the criteria for a positive result described in A.4.2.2.3, but which are sufficiently
close to the limit to be considered significant;
(d) Positive data from non-standard methods;
(e) Positive results from close structural
analogues.
A.4.2.2.4.4 Immunological contact urticaria.
A.4.2.2.4.4.1 Substances meeting the criteria for classification as respiratory sensitizers may, in addition, cause immunological
contact urticaria. Consideration shall be
given to classifying these substances as skin
sensitizers.
A.4.2.2.4.4.2 Substances
which
cause
immunological contact urticaria without
meeting the criteria for respiratory sensitizers shall be considered for classification
as skin sensitizers.
A.4.2.2.4.4.3 There is no recognized animal
model available to identify substances which
cause immunological contact urticaria.
Therefore, classification will normally be
based on human evidence, similar to that for
skin sensitization.
A.4.3

CLASSIFICATION CRITERIA FOR
MIXTURES

A.4.3.1 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
When reliable and good quality evidence,
as described in the criteria for substances,

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Occupational Safety and Health Admin., Labor
from human experience or appropriate studies in experimental animals, is available for
the mixture, then the mixture shall be classified by weight of evidence evaluation of
these data. Care must be exercised in evaluating data on mixtures that the dose used
does not render the results inconclusive.

§ 1910.1200

bridging principles as found in paragraph
A.0.5 of this Appendix: Dilution, Batching,
Concentration of mixtures, Interpolation,
Substantially
similar
mixtures,
and
Aerosols.

A.4.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES

A.4.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE

A.4.3.2.1 Where the mixture itself has not
been tested to determine its sensitizing properties, but there are sufficient data on both
the individual ingredients and similar tested
mixtures to adequately characterize the hazards of the mixture, these data will be used
in accordance with the following agreed

The mixture shall be classified as a respiratory or skin sensitizer when at least one
ingredient has been classified as a respiratory or skin sensitizer and is present at
or above the appropriate cut-off value/concentration limit for the specific endpoint as
shown in Table A.4.5.

TABLE A.4.5—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS EITHER RESPIRATORY SENSITIZERS OR SKIN SENSITIZERS THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
Cut-off values/concentration limits triggering classification of a mixture as:
Respiratory Sensitizer
Category 1

Ingredient classified as:

Respiratory Sensitizer, Category 1 ...................
Respiratory Sensitizer, Sub-category 1A ..........
Respiratory Sensitizer, Sub-category 1B ..........
Skin Sensitizer, Category 1 ...............................
Skin Sensitizer, Sub-category 1A .....................
Skin Sensitizer, Sub-category 1B .....................

A.5

Solid/liquid

Gas

≥0.1%
≥0.1%
≥1.0%
........................................
........................................
........................................

≥0.1%
≥0.1%
≥0.2%
........................................
........................................
........................................

GERM CELL MUTAGENICITY

A.5.1

Skin Sensitizer
Category 1

DEFINITIONS AND GENERAL
CONSIDERATIONS

A.5.1.1 A mutation is defined as a permanent change in the amount or structure of
the genetic material in a cell. The term mutation applies both to heritable genetic
changes that may be manifested at the
phenotypic level and to the underlying DNA
modifications when known (including, for example, specific base pair changes and chromosomal translocations). The term mutagenic and mutagen will be used for agents giving rise to an increased occurrence of
mutations in populations of cells and/or organisms.
A.5.1.2 The more general terms genotoxic
and genotoxicity apply to agents or processes
which alter the structure, information content, or segregation of DNA, including those
which cause DNA damage by interfering with

All physical states

≥0.1%
≥0.1%
≥1.0%

normal replication processes, or which in a
non-physiological
manner
(temporarily)
alter its replication. Genotoxicity test results are usually taken as indicators for mutagenic effects.
A.5.1.3 This hazard class is primarily concerned with chemicals that may cause
mutations in the germ cells of humans that
can be transmitted to the progeny. However,
mutagenicity/genotoxicity tests in vitro and
in mammalian somatic cells in vivo are also
considered in classifying substances and
mixtures within this hazard class.
A.5.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

A.5.2.1 The classification system provides
for two different categories of germ cell
mutagens to accommodate the weight of evidence available. The two-category system is
described in the Figure A.5.1.

FIGURE A.5.1—HAZARD CATEGORIES FOR GERM CELL MUTAGENS
CATEGORY 1: Substances known to induce heritable mutations or to be regarded as if they
induce heritable mutations in the germ cells of humans.
Category 1A: Substances known to induce heritable mutations in germ cells of humans.
Positive evidence from human epidemiological studies.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

FIGURE A.5.1—HAZARD CATEGORIES FOR GERM CELL MUTAGENS—Continued
Category 1B: Substances which should be regarded as if they induce heritable mutations in
the germ cells of humans.
(a) Positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals;
or
(b) Positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to
germ cells. This supporting evidence may, for example, be derived from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the
substance or its metabolite(s) to interact with the genetic material of germ cells; or
(c) Positive results from tests showing mutagenic effects in the germ cells of humans,
without demonstration of transmission to progeny; for example, an increase in the
frequency of aneuploidy in sperm cells of exposed people.
CATEGORY 2: Substances which cause concern for humans owing to the possibility that they
may induce heritable mutations in the germ cells of humans.
Positive evidence obtained from experiments in mammals and/or in some cases from
in vitro experiments, obtained from:
(a) Somatic cell mutagenicity tests in vivo, in mammals; or
(b) Other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Note: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity
relationship to known germ cell mutagens, should be considered
for classification as Category 2 mutagens.

A.5.2.2 Specific considerations for classification of substances as germ cell mutagens:
A.5.2.2.1 To arrive at a classification, test
results are considered from experiments determining mutagenic and/or genotoxic effects in germ and/or somatic cells of exposed
animals. Mutagenic and/or genotoxic effects
determined in in vitro tests shall also be considered.
A.5.2.2.2 The system is hazard based,
classifying chemicals on the basis of their
intrinsic ability to induce mutations in germ
cells. The scheme is, therefore, not meant for
the (quantitative) risk assessment of chemical substances.
A.5.2.2.3 Classification for heritable effects in human germ cells is made on the
basis of scientifically validated tests. Evaluation of the test results shall be done using
expert judgment and all the available evidence shall be weighed for classification.
A.5.2.2.4 The classification of substances
shall be based on the total weight of evidence available, using expert judgment. In
those instances where a single well-con5 It should be noted that the classification criteria for health hazards usually include a tiered
scheme in which test data available on the complete mixture are considered as the first tier in
the evaluation, followed by the applicable bridging principles, and lastly, cut-off values/concentration limits or additivity. However, this approach is not used for Germ Cell Mutagenicity.
These criteria for Germ Cell Mutagenicity con-

ducted test is used for classification, it shall
provide clear and unambiguously positive results. The relevance of the route of exposure
used in the study of the substance compared
to the route of human exposure should also
be taken into account.
A.5.3

CLASSIFICATION CRITERIA FOR
MIXTURES 5

A.5.3.1 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.5.3.1.1 Classification of mixtures shall
be based on the available test data for the individual ingredients of the mixture using
cut-off values/concentration limits for the
ingredients classified as germ cell mutagens.
A.5.3.1.2 The mixture will be classified as
a mutagen when at least one ingredient has
been classified as a Category 1A, Category 1B
or Category 2 mutagen and is present at or

sider the cut-off values/concentration limits as
the primary tier and allow the classification to
be modified only on a case-by-case evaluation
based on available test data for the mixture as
a whole.

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Occupational Safety and Health Admin., Labor

§ 1910.1200

above the appropriate cut-off value/concentration limit as shown in Table A.5.1
below for Category 1 and 2 respectively.

TABLE A.5.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS GERM CELL MUTAGENS THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
Cut-off/concentration limits triggering classification
of a mixture as:

Ingredient classified as:

Category 1 mutagen
Category 1A/B mutagen ................................................................................
Category 2 mutagen ......................................................................................

Category 2 mutagen

≥0.1%
........................................

≥1.0%

Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v
units).

A.5.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE MIXTURE
ITSELF
The classification may be modified on a
case-by-case basis based on the available test
data for the mixture as a whole. In such
cases, the test results for the mixture as a
whole must be shown to be conclusive taking
into account dose and other factors such as
duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ
cell mutagenicity test systems.
A.5.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.5.3.3.1 Where the mixture itself has not
been tested to determine its germ cell mutagenicity hazard, but there are sufficient data
on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data
will be used in accordance with the following
bridging principles as found in paragraph
A.0.5 of this Appendix: Dilution, Batching,
and Substantially similar mixtures.
A.5.4

EXAMPLES OF SCIENTIFICALLY
VALIDATED TEST METHODS

A.5.4.1 Examples of in vivo heritable germ
cell mutagenicity tests are:
(a) Rodent dominant lethal mutation test
(OECD 478)
(b) Mouse heritable translocation assay
(OECD 485)
(c) Mouse specific locus test
A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
(a) Mammalian bone marrow chromosome
aberration test (OECD 475)
(b) Mouse spot test (OECD 484)
(c) Mammalian erythrocyte micronucleus
test (OECD 474)
A.5.4.3 Examples
of
mutagenicity/
genotoxicity tests in germ cells are:
(a) Mutagenicity tests:
(i)
Mammalian
spermatogonial
chromosome aberration test (OECD 483)
(ii) Spermatid micronucleus assay

(b) Genotoxicity tests:
(i) Sister chromatid exchange analysis in
spermatogonia
(ii) Unscheduled DNA synthesis test (UDS)
in testicular cells
A.5.4.4 Examples of genotoxicity tests in somatic cells are:
(a) Liver Unscheduled DNA Synthesis
(UDS) in vivo (OECD 486)
(b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
A.5.4.5 Examples of in vitro mutagenicity
tests are:
(a) In vitro mammalian chromosome aberration test (OECD 473)
(b) In vitro mammalian cell gene mutation
test (OECD 476)
(c) Bacterial reverse mutation tests (OECD
471)
A.5.4.6 As new, scientifically validated tests
arise, these may also be used in the total
weight of evidence to be considered.
A.6

CARCINOGENICITY
A.6.1

DEFINITIONS

Carcinogen means a substance or a mixture
of substances which induce cancer or increase its incidence. Substances and mixtures which have induced benign and malignant tumors in well-performed experimental
studies on animals are considered also to be
presumed or suspected human carcinogens
unless there is strong evidence that the
mechanism of tumor formation is not relevant for humans.
Classification of a substance or mixture as
posing a carcinogenic hazard is based on its
inherent properties and does not provide information on the level of the human cancer
risk which the use of the substance or mixture may represent.

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§ 1910.1200
A.6.2

29 CFR Ch. XVII (7–1–13 Edition)

CLASSIFICATION CRITERIA FOR
SUBSTANCES 6

A.6.2.1 For the purpose of classification for
carcinogenicity, substances are allocated to

one of two categories based on strength of
evidence and additional weight of evidence
considerations. In certain instances, routespecific classification may be warranted.

FIGURE A.6.1—HAZARD CATEGORIES FOR CARCINOGENS
CATEGORY 1: Known or presumed human carcinogens.
The classification of a substance as a Category 1 carcinogen is done on the basis of
epidemiological and/or animal data. This classification is further distinguished on
the basis of whether the evidence for classification is largely from human data
(Category 1A) or from animal data (Category 1B):
Category 1A: Known to have carcinogenic potential for humans. Classification in this category
is largely based on human evidence.
Category 1B: Presumed to have carcinogenic potential for humans. Classification in this category is largely based on animal evidence.
The classification of a substance in Category 1A and 1B is based on strength of evidence together with weight of evidence considerations (See paragraph A.6.2.5).
Such evidence may be derived from:
—human studies that establish a causal relationship between human exposure to a substance and the development of cancer (known human carcinogen); or
—animal experiments for which there is sufficient evidence to demonstrate
animal carcinogenicity (presumed human carcinogen).
In addition, on a case by case basis, scientific judgment may warrant a decision of
presumed human carcinogenicity derived from studies showing limited evidence of
carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals.
CATEGORY 2: Suspected human carcinogens.
The classification of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to
place the substance in Category 1A or B. This classification is based on strength
of evidence together with weight of evidence considerations (See paragraph
A.6.2.5). Such evidence may be from either limited evidence of carcinogenicity in
human studies or from limited evidence of carcinogenicity in animal studies.
Other considerations: Where the weight of evidence for the carcinogenicity of a substance
does not meet the above criteria, any positive study conducted in accordance with established scientific principles, and which reports statistically significant findings regarding the
carcinogenic potential of the substance, must be noted on the safety data sheet.

A.6.2.2 Classification as a carcinogen is
made on the basis of evidence from reliable
and acceptable methods, and is intended to
be used for substances which have an intrinsic property to produce such toxic effects.
The evaluations are to be based on all existing data, peer-reviewed published studies and
additional data accepted by regulatory agencies.
A.6.2.3 Carcinogen classification is a onestep, criterion-based process that involves
two interrelated determinations: evaluations
of strength of evidence and consideration of
all other relevant information to place sub-

stances with human cancer potential into
hazard categories.
A.6.2.4 Strength of evidence involves the
enumeration of tumors in human and animal
studies and determination of their level of
statistical significance. Sufficient human
evidence demonstrates causality between
human exposure and the development of cancer, whereas sufficient evidence in animals
shows a causal relationship between the
agent and an increased incidence of tumors.
Limited evidence in humans is demonstrated
by a positive association between exposure
and cancer, but a causal relationship cannot

6 See Non-mandatory Appendix F Part A for
further guidance regarding hazard classification
for carcinogenicity. This appendix is consistent
with the GHS adn is provided as guidance ex-

cerpted from the International Agency for Research on Cancer (IARC) ‘‘Monographs on the
Evaluation of Carcinogenic Risks to Humans’’
(2006).

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Occupational Safety and Health Admin., Labor
be stated. Limited evidence in animals is
provided when data suggest a carcinogenic
effect, but are less than sufficient. (Guidance
on consideration of important factors in the
classification of carcinogenicity and a more
detailed description of the terms ‘‘limited’’
and ‘‘sufficient’’ have been developed by the
International Agency for Research on Cancer
(IARC) and are provided in non-mandatory
Appendix F).
A.6.2.5 Weight of evidence: Beyond the determination of the strength of evidence for
carcinogenicity, a number of other factors
should be considered that influence the overall likelihood that an agent may pose a carcinogenic hazard in humans. The full list of
factors that influence this determination is
very lengthy, but some of the important
ones are considered here.
A.6.2.5.1 These factors can be viewed as either increasing or decreasing the level of
concern for human carcinogenicity. The relative emphasis accorded to each factor depends upon the amount and coherence of evidence bearing on each. Generally there is a
requirement for more complete information
to decrease than to increase the level of concern. Additional considerations should be
used in evaluating the tumor findings and
the other factors in a case-by-case manner.
A.6.2.5.2 Some important factors which
may be taken into consideration, when assessing the overall level of concern are:
(a) Tumor type and background incidence;
(b) Multisite responses;
(c) Progression of lesions to malignancy;
(d) Reduced tumor latency;
Additional factors which may increase or
decrease the level of concern include:
(e) Whether responses are in single or both
sexes;
(f) Whether responses are in a single species or several species;
(g) Structural similarity or not to a substance(s) for which there is good evidence of
carcinogenicity;
(h) Routes of exposure;

§ 1910.1200

(i) Comparison of absorption, distribution,
metabolism and excretion between test animals and humans;
(j) The possibility of a confounding effect
of excessive toxicity at test doses; and,
(k) Mode of action and its relevance for humans, such as mutagenicity, cytotoxicity
with
growth
stimulation,
mitogenesis,
immunosuppression.
Mutagenicity: It is recognized that genetic
events are central in the overall process of
cancer development. Therefore evidence of
mutagenic activity in vivo may indicate that
a substance has a potential for carcinogenic
effects.
A.6.2.5.3 A substance that has not been
tested for carcinogenicity may in certain instances be classified in Category 1A, Category 1B, or Category 2 based on tumor data
from a structural analogue together with
substantial support from consideration of
other important factors such as formation of
common significant metabolites, e.g., for
benzidine congener dyes.
A.6.2.5.4 The classification should also
take into consideration whether or not the
substance is absorbed by a given route(s); or
whether there are only local tumors at the
site of administration for the tested route(s),
and adequate testing by other major route(s)
show lack of carcinogenicity.
A.6.2.5.5 It is important that whatever is
known
of
the
physico-chemical,
toxicokinetic and toxicodynamic properties
of the substances, as well as any available
relevant information on chemical analogues,
i.e., structure activity relationship, is taken
into consideration when undertaking classification.
A.6.3

CLASSIFICATION CRITERIA FOR
MIXTURES 7

A.6.3.1 The mixture shall be classified as a
carcinogen when at least one ingredient has
been classified as a Category 1 or Category 2
carcinogen and is present at or above the appropriate cut-off value/concentration limit
as shown in Table A.6.1.

TABLE A.6.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS CARCINOGEN THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
Category 1
carcinogen

Ingredient classified as:
Category 1 carcinogen ..................................................................................

7 It should be noted that the classification criteria for health hazards usually include a tiered
scheme in which test data available on the complete mixture are considered as the first tier in
the evaluation, followed by the applicable bridging principles, and lastly, cut-off values/concentration limit or additivity. However, this ap-

Category 2
carcinogen

≥0.1%

proach is not used for Carcinogenicity. These
criteria for Carcinogenicity consider the cut-off
values/concentration limits as the primary tier
and allow the classification to be modified only
on a case-by-case evaluation based on available
test data for the mixture as a whole.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

TABLE A.6.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS CARCINOGEN THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE—Continued
Ingredient classified as:

Category 1
carcinogen

Category 2 carcinogen ..................................................................................

................................

Category 2
carcinogen
≥0.1% (note 1).

Note: If a Category 2 carcinogen ingredient is present in the mixture at a concentration between 0.1% and 1%, information is
required on the SDS for a product. However, a label warning is optional. If a Category 2 carcinogen ingredient is present in the
mixture at a concentration of ≥1%, both an SDS and a label is required and the information must be included on each.

A.6.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
A mixture may be classified based on the
available test data for the mixture as a
whole. In such cases, the test results for the
mixture as a whole must be shown to be conclusive taking into account dose and other
factors such as duration, observations and
analysis (e.g., statistical analysis, test sensitivity) of carcinogenicity test systems.
A.6.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
Where the mixture itself has not been tested to determine its carcinogenic hazard, but
there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards
of the mixture, these data will be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution; Batching; and Substantially similar mixtures.
A.6.4

CLASSIFICATION OF CARCINOGENICITY 8

A.6.4.1 Chemical manufacturers, importers and employers evaluating chemicals may
treat the following sources as establishing
that a substance is a carcinogen or potential
carcinogen for hazard communication purposes in lieu of applying the criteria described herein:
A.6.4.1.1 National Toxicology Program
(NTP), ‘‘Report on Carcinogens’’ (latest edition);
A.6.4.1.2 International Agency for Research on Cancer (IARC) ‘‘Monographs on
the Evaluation of Carcinogenic Risks to Humans’’ (latest editions)
A.6.4.2 Where OSHA has included cancer
as a health hazard to be considered by classifiers for a chemical covered by 29 CFR part
1910, Subpart Z, Toxic and Hazardous Substances, chemical manufacturers, importers,
and employers shall classify the chemical as
a carcinogen.
8 See Non-mandatory Appendix F for further
guidance regarding hazard classification for
carcinogenicity and how to relate carcinogenicity classification information from IARC
and NTP to GHS.

A.7

REPRODUCTIVE TOXICITY

A.7.1

DEFINITIONS AND GENERAL
CONSIDERATIONS

A.7.1.1 Reproductive toxicity includes adverse effects on sexual function and fertility in
adult males and females, as well as adverse
effects on development of the offspring. Some
reproductive toxic effects cannot be clearly
assigned to either impairment of sexual
function and fertility or to developmental
toxicity. Nonetheless, chemicals with these
effects shall be classified as reproductive
toxicants.
For classification purposes, the known induction of genetically based inheritable effects in the offspring is addressed in Germ cell
mutagenicity (See A.5).
A.7.1.2 Adverse effects on sexual function
and fertility means any effect of chemicals
that interferes with reproductive ability or
sexual capacity. This includes, but is not
limited to, alterations to the female and
male reproductive system, adverse effects on
onset of puberty, gamete production and
transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions
that are dependent on the integrity of the reproductive systems.
A.7.1.3 Adverse effects on development of the
offspring means any effect of chemicals
which interferes with normal development of
the conceptus either before or after birth,
which is induced during pregnancy or results
from parental exposure. These effects can be
manifested at any point in the life span of
the organism. The major manifestations of
developmental toxicity include death of the
developing organism, structural abnormality, altered growth and functional deficiency.
A.7.1.4 Adverse effects on or via lactation
are also included in reproductive toxicity,
but for classification purposes, such effects
are treated separately (See A.7.2.1).
A.7.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

A.7.2.1 For the purpose of classification
for reproductive toxicity, substances shall be
classified in one of two categories in accordance with Figure A.7.1(a). Effects on sexual
function and fertility, and on development,

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Occupational Safety and Health Admin., Labor
shall be considered. In addition, effects on or
via lactation shall be classified in a separate

§ 1910.1200

hazard category in accordance with Figure
A.7.1(b).

FIGURE A.7.1(a)—HAZARD CATEGORIES FOR REPRODUCTIVE TOXICANTS
CATEGORY 1: Known or presumed human reproductive toxicant.
Substance shall be classified in Category 1 for reproductive toxicity when they are
known to have produced an adverse effect on sexual function and fertility or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. The classification
of a substance is further distinguished on the basis of whether the evidence for
classification is primarily from human data (Category 1A) or from animal data (Category 1B).
Category 1A: Known human reproductive toxicant.
The classification of a substance in this category is largely based on evidence from
humans.
Category 1B: Presumed human reproductive toxicant.
The classification of a substance in this category is largely based on evidence from
experimental animals. Data from animal studies shall provide sufficient evidence of
an adverse effect on sexual function and fertility or on development in the absence
of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence
of other toxic effects. However, when there is mechanistic information that raises
doubt about the relevance of the effect for humans, classification in Category 2
may be more appropriate.
CATEGORY 2: Suspected human reproductive toxicant.
Substances shall be classified in Category 2 for reproductive toxicity when there is
some evidence from humans or experimental animals, possibly supplemented with
other information, of an adverse effect on sexual function and fertility, or on development, in the absence of other toxic effects, or if occurring together with other
toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects, and where the evidence is not sufficiently convincing to place the substance in Category 1. For instance, deficiencies in the study may make the quality of evidence less convincing,
and in view of this, Category 2 would be the more appropriate classification.
FIGURE A.7.1(b)—HAZARD CATEGORY FOR EFFECTS ON OR VIA LACTATION
EFFECTS ON OR VIA LACTATION
Effects on or via lactation shall be classified in a separate single category. Chemicals that are
absorbed by women and have been shown to interfere with lactation or that may be present
(including metabolites) in breast milk in amounts sufficient to cause concern for the health
of a breastfed child, shall be classified to indicate this property hazardous to breastfed babies. This classification shall be assigned on the basis of:
(a) absorption, metabolism, distribution and excretion studies that indicate the likelihood the substance would be present in potentially toxic levels in breast milk; and/
or
(b) results of one or two generation studies in animals which provide clear evidence
of adverse effect in the offspring due to transfer in the milk or adverse effect on the
quality of the milk; and/or
(c) human evidence indicating a hazard to babies during the lactation period.

A.7.2.2

BASIS OF CLASSIFICATION

A.7.2.2.1 Classification is made on the
basis of the criteria, outlined above, an assessment of the total weight of evidence, and

the use of expert judgment. Classification as
a reproductive toxicant is intended to be
used for substances which have an intrinsic,

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

specific property to produce an adverse effect on reproduction and substances should
not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects.
A.7.2.2.2 In the evaluation of toxic effects
on the developing offspring, it is important
to consider the possible influence of maternal toxicity.
A.7.2.2.3 For human evidence to provide
the primary basis for a Category 1A classification there must be reliable evidence of an
adverse effect on reproduction in humans.
Evidence used for classification shall be from
well conducted epidemiological studies, if
available, which include the use of appropriate controls, balanced assessment, and
due consideration of bias or confounding factors. Less rigorous data from studies in humans may be sufficient for a Category 1A
classification if supplemented with adequate
data from studies in experimental animals,
but classification in Category 1B may also be
considered.
A.7.2.3

WEIGHT OF EVIDENCE

A.7.2.3.1 Classification as a reproductive
toxicant is made on the basis of an assessment of the total weight of evidence using
expert judgment. This means that all available information that bears on the determination of reproductive toxicity is considered together. Included is information such
as epidemiological studies and case reports
in humans and specific reproduction studies
along with sub-chronic, chronic and special
study results in animals that provide relevant information regarding toxicity to reproductive and related endocrine organs.
Evaluation of substances chemically related
to the material under study may also be included, particularly when information on the
material is scarce. The weight given to the
available evidence will be influenced by factors such as the quality of the studies, consistency of results, nature and severity of effects, level of statistical significance for
intergroup differences, number of endpoints
affected, relevance of route of administration to humans and freedom from bias. Both
positive and negative results are considered
together in a weight of evidence determination. However, a single, positive study performed according to good scientific principles and with statistically or biologically
significant positive results may justify classification (See also A.7.2.2.3).
A.7.2.3.2 Toxicokinetic studies in animals
and humans, site of action and mechanism or
mode of action study results may provide
relevant information, which could reduce or
increase concerns about the hazard to human
health. If it is conclusively demonstrated
that the clearly identified mechanism or
mode of action has no relevance for humans
or when the toxicokinetic differences are so
marked that it is certain that the hazardous

property will not be expressed in humans
then a chemical which produces an adverse
effect on reproduction in experimental animals should not be classified.
A.7.2.3.3 In some reproductive toxicity
studies in experimental animals the only effects recorded may be considered of low or
minimal toxicological significance and classification may not necessarily be the outcome. These effects include, for example,
small changes in semen parameters or in the
incidence of spontaneous defects in the fetus,
small changes in the proportions of common
fetal variants such as are observed in skeletal examinations, or in fetal weights, or
small differences in postnatal developmental
assessments.
A.7.2.3.4 Data from animal studies shall
provide sufficient evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if developmental toxicity occurs together with other
toxic effects in the dam (mother), the potential influence of the generalized adverse effects should be assessed to the extent possible. The preferred approach is to consider
adverse effects in the embryo/fetus first, and
then evaluate maternal toxicity, along with
any other factors which are likely to have
influenced these effects, as part of the
weight of evidence. In general, developmental effects that are observed at maternally toxic doses should not be automatically discounted. Discounting developmental
effects that are observed at maternally toxic
doses can only be done on a case-by-case
basis when a causal relationship is established or refuted.
A.7.2.3.5 If appropriate information is
available it is important to try to determine
whether developmental toxicity is due to a
specific maternally mediated mechanism or
to a non-specific secondary mechanism, like
maternal stress and the disruption of homeostasis. Generally, the presence of maternal
toxicity should not be used to negate findings of embryo/fetal effects, unless it can be
clearly demonstrated that the effects are
secondary non-specific effects. This is especially the case when the effects in the offspring are significant, e.g., irreversible effects such as structural malformations. In
some situations it is reasonable to assume
that reproductive toxicity is due to a secondary consequence of maternal toxicity and
discount the effects, for example if the chemical is so toxic that dams fail to thrive and
there is severe inanition; they are incapable
of nursing pups; or they are prostrate or
dying.
A.7.2.4

MATERNAL TOXICITY

A.7.2.4.1 Development of the offspring
throughout gestation and during the early
postnatal stages can be influenced by toxic
effects in the mother either through non-specific mechanisms related to stress and the

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Occupational Safety and Health Admin., Labor
disruption of maternal homeostasis, or by
specific maternally-mediated mechanisms.
So, in the interpretation of the developmental outcome to decide classification for
developmental effects it is important to consider the possible influence of maternal toxicity. This is a complex issue because of uncertainties surrounding the relationship between maternal toxicity and developmental
outcome. Expert judgment and a weight of
evidence approach, using all available studies, shall be used to determine the degree of
influence to be attributed to maternal toxicity when interpreting the criteria for classification for developmental effects. The adverse effects in the embryo/fetus shall be
first considered, and then maternal toxicity,
along with any other factors which are likely to have influenced these effects, as weight
of evidence, to help reach a conclusion about
classification.
A.7.2.4.2 Based on pragmatic observation,
it is believed that maternal toxicity may,
depending on severity, influence development via non-specific secondary mechanisms, producing effects such as depressed
fetal weight, retarded ossification, and possibly resorptions and certain malformations
in some strains of certain species. However,
the limited numbers of studies which have
investigated the relationship between developmental effects and general maternal toxicity have failed to demonstrate a consistent, reproducible relationship across species. Developmental effects which occur even
in the presence of maternal toxicity are considered to be evidence of developmental toxicity, unless it can be unequivocally demonstrated on a case by case basis that the developmental effects are secondary to maternal toxicity. Moreover, classification shall
be considered where there is a significant
toxic effect in the offspring, e.g., irreversible
effects such as structural malformations,
embryo/fetal lethality, or significant postnatal functional deficiencies.
A.7.2.4.3 Classification shall not automatically be discounted for chemicals that
produce developmental toxicity only in association with maternal toxicity, even if a specific maternally-mediated mechanism has
been demonstrated. In such a case, classification in Category 2 may be considered more
appropriate than Category 1. However, when
a chemical is so toxic that maternal death or
severe inanition results, or the dams (mothers) are prostrate and incapable of nursing
the pups, it is reasonable to assume that developmental toxicity is produced solely as a
secondary consequence of maternal toxicity
and discount the developmental effects. Classification is not necessarily the outcome in
the case of minor developmental changes,
e.g., a small reduction in fetal/pup body
weight or retardation of ossification when
seen in association with maternal toxicity.

§ 1910.1200

A.7.2.4.4 Some of the endpoints used to assess maternal toxicity are provided below.
Data on these endpoints, if available, shall
be evaluated in light of their statistical or
biological significance and dose-response relationship.
(a) Maternal mortality: An increased incidence of mortality among the treated dams
over the controls shall be considered evidence of maternal toxicity if the increase occurs in a dose-related manner and can be attributed to the systemic toxicity of the test
material. Maternal mortality greater than
10% is considered excessive and the data for
that dose level shall not normally be considered to need further evaluation.
(b) Mating index (Number of animals with
seminal plugs or sperm/Number of mated ×
100)
(c) Fertility index (Number of animals
with implants/Number of matings × 100)
(d) Gestation length (If allowed to deliver)
(e) Body weight and body weight change:
Consideration of the maternal body weight
change and/or adjusted (corrected) maternal
body weight shall be included in the evaluation of maternal toxicity whenever such data
are available. The calculation of an adjusted
(corrected) mean maternal body weight
change, which is the difference between the
initial and terminal body weight minus the
gravid uterine weight (or alternatively, the
sum of the weights of the fetuses), may indicate whether the effect is maternal or intrauterine. In rabbits, the body weight gain
may not be a useful indicator of maternal
toxicity because of normal fluctuations in
body weight during pregnancy.
(f) Food and water consumption (if relevant): The observation of a significant decrease in the average food or water consumption in treated dams (mothers) compared to
the control group may be useful in evaluating maternal toxicity, particularly when
the test material is administered in the diet
or drinking water. Changes in food or water
consumption must be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of
maternal
toxicity
or
more
simply,
unpalatability of the test material in feed or
water.
(g) Clinical evaluations (including clinical
signs, markers, and hematology and clinical
chemistry studies): The observation of increased incidence of significant clinical signs
of toxicity in treated dams (mothers) relative to the control group is useful in evaluating maternal toxicity. If this is to be used
as the basis for the assessment of maternal
toxicity, the types, incidence, degree and duration of clinical signs shall be reported in
the study. Clinical signs of maternal intoxication include, but are not limited to: coma,
prostration, hyperactivity, loss of righting
reflex, ataxia, or labored breathing.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

(h) Post-mortem data: Increased incidence
and/or severity of post-mortem findings may
be indicative of maternal toxicity. This can
include gross or microscopic pathological
findings or organ weight data, including absolute organ weight, organ-to-body weight
ratio, or organ-to-brain weight ratio. When
supported
by
findings
of
adverse
histopathological effects in the affected
organ(s), the observation of a significant
change in the average weight of suspected
target organ(s) of treated dams (mothers),
compared to those in the control group, may
be considered evidence of maternal toxicity.
A.7.2.5

ANIMAL AND EXPERIMENTAL DATA

A.7.2.5.1 A number of scientifically validated test methods are available, including
methods for developmental toxicity testing
(e.g., OECD Test Guideline 414, ICH Guideline S5A, 1993), methods for peri- and postnatal toxicity testing (e.g., ICH S5B, 1995),
and methods for one or two-generation toxicity testing (e.g., OECD Test Guidelines 415,
416)
A.7.2.5.2 Results obtained from screening
tests (e.g., OECD Guidelines 421—Reproduction/Developmental Toxicity Screening Test,
and 422—Combined Repeated Dose Toxicity
Study with Reproduction/Development Toxicity Screening Test) can also be used to justify classification, although the quality of
this evidence is less reliable than that obtained through full studies.
A.7.2.5.3 Adverse effects or changes, seen
in short- or long-term repeated dose toxicity
studies, which are judged likely to impair reproductive function and which occur in the
absence of significant generalized toxicity,
may be used as a basis for classification, e.g.,
histopathological changes in the gonads.
A.7.2.5.4 Evidence from in vitro assays, or
non-mammalian tests, and from analogous
substances using structure-activity relationship (SAR), can contribute to the procedure
for classification. In all cases of this nature,
expert judgment must be used to assess the
adequacy of the data. Inadequate data shall
not be used as a primary support for classification.
A.7.2.5.5 It is preferable that animal studies are conducted using appropriate routes of
administration which relate to the potential
route of human exposure. However, in practice, reproductive toxicity studies are commonly conducted using the oral route, and
such studies will normally be suitable for
evaluating the hazardous properties of the
substance with respect to reproductive toxicity. However, if it can be conclusively demonstrated that the clearly identified mechanism or mode of action has no relevance for
humans or when the toxicokinetic differences are so marked that it is certain that
the hazardous property will not be expressed
in humans then a substance which produces

an adverse effect on reproduction in experimental animals should not be classified.
A.7.2.5.6 Studies involving routes of administration
such
as
intravenous
or
intraperitoneal injection, which may result
in exposure of the reproductive organs to unrealistically high levels of the test substance, or elicit local damage to the reproductive organs, e.g., by irritation, must be
interpreted with extreme caution and on
their own are not normally the basis for
classification.
A.7.2.5.7 There is general agreement about
the concept of a limit dose, above which the
production of an adverse effect may be considered to be outside the criteria which lead
to classification. Some test guidelines specify a limit dose, other test guidelines qualify
the limit dose with a statement that higher
doses may be necessary if anticipated human
exposure is sufficiently high that an adequate margin of exposure would not be
achieved. Also, due to species differences in
toxicokinetics, establishing a specific limit
dose may not be adequate for situations
where humans are more sensitive than the
animal model.
A.7.2.5.8 In principle, adverse effects on
reproduction seen only at very high dose levels in animal studies (for example doses that
induce prostration, severe inappetence, excessive mortality) do not normally lead to
classification, unless other information is
available, for example, toxicokinetics information indicating that humans may be more
susceptible than animals, to suggest that
classification is appropriate.
A.7.2.5.9 However, specification of the actual ‘‘limit dose’’ will depend upon the test
method that has been employed to provide
the test results.
A.7.3

CLASSIFICATION CRITERIA FOR
MIXTURES 9

A.7.3.1 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.7.3.1.1 The mixture shall be classified as
a reproductive toxicant when at least one ingredient has been classified as a Category 1
9 It should be noted that the classification criteria for health hazards usually include a tiered
scheme in which test data available on the complete mixture are considered as the first tier in
the evaluation, followed by the applicable bridging principles, and lastly, cut-off values/concentration limits or additivity. However, this approach is not used for Reproductive Toxicity.
These criteria for Reproductive Toxicity consider the cut-off values/concentration limits as
the primary tier and allow the classification to
be modified only on a case-by-case evaluation

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Occupational Safety and Health Admin., Labor
or Category 2 reproductive toxicant and is
present at or above the appropriate cut-off
value/concentration limit specified in Table
A.7.1 for Category 1 and 2, respectively.
A.7.3.1.2 The mixture shall be classified
for effects on or via lactation when at least

§ 1910.1200

one ingredient has been classified for effects
on or via lactation and is present at or above
the appropriate cut-off value/concentration
limit specified in Table A.7.1 for the additional category for effects on or via lactation.

TABLE A.7.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS REPRODUCTIVE TOXICANTS OR FOR EFFECTS ON OR VIA LACTATION THAT TRIGGER CLASSIFICATION OF THE MIXTURE
Cut-off values/concentration limits triggering classification of a mixture as:
Ingredients classified as:

Category 1 reproductive
toxicant

Category 2 reproductive
toxicant

Category 1 reproductive toxicant ................
Category 2 reproductive toxicant ................
Additional category for effects on or via
lactation ....................................................

≥0.1%
..........................................

..........................................
≥0.1%

..........................................

..........................................

A.7.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
Available test data for the mixture as a
whole may be used for classification on a
case-by-case basis. In such cases, the test results for the mixture as a whole must be
shown to be conclusive taking into account
dose and other factors such as duration, observations and analysis (e.g., statistical
analysis, test sensitivity) of reproduction
test systems.
A.7.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.7.3.3.1 Where the mixture itself has not
been tested to determine its reproductive
toxicity, but there are sufficient data on
both the individual ingredients and similar
tested mixtures to adequately characterize
the hazards of the mixture, these data shall
be used in accordance with the following
bridging principles as found in paragraph
A.0.5 of this Appendix: Dilution, Batching,
and Substantially similar mixtures.
A.8

SPECIFIC TARGET ORGAN TOXICITY
SINGLE EXPOSURE
A.8.1

DEFINITIONS AND GENERAL
CONSIDERATIONS

A.8.1.1 Specific target organ toxicity—single
exposure, (STOT–SE) means specific, non-lethal target organ toxicity arising from a single exposure to a chemical. All significant
health effects that can impair function, both
reversible and irreversible, immediate and/or
delayed and not specifically addressed in A.1
to A.7 and A.10 of this Appendix are included.
Specific target organ toxicity following re-

Additional category for
effects on or via lactation

≥0.1%

peated exposure is classified in accordance
with SPECIFIC TARGET ORGAN TOXICITY—
REPEATED EXPOSURE (A.9 of this Appendix) and is therefore not included here.
A.8.1.2 Classification identifies the chemical as being a specific target organ toxicant
and, as such, it presents a potential for adverse health effects in people who are exposed to it.
A.8.1.3 The adverse health effects produced by a single exposure include consistent
and identifiable toxic effects in humans; or,
in experimental animals, toxicologically significant changes which have affected the
function or morphology of a tissue/organ, or
have produced serious changes to the biochemistry or hematology of the organism,
and these changes are relevant for human
health. Human data is the primary source of
evidence for this hazard class.
A.8.1.4 Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalized changes of a less severe nature involving several organs.
A.8.1.5 Specific target organ toxicity can
occur by any route that is relevant for humans, i.e., principally oral, dermal or inhalation.
A.8.1.6 The classification criteria for specific organ systemic toxicity single exposure
are organized as criteria for substances Categories 1 and 2 (See A.8.2.1), criteria for substances Category 3 (See A.8.2.2) and criteria
for mixtures (See A.8.3). See also Figure
A.8.1.

based on available test data for the mixture as
a whole.

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§ 1910.1200
A.8.2
A.8.2.1

29 CFR Ch. XVII (7–1–13 Edition)

CLASSIFICATION CRITERIA FOR
SUBSTANCES
SUBSTANCES OF CATEGORY 1 AND
CATEGORY 2

A.8.2.1.1 Substances shall be classified for
immediate or delayed effects separately, by

the use of expert judgment on the basis of
the weight of all evidence available, including the use of recommended guidance values
(See A.8.2.1.9). Substances shall then be classified in Category 1 or 2, depending upon the
nature and severity of the effect(s) observed,
in accordance with Figure A.8.1.

FIGURE A.8.1—HAZARD CATEGORIES FOR SPECIFIC TARGET ORGAN TOXICITY FOLLOWING SINGLE
EXPOSURE
CATEGORY 1: Substances that have produced significant toxicity in humans, or that, on the
basis of evidence from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following single exposure
Substances are classified in Category 1 for STOT–SE on the basis of:
(a) reliable and good quality evidence from human cases or epidemiological studies; or
(b) observations from appropriate studies in experimental animals in which significant and/or
severe toxic effects of relevance to human health were produced at generally low exposure
concentrations. Guidance dose/concentration values are provided below (See A.8.2.1.9) to
be used as part of weight-of-evidence evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to be harmful to human health following single
exposure
Substances are classified in Category 2 for STOT–SE on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to
human health, were produced at generally moderate exposure concentrations. Guidance
dose/concentration values are provided below (See A.8.2.1.9) in order to help in classification.
In exceptional cases, human evidence can also be used to place a substance in Category 2
(See A.8.2.1.6).
CATEGORY 3: Transient target organ effects
There are target organ effects for which a substance does not meet the criteria to be classified in Categories 1 or 2 indicated above. These are effects which adversely alter human
function for a short duration after exposure and from which humans may recover in a reasonable period without leaving significant alteration of structure or function. This category
only includes narcotic effects and respiratory tract irritation. Substances are classified specifically for these effects as discussed in A.8.2.2.
Note: The primary target organ/system shall be identified where possible, and where this is
not possible, the substance shall be identified as a general toxicant. The data shall be evaluated and, where possible, shall not include secondary effects (e.g., a hepatotoxicant can
produce secondary effects in the nervous or gastro-intestinal systems).

A.8.2.1.2 The relevant route(s) of exposure
by which the classified substance produces
damage shall be identified.
A.8.2.1.3 Classification is determined by
expert judgment, on the basis of the weight
of all evidence available including the guidance presented below.
A.8.2.1.4 Weight of evidence of all available data, including human incidents, epidemiology, and studies conducted in experimental animals is used to substantiate specific target organ toxic effects that merit
classification.
A.8.2.1.5 The information required to
evaluate specific target organ toxicity comes
either from single exposure in humans (e.g.,
exposure at home, in the workplace or environmentally), or from studies conducted in

experimental animals. The standard animal
studies in rats or mice that provide this information are acute toxicity studies which
can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target
tissues/organs to be identified. Results of
acute toxicity studies conducted in other
species may also provide relevant information.
A.8.2.1.6 In exceptional cases, based on expert judgment, it may be appropriate to
place certain substances with human evidence of target organ toxicity in Category 2:
(a) when the weight of human evidence is not
sufficiently convincing to warrant Category

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Occupational Safety and Health Admin., Labor
1 classification, and/or (b) based on the nature and severity of effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In
other words, if there are also animal data
available on the substance that warrant Category 1 classification, the chemical shall be
classified as Category 1.
A.8.2.1.7 Effects considered to support
classification for Category 1 and 2
A.8.2.1.7.1 Classification is supported by
evidence associating single exposure to the
substance with a consistent and identifiable
toxic effect.
A.8.2.1.7.2 Evidence from human experience/incidents is usually restricted to reports of adverse health consequences, often
with uncertainty about exposure conditions,
and may not provide the scientific detail
that can be obtained from well-conducted
studies in experimental animals.
A.8.2.1.7.3 Evidence
from
appropriate
studies in experimental animals can furnish
much more detail, in the form of clinical observations, and macroscopic and microscopic
pathological examination and this can often
reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence,
and evidence relevance to human health,
must be taken into consideration in the classification process. Relevant toxic effects in
humans and/or animals include, but are not
limited to:
(a) Morbidity resulting from single exposure;
(b) Significant functional changes, more
than transient in nature, in the respiratory
system, central or peripheral nervous systems, other organs or other organ systems,
including signs of central nervous system depression and effects on special senses (e.g.,
sight, hearing and sense of smell);
(c) Any consistent and significant adverse
change in clinical biochemistry, hematology,
or urinalysis parameters;
(d) Significant organ damage that may be
noted at necropsy and/or subsequently seen
or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis
or granuloma formation in vital organs with
regenerative capacity;
(f) Morphological changes that are potentially reversible but provide clear evidence
of marked organ dysfunction; and,
(g) Evidence of appreciable cell death (including cell degeneration and reduced cell

§ 1910.1200

number) in vital organs incapable of regeneration.
A.8.2.1.8 Effects considered not to support
classification for Category 1 and 2
Effects may be seen in humans and/or animals that do not justify classification. Such
effects include, but are not limited to:
(a) Clinical observations or small changes
in bodyweight gain, food consumption or
water intake that may have some toxicological importance but that do not, by
themselves, indicate ‘‘significant’’ toxicity;
(b) Small changes in clinical biochemistry,
hematology or urinalysis parameters and/or
transient effects, when such changes or effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ dysfunction;
(d) Adaptive responses that are not considered toxicologically relevant; and,
(e)
Substance-induced
species-specific
mechanisms of toxicity, i.e., demonstrated
with reasonable certainty to be not relevant
for human health, shall not justify classification.
A.8.2.1.9 Guidance values to assist with
classification based on the results obtained
from studies conducted in experimental animals for Category 1 and 2
A.8.2.1.9.1 In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/
concentration ‘‘guidance values’’ are provided for consideration of the dose/concentration which has been shown to produce
significant health effects. The principal argument for proposing such guidance values is
that all chemicals are potentially toxic and
there has to be a reasonable dose/concentration above which a degree of toxic effect is
acknowledged.
A.8.2.1.9.2 Thus, in animal studies, when
significant toxic effects are observed that indicate classification, consideration of the
dose/concentration at which these effects
were seen, in relation to the suggested guidance values, provides useful information to
help assess the need to classify (since the
toxic effects are a consequence of the hazardous property(ies) and also the dose/concentration).
A.8.2.1.9.3 The guidance value (C) ranges
for single-dose exposure which has produced
a significant non-lethal toxic effect are those
applicable to acute toxicity testing, as indicated in Table A.8.1.

TABLE A.8.1—GUIDANCE VALUE RANGES FOR SINGLE-DOSE EXPOSURES
Guidance value ranges for:
Route of exposure
Oral (rat) ......................

Units
mg/kg body weight .......

Category 1

Category 2

Category 3

C ≤300 .........................

2000 ≥C >300 ..............

Guidance values do not
apply.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

TABLE A.8.1—GUIDANCE VALUE RANGES FOR SINGLE-DOSE EXPOSURES—Continued
Guidance value ranges for:
Route of exposure

Units
Category 1

Dermal (rat or rabbit) ...
Inhalation (rat) gas .......
Inhalation (rat) vapor ...
Inhalation (rat) dust/
mist/fume.

mg/kg body weight .......
ppmV/4h .......................
mg/1/4h ........................
mg/l/4h .........................

C
C
C
C

Category 2

≤1,000 ......................
≤2,500 ......................
≤10 ...........................
≤1.0 ..........................

A.8.2.1.9.4 The guidance values and ranges
mentioned in Table A.8.1 are intended only
for guidance purposes, i.e., to be used as part
of the weight of evidence approach, and to
assist with decisions about classification.
They are not intended as strict demarcation
values. Guidance values are not provided for
Category 3 since this classification is primarily based on human data; animal data
may be included in the weight of evidence
evaluation.
A.8.2.1.9.5 Thus, it is feasible that a specific profile of toxicity occurs at a dose/concentration below the guidance value, e.g.,
<2000 mg/kg body weight by the oral route,
however the nature of the effect may result
in the decision not to classify. Conversely, a
specific profile of toxicity may be seen in
animal studies occurring at above a guidance
value, e.g., ≥2000 mg/kg body weight by the
oral route, and in addition there is supplementary information from other sources,
e.g., other single dose studies, or human case
experience, which supports a conclusion
that, in view of the weight of evidence, classification is the prudent action to take.
A.8.2.1.10 Other considerations
A.8.2.1.10.1 When a substance is characterized only by use of animal data the classification process includes reference to dose/
concentration guidance values as one of the
elements that contribute to the weight of
evidence approach.
A.8.2.1.10.2 When
well-substantiated
human data are available showing a specific
target organ toxic effect that can be reliably
attributed to single exposure to a substance,
the substance shall be classified. Positive
human data, regardless of probable dose, predominates over animal data. Thus, if a substance is unclassified because specific target
organ toxicity observed was considered not
relevant or significant to humans, if subsequent human incident data become available
showing a specific target organ toxic effect,
the substance shall be classified.
A.8.2.1.10.3 A substance that has not been
tested for specific target organ toxicity
shall, where appropriate, be classified on the
basis of data from a scientifically validated
structure activity relationship and expert
judgment-based extrapolation from a structural analogue that has previously been classified together with substantial support from

Category 3

2000 ≥C >1,000.
20,000 ≥C >2,500.
20 ≥C >10.
5.0 ≥C >1.0.

consideration of other important factors
such as formation of common significant metabolites.
A.8.2.2

SUBSTANCES OF CATEGORY 3

A.8.2.2.1 Criteria for respiratory tract irritation
The criteria for classifying substances as
Category 3 for respiratory tract irritation
are:
(a) Respiratory irritant effects (characterized by localized redness, edema, pruritis
and/or pain) that impair function with symptoms such as cough, pain, choking, and
breathing difficulties are included. It is recognized that this evaluation is based primarily on human data;
(b) Subjective human observations supported by objective measurements of clear
respiratory tract irritation (RTI) (e.g.,
electrophysiological responses, biomarkers
of inflammation in nasal or bronchoalveolar
lavage fluids);
(c) The symptoms observed in humans
shall also be typical of those that would be
produced in the exposed population rather
than being an isolated idiosyncratic reaction
or response triggered only in individuals
with hypersensitive airways. Ambiguous reports simply of ‘‘irritation’’ should be excluded as this term is commonly used to describe a wide range of sensations including
those such as smell, unpleasant taste, a tickling sensation, and dryness, which are outside the scope of classification for respiratory tract irritation;
(d) There are currently no scientifically
validated animal tests that deal specifically
with RTI; however, useful information may
be obtained from the single and repeated inhalation toxicity tests. For example, animal
studies may provide useful information in
terms of clinical signs of toxicity (dyspnoea,
rhinitis etc) and histopathology (e.g., hyperemia, edema, minimal inflammation, thickened mucous layer) which are reversible and
may be reflective of the characteristic clinical symptoms described above. Such animal
studies can be used as part of weight of evidence evaluation; and,
(e) This special classification will occur
only when more severe organ effects including the respiratory system are not observed

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Occupational Safety and Health Admin., Labor
as those effects would require a higher classification.
A.8.2.2.2 Criteria for narcotic effects
The criteria for classifying substances in
Category 3 for narcotic effects are:
(a) Central nervous system depression including narcotic effects in humans such as
drowsiness, narcosis, reduced alertness, loss
of reflexes, lack of coordination, and vertigo
are included. These effects can also be manifested as severe headache or nausea, and can
lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function,
deficits in perception and coordination, reaction time, or sleepiness; and,
(b) Narcotic effects observed in animal
studies may include lethargy, lack of coordination righting reflex, narcosis, and ataxia.
If these effects are not transient in nature,
then they shall be considered for classification as Category 1 or 2.
A.8.3

CLASSIFICATION CRITERIA FOR
MIXTURES

A.8.3.1 Mixtures are classified using the
same criteria as for substances, or alternatively as described below. As with substances, mixtures may be classified for specific target organ toxicity following single
exposure, repeated exposure, or both.
A.8.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR THE COMPLETE
MIXTURE
When reliable and good quality evidence
from human experience or appropriate studies in experimental animals, as described in
the criteria for substances, is available for
the mixture, then the mixture shall be classified by weight of evidence evaluation of
this data. Care shall be exercised in evalu-

§ 1910.1200

ating data on mixtures, that the dose, duration, observation or analysis, do not render
the results inconclusive.
A.8.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.8.3.3.1 Where the mixture itself has not
been tested to determine its specific target
organ toxicity, but there are sufficient data
on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data
shall be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution,
Batching, Concentration of mixtures, Interpolation within one toxicity category, Substantially similar mixtures, or Aerosols.
A.8.3.4 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.8.3.4.1 Where there is no reliable evidence or test data for the specific mixture
itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ toxicant (specific organ
specified), following single exposure, repeated exposure, or both when at least one
ingredient has been classified as a Category
1 or Category 2 specific target organ toxicant
and is present at or above the appropriate
cut-off value/concentration limit specified in
Table A.8.2 for Categories 1 and 2, respectively.

TABLE A.8.2—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS A SPECIFIC TARGET ORGAN TOXICANT THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
AS CATEGORY 1 OR 2
Cut-off values/concentration
limits triggering classification of
a mixture as:

Ingredient classified as:

Category 1
Category 1
Category 2

Target organ toxicant ...............................................................................................
Target organ toxicant ...............................................................................................

A.8.3.4.2 These cut-off values and consequent classifications shall be applied
equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for
either or both single and repeated dose toxicity independently.
A.8.3.4.4 Care shall be exercised when
toxicants affecting more than one organ system are combined that the potentiation or
synergistic interactions are considered, be-

Category 2

≥1.0%
........................

cause certain substances can cause target
organ toxicity at <1% concentration when
other ingredients in the mixture are known
to potentiate its toxic effect.
A.8.3.4.5 Care shall be exercised when extrapolating the toxicity of a mixture that
contains Category 3 ingredient(s). A cut-off
value/concentration limit of 20%, considered
as an additive of all Category 3 ingredients
for each hazard endpoint, is appropriate;
however, this cut-off value/concentration

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

limit may be higher or lower depending on
the Category 3 ingredient(s) involved and the
fact that some effects such as respiratory
tract irritation may not occur below a certain concentration while other effects such
as narcotic effects may occur below this 20%
value. Expert judgment shall be exercised.
Respiratory tract irritation and narcotic effects are to be evaluated separately in accordance with the criteria given in A.8.2.2.
When conducting classifications for these
hazards, the contribution of each ingredient
should be considered additive, unless there is
evidence that the effects are not additive.
A.9 SPECIFIC TARGET ORGAN TOXICITY
REPEATED OR PROLONGED EXPOSURE
A.9.1

DEFINITIONS AND GENERAL
CONSIDERATIONS

A.9.1.1 Specific target organ toxicity—repeated exposure (STOT–RE) means specific
target organ toxicity arising from repeated
exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in A.1 to A.7 and A.10 of this Appendix are included. Specific target organ toxicity following a single-event exposure is
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY—SINGLE EXPOSURE
(A.8 of this Appendix) and is therefore not included here.
A.9.1.2 Classification identifies the substance or mixture as being a specific target
organ toxicant and, as such, it may present

a potential for adverse health effects in people who are exposed to it.
A.9.1.3 These adverse health effects produced by repeated exposure include consistent and identifiable toxic effects in humans,
or,
in
experimental
animals,
toxicologically significant changes which
have affected the function or morphology of
a tissue/organ, or have produced serious
changes to the biochemistry or hematology
of the organism and these changes are relevant for human health. Human data will be
the primary source of evidence for this hazard class.
A.9.1.4 Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalized changes of a less severe nature involving several organs.
A.9.1.5 Specific target organ toxicity can
occur by any route that is relevant for humans, e.g., principally oral, dermal or inhalation.
A.9.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

A.9.2.1 Substances shall be classified as
STOT–RE by expert judgment on the basis of
the weight of all evidence available, including the use of recommended guidance values
which take into account the duration of exposure and the dose/concentration which produced the effect(s), (See A.9.2.9). Substances
shall be placed in one of two categories, depending upon the nature and severity of the
effect(s) observed, in accordance with Figure
A.9.1.

FIGURE A.9.1—HAZARD CATEGORIES FOR SPECIFIC TARGET ORGAN TOXICITY FOLLOWING REPEATED
EXPOSURE
CATEGORY 1: Substances that have produced significant toxicity in humans, or that, on the
basis of evidence from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following repeated or prolonged exposure
Substances are classified in Category 1 for specific target organ toxicity (repeated
exposure) on the basis of:
(a) reliable and good quality evidence from human cases or epidemiological studies;
or,
(b) observations from appropriate studies in experimental animals in which significant
and/or severe toxic effects, of relevance to human health, were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below (See A.9.2.9) to be used as part of weight-of-evidence evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated or prolonged exposure
Substances are classified in Category 2 for specific target organ toxicity (repeated
exposure) on the basis of observations from appropriate studies in experimental
animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below (See A.9.2.9) in order to help in classification.
In exceptional cases human evidence can also be used to place a substance in Category 2 (See A.9.2.6).

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Occupational Safety and Health Admin., Labor

§ 1910.1200

FIGURE A.9.1—HAZARD CATEGORIES FOR SPECIFIC TARGET ORGAN TOXICITY FOLLOWING REPEATED
EXPOSURE—Continued
Note: The primary target organ/system shall be identified where possible, or the substance
shall be identified as a general toxicant. The data shall be carefully evaluated and, where
possible, shall not include secondary effects (e.g., a hepatotoxicant can produce secondary
effects in the nervous or gastro-intestinal systems).

A.9.2.2 The relevant route of exposure by
which the classified substance produces damage shall be identified.
A.9.2.3 Classification is determined by expert judgment, on the basis of the weight of
all evidence available including the guidance
presented below.
A.9.2.4 Weight of evidence of all data, including human incidents, epidemiology, and
studies conducted in experimental animals,
is used to substantiate specific target organ
toxic effects that merit classification.
A.9.2.5 The information required to evaluate specific target organ toxicity comes either from repeated exposure in humans, e.g.,
exposure at home, in the workplace or environmentally, or from studies conducted in
experimental animals. The standard animal
studies in rats or mice that provide this information are 28 day, 90 day or lifetime studies
(up
to
2
years)
that
include
hematological, clinico-chemical and detailed
macroscopic and microscopic examination to
enable the toxic effects on target tissues/organs to be identified. Data from repeat dose
studies performed in other species may also
be used. Other long-term exposure studies,
e.g., for carcinogenicity, neurotoxicity or reproductive toxicity, may also provide evidence of specific target organ toxicity that
could be used in the assessment of classification.
A.9.2.6 In exceptional cases, based on expert judgment, it may be appropriate to
place certain substances with human evidence of specific target organ toxicity in
Category 2: (a) when the weight of human
evidence is not sufficiently convincing to
warrant Category 1 classification, and/or (b)
based on the nature and severity of effects.
Dose/concentration levels in humans shall
not be considered in the classification and
any available evidence from animal studies
shall be consistent with the Category 2 classification. In other words, if there are also
animal data available on the substance that
warrant Category 1 classification, the substance shall be classified as Category 1.
A.9.2.7

EFFECTS CONSIDERED TO SUPPORT
CLASSIFICATION

A.9.2.7.1 Classification is supported by reliable evidence associating repeated exposure
to the substance with a consistent and identifiable toxic effect.

A.9.2.7.2 Evidence from human experience/
incidents is usually restricted to reports of
adverse health consequences, often with uncertainty about exposure conditions, and
may not provide the scientific detail that
can be obtained from well-conducted studies
in experimental animals.
A.9.2.7.3 Evidence from appropriate studies in experimental animals can furnish
much more detail, in the form of clinical observations, hematology, clinical chemistry,
macroscopic and microscopic pathological
examination and this can often reveal hazards that may not be life-threatening but
could indicate functional impairment. Consequently all available evidence, and relevance to human health, must be taken into
consideration in the classification process.
Relevant toxic effects in humans and/or animals include, but are not limited to:
(a) Morbidity or death resulting from repeated or long-term exposure. Morbidity or
death may result from repeated exposure,
even to relatively low doses/concentrations,
due to bioaccumulation of the substance or
its metabolites, or due to the overwhelming
of the de-toxification process by repeated exposure;
(b) Significant functional changes in the
central or peripheral nervous systems or
other organ systems, including signs of central nervous system depression and effects
on special senses (e.g., sight, hearing and
sense of smell);
(c) Any consistent and significant adverse
change in clinical biochemistry, hematology,
or urinalysis parameters;
(d) Significant organ damage that may be
noted at necropsy and/or subsequently seen
or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis
or granuloma formation in vital organs with
regenerative capacity;
(f) Morphological changes that are potentially reversible but provide clear evidence
of marked organ dysfunction (e.g., severe
fatty change in the liver); and,
(g) Evidence of appreciable cell death (including cell degeneration and reduced cell
number) in vital organs incapable of regeneration.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

A.9.2.8 EFFECTS CONSIDERED NOT TO
SUPPORT CLASSIFICATION
Effects may be seen in humans and/or animals that do not justify classification. Such
effects include, but are not limited to:
(a) Clinical observations or small changes
in bodyweight gain, food consumption or
water intake that may have some toxicological importance but that do not, by
themselves, indicate ‘‘significant’’ toxicity;
(b) Small changes in clinical biochemistry,
hematology or urinalysis parameters and/or
transient effects, when such changes or effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ dysfunction;
(d) Adaptive responses that are not considered toxicologically relevant;
(e)
Substance-induced
species-specific
mechanisms of toxicity, i.e., demonstrated
with reasonable certainty to be not relevant
for human health, shall not justify classification.
A.9.2.9 GUIDANCE VALUES TO ASSIST WITH
CLASSIFICATION BASED ON THE RESULTS OBTAINED FROM STUDIES CONDUCTED IN EXPERIMENTAL ANIMALS
A.9.2.9.1 In studies conducted in experimental animals, reliance on observation of
effects alone, without reference to the duration of experimental exposure and dose/concentration, omits a fundamental concept of
toxicology, i.e., all substances are potentially toxic, and what determines the toxicity is a function of the dose/concentration
and the duration of exposure. In most studies
conducted in experimental animals the test
guidelines use an upper limit dose value.
A.9.2.9.2 In order to help reach a decision
about whether a substance shall be classified
or not, and to what degree it shall be classified (Category 1 vs. Category 2), dose/concentration ‘‘guidance values’’ are provided in
Table A.9.1 for consideration of the dose/concentration which has been shown to produce
significant health effects. The principal argument for proposing such guidance values is

that all chemicals are potentially toxic and
there has to be a reasonable dose/concentration above which a degree of toxic effect is
acknowledged. Also, repeated-dose studies
conducted in experimental animals are designed to produce toxicity at the highest
dose used in order to optimize the test objective and so most studies will reveal some
toxic effect at least at this highest dose.
What is therefore to be decided is not only
what effects have been produced, but also at
what dose/concentration they were produced
and how relevant is that for humans.
A.9.2.9.3 Thus, in animal studies, when
significant toxic effects are observed that indicate classification, consideration of the duration of experimental exposure and the
dose/concentration at which these effects
were seen, in relation to the suggested guidance values, provides useful information to
help assess the need to classify (since the
toxic effects are a consequence of the hazardous property(ies) and also the duration of
exposure and the dose/concentration).
A.9.2.9.4 The decision to classify at all can
be influenced by reference to the dose/concentration guidance values at or below which
a significant toxic effect has been observed.
A.9.2.9.5 The guidance values refer to effects seen in a standard 90-day toxicity study
conducted in rats. They can be used as a
basis to extrapolate equivalent guidance values for toxicity studies of greater or lesser
duration, using dose/exposure time extrapolation similar to Haber’s rule for inhalation,
which states essentially that the effective
dose is directly proportional to the exposure
concentration and the duration of exposure.
The assessment should be done on a case-bycase basis; for example, for a 28-day study
the guidance values below would be increased by a factor of three.
A.9.2.9.6 Thus for Category 1 classification, significant toxic effects observed in a
90-day repeated-dose study conducted in experimental animals and seen to occur at or
below the (suggested) guidance values (C) as
indicated in Table A.9.1 would justify classification:

TABLE A.9.1—GUIDANCE VALUES TO ASSIST IN CATEGORY 1 CLASSIFICATION
[Applicable to a 90-day study]
Guidance values
(dose/concentration)

Route of exposure

Units

Oral (rat) ..................................................................
Dermal (rat or rabbit) ...............................................
Inhalation (rat) gas ...................................................
Inhalation (rat) vapor ...............................................
Inhalation (rat) dust/mist/fume .................................

mg/kg body weight/day ...........................................
mg/kg body weight/day ...........................................
ppmV/6h/day ...........................................................
mg/liter/6h/day .........................................................
mg/liter/6h/day .........................................................

A.9.2.9.7 For Category 2 classification,
significant toxic effects observed in a 90-day
repeated-dose study conducted in experi-

C
C
C
C
C

≤10.
≤20.
≤50.
≤0.2.
≤0.02.

mental animals and seen to occur within the

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Occupational Safety and Health Admin., Labor

§ 1910.1200

(suggested) guidance value ranges as indicated in Table A.9.2 would justify classification:

TABLE A.9.2—GUIDANCE VALUES TO ASSIST IN CATEGORY 2 CLASSIFICATION
[Applicable to a 90-day study]
Guidance values
(dose/concentration)

Route of exposure

Units

Oral (rat) ..................................................................
Dermal (rat or rabbit) ...............................................
Inhalation (rat) gas ...................................................
Inhalation (rat) vapor ...............................................
Inhalation (rat) dust/mist/fume .................................

mg/kg body weight/day ...........................................
mg/kg body weight/day ...........................................
ppmV/6h/day ...........................................................
mg/liter/6h/day .........................................................
mg/liter/6h/day .........................................................

A.9.2.9.8 The guidance values and ranges
mentioned in A.2.9.9.6 and A.2.9.9.7 are intended only for guidance purposes, i.e., to be
used as part of the weight of evidence approach, and to assist with decisions about
classification. They are not intended as
strict demarcation values.
A.9.2.9.9 Thus, it is possible that a specific
profile of toxicity occurs in repeat-dose animal studies at a dose/concentration below
the guidance value, e.g., <100 mg/kg body
weight/day by the oral route, however the
nature of the effect, e.g., nephrotoxicity seen
only in male rats of a particular strain
known to be susceptible to this effect, may
result in the decision not to classify. Conversely, a specific profile of toxicity may be
seen in animal studies occurring at above a
guidance value, e.g., ≥100 mg/kg body weight/
day by the oral route, and in addition there
is supplementary information from other
sources, e.g., other long-term administration
studies, or human case experience, which
supports a conclusion that, in view of the
weight of evidence, classification is prudent.
A.9.2.10

OTHER CONSIDERATIONS

A.9.2.10.1 When a substance is characterized only by use of animal data the classification process includes reference to dose/
concentration guidance values as one of the
elements that contribute to the weight of
evidence approach.
A.9.2.10.2 When well-substantiated human
data are available showing a specific target
organ toxic effect that can be reliably attributed to repeated or prolonged exposure to a
substance, the substance shall be classified.
Positive human data, regardless of probable
dose, predominates over animal data. Thus,
if a substance is unclassified because no specific target organ toxicity was seen at or
below the dose/concentration guidance value
for animal testing, if subsequent human incident data become available showing a specific target organ toxic effect, the substance
shall be classified.
A.9.2.10.3 A substance that has not been
tested for specific target organ toxicity may
in certain instances, where appropriate, be

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

A.9.3.4 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.9.3.4.1 Where there is no reliable evidence or test data for the specific mixture
itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is based on the classifica-

tion of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ toxicant (specific organ
specified), following single exposure, repeated exposure, or both when at least one
ingredient has been classified as a Category
1 or Category 2 specific target organ toxicant
and is present at or above the appropriate
cut-off value/concentration limit specified in
Table A.9.3 for Category 1 and 2 respectively.

TABLE A.9.3—CUT-OFF VALUE/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED
AS A SPECIFIC TARGET ORGAN TOXICANT THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
AS CATEGORY 1 OR 2
Cut-off values/concentration
limits triggering classification of
a
mixture as:

Ingredient classified as:

Category 1
Category 1
Category 2

Target organ toxicant ...............................................................................................
Target organ toxicant ...............................................................................................

A.9.3.4.2 These cut-off values and consequent classifications shall be applied
equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.9.3.4.3 Mixtures shall be classified for
either or both single- and repeated-dose toxicity independently.
A.9.3.4.4 Care shall be exercised when
toxicants affecting more than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances can cause specific
target organ toxicity at <1% concentration
when other ingredients in the mixture are
known to potentiate its toxic effect.
A.10
A.10.1

ASPIRATION HAZARD

DEFINITIONS AND GENERAL AND
SPECIFIC CONSIDERATIONS

A.10.1.1 Aspiration means the entry of a
liquid or solid chemical directly through the
oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory
system.

A.10.1.5.2 Although the definition of aspiration in A.10.1.1 includes the entry of solids
into the respiratory system, classification
according to (b) in table A.10.1 for Category
1 is intended to apply to liquid substances
and mixtures only.

Category 2

≥1.0%
........................

≥1.0%

A.10.1.2 Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury
or death following aspiration.
A.10.1.3 Aspiration is initiated at the moment of inspiration, in the time required to
take one breath, as the causative material
lodges at the crossroad of the upper respiratory and digestive tracts in the
laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or mixture can occur as it is vomited following ingestion. This may have consequences for labeling, particularly where, due to acute toxicity, a recommendation may be considered
to induce vomiting after ingestion. However,
if the substance/mixture also presents an aspiration toxicity hazard, the recommendation to induce vomiting may need to be
modified.
A.10.1.5

SPECIFIC CONSIDERATIONS

A.10.1.5.1 The classification criteria refer
to kinematic viscosity. The following provides the conversion between dynamic and
kinematic viscosity:

A.10.1.5.3 Classification of aerosol/mist
products.
Aerosol and mist products are usually dispensed in containers such as self-pressurized

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512

Occupational Safety and Health Admin., Labor
containers, trigger and pump sprayers. Classification for these products shall be considered if their use may form a pool of product
in the mouth, which then may be aspirated.
If the mist or aerosol from a pressurized container is fine, a pool may not be formed. On
the other hand, if a pressurized container
dispenses product in a stream, a pool may be
formed that may then be aspirated. Usually,

§ 1910.1200

the mist produced by trigger and pump
sprayers is coarse and therefore, a pool may
be formed that then may be aspirated. When
the pump mechanism may be removed and
contents are available to be swallowed then
the classification of the products should be
considered.
A.10.2

CLASSIFICATION CRITERIA FOR
SUBSTANCES

TABLE A.10.1—CRITERIA FOR ASPIRATION TOXICITY
Category

Criteria

Category 1: Chemicals known to cause human aspiration toxicity hazards or to be regarded as if they cause human aspiration toxicity hazard.

A substance shall be classified in Category 1:
(a) If reliable and good quality human evidence indicates
that it causes aspiration toxicity (See note); or
(b) If it is a hydrocarbon and has a kinematic viscosity
≤20.5 mm2/s, measured at 40 °C.

Note: Examples of substances included in Category 1 are certain hydrocarbons, turpentine and pine oil.

A.10.3

CLASSIFICATION CRITERIA FOR
MIXTURES

APPENDIX B TO § 1910.1200—PHYSICAL CRITERIA
(MANDATORY)

A.10.3.1 CLASSIFICATION WHEN DATA ARE
AVAILABLE FOR THE COMPLETE MIXTURE

B.1

A mixture shall be classified in Category 1
based on reliable and good quality human
evidence.
A.10.3.2 CLASSIFICATION OF MIXTURES WHEN
DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE: BRIDGING PRINCIPLES
A.10.3.2.1 Where the mixture itself has not
been tested to determine its aspiration toxicity, but there are sufficient data on both
the individual ingredients and similar tested
mixtures to adequately characterize the hazard of the mixture, these data shall be used
in accordance with the following bridging
principles as found in paragraph A.0.5 of this
Appendix: Dilution; Batching; Concentration
of mixtures; Interpolation within one toxicity category; and Substantially similar
mixtures. For application of the dilution
bridging principle, the concentration of aspiration toxicants shall not be less than 10%.
A.10.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.10.3.3.1 A mixture which contains ≥10%
of an ingredient or ingredients classified in
Category 1, and has a kinematic viscosity
≤20.5 mm2/s, measured at 40 °C, shall be classified in Category 1.
A.10.3.3.2 In the case of a mixture which
separates into two or more distinct layers,
one of which contains ≥10% of an ingredient
or ingredients classified in Category 1 and
has a kinematic viscosity ≤20.5 mm2/s, measured at 40 °C, then the entire mixture shall
be classified in Category 1.

B.1.1

EXPLOSIVES

DEFINITIONS AND GENERAL
CONSIDERATIONS

B.1.1.1 An explosive chemical is a solid or
liquid chemical which is in itself capable by
chemical reaction of producing gas at such a
temperature and pressure and at such a
speed as to cause damage to the surroundings. Pyrotechnic chemicals are included even when they do not evolve gases.
A pyrotechnic chemical is a chemical designed to produce an effect by heat, light,
sound, gas or smoke or a combination of
these as the result of non-detonative selfsustaining exothermic chemical reactions.
An explosive item is an item containing one
or more explosive chemicals.
A pyrotechnic item is an item containing
one or more pyrotechnic chemicals.
An unstable explosive is an explosive which
is thermally unstable and/or too sensitive for
normal handling, transport, or use.
An intentional explosive is a chemical or
item which is manufactured with a view to
produce a practical explosive or pyrotechnic
effect.
B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices containing explosive chemicals in such quantity
or of such a character that their inadvertent
or accidental ignition or initiation shall not
cause any effect external to the device either
by projection, fire, smoke, heat or loud
noise; and
(c) Chemicals and items not included under
(a) and (b) above which are manufactured
with the view to producing a practical explosive or pyrotechnic effect.

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§ 1910.1200
B.1.2

29 CFR Ch. XVII (7–1–13 Edition)
CLASSIFICATION CRITERIA

Chemicals and items of this class shall be
classified as unstable explosives or shall be
assigned to one of the following six divisions
depending on the type of hazard they
present:
(a) Division 1.1—Chemicals and items
which have a mass explosion hazard (a mass
explosion is one which affects almost the entire quantity present virtually instantaneously);
(b) Division 1.2—Chemicals and items
which have a projection hazard but not a
mass explosion hazard;
(c) Division 1.3—Chemicals and items
which have a fire hazard and either a minor
blast hazard or a minor projection hazard or
both, but not a mass explosion hazard:
(i) Combustion of which gives rise to considerable radiant heat; or
(ii) Which burn one after another, producing minor blast or projection effects or
both;
(d) Division 1.4—Chemicals and items
which present no significant hazard: chemicals and items which present only a small
hazard in the event of ignition or initiation.
The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package;
(e) Division 1.5—Very insensitive chemicals which have a mass explosion hazard:
chemicals which have a mass explosion hazard but are so insensitive that there is very
little probability of initiation or of transition from burning to detonation under normal conditions;
(f) Division 1.6—Extremely insensitive
items which do not have a mass explosion
hazard: items which contain only extremely
insensitive detonating chemicals and which
demonstrate a negligible probability of accidental initiation or propagation.
B.1.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.1.3.1 Explosives shall be classified as unstable explosives or shall be assigned to one
of the six divisions identified in B.1.2 in accordance with the three step procedure in
Part I of the UN ST/SG/AC.10 (incorporated
by reference; See § 1910.6). The first step is to
ascertain whether the substance or mixture
has explosive effects (Test Series 1). The second step is the acceptance procedure (Test
Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7).
The assessment whether a candidate for
‘‘ammonium nitrate emulsion or suspension
or gel, intermediate for blasting explosives
(ANE)’’ is insensitive enough for inclusion as
an oxidizing liquid (See B.13) or an oxidizing

solid (See B.14) is determined by Test Series
8 tests.
NOTE: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for
the purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested
and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.1.3.2 Explosive properties are associated
with the presence of certain chemical groups
in a molecule which can react to produce
very rapid increases in temperature or pressure. The screening procedure in B.1.3.1 is
aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the chemical as a potential explosive,
the acceptance procedure (See section 10.3 of
the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6)) is necessary for classification.
NOTE: Neither a Series 1 type (a) propagation of detonation test nor a Series 2 type (a)
test of sensitivity to detonative shock is necessary if the exothermic decomposition energy of organic materials is less than 800 J/
g.
B.1.3.3 If a mixture contains any known
explosives, the acceptance procedure is necessary for classification.
B.1.3.4 A chemical is not classified as explosive if:
(a) There are no chemical groups associated with explosive properties present in the
molecule. Examples of groups which may indicate explosive properties are given in
Table A6.1 in Appendix 6 of the UN ST/SG/
AC.10 (incorporated by reference; See
§ 1910.6); or
(b) The substance contains chemical
groups associated with explosive properties
which include oxygen and the calculated oxygen balance is less than ¥200.
The oxygen balance is calculated for the
chemical reaction:
CXHyOz + [x + (y/4) ¥ (z/2)] O2 → x. CO2 + (y/
2) H2O
using the formula:
oxygen balance = ¥1600 [2x +(y/2) ¥z]/molecular weight;
or
(c) The organic substance or a homogenous
mixture of organic substances contains
chemical groups associated with explosive
properties but the exothermic decomposition
energy is less than 500 J/g and the onset of
exothermic decomposition is below 500 °C
(932 °F). The exothermic decomposition energy may be determined using a suitable
calorimetric technique; or

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Occupational Safety and Health Admin., Labor
(d) For mixtures of inorganic oxidizing
substances with organic material(s), the concentration of the inorganic oxidizing substance is:
(i) Less than 15%, by mass, if the oxidizing
substance is assigned to Category 1 or 2;
(ii) Less than 30%, by mass, if the oxidizing
substance is assigned to Category 3.

§ 1910.1200
B.2

FLAMMABLE GASES
B.2.1

DEFINITION

Flammable gas means a gas having a flammable range with air at 20 °C (68 °F) and a
standard pressure of 101.3 kPa (14.7 psi).
B.2.2

CLASSIFICATION CRITERIA

A flammable gas shall be classified in one
of the two categories for this class in accordance with Table B.2.1:

TABLE B.2.1—CRITERIA FOR FLAMMABLE GASES
Category

Criteria

1 .................................

Gases, which at 20 °C (68 °F) and a standard pressure of 101.3 kPa (14.7 psi):
(a) are ignitable when in a mixture of 13% or less by volume in air; or
(b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.
Gases, other than those of Category 1, which, at 20 °C (68 °F) and a standard pressure of 101.3 kPa
(14.7 psi), have a flammable range while mixed in air.

2 .................................

NOTE: Aerosols should not be classified as
flammable gases. See B.3.
B.2.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

Flammability shall be determined by tests
or by calculation in accordance with ISO
10156 (incorporated by reference; See § 1910.6).
Where insufficient data are available to use
this method, equivalent validated methods
may be used.
B.3

FLAMMABLE AEROSOLS
B.3.1

DEFINITION

Aerosol means any non-refillable receptacle
containing a gas compressed, liquefied or
dissolved under pressure, and fitted with a
release device allowing the contents to be
ejected as particles in suspension in a gas, or
as a foam, paste, powder, liquid or gas.

B.3.2

CLASSIFICATION CRITERIA

B.3.2.1 Aerosols shall be considered for
classification as flammable if they contain
any component which is classified as flammable in accordance with this Appendix, i.e.:
Flammable liquids (See B.6);
Flammable gases (See B.2);
Flammable solids (See B.7).
NOTE 1: Flammable components do not include pyrophoric, self-heating or water-reactive chemicals.
NOTE 2: Flammable aerosols do not fall additionally within the scope of flammable
gases, flammable liquids, or flammable solids.
B.3.2.2 A flammable aerosol shall be classified in one of the two categories for this
class in accordance with Table B.3.1.

TABLE B.3.1—CRITERIA FOR FLAMMABLE AEROSOLS
Category

Criteria

1 .................................

Contains ≥ 85% flammable components and the chemical heat of combustion is ≥ 30 kJ/g; or
(a) For spray aerosols, in the ignition distance test, ignition occurs at a distance ≥ 75 cm (29.5 in), or
(b) For foam aerosols, in the aerosol foam flammability test
(i) The flame height is ≥ 20 cm (7.87 in) and the flame duration ≥ 2 s; or
(ii) The flame height is ≥ 4 cm (1.57 in) and the flame duration ≥ 7 s
Contains > 1% flammable components, or the heat of combustion is ≥ 20 kJ/g; and
(a) for spray aerosols, in the ignition distance test, ignition occurs at a distance ≥ 15 cm (5.9 in), or
in the enclosed space ignition test, the
(i) Time equivalent is ≤ 300 s/m3; or
(ii) Deflagration density is ≤ 300 g/m3
(b) For foam aerosols, in the aerosol foam flammability test, the flame height is ≥ 4 cm and the flame
duration is ≥ 2 s
and it does not meet the criteria for Category 1

2 .................................

NOTE: Aerosols not submitted to the flammability classification procedures in this

Appendix shall be classified as extremely
flammable (Category 1).

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§ 1910.1200
B.3.3

29 CFR Ch. XVII (7–1–13 Edition)

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.3.3.1 To classify a flammable aerosol,
data on its flammable components, on its
chemical heat of combustion and, if applicable, the results of the aerosol foam flammability test (for foam aerosols) and of the ignition distance test and enclosed space test
(for spray aerosols) are necessary.

B.3.3.2 The chemical heat of combustion
(DHc), in kilojoules per gram (kJ/g), is the
product of the theoretical heat of combustion (DHcomb), and a combustion efficiency,
usually less than 1.0 (a typical combustion
efficiency is 0.95 or 95%).
For a composite aerosol formulation, the
chemical heat of combustion is the summation of the weighted heats of combustion for
the individual components, as follows:

B.4

Where:
DHc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the
product;
DHc(i) = specific heat of combustion (kJ/g) of
component i in the product;
The chemical heats of combustion shall be
found in literature, calculated or determined
by tests (See ASTM D240–02, ISO 13943, Sections 86.1 to 86.3, and NFPA 30B (incorporated by reference; See § 1910.6)).
B.3.3.3 The Ignition Distance Test, Enclosed Space Ignition Test and Aerosol Foam
Flammability Test shall be performed in accordance with sub-sections 31.4, 31.5 and 31.6
of the of the UN ST/SG/AC.10 (incorporated
by reference; See § 1910.6).

OXIDIZING GASES
B.4.1

DEFINITION

Oxidizing gas means any gas which may,
generally by providing oxygen, cause or contribute to the combustion of other material
more than air does.
NOTE: ‘‘Gases which cause or contribute to
the combustion of other material more than
air does’’ means pure gases or gas mixtures
with an oxidizing power greater than 23.5%
(as determined by a method specified in ISO
10156 or 10156–2 (incorporated by reference,
See § 1910.6) or an equivalent testing method.)
B.4.2

CLASSIFICATION CRITERIA

An oxidizing gas shall be classified in a single category for this class in accordance with
Table B.4.1:

TABLE B.4.1—CRITERIA FOR OXIDIZING GASES
Category

Criteria

1 .................................

Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does.

B.4.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

Classification shall be in accordance with
tests or calculation methods as described in
ISO 10156 (incorporated by reference; See
§ 1910.6) and ISO 10156–2 (incorporated by reference; See § 1910.6).
B.5

B.5.2

CLASSIFICATION CRITERIA

Gases under pressure shall be classified in
one of four groups in accordance with Table
B.5.1:

GASES UNDER PRESSURE
B.5.1

kPa (29 psi) (gauge) or more, or which are
liquefied or liquefied and refrigerated.
They comprise compressed gases, liquefied
gases, dissolved gases and refrigerated liquefied gases.

DEFINITION

Gases under pressure are gases which are
contained in a receptacle at a pressure of 200

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516

Occupational Safety and Health Admin., Labor

§ 1910.1200

TABLE B.5.1—CRITERIA FOR GASES UNDER PRESSURE
Group

Criteria

Compressed gas ...................

A gas which when under pressure is entirely gaseous at ¥50 °C (¥8 °F), including all gases
with a critical temperature1 ≤¥50 °C (¥58 °F).
A gas which when under pressure is partially liquid at temperatures above ¥50 °C (¥58 °F). A
distinction is made between:
(a) High pressure liquefied gas: A gas with a critical temperature 1 between ¥50 °C (¥58
°F) and +65 °C (149 °F); and
(b) Low pressure liquefied gas: A gas with a critical temperature 1 above +65 °C (149 °F).
A gas which is made partially liquid because of its low temperature.
A gas which when under pressure is dissolved in a liquid phase solvent.

Liquefied gas .........................

Refrigerated liquefied gas .....
Dissolved gas ........................

1 The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of
compression.

B.6

FLAMMABLE LIQUIDS
B.6.1

mixture with air near the surface of the liquid, as determined by a method identified in
Section B.6.3.

DEFINITION

Flammable liquid means a liquid having a
flash point of not more than 93 °C (199.4 °F).
Flash point means the minimum temperature at which a liquid gives off vapor in sufficient concentration to form an ignitable

B.6.2

CLASSIFICATION CRITERIA

A flammable liquid shall be classified in
one of four categories in accordance with
Table B.6.1:

TABLE B.6.1—CRITERIA FOR FLAMMABLE LIQUIDS
Category
1
2
3
4

Criteria

.......................................
.......................................
.......................................
.......................................

B.6.3

Flash
Flash
Flash
Flash

point
point
point
point

<23 °C (73.4 °F) and initial boiling point ≤35 °C (95 °F).
<23 °C (73.4 °F) and initial boiling point >35 °C (95 °F).
≥23 °C (73.4 °F) and ≤60 °C (140 °F).
>60 °C (140 °F) and ≤93 °C (199.4 °F).

B.7.2

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

The flash point shall be determined in accordance with ASTM D56–05, ASTM D3278,
ASTM D3828, ASTM D93–08 (incorporated by
reference; See § 1910.6), or any other method
specified in GHS Revision 3, Chapter 2.6.
The initial boiling point shall be determined in accordance with ASTM D86–07a or
ASTM D1078 (incorporated by reference; See
§ 1910.6).
B.7

FLAMMABLE SOLIDS
B.7.1

DEFINITIONS

Flammable solid means a solid which is a
readily combustible solid, or which may
cause or contribute to fire through friction.
Readily combustible solids are powdered,
granular, or pasty chemicals which are dangerous if they can be easily ignited by brief
contact with an ignition source, such as a
burning match, and if the flame spreads rapidly.

CLASSIFICATION CRITERIA

B.7.2.1 Powdered,
granular
or
pasty
chemicals shall be classified as flammable
solids when the time of burning of one or
more of the test runs, performed in accordance with the test method described in the
UN ST/SG/AC.10 (incorporated by reference;
See § 1910.6), Part III, sub-section 33.2.1, is
less than 45 s or the rate of burning is more
than 2.2 mm/s (0.0866 in/s).
B.7.2.2 Powders of metals or metal alloys
shall be classified as flammable solids when
they can be ignited and the reaction spreads
over the whole length of the sample in 10
min or less.
B.7.2.3 Solids which may cause fire
through friction shall be classified in this
class by analogy with existing entries (e.g.,
matches) until definitive criteria are established.
B.7.2.4 A flammable solid shall be classified in one of the two categories for this
class using Method N.1 as described in Part
III, sub-section 33.2.1 of the UN ST/SG/AC.10
(incorporated by reference; See § 1910.6), in
accordance with Table B.7.1:

TABLE B.7.1—CRITERIA FOR FLAMMABLE SOLIDS
Category

Criteria

1 ...................................................................................................

Burning rate test:

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)
TABLE B.7.1—CRITERIA FOR FLAMMABLE SOLIDS—Continued
Category

Criteria

2 ...................................................................................................

NOTE: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for
the purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested
and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.8

SELF-REACTIVE CHEMICALS
B.8.1

DEFINITIONS

Self-reactive chemicals are thermally unstable liquid or solid chemicals liable to undergo a strongly exothermic decomposition
even without participation of oxygen (air).
This definition excludes chemicals classified
under this section as explosives, organic peroxides, oxidizing liquids or oxidizing solids.
A self-reactive chemical is regarded as possessing explosive properties when in laboratory testing the formulation is liable to detonate, to deflagrate rapidly or to show a violent effect when heated under confinement.
B.8.2

CLASSIFICATION CRITERIA

B.8.2.1 A self-reactive chemical shall be
considered for classification in this class unless:
(a) It is classified as an explosive according
to B.1 of this appendix;
(b) It is classified as an oxidizing liquid or
an oxidizing solid according to B.13 or B.14 of
this appendix, except that a mixture of oxidizing substances which contains 5% or more
of combustible organic substances shall be
classified as a self-reactive chemical according to the procedure defined in B.8.2.2;
(c) It is classified as an organic peroxide
according to B.15 of this appendix;
(d) Its heat of decomposition is less than
300 J/g; or
(e) Its self-accelerating decomposition
temperature (SADT) is greater than 75 °C
(167 °F) for a 50 kg (110 lb) package.
B.8.2.2 Mixtures of oxidizing substances,
meeting the criteria for classification as oxidizing liquids or oxidizing solids, which contain 5% or more of combustible organic substances and which do not meet the criteria

Chemicals other than metal powders:
(a) Wetted zone does not stop fire; and
(b) Burning time <45 s or burning rate >2.2 mm/s.
Metal powders: Burning time ≤5 min.
Burning rate test:
Chemicals other than metal powders:
(a) Wetted zone stops the fire for at least 4 min; and
(b) Burning time <45 s or burning rate >2.2 mm/s.
Metal powders: Burning time >5 min and ≤10 min.

mentioned in B.8.2.1 (a), (c), (d) or (e), shall
be subjected to the self-reactive chemicals
classification procedure in B.8.2.3. Such a
mixture showing the properties of a self-reactive chemical type B to F shall be classified as a self-reactive chemical.
B.8.2.3 Self-reactive chemicals shall be
classified in one of the seven categories of
‘‘types A to G’’ for this class, according to
the following principles:
(a) Any self-reactive chemical which can
detonate or deflagrate rapidly, as packaged,
will be defined as self-reactive chemical
TYPE A;
(b) Any self-reactive chemical possessing
explosive properties and which, as packaged,
neither detonates nor deflagrates rapidly,
but is liable to undergo a thermal explosion
in that package will be defined as self-reactive chemical TYPE B;
(c) Any self-reactive chemical possessing
explosive properties when the chemical as
packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion will be
defined as self-reactive chemical TYPE C;
(d) Any self-reactive chemical which in
laboratory testing meets the criteria in
(d)(i), (ii), or (iii) will be defined as self-reactive chemical TYPE D:
(i) Detonates partially, does not deflagrate
rapidly and shows no violent effect when
heated under confinement; or
(ii) Does not detonate at all, deflagrates
slowly and shows no violent effect when
heated under confinement; or
(iii) Does not detonate or deflagrate at all
and shows a medium effect when heated
under confinement;
(e) Any self-reactive chemical which, in
laboratory testing, neither detonates nor
deflagrates at all and shows low or no effect
when heated under confinement will be defined as self-reactive chemical TYPE E;
(f) Any self-reactive chemical which, in
laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows only a low or no effect when heated
under confinement as well as low or no explosive power will be defined as self-reactive
chemical TYPE F;
(g) Any self-reactive chemical which, in
laboratory testing, neither detonates in the

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Occupational Safety and Health Admin., Labor
cavitated state nor deflagrates at all and
shows no effect when heated under confinement nor any explosive power, provided that
it is thermally stable (self-accelerating decomposition temperature is 60 °C (140 °F) to
75 °C (167 °F) for a 50 kg (110 lb) package),
and, for liquid mixtures, a diluent having a
boiling point greater than or equal to 150 °C
(302 °F) is used for desensitization will be defined as self-reactive chemical TYPE G. If
the mixture is not thermally stable or a diluent having a boiling point less than 150 °C
(302 °F) is used for desensitization, the mixture shall be defined as self-reactive chemical TYPE F.
B.8.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

§ 1910.1200

(a) There are no chemical groups present in
the molecule associated with explosive or
self-reactive properties; examples of such
groups are given in Tables A6.1 and A6.2 in
the Appendix 6 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6); or
(b) For a single organic substance or a homogeneous mixture of organic substances,
the estimated SADT is greater than 75 °C
(167 °F) or the exothermic decomposition energy is less than 300 J/g. The onset temperature and decomposition energy may be estimated using a suitable calorimetric technique (See 20.3.3.3 in Part II of the UN ST/SG/
AC.10 (incorporated by reference; See
§ 1910.6)).
B.9

B.8.3.1 For purposes of classification, the
properties of self-reactive chemicals shall be
determined in accordance with test series A
to H as described in Part II of the UN ST/SG/
AC.10 (incorporated by reference; See
§ 1910.6).
B.8.3.2 Self-accelerating
decomposition
temperature (SADT) shall be determined in
accordance with the UN ST/SG/AC.10, Part
II, section 28 (incorporated by reference; See
§ 1910.6).
B.8.3.3 The classification procedures for
self-reactive substances and mixtures need
not be applied if:

PYROPHORIC LIQUIDS
B.9.1

DEFINITION

Pyrophoric liquid means a liquid which,
even in small quantities, is liable to ignite
within five minutes after coming into contact with air.
B.9.2

CLASSIFICATION CRITERIA

A pyrophoric liquid shall be classified in a
single category for this class using test N.3
in Part III, sub-section 33.3.1.5 of the UN ST/
SG/AC.10 (incorporated by reference; See
§ 1910.6), in accordance with Table B.9.1:

TABLE B.9.1—CRITERIA FOR PYROPHORIC LIQUIDS
Category

Criteria

1 .................................

The liquid ignites within 5 min when added to an inert carrier and exposed to air, or it ignites or chars a
filter paper on contact with air within 5 min.

B.9.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.10

PYROPHORIC SOLIDS
B.10.1

The classification procedure for pyrophoric
liquids need not be applied when experience
in production or handling shows that the
chemical does not ignite spontaneously on
coming into contact with air at normal temperatures (i.e., the substance is known to be
stable at room temperature for prolonged periods of time (days)).

DEFINITION

Pyrophoric solid means a solid which, even
in small quantities, is liable to ignite within
five minutes after coming into contact with
air.
B.10.2

CLASSIFICATION CRITERIA

A pyrophoric solid shall be classified in a
single category for this class using test N.2
in Part III, sub-section 33.3.1.4 of the UN ST/
SG/AC.10 (incorporated by reference; See
§ 1910.6), in accordance with Table B.10.1:

TABLE B.10.1—CRITERIA FOR PYROPHORIC SOLIDS
Category

Criteria

1 .............................................

The solid ignites within 5 min of coming into contact with air.

NOTE: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for

the purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.10.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

The classification procedure for pyrophoric
solids need not be applied when experience in
production or handling shows that the chemical does not ignite spontaneously on coming
into contact with air at normal temperatures (i.e., the chemical is known to be stable at room temperature for prolonged periods of time (days)).
B.11

SELF-HEATING CHEMICALS
B.11.1

DEFINITION

A self-heating chemical is a solid or liquid
chemical, other than a pyrophoric liquid or
solid, which, by reaction with air and with-

out energy supply, is liable to self-heat; this
chemical differs from a pyrophoric liquid or
solid in that it will ignite only when in large
amounts (kilograms) and after long periods
of time (hours or days).
NOTE: Self-heating of a substance or mixture is a process where the gradual reaction
of that substance or mixture with oxygen (in
air) generates heat. If the rate of heat production exceeds the rate of heat loss, then
the temperature of the substance or mixture
will rise which, after an induction time, may
lead to self-ignition and combustion.
B.11.2

CLASSIFICATION CRITERIA

B.11.2.1 A self-heating chemical shall be
classified in one of the two categories for
this class if, in tests performed in accordance
with test method N.4 in Part III, sub-section
33.3.1.6 of the UN ST/SG/AC.10 (incorporated
by reference; See § 1910.6), the result meets
the criteria shown in Table B.11.1.

TABLE B.11.1—CRITERIA FOR SELF-HEATING CHEMICALS
Category

Criteria

1 .................................
2 .................................

A positive result is obtained in a test using a 25 mm sample cube at 140 °C (284 °F).
A negative result is obtained in a test using a 25 mm cube sample at 140 °C (284 °F), a positive result
is obtained in a test using a 100 mm sample cube at 140 °C (284 °F), and:
(a) The unit volume of the chemical is more than 3 m3; or
(b) A positive result is obtained in a test using a 100 mm cube sample at 120 °C (248 °F) and the
unit volume of the chemical is more than 450 liters; or
(c) A positive result is obtained in a test using a 100 mm cube sample at 100 °C (212 °F).

B.11.2.2 Chemicals with a temperature of
spontaneous combustion higher than 50 °C
(122 °F) for a volume of 27 m3 shall not be
classified as self-heating chemicals.
B.11.2.3 Chemicals with a spontaneous ignition temperature higher than 50 °C (122 °F)
for a volume of 450 liters shall not be classified in Category 1 of this class.
B.11.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

of the fire and explosion risks in drying powders, Plant Operations Progress, 4 (3), 181–
189, 1985) with an onset temperature 60°K
above the reference temperature for a volume of 1 l.
B.12 CHEMICALS WHICH, IN CONTACT
WITH WATER, EMIT FLAMMABLE GASES
B.12.1

B.11.3.1 The classification procedure for
self-heating chemicals need not be applied if
the results of a screening test can be adequately correlated with the classification
test and an appropriate safety margin is applied.
B.11.3.2 Examples of screening tests are:
(a) The Grewer Oven test (VDI guideline
2263, part 1, 1990, Test methods for the Determination of the Safety Characteristics of
Dusts) with an onset temperature 80°K above
the reference temperature for a volume of 1
l;
(b) The Bulk Powder Screening Test (Gibson, N. Harper, D. J. Rogers, R. Evaluation

DEFINITION

Chemicals which, in contact with water, emit
flammable gases are solid or liquid chemicals
which, by interaction with water, are liable
to become spontaneously flammable or to
give off flammable gases in dangerous quantities.
B.12.2

CLASSIFICATION CRITERIA

B.12.2.1 A chemical which, in contact with
water, emits flammable gases shall be classified in one of the three categories for this
class, using test N.5 in Part III, sub-section
33.4.1.4 of the UN ST/SG/AC.10 (incorporated
by reference; See § 1910.6), in accordance with
Table B.12.1:

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Occupational Safety and Health Admin., Labor

§ 1910.1200

TABLE B.12.1—CRITERIA FOR CHEMICALS WHICH, IN CONTACT WITH WATER, EMIT FLAMMABLE
GASES
Category

Criteria

1 .................................

Any chemical which reacts vigorously with water at ambient temperatures and demonstrates generally a
tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient
temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 liters per
kilogram of chemical over any one minute.
Any chemical which reacts readily with water at ambient temperatures such that the maximum rate of
evolution of flammable gas is equal to or greater than 20 liters per kilogram of chemical per hour, and
which does not meet the criteria for Category 1.
Any chemical which reacts slowly with water at ambient temperatures such that the maximum rate of
evolution of flammable gas is equal to or greater than 1 liter per kilogram of chemical per hour, and
which does not meet the criteria for Categories 1 and 2.

2 .................................

3 .................................

NOTE: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for
the purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested
and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.12.2.2 A chemical is classified as a
chemical which, in contact with water emits
flammable gases if spontaneous ignition
takes place in any step of the test procedure.
B.12.3

(b) Experience in production or handling
shows that the chemical does not react with
water, (e.g., the chemical is manufactured
with water or washed with water); or
(c) The chemical is known to be soluble in
water to form a stable mixture.
B.13

B.13.1

The classification procedure for this class
need not be applied if:
(a) The chemical structure of the chemical
does not contain metals or metalloids;

DEFINITION

Oxidizing liquid means a liquid which, while
in itself not necessarily combustible, may,
generally by yielding oxygen, cause, or contribute to, the combustion of other material.
B.13.2

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

OXIDIZING LIQUIDS

CLASSIFICATION CRITERIA

An oxidizing liquid shall be classified in
one of the three categories for this class
using test O.2 in Part III, sub-section 34.4.2 of
the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with
Table B.13.1:

TABLE B.13.1—CRITERIA FOR OXIDIZING LIQUIDS
Category

Criteria

1 .................................

Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, spontaneously ignites; or the mean pressure rise time of a 1:1 mixture, by mass, of chemical and cellulose is less than
that of a 1:1 mixture, by mass, of 50% perchloric acid and cellulose;
Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, exhibits a mean
pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of
40% aqueous sodium chlorate solution and cellulose; and the criteria for Category 1 are not met;
Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, exhibits a mean
pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of
65% aqueous nitric acid and cellulose; and the criteria for Categories 1 and 2 are not met.

2 .................................

3 .................................

B.13.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.13.3.1 For organic chemicals, the classification procedure for this class shall not be
applied if:
(a) The chemical does not contain oxygen,
fluorine or chlorine; or
(b) The chemical contains oxygen, fluorine
or chlorine and these elements are chemically bonded only to carbon or hydrogen.
B.13.3.2 For inorganic chemicals, the classification procedure for this class shall not

be applied if the chemical does not contain
oxygen or halogen atoms.
B.13.3.3 In the event of divergence between test results and known experience in
the handling and use of chemicals which
shows them to be oxidizing, judgments based
on known experience shall take precedence
over test results.
B.13.3.4 In cases where chemicals generate
a pressure rise (too high or too low), caused
by chemical reactions not characterizing the
oxidizing properties of the chemical, the test
described in Part III, sub-section 34.4.2 of the

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

UN ST/SG/AC.10 (incorporated by reference;
See § 1910.6) shall be repeated with an inert
substance (e.g., diatomite (kieselguhr)) in
place of the cellulose in order to clarify the
nature of the reaction.
B.14

OXIDIZING SOLIDS
B.14.1

DEFINITION

Oxidizing solid means a solid which, while
in itself is not necessarily combustible, may,

generally by yielding oxygen, cause, or contribute to, the combustion of other material.
B.14.2

CLASSIFICATION CRITERIA

An oxidizing solid shall be classified in one
of the three categories for this class using
test O.1 in Part III, sub-section 34.4.1 of the
UN ST/SG/AC.10 (incorporated by reference;
See § 1910.6), in accordance with Table B.14.1:

TABLE B.14.1—CRITERIA FOR OXIDIZING SOLIDS
Category

Criteria

1 .................................

Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.

2 .................................

3 .................................

NOTE 1: Some oxidizing solids may present
explosion hazards under certain conditions
(e.g., when stored in large quantities). For
example, some types of ammonium nitrate
may give rise to an explosion hazard under
extreme conditions and the ‘‘Resistance to
detonation test’’ (IMO: Code of Safe Practice
for Solid Bulk Cargoes, 2005, Annex 3, Test 5)
may be used to assess this hazard. When information indicates that an oxidizing solid
may present an explosion hazard, it shall be
indicated on the Safety Data Sheet.
NOTE 2: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for
the purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested
and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.14.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.14.3.1 For organic chemicals, the classification procedure for this class shall not be
applied if:
(a) The chemical does not contain oxygen,
fluorine or chlorine; or
(b) The chemical contains oxygen, fluorine
or chlorine and these elements are chemically bonded only to carbon or hydrogen.
B.14.3.2 For inorganic chemicals, the classification procedure for this class shall not
be applied if the chemical does not contain
oxygen or halogen atoms.
B.14.3.3 In the event of divergence between test results and known experience in
the handling and use of chemicals which

shows them to be oxidizing, judgements
based on known experience shall take precedence over test results.
B.15

ORGANIC PEROXIDES
B.15.1

DEFINITION

B.15.1.1 Organic peroxide means a liquid or
solid organic chemical which contains the
bivalent –0–0– structure and as such is considered a derivative of hydrogen peroxide,
where one or both of the hydrogen atoms
have been replaced by organic radicals. The
term organic peroxide includes organic peroxide mixtures containing at least one organic peroxide. Organic peroxides are thermally unstable chemicals, which may undergo exothermic self-accelerating decomposition. In addition, they may have one or more
of the following properties:
(a) Be liable to explosive decomposition;
(b) Burn rapidly;
(c) Be sensitive to impact or friction;
(d) React dangerously with other substances.
B.15.1.2 An organic peroxide is regarded as
possessing explosive properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a
violent effect when heated under confinement.
B.15.2

CLASSIFICATION CRITERIA

B.15.2.1 Any organic peroxide shall be
considered for classification in this class, unless it contains:
(a) Not more than 1.0% available oxygen
from the organic peroxides when containing
not more than 1.0% hydrogen peroxide; or

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Occupational Safety and Health Admin., Labor

§ 1910.1200

(b) Not more than 0.5% available oxygen
from the organic peroxides when containing
more than 1.0% but not more than 7.0% hydrogen peroxide.

NOTE: The available oxygen content (%) of
an organic peroxide mixture is given by the
formula:

Where:
ni = number of peroxygen groups per molecule of organic peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.
B.15.2.2 Organic peroxides shall be classified in one of the seven categories of ‘‘Types
A to G’’ for this class, according to the following principles:
(a) Any organic peroxide which, as packaged, can detonate or deflagrate rapidly
shall be defined as organic peroxide TYPE A;
(b) Any organic peroxide possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is
liable to undergo a thermal explosion in that
package shall be defined as organic peroxide
TYPE B;
(c) Any organic peroxide possessing explosive properties when the chemical as packaged cannot detonate or deflagrate rapidly
or undergo a thermal explosion shall be defined as organic peroxide TYPE C;
(d) Any organic peroxide which in laboratory testing meets the criteria in (d)(i), (ii),
or (iii) shall be defined as organic peroxide
TYPE D:
(i) Detonates partially, does not deflagrate
rapidly and shows no violent effect when
heated under confinement; or
(ii) Does not detonate at all, deflagrates
slowly and shows no violent effect when
heated under confinement; or
(iii) Does not detonate or deflagrate at all
and shows a medium effect when heated
under confinement;
(e) Any organic peroxide which, in laboratory
testing,
neither
detonates
nor
deflagrates at all and shows low or no effect
when heated under confinement shall be defined as organic peroxide TYPE E;
(f) Any organic peroxide which, in laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows only a low or no effect when heated
under confinement as well as low or no explosive power shall be defined as organic peroxide TYPE F;
(g) Any organic peroxide which, in laboratory testing, neither detonates in the

cavitated state nor deflagrates at all and
shows no effect when heated under confinement nor any explosive power, provided that
it is thermally stable (self-accelerating decomposition temperature is 60 °C (140 °F) or
higher for a 50 kg (110 lb) package), and, for
liquid mixtures, a diluent having a boiling
point of not less than 150 °C (302 °F) is used
for desensitization, shall be defined as organic peroxide TYPE G. If the organic peroxide is not thermally stable or a diluent
having a boiling point less than 150 °C (302
°F) is used for desensitization, it shall be defined as organic peroxide TYPE F.
B.15.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

B.15.3.1 For purposes of classification, the
properties of organic peroxides shall be determined in accordance with test series A to
H as described in Part II of the UN ST/SG/
AC.10 (incorporated by reference; See
§ 1910.6).
B.15.3.2 Self-accelerating
decomposition
temperature (SADT) shall be determined in
accordance with the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), Part II,
section 28.
B.15.3.3 Mixtures of organic peroxides
may be classified as the same type of organic
peroxide as that of the most dangerous ingredient. However, as two stable ingredients
can form a thermally less stable mixture,
the SADT of the mixture shall be determined.
B.16

CORROSIVE TO METALS
B.16.1

DEFINITION

A chemical which is corrosive to metals means
a chemical which by chemical action will
materially damage, or even destroy, metals.
B.16.2

CLASSIFICATION CRITERIA

A chemical which is corrosive to metals
shall be classified in a single category for
this class, using the test in Part III, sub-section 37.4 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.16.1:

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)
TABLE B.16.1—CRITERIA FOR CHEMICALS CORROSIVE TO METAL

Category

Criteria

1 .................................

Corrosion rate on either steel or aluminium surfaces exceeding 6.25 mm per year at a test temperature
of 55 °C (131 °F) when tested on both materials.

NOTE: Where an initial test on either steel
or aluminium indicates the chemical being
tested is corrosive, the follow-up test on the
other metal is not necessary.
B.16.3

ADDITIONAL CLASSIFICATION
CONSIDERATIONS

The specimen to be used for the test shall
be made of the following materials:
(a) For the purposes of testing steel, steel
types S235JR+CR (1.0037 resp.St 37–2),
S275J2G3+CR (1.0144 resp.St 44–3), ISO 3574,
Unified Numbering System (UNS) G 10200, or
SAE 1020;
(b) For the purposes of testing aluminium:
Non-clad types 7075–T6 or AZ5GU–T6.
APPENDIX C TO § 1910.1200—ALLOCATION OF
LABEL ELEMENTS (MANDATORY)
C.1 The label for each hazardous chemical
shall include the product identifier used on
the safety data sheet.
C.1.1 The labels on shipped containers
shall also include the name, address, and
telephone number of the chemical manufacturer, importer, or responsible party.
C.2 The label for each hazardous chemical
that is classified shall include the signal
word, hazard statement(s), pictogram(s), and
precautionary statement(s) specified in C.4
for each hazard class and associated hazard
category, except as provided for in C.2.1
through C.2.4.
C.2.1

PRECEDENCE OF HAZARD INFORMATION

C.2.1.1 If the signal word ‘‘Danger’’ is included, the signal word ‘‘Warning’’ shall not
appear;
C.2.1.2 If the skull and crossbones pictogram is included, the exclamation mark pic-

togram shall not appear where it is used for
acute toxicity;
C.2.1.3 If the corrosive pictogram is included, the exclamation mark pictogram
shall not appear where it is used for skin or
eye irritation;
C.2.1.4 If the health hazard pictogram is
included for respiratory sensitization, the
exclamation mark pictogram shall not appear where it is used for skin sensitization or
for skin or eye irritation.
C.2.2

HAZARD STATEMENT TEXT

C.2.2.1 The text of all applicable hazard
statements shall appear on the label, except
as otherwise specified. The information in
italics shall be included as part of the hazard
statement as provided. For example: ‘‘causes
damage to organs (state all organs affected)
through prolonged or repeated exposure
(state route of exposure if no other routes of exposure cause the hazard)’’. Hazard statements
may be combined where appropriate to reduce the information on the label and improve readability, as long as all of the hazards are conveyed as required.
C.2.2.2 If the chemical manufacturer, importer, or responsible party can demonstrate
that all or part of the hazard statement is
inappropriate to a specific substance or mixture, the corresponding statement may be
omitted from the label.
C.2.3

PICTOGRAMS

C.2.3.1 Pictograms shall be in the shape of
a square set at a point and shall include a
black hazard symbol on a white background
with a red frame sufficiently wide to be
clearly visible. A square red frame set at a
point without a hazard symbol is not a pictogram and is not permitted on the label.

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§ 1910.1200

C.2.4

29 CFR Ch. XVII (7–1–13 Edition)

PRECAUTIONARY STATEMENT TEXT

C.2.4.1 There are four types of precautionary statements presented, ‘‘prevention,’’ ‘‘response,’’ ‘‘storage,’’ and ‘‘disposal.’’ The core part of the precautionary
statement is presented in bold print. This is
the text, except as otherwise specified, that
shall appear on the label. Where additional
information is required, it is indicated in
plain text.
C.2.4.2 When a backslash or diagonal
mark (/) appears in the precautionary statement text, it indicates that a choice has to
be made between the separated phrases. In
such cases, the chemical manufacturer, importer, or responsible party can choose the
most appropriate phrase(s). For example,
‘‘Wear protective gloves/protective clothing/
eye protection/face protection’’ could read
‘‘wear eye protection’’.
C.2.4.3 When three full stops (* * *) appear
in the precautionary statement text, they
indicate that all applicable conditions are
not listed. For example, in ‘‘Use explosionproof
electrical/ventilating/lighting/* * */
equipment’’, the use of ‘‘* * *’’ indicates that
other equipment may need to be specified. In
such cases, the chemical manufacturer, importer, or responsible party can choose the
other conditions to be specified.
C.2.4.4 When text in italics is used in a precautionary statement, this indicates specific
conditions applying to the use or allocation
of the precautionary statement. For example, ‘‘Use explosion-proof electrical/ventilating/lighting/* * */equipment’’ is only required for flammable solids ‘‘if dust clouds
can occur’’. Text in italics is intended to be
an explanatory, conditional note and is not
intended to appear on the label.
C.2.4.5 Where square brackets ([ ]) appear
around text in a precautionary statement,
this indicates that the text in square brack-

ets is not appropriate in every case and
should be used only in certain circumstances. In these cases, conditions for
use explaining when the text should be used
are provided. For example, one precautionary statement states: ‘‘[In case of inadequate ventilation] wear respiratory protection.’’ This statement is given with the
condition for use ‘‘– text in square brackets
may be used if additional information is provided with the chemical at the point of use
that explains what type of ventilation would
be adequate for safe use’’. This means that,
if additional information is provided with
the chemical explaining what type of ventilation would be adequate for safe use, the
text in square brackets should be used and
the statement would read: ‘‘In case of inadequate ventilation wear respiratory protection.’’ However, if the chemical is supplied
without such ventilation information, the
text in square brackets should not be used,
and the precautionary statement should
read: ‘‘Wear respiratory protection.’’
C.2.4.6 Precautionary statements may be
combined or consolidated to save label space
and improve readability. For example, ‘‘Keep
away from heat, sparks and open flame,’’
‘‘Store in a well-ventilated place’’ and ‘‘Keep
cool’’ can be combined to read ‘‘Keep away
from heat, sparks and open flame and store
in a cool, well-ventilated place.’’
C.2.4.7 In most cases, the precautionary
statements are independent (e.g., the phrases
for explosive hazards do not modify those related to certain health hazards, and products
that are classified for both hazard classes
shall bear appropriate precautionary statements for both). Where a chemical is classified for a number of hazards, and the precautionary statements are similar, the most
stringent shall be included on the label (this
will be applicable mainly to preventive
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Occupational Safety and Health Admin., Labor
imposed by the chemical manufacturer, importer or responsible party in situations
where phrases concern ‘‘Response.’’ Rapid
action may be crucial. For example, if a
chemical is carcinogenic and acutely toxic,
rapid action may be crucial, and first aid
measures for acute toxicity will take precedence over those for long-term effects. In addition, medical attention to delayed health
effects may be required in cases of incidental
exposure, even if not associated with immediate symptoms of intoxication.
C.2.4.8 If the chemical manufacturer, importer, or responsible party can demonstrate
that a precautionary statement is inappropriate to a specific substance or mixture, the
precautionary statement may be omitted
from the label.
C.3

SUPPLEMENTARY HAZARD INFORMATION

§ 1910.1200

wide variation or undermine the required information, supplementary information on
the label is limited to when it provides further detail and does not contradict or cast
doubt on the validity of the standardized
hazard information.
C.3.2 Where the chemical manufacturer,
importer, or distributor chooses to add supplementary information on the label, the
placement of supplemental information shall
not impede identification of information required by this section.
C.3.3 Where an ingredient with unknown
acute toxicity is used in a mixture at a concentration ≥1%, and the mixture is not classified based on testing of the mixture as a
whole, a statement that X% of the mixture
consists of ingredient(s) of unknown acute
toxicity is required on the label.

C.3.1 To ensure that non-standardized information does not lead to unnecessarily

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29 CFR Ch. XVII (7–1–13 Edition)

APPENDIX D TO § 1910.1200—SAFETY DATA
SHEETS (MANDATORY)
A safety data sheet (SDS) shall include the
information specified in Table D.1 under the

section number and heading indicated for
sections 1–11 and 16. If no relevant information is found for any given subheading within a section, the SDS shall clearly indicate

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§ 1910.1200

that no applicable information is available.
Sections 12–15 may be included in the SDS,
but are not mandatory.

TABLE D.1—MINIMUM INFORMATION FOR AN SDS
Heading

Subheading

1. Identification ............................................

(a) Product identifier used on the label;
(b) Other means of identification;
(c) Recommended use of the chemical and restrictions on use;
(d) Name, address, and telephone number of the chemical manufacturer, importer,
or other responsible party;
(e) Emergency phone number.
(a) Classification of the chemical in accordance with paragraph (d) of § 1910.1200;
(b) Signal word, hazard statement(s), symbol(s) and precautionary statement(s) in
accordance with paragraph (f) of § 1910.1200. (Hazard symbols may be provided
as graphical reproductions in black and white or the name of the symbol, e.g.,
flame, skull and crossbones);
(c) Describe any hazards not otherwise classified that have been identified during
the classification process;
(d) Where an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥1% and the mixture is not classified based on testing of the mixture
as a whole, a statement that X% of the mixture consists of ingredient(s) of unknown acute toxicity is required.
Except as provided for in paragraph (i) of § 1910.1200 on trade secrets:
For Substances
(a) Chemical name;
(b) Common name and synonyms;
(c) CAS number and other unique identifiers;
(d) Impurities and stabilizing additives which are themselves classified and which
contribute to the classification of the substance.
For Mixtures
In addition to the information required for substances:
(a) The chemical name and concentration (exact percentage) or concentration
ranges of all ingredients which are classified as health hazards in accordance
with paragraph (d) of § 1910.1200 and
(1) Are present above their cut-off/concentration limits; or
(2) Present a health risk below the cut-off/concentration limits.
(b) The concentration (exact percentage) shall be specified unless a trade secret
claim is made in accordance with paragraph (i) of § 1910.1200, when there is
batch-to-batch variability in the production of a mixture, or for a group of substantially similar mixtures (See A.0.5.1.2) with similar chemical composition. In
these cases, concentration ranges may be used.
For All Chemicals Where a Trade Secret is Claimed
Where a trade secret is claimed in accordance with paragraph (i) of § 1910.1200, a
statement that the specific chemical identity and/or exact percentage (concentration) of composition has been withheld as a trade secret is required.
(a) Description of necessary measures, subdivided according to the different routes
of exposure, i.e., inhalation, skin and eye contact, and ingestion;
(b) Most important symptoms/effects, acute and delayed.
(c) Indication of immediate medical attention and special treatment needed, if necessary.
(a) Suitable (and unsuitable) extinguishing media.
(b) Specific hazards arising from the chemical (e.g., nature of any hazardous combustion products).
(c) Special protective equipment and precautions for fire-fighters.
(a) Personal precautions, protective equipment, and emergency procedures.
(b) Methods and materials for containment and cleaning up.
(a) Precautions for safe handling.
(b) Conditions for safe storage, including any incompatibilities.
(a) OSHA permissible exposure limit (PEL), American Conference of Governmental
Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet, where available.
(b) Appropriate engineering controls.
(c) Individual protection measures, such as personal protective equipment.
(a) Appearance (physical state, color, etc.);
(b) Odor;
(c) Odor threshold;
(d) pH;
(e) Melting point/freezing point;
(f) Initial boiling point and boiling range;
(g) Flash point;
(h) Evaporation rate;
(i) Flammability (solid, gas);

2. Hazard(s) identification ...........................

3. Composition/information on ingredients

4. First-aid measures ..................................

5. Fire-fighting measures ............................

6. Accidental release measures ..................
7. Handling and storage ..............................
8. Exposure controls/personal protection ...

9. Physical and chemical properties ...........

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)
TABLE D.1—MINIMUM INFORMATION FOR AN SDS—Continued

Heading

Subheading

10. Stability and reactivity ...........................

11. Toxicological information ......................

12. Ecological information (Non-mandatory)

13. Disposal considerations (Non-mandatory).
14. Transport information (Non-mandatory)

15. Regulatory information (Non-mandatory).
16. Other information, including date of
preparation or last revision.

(j) Upper/lower flammability or explosive limits;
(k) Vapor pressure;
(l) Vapor density;
(m) Relative density;
(n) Solubility(ies);
(o) Partition coefficient: n-octanol/water;
(p) Auto-ignition temperature;
(q) Decomposition temperature;
(r) Viscosity.
(a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous reactions;
(d) Conditions to avoid (e.g., static discharge, shock, or vibration);
(e) Incompatible materials;
(f) Hazardous decomposition products.
Description of the various toxicological (health) effects and the available data used
to identify those effects, including:
(a) Information on the likely routes of exposure (inhalation, ingestion, skin and eye
contact);
(b) Symptoms related to the physical, chemical and toxicological characteristics;
(c) Delayed and immediate effects and also chronic effects from short- and longterm exposure;
(d) Numerical measures of toxicity (such as acute toxicity estimates).
(e) Whether the hazardous chemical is listed in the National Toxicology Program
(NTP) Report on Carcinogens (latest edition) or has been found to be a potential
carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest edition), or by OSHA.
(a) Ecotoxicity (aquatic and terrestrial, where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as hazardous to the ozone layer).
Description of waste residues and information on their safe handling and methods
of disposal, including the disposal of any contaminated packaging.
(a) UN number;
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g., Marine pollutant (Yes/No));
(f) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code);
(g) Special precautions which a user needs to be aware of, or needs to comply
with, in connection with transport or conveyance either within or outside their
premises.
Safety, health and environmental regulations specific for the product in question.
The date of preparation of the SDS or the last change to it.

APPENDIX E TO § 1910.1200—DEFINITION OF
‘‘TRADE SECRET’’ (MANDATORY)
The following is a reprint of the Restatement of Torts section 757, comment b (1939):
b. Definition of trade secret. A trade secret
may consist of any formula, pattern, device
or compilation of information which is used
in one’s business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it. It may be
a formula for a chemical compound, a process of manufacturing, treating or preserving
materials, a pattern for a machine or other
device, or a list of customers. It differs from
other secret information in a business (see
s759 of the Restatement of Torts which is not
included in this Appendix) in that it is not
simply information as to single or ephemeral

events in the conduct of the business, as, for
example, the amount or other terms of a secret bid for a contract or the salary of certain employees, or the security investments
made or contemplated, or the date fixed for
the announcement of a new policy or for
bringing out a new model or the like. A trade
secret is a process or device for continuous
use in the operations of the business. Generally it relates to the production of goods,
as, for example, a machine or formula for the
production of an article. It may, however, relate to the sale of goods or to other operations in the business, such as a code for determining discounts, rebates or other concessions in a price list or catalogue, or a list of
specialized customers, or a method of bookkeeping or other office management.

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Occupational Safety and Health Admin., Labor
Secrecy. The subject matter of a trade secret must be secret. Matters of public knowledge or of general knowledge in an industry
cannot be appropriated by one as his secret.
Matters which are completely disclosed by
the goods which one markets cannot be his
secret. Substantially, a trade secret is
known only in the particular business in
which it is used. It is not requisite that only
the proprietor of the business know it. He
may, without losing his protection, communicate it to employees involved in its use. He
may likewise communicate it to others
pledged to secrecy. Others may also know of
it independently, as, for example, when they
have discovered the process or formula by
independent invention and are keeping it secret. Nevertheless, a substantial element of
secrecy must exist, so that, except by the
use of improper means, there would be difficulty in acquiring the information. An
exact definition of a trade secret is not possible. Some factors to be considered in determining whether given information is one’s
trade secret are: (1) The extent to which the
information is known outside of his business;
(2) the extent to which it is known by employees and others involved in his business;
(3) the extent of measures taken by him to
guard the secrecy of the information; (4) the
value of the information to him and his competitors; (5) the amount of effort or money
expended by him in developing the information; (6) the ease or difficulty with which the
information could be properly acquired or
duplicated by others.
Novelty and prior art. A trade secret may be
a device or process which is patentable; but
it need not be that. It may be a device or
process which is clearly anticipated in the
prior art or one which is merely a mechanical improvement that a good mechanic can
make. Novelty and invention are not requisite for a trade secret as they are for patentability. These requirements are essential
to patentability because a patent protects
against unlicensed use of the patented device
or process even by one who discovers it properly through independent research. The patent monopoly is a reward to the inventor.
But such is not the case with a trade secret.
Its protection is not based on a policy of rewarding or otherwise encouraging the development of secret processes or devices. The
protection is merely against breach of faith
and reprehensible means of learning another’s secret. For this limited protection it
is not appropriate to require also the kind of
novelty and invention which is a requisite of
patentability. The nature of the secret is,
however, an important factor in determining
the kind of relief that is appropriate against
one who is subject to liability under the rule
stated in this Section. Thus, if the secret
consists of a device or process which is a
novel invention, one who acquires the secret
wrongfully is ordinarily enjoined from fur-

§ 1910.1200

ther use of it and is required to account for
the profits derived from his past use. If, on
the other hand, the secret consists of mechanical improvements that a good mechanic can make without resort to the secret, the wrongdoer’s liability may be limited to damages, and an injunction against
future use of the improvements made with
the aid of the secret may be inappropriate.
APPENDIX F TO § 1910.1200—GUIDANCE FOR
HAZARD CLASSIFICATIONS RE: CARCINOGENICITY (NON-MANDATORY)
The mandatory criteria for classification
of a chemical for carcinogenicity under HCS
(§ 1910.1200) are found in Appendix A.6 to this
section. This non-mandatory Appendix provides additional guidance on hazard classification for carcinogenicity. Part A of Appendix F includes background guidance provided by GHS based on the Preamble of the
International Agency for Research on Cancer
(IARC) ‘‘Monographs on the Evaluation of
Carcinogenic Risks to Humans’’ (2006). Part
B provides IARC classification information.
Part C provides background guidance from
the National Toxicology Program (NTP)
‘‘Report on Carcinogens’’ (RoC), and Part D
is a table that compares GHS carcinogen
hazard categories to carcinogen classifications under IARC and NTP, allowing classifiers to be able to use information from
IARC and NTP RoC carcinogen classifications to complete their classifications under
the GHS, and thus the HCS.
PART A: BACKGROUND GUIDANCE 1
As noted in Footnote 6 of Appendix A.6. to
this section, the GHS includes as guidance
for classifiers information taken from the
Preamble of the International Agency for
Research on Cancer (IARC) ‘‘Monographs on
the Evaluation of Carcinogenic Risks to Humans’’ (2006), providing guidance on the evaluation of the strength and evidence of carcinogenic risks to humans. This guidance
also discusses some additional considerations in classification and an approach to
analysis, rather than hard-and-fast rules.
Part A is consistent with Appendix A.6, and
should help in evaluating information to determine carcinogenicity.
Carcinogenicity in humans:
The evidence relevant to carcinogenicity
from studies in humans is classified into one
of the following categories:
1 The text of Appendix F, Part A, on the IARC
Monographs, is paraphrased from the 2006 Preamble to the ‘‘Monographs on the Evaluation of
Carcinogenic Risks to Humans’’; the Classifier is
referred to the full IARC Preamble for the complete text. The text is not part of the agreed
GHS text on the harmonized system developed
by the OECD Task Force-HCL.

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

(a) Sufficient evidence of carcinogenicity:
A causal relationship has been established
between exposure to the agent and human
cancer. That is, a positive relationship has
been observed between the exposure and cancer in studies in which chance, bias and confounding could be ruled out with reasonable
confidence.
(b) Limited evidence of carcinogenicity: A
positive association has been observed between exposure to the agent and cancer for
which a causal interpretation is considered
by the Working Group to be credible, but
chance, bias or confounding could not be
ruled out with reasonable confidence.
In some instances, the above categories
may be used to classify the degree of evidence related to carcinogenicity in specific
organs or tissues.
Carcinogenicity in experimental animals:
The evidence relevant to carcinogenicity
in experimental animals is classified into
one of the following categories:
(a) Sufficient evidence of carcinogenicity:
A causal relationship has been established
between the agent and an increased incidence of malignant neoplasms or of an appropriate combination of benign and malignant
neoplasms in two or more species of animals
or two or more independent studies in one
species carried out at different times or in
different laboratories or under different protocols. An increased incidence of tumors in
both sexes of a single species in a well-conducted study, ideally conducted under Good
Laboratory Practices, can also provide sufficient evidence.
Exceptionally, a single study in one species
and sex might be considered to provide sufficient evidence of carcinogenicity when malignant neoplasms occur to an unusual degree with regard to incidence, site, type of
tumor or age at onset, or when there are
strong findings of tumors at multiple sites.
(b) Limited evidence of carcinogenicity:
The data suggest a carcinogenic effect but
are limited for making a definitive evaluation because, e.g. the evidence of carcinogenicity is restricted to a single experiment;
there are unresolved questions regarding the
adequacy of the design, conduct or interpretation of the studies; the agent increases the
incidence only of benign neoplasms or lesions of uncertain neoplastic potential; or
the evidence of carcinogenicity is restricted
to studies that demonstrate only promoting
activity in a narrow range of tissues or organs.
Guidance on How To Consider Important Factors in Classification of Carcinogenicity (See
Reference Section)
The weight of evidence analysis called for
in GHS and the HCS (§ 1910.1200) is an integrative approach that considers important
factors in determining carcinogenic potential along with the strength of evidence anal-

ysis. The IPCS ‘‘Conceptual Framework for
Evaluating a Mode of Action for Chemical Carcinogenesis’’
(2001),
International
Life
Sciences Institute (ILSI) ‘‘Framework for
Human Relevance Analysis of Information on
Carcinogenic Modes of Action’’ (Meek, et al.,
2003; Cohen et al., 2003, 2004), and Preamble to
the IARC Monographs (2006; Section B.6.
(Scientific Review and Evaluation; Evaluation and Rationale)) provide a basis for systematic assessments that may be performed
in a consistent fashion. The IPCS also convened a panel in 2004 to further develop and
clarify the human relevance framework.
However, the above documents are not intended to dictate answers, nor provide lists
of criteria to be checked off.
Mode of Action
Various documents on carcinogen assessment all note that mode of action in and of
itself, or consideration of comparative metabolism, should be evaluated on a case-bycase basis and are part of an analytic evaluative approach. One must look closely at any
mode of action in animal experiments, taking
into
consideration
comparative
toxicokinetics/toxicodynamics between the
animal test species and humans to determine
the relevance of the results to humans. This
may lead to the possibility of discounting
very specific effects of certain types of substances. Life stage-dependent effects on cellular differentiation may also lead to qualitative differences between animals and humans. Only if a mode of action of tumor development is conclusively determined not to
be operative in humans may the carcinogenic evidence for that tumor be discounted.
However, a weight of evidence evaluation for
a substance calls for any other tumorigenic
activity to be evaluated, as well.
Responses in Multiple Animal Experiments
Positive responses in several species add to
the weight of evidence that a substance is a
carcinogen. Taking into account all of the
factors listed in A.6.2.5.2 and more, such
chemicals with positive outcomes in two or
more species would be provisionally considered to be classified in GHS Category 1B
until human relevance of animal results are
assessed in their entirety. It should be noted,
however, that positive results for one species
in at least two independent studies, or a single positive study showing unusually strong
evidence of malignancy may also lead to
Category 1B.
Responses Are in One Sex or Both Sexes
Any case of gender-specific tumors should
be evaluated in light of the total
tumorigenic response to the substance observed at other sites (multi-site responses or
incidence above background) in determining
the carcinogenic potential of the substance.

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Occupational Safety and Health Admin., Labor
If tumors are seen only in one sex of an
animal species, the mode of action should be
carefully evaluated to see if the response is
consistent with the postulated mode of action. Effects seen only in one sex in a test
species may be less convincing than effects
seen in both sexes, unless there is a clear
patho-physiological difference consistent
with the mode of action to explain the single
sex response.
Confounding Effects of Excessive Toxicity or
Localized Effects
Tumors occurring only at excessive doses
associated with severe toxicity generally
have doubtful potential for carcinogenicity
in humans. In addition, tumors occurring
only at sites of contact and/or only at excessive doses need to be carefully evaluated for
human relevance for carcinogenic hazard.
For example, forestomach tumors, following
administration by gavage of an irritating or
corrosive, non-mutagenic chemical, may be
of questionable relevance. However, such determinations must be evaluated carefully in
justifying the carcinogenic potential for humans; any occurrence of other tumors at distant sites must also be considered.
Tumor Type, Reduced Tumor Latency
Unusual tumor types or tumors occurring
with reduced latency may add to the weight
of evidence for the carcinogenic potential of
a substance, even if the tumors are not statistically significant.
Toxicokinetic behavior is normally assumed to be similar in animals and humans,
at least from a qualitative perspective. On
the other hand, certain tumor types in animals may be associated with toxicokinetics
or toxicodynamics that are unique to the
animal species tested and may not be predictive of carcinogenicity in humans. Very
few such examples have been agreed internationally. However, one example is the lack
of human relevance of kidney tumors in
male rats associated with compounds causing a2u-globulin nephropathy (IARC, Scientific Publication N° 147 2). Even when a
particular tumor type may be discounted,
expert judgment must be used in assessing
the total tumor profile in any animal experiment.
PART B: INTERNATIONAL AGENCY FOR
RESEARCH ON CANCER (IARC) 3
IARC Carcinogen Classification Categories:
2 While most international agencies do not
consider kidney tumors coincident with α2uglobulin nephropathy to be a predictor of risk in
humans, this view is not universally held. (See:
Doi et al., 2007).
3 Preamble of the International Agency for Research on Cancer (IARC) ‘‘Monographs on the

§ 1910.1200

Group 1: The agent is carcinogenic to humans
This category is used when there is sufficient evidence of carcinogenicity in humans.
Exceptionally, an agent may be placed in
this category when evidence of carcinogenicity in humans is less than sufficient but
there is sufficient evidence of carcinogenicity
in experimental animals and strong evidence
in exposed humans that the agent acts
through a relevant mechanism of carcinogenicity.
Group 2:
This category includes agents for which, at
one extreme, the degree of evidence of carcinogenicity in humans is almost sufficient,
as well as those for which, at the other extreme, there are no human data but for
which there is evidence of carcinogenicity in
experimental animals. Agents are assigned
to either Group 2A (probably carcinogenic to
humans) or Group 2B (possibly carcinogenic to
humans) on the basis of epidemiological and
experimental evidence of carcinogenicity
and mechanistic and other relevant data.
The terms probably carcinogenic and possibly
carcinogenic have no quantitative significance and are used simply as descriptors of
different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.
Group 2A: The agent is probably carcinogenic to human.
This category is used when there is limited
evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals. In some cases, an agent may
be classified in this category when there is
inadequate evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity
in experimental animals and strong evidence
that the carcinogenesis is mediated by a
mechanism that also operates in humans.
Exceptionally, an agent may be classified in
this category solely on the basis of limited
evidence of carcinogenicity in humans. An
agent may be assigned to this category if it
clearly belongs, based on mechanistic considerations, to a class of agents for which
one or more members have been classified in
Group 1 or Group 2A.
Group 2B: The agent is possibly carcinogenic
to humans.
This category is used for agents for which
there is limited evidence of carcinogenicity in
humans and less than sufficient evidence of
carcinogenicity in experimental animals. It
may also be used when there is inadequate
evidence of carcinogenicity in humans but
there is sufficient evidence of carcinogenicity
in experimental animals. In some instances,
Evaluation of Carcinogenic Risks to Humans’’
(2006).

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§ 1910.1200

29 CFR Ch. XVII (7–1–13 Edition)

an agent for which there is inadequate evidence of carcinogenicity in humans and less
than sufficient evidence of carcinogenicity in
experimental animals together with supporting evidence from mechanistic and other
relevant data may be placed in this group.
An agent may be classified in this category
solely on the basis of strong evidence from
mechanistic and other relevant data.
PART C: NATIONAL TOXICOLOGY PROGRAM
(NTP), ‘‘REPORT ON CARCINOGENS’’, BACKGROUND GUIDANCE
NTP Listing Criteria 4:
The criteria for listing an agent, substance, mixture, or exposure circumstance in
the Report on Carcinogens (RoC) are as follows:
Known To Be A Human Carcinogen: There
is sufficient evidence of carcinogenicity from
studies in humans 5 that indicates a causal
relationship between exposure to the agent,
substance, or mixture, and human cancer.
Reasonably Anticipated To Be A Human
Carcinogen: There is limited evidence of carcinogenicity from studies in humans that indicates that a causal interpretation is credible, but that alternative explanations, such
as chance, bias, or confounding factors, could
not adequately be excluded,
or
there is sufficient evidence of carcinogenicity from studies in experimental animals that indicates there is an increased incidence of malignant and/or a combination of
malignant and benign tumors in multiple
species or at multiple tissue sites, or by multiple routes of exposure, or to an unusual degree with regard to incidence, site, or type of
tumor, or age at onset,
or

there is less than sufficient evidence of carcinogenicity in humans or laboratory animals; however, the agent, substance, or mixture belongs to a well-defined, structurallyrelated class of substances whose members
are listed in a previous Report on Carcinogens as either known to be a human carcinogen or reasonably anticipated to be a
human carcinogen, or there is convincing
relevant information that the agent acts
through mechanisms indicating it would
likely cause cancer in humans.
Conclusions regarding carcinogenicity in
humans or experimental animals are based
on scientific judgment, with consideration
given to all relevant information. Relevant
information includes, but is not limited to,
dose response, route of exposure, chemical
structure, metabolism, pharmacokinetics,
sensitive sub-populations, genetic effects, or
other data relating to mechanism of action
or factors that may be unique to a given substance. For example, there may be substances for which there is evidence of carcinogenicity in laboratory animals, but
there are compelling data indicating that
the agent acts through mechanisms that do
not operate in humans and would therefore
not reasonably be anticipated to cause cancer in humans.
PART D: TABLE RELATING APPROXIMATE
EQUIVALENCES AMONG IARC, NTP ROC, AND
GHS CARCINOGENICITY CLASSIFICATIONS
The following table may be used to perform hazard classifications for carcinogenicity under the HCS (§ 1910.1200). It relates the approximated GHS hazard categories for carcinogenicity to the classifications provided by IARC and NTP, as described in Parts B and C of this Appendix.

APPROXIMATE EQUIVALENCES AMONG CARCINOGEN CLASSIFICATION SCHEMES
IARC

GHS

Group 1 ....................................
Group 2A ..................................
Group 2B ..................................

Category 1A ............................
Category 1B ............................
Category 2 ...............................

NTP RoC

Note 1:
1. Limited evidence of carcinogenicity from
studies in humans (corresponding to IARC 2A/
GHS 1B);
2. Sufficient evidence of carcinogenicity from
studies in experimental animals (again, essentially corresponding to IARC 2A/GHS 1B);

4 See:

http://ntp.niehs.nih.gov/go/15209.
evidence can include traditional cancer
epidemiology studies, data from clinical studies,
and/or data derived from the study of tissues or
5 This

Known.
Reasonably Anticipated (See Note 1).
Reasonably Anticipated (See Note 1).

3. Less than sufficient evidence of carcinogenicity in humans or laboratory animals; however:
a. The agent, substance, or mixture belongs to
a well-defined, structurally-related class of substances whose members are listed in a previous
RoC as either ‘‘Known’’ or ‘‘Reasonably Anticipated’’ to be a human carcinogen, or

cells from humans exposed to the substance in
question that can be useful for evaluating
whether a relevant cancer mechanism is operating in people.

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Occupational Safety and Health Admin., Labor
b. There is convincing relevant information
that the agent acts through mechanisms indicating it would likely cause cancer in humans.
*REFERENCES
Cohen, S.M., J. Klaunig, M.E. Meek, R.N.
Hill, T. Pastoor, L. Lehman-McKeeman,
J. Bucher, D.G. Longfellow, J. Seed, V.
Dellarco, P. Fenner-Crisp, and D. Patton.
2004. Evaluating the human relevance of
chemically induced animal tumors.
Toxicol. Sci. 78(2):181–186.
Cohen, S.M., M.E. Meek, J.E. Klaunig, D.E.
Patton, P.A. Fenner-Crisp. 2003. The
human relevance of information on carcinogenic modes of action: Overview.
Crit. Rev. Toxicol. 33(6):581–9.
Meek, M.E., J.R. Bucher, S.M. Cohen, V.
Dellarco,
R.N.
Hill,
L.
LehmanMcKeeman, D.G. Longfellow, T. Pastoor,
J. Seed, D.E. Patton. 2003. A framework
for human relevance analysis of information on carcinogenic modes of action.
Crit. Rev. Toxicol. 33(6):591–653.
Sonich-Mullin, C., R. Fielder, J. Wiltse, K.
Baetcke, J. Dempsey, P. Fenner-Crisp, D.
Grant, M. Hartley, A. Knapp, D. Kroese,
I. Mangelsdorf, E. Meek, J.M. Rice, and
M. Younes. 2001. The conceptual framework for evaluating a mode of action for
chemical carcinogenesis. Reg. Toxicol.
Pharm. 34:146–152.
International Programme on Chemical Safety Harmonization Group. 2004. Report of
the First Meeting of the Cancer Working
Group. World Health Organization. Report IPCS/HSC–CWG–1/04. Geneva.
International Agency for Research on Cancer. IARC Monographs on the Evaluation
of Carcinogenic Risks to Human. Preambles to Volumes. World Health Organization. Lyon, France.
Cohen, S.M., P.A. Fenner-Crisp, and D.E.
Patton. 2003. Special Issue: Cancer Modes
of Action and Human Relevance. Critical
Reviews in Toxicology, R.O. McClellan,
ed., Volume 33/Issue 6. CRC Press.
Capen, C.C., E. Dybing, and J.D. Wilbourn.
1999. Species differences in thyroid, kidney and urinary bladder carcinogenesis.
International Agency for Research on
Cancer, Scientific Publication N° 147.
Doi, A.M., G. Hill, J. Seely, J.R. Hailey, G.
Kissling, and J.R. Buchera. 2007. a2uGlobulin nephropathy and renal tumors
in National Toxicology Program studies.
Toxicol. Pathol. 35:533–540.
[59 FR 6170, Feb. 9, 1994, as amended at 59 FR
17479, Apr. 13, 1994; 59 FR 65948, Dec. 22, 1994;
61 FR 9245, Mar. 7. 1996; 77 FR 17785, Mar. 26,
2012; 78 FR 9313, Feb. 8, 2013]

§ 1910.1450

§ 1910.1201 Retention of DOT markings, placards and labels.
(a) Any employer who receives a
package of hazardous material which is
required to be marked, labeled or placarded in accordance with the U. S. Department of Transportation’s Hazardous Materials Regulations (49 CFR
Parts 171 through 180) shall retain
those markings, labels and placards on
the package until the packaging is sufficiently cleaned of residue and purged
of vapors to remove any potential hazards.
(b) Any employer who receives a
freight container, rail freight car,
motor vehicle, or transport vehicle
that is required to be marked or placarded in accordance with the Hazardous Materials Regulations shall retain those markings and placards on
the freight container, rail freight car,
motor vehicle or transport vehicle
until the hazardous materials which require the marking or placarding are
sufficiently removed to prevent any potential hazards.
(c) Markings, placards and labels
shall be maintained in a manner that
ensures that they are readily visible.
(d) For non-bulk packages which will
not be reshipped, the provisions of this
section are met if a label or other acceptable marking is affixed in accordance with the Hazard Communication
Standard (29 CFR 1910.1200).
(e) For the purposes of this section,
the term ‘‘hazardous material’’ and
any other terms not defined in this section have the same definition as in the
Hazardous Materials Regulations (49
CFR Parts 171 through 180).
[59 FR 36700, July 19, 1994]

§ 1910.1450 Occupational exposure to
hazardous chemicals in laboratories.
(a) Scope and application. (1) This section shall apply to all employers engaged in the laboratory use of hazardous chemicals as defined below.
(2) Where this section applies, it shall
supersede, for laboratories, the requirements of all other OSHA health standards in 29 CFR part 1910, subpart Z, except as follows:

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