Professional Documents
Culture Documents
29 CFR 1200
29 CFR 1200
29 CFR 1200
1200
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
the written hazard communication pro- (ii) Any chemical substance or mix-
gram under paragraph (h)(2)(iii) of this ture as such terms are defined in the
section; and, Toxic Substances Control Act (15
(iv) Laboratory employers that ship U.S.C. 2601 et seq.), when subject to the
hazardous chemicals are considered to labeling requirements of that Act and
be either a chemical manufacturer or a labeling regulations issued under that
distributor under this rule, and thus Act by the Environmental Protection
must ensure that any containers of Agency.
hazardous chemicals leaving the lab- (iii) Any food, food additive, color ad-
oratory are labeled in accordance with ditive, drug, cosmetic, or medical or
paragraph (f) of this section, and that a veterinary device or product, including
safety data sheet is provided to dis- materials intended for use as ingredi-
tributors and other employers in ac- ents in such products (e.g. flavors and
cordance with paragraphs (g)(6) and fragrances), as such terms are defined
(g)(7) of this section. in the Federal Food, Drug, and Cos-
(4) In work operations where employ- metic Act (21 U.S.C. 301 et seq.) or the
ees only handle chemicals in sealed Virus-Serum-Toxin Act of 1913 (21
containers which are not opened under U.S.C. 151 et seq.), and regulations
normal conditions of use (such as are issued under those Acts, when they are
found in marine cargo handling, subject to the labeling requirements
warehousing, or retail sales), this sec- under those Acts by either the Food
tion applies to these operations only as and Drug Administration or the De-
follows: partment of Agriculture;
(i) Employers shall ensure that labels (iv) Any distilled spirits (beverage al-
on incoming containers of hazardous cohols), wine, or malt beverage in-
chemicals are not removed or defaced; tended for nonindustrial use, as such
(ii) Employers shall maintain copies terms are defined in the Federal Alco-
of any safety data sheets that are re-
hol Administration Act (27 U.S.C. 201 et
ceived with incoming shipments of the
seq.) and regulations issued under that
sealed containers of hazardous chemi-
Act, when subject to the labeling re-
cals, shall obtain a safety data sheet as
quirements of that Act and labeling
soon as possible for sealed containers
regulations issued under that Act by
of hazardous chemicals received with-
the Bureau of Alcohol, Tobacco, Fire-
out a safety data sheet if an employee
arms and Explosives;
requests the safety data sheet, and
shall ensure that the safety data sheets (v) Any consumer product or haz-
are readily accessible during each work ardous substance as those terms are de-
shift to employees when they are in fined in the Consumer Product Safety
their work area(s); and, Act (15 U.S.C. 2051 et seq.) and Federal
(iii) Employers shall ensure that em- Hazardous Substances Act (15 U.S.C.
ployees are provided with information 1261 et seq.) respectively, when subject
and training in accordance with para- to a consumer product safety standard
graph (h) of this section (except for the or labeling requirement of those Acts,
location and availability of the written or regulations issued under those Acts
hazard communication program under by the Consumer Product Safety Com-
paragraph (h)(2)(iii) of this section), to mission; and,
the extent necessary to protect them (vi) Agricultural or vegetable seed
in the event of a spill or leak of a haz- treated with pesticides and labeled in
ardous chemical from a sealed con- accordance with the Federal Seed Act
tainer. (7 U.S.C. 1551 et seq.) and the labeling
(5) This section does not require la- regulations issued under that Act by
beling of the following chemicals: the Department of Agriculture.
(i) Any pesticide as such term is de- (6) This section does not apply to: (i)
fined in the Federal Insecticide, Fun- Any hazardous waste as such term is
gicide, and Rodenticide Act (7 U.S.C. defined by the Solid Waste Disposal
136 et seq.), when subject to the labeling Act, as amended by the Resource Con-
requirements of that Act and labeling servation and Recovery Act of 1976, as
regulations issued under that Act by amended (42 U.S.C. 6901 et seq.), when
the Environmental Protection Agency; subject to regulations issued under
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Occupational Safety and Health Admin., Labor § 1910.1200
that Act by the Environmental Protec- or importer of the product, and the use
tion Agency; results in a duration and frequency of
(ii) Any hazardous substance as such exposure which is not greater than the
term is defined by the Comprehensive range of exposures that could reason-
Environmental Response, Compensa- ably be experienced by consumers when
tion and Liability Act (CERCLA) (42 used for the purpose intended;
U.S.C. 9601 et seq.) when the hazardous (x) Nuisance particulates where the
substance is the focus of remedial or chemical manufacturer or importer
removal action being conducted under can establish that they do not pose any
CERCLA in accordance with Environ- physical or health hazard covered
mental Protection Agency regulations. under this section;
(iii) Tobacco or tobacco products; (xi) Ionizing and nonionizing radi-
(iv) Wood or wood products, including ation; and,
lumber which will not be processed, (xii) Biological hazards.
where the chemical manufacturer or (c) Definitions. Article means a manu-
importer can establish that the only factured item other than a fluid or par-
hazard they pose to employees is the ticle: (i) which is formed to a specific
potential for flammability or combus- shape or design during manufacture;
tibility (wood or wood products which (ii) which has end use function(s) de-
have been treated with a hazardous pendent in whole or in part upon its
chemical covered by this standard, and shape or design during end use; and (iii)
wood which may be subsequently sawed which under normal conditions of use
or cut, generating dust, are not ex- does not release more than very small
empted); quantities, e.g., minute or trace
(v) Articles (as that term is defined amounts of a hazardous chemical (as
in paragraph (c) of this section); determined under paragraph (d) of this
(vi) Food or alcoholic beverages section), and does not pose a physical
which are sold, used, or prepared in a hazard or health risk to employees.
retail establishment (such as a grocery Assistant Secretary means the Assist-
store, restaurant, or drinking place), ant Secretary of Labor for Occupa-
and foods intended for personal con- tional Safety and Health, U.S. Depart-
sumption by employees while in the ment of Labor, or designee.
workplace; Chemical means any substance, or
(vii) Any drug, as that term is de- mixture of substances.
fined in the Federal Food, Drug, and Chemical manufacturer means an em-
Cosmetic Act (21 U.S.C. 301 et seq.), ployer with a workplace where chem-
when it is in solid, final form for direct ical(s) are produced for use or distribu-
administration to the patient (e.g., tab- tion.
lets or pills); drugs which are packaged Chemical name means the scientific
by the chemical manufacturer for sale designation of a chemical in accord-
to consumers in a retail establishment ance with the nomenclature system de-
(e.g., over-the-counter drugs); and veloped by the International Union of
drugs intended for personal consump- Pure and Applied Chemistry (IUPAC)
tion by employees while in the work- or the Chemical Abstracts Service
place (e.g., first aid supplies); (CAS) rules of nomenclature, or a name
(viii) Cosmetics which are packaged that will clearly identify the chemical
for sale to consumers in a retail estab- for the purpose of conducting a hazard
lishment, and cosmetics intended for classification.
personal consumption by employees Classification means to identify the
while in the workplace; relevant data regarding the hazards of
(ix) Any consumer product or haz- a chemical; review those data to ascer-
ardous substance, as those terms are tain the hazards associated with the
defined in the Consumer Product Safe- chemical; and decide whether the
ty Act (15 U.S.C. 2051 et seq.) and Fed- chemical will be classified as hazardous
eral Hazardous Substances Act (15 according to the definition of haz-
U.S.C. 1261 et seq.) respectively, where ardous chemical in this section. In ad-
the employer can show that it is used dition, classification for health and
in the workplace for the purpose in- physical hazards includes the deter-
tended by the chemical manufacturer mination of the degree of hazard, where
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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Occupational Safety and Health Admin., Labor § 1910.1200
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
Trade secret means any confidential (ii) When classifying mixtures they
formula, pattern, process, device, infor- produce or import, chemical manufac-
mation or compilation of information turers and importers of mixtures may
that is used in an employer’s business, rely on the information provided on
and that gives the employer an oppor- the current safety data sheets of the
tunity to obtain an advantage over individual ingredients, except where
competitors who do not know or use it. the chemical manufacturer or importer
Appendix E to § 1910.1200—Definition of knows, or in the exercise of reasonable
Trade Secret, sets out the criteria to diligence should know, that the safety
be used in evaluating trade secrets. data sheet misstates or omits informa-
Use means to package, handle, react, tion required by this section.
emit, extract, generate as a byproduct, (e) Written hazard communication pro-
or transfer. gram. (1) Employers shall develop, im-
Work area means a room or defined plement, and maintain at each work-
space in a workplace where hazardous place, a written hazard communication
chemicals are produced or used, and program which at least describes how
where employees are present. the criteria specified in paragraphs (f),
Workplace means an establishment, (g), and (h) of this section for labels
job site, or project, at one geographical and other forms of warning, safety data
location containing one or more work sheets, and employee information and
areas. training will be met, and which also in-
(d) Hazard classification. (1) Chemical cludes the following:
manufacturers and importers shall (i) A list of the hazardous chemicals
evaluate chemicals produced in their known to be present using a product
workplaces or imported by them to identifier that is referenced on the ap-
classify the chemicals in accordance propriate safety data sheet (the list
with this section. For each chemical, may be compiled for the workplace as a
the chemical manufacturer or importer
whole or for individual work areas);
shall determine the hazard classes,
and,
and, where appropriate, the category of
(ii) The methods the employer will
each class that apply to the chemical
being classified. Employers are not re- use to inform employees of the hazards
quired to classify chemicals unless of non-routine tasks (for example, the
they choose not to rely on the classi- cleaning of reactor vessels), and the
fication performed by the chemical hazards associated with chemicals con-
manufacturer or importer for the tained in unlabeled pipes in their work
chemical to satisfy this requirement. areas.
(2) Chemical manufacturers, import- (2) Multi-employer workplaces. Em-
ers or employers classifying chemicals ployers who produce, use, or store haz-
shall identify and consider the full ardous chemicals at a workplace in
range of available scientific literature such a way that the employees of other
and other evidence concerning the po- employer(s) may be exposed (for exam-
tential hazards. There is no require- ple, employees of a construction con-
ment to test the chemical to determine tractor working on-site) shall addition-
how to classify its hazards. Appendix A ally ensure that the hazard commu-
to § 1910.1200 shall be consulted for clas- nication programs developed and im-
sification of health hazards, and Ap- plemented under this paragraph (e) in-
pendix B to § 1910.1200 shall be con- clude the following:
sulted for the classification of physical (i) The methods the employer will
hazards. use to provide the other employer(s)
(3) Mixtures. (i) Chemical manufac- on-site access to safety data sheets for
turers, importers, or employers evalu- each hazardous chemical the other em-
ating chemicals shall follow the proce- ployer(s)’ employees may be exposed to
dures described in Appendices A and B while working;
to § 1910.1200 to classify the hazards of (ii) The methods the employer will
the chemicals, including determina- use to inform the other employer(s) of
tions regarding when mixtures of the any precautionary measures that need
classified chemicals are covered by this to be taken to protect employees dur-
section. ing the workplace’s normal operating
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
will provide employees with the spe- label before the chemical is shipped or
cific information regarding the phys- introduced into the workplace again.
ical and health hazards of the haz- (g) Safety data sheets. (1) Chemical
ardous chemical. manufacturers and importers shall ob-
(7) The employer may use signs, plac- tain or develop a safety data sheet for
ards, process sheets, batch tickets, op- each hazardous chemical they produce
erating procedures, or other such writ- or import. Employers shall have a safe-
ten materials in lieu of affixing labels ty data sheet in the workplace for each
to individual stationary process con- hazardous chemical which they use.
tainers, as long as the alternative (2) The chemical manufacturer or im-
method identifies the containers to porter preparing the safety data sheet
which it is applicable and conveys the shall ensure that it is in English (al-
information required by paragraph though the employer may maintain
(f)(6) of this section to be on a label. copies in other languages as well), and
The employer shall ensure the written includes at least the following section
materials are readily accessible to the numbers and headings, and associated
employees in their work area through- information under each heading, in the
out each work shift. order listed (See Appendix D to
(8) The employer is not required to § 1910.1200—Safety Data Sheets, for the
label portable containers into which specific content of each section of the
hazardous chemicals are transferred safety data sheet):
from labeled containers, and which are (i) Section 1, Identification;
intended only for the immediate use of (ii) Section 2, Hazard(s) identifica-
the employee who performs the trans- tion;
fer. For purposes of this section, drugs (iii) Section 3, Composition/informa-
which are dispensed by a pharmacy to tion on ingredients;
a health care provider for direct ad- (iv) Section 4, First-aid measures;
ministration to a patient are exempted
(v) Section 5, Fire-fighting measures;
from labeling.
(vi) Section 6, Accidental release
(9) The employer shall not remove or
measures;
deface existing labels on incoming con-
tainers of hazardous chemicals, unless (vii) Section 7, Handling and storage;
the container is immediately marked (viii) Section 8, Exposure controls/
with the required information. personal protection;
(10) The employer shall ensure that (ix) Section 9, Physical and chemical
workplace labels or other forms of properties;
warning are legible, in English, and (x) Section 10, Stability and reac-
prominently displayed on the con- tivity;
tainer, or readily available in the work (xi) Section 11, Toxicological infor-
area throughout each work shift. Em- mation;
ployers having employees who speak (xii) Section 12, Ecological informa-
other languages may add the informa- tion;
tion in their language to the material (xiii) Section 13, Disposal consider-
presented, as long as the information is ations;
presented in English as well. (xiv) Section 14, Transport informa-
(11) Chemical manufacturers, import- tion;
ers, distributors, or employers who be- (xv) Section 15, Regulatory informa-
come newly aware of any significant tion; and
information regarding the hazards of a (xvi) Section 16, Other information,
chemical shall revise the labels for the including date of preparation or last
chemical within six months of becom- revision.
ing aware of the new information, and
shall ensure that labels on containers NOTE 1 TO PARAGRAPH (g)(2): To be con-
sistent with the GHS, an SDS must also in-
of hazardous chemicals shipped after
clude the headings in paragraphs (g)(2)(xii)
that time contain the new information. through (g)(2)(xv) in order.
If the chemical is not currently pro- NOTE 2 TO PARAGRAPH (g)(2): OSHA will not
duced or imported, the chemical manu- be enforcing information requirements in
facturer, importer, distributor, or em- sections 12 through 15, as these areas are not
ployer shall add the information to the under its jurisdiction.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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Occupational Safety and Health Admin., Labor § 1910.1200
later than at the time the information A.0.1.2 For many hazard classes, the cri-
is provided to the Assistant Secretary teria are semi-quantitative or qualitative
so that suitable determinations of and expert judgment is required to interpret
the data for classification purposes.
trade secret status can be made and
the necessary protections can be imple- A.0.2 AVAILABLE DATA, TEST METHODS AND
mented. TEST DATA QUALITY
(13) Nothing in this paragraph shall
A.0.2.1 There is no requirement for test-
be construed as requiring the disclo-
ing chemicals.
sure under any circumstances of proc-
A.0.2.2 The criteria for determining
ess information which is a trade secret. health hazards are test method neutral, i.e.,
(j) Effective dates. (1) Employers shall they do not specify particular test methods,
train employees regarding the new as long as the methods are scientifically
label elements and safety data sheets validated.
format by December 1, 2013. A.0.2.3 The term ‘‘scientifically vali-
(2) Chemical manufacturers, import- dated’’ refers to the process by which the re-
ers, distributors, and employers shall liability and the relevance of a procedure are
be in compliance with all modified pro- established for a particular purpose. Any
visions of this section no later than test that determines hazardous properties,
which is conducted according to recognized
June 1, 2015, except: scientific principles, can be used for purposes
(i) After December 1, 2015, the dis- of a hazard determination for health hazards.
tributor shall not ship containers la- Test conditions need to be standardized so
beled by the chemical manufacturer or that the results are reproducible with a
importer unless the label has been given substance, and the standardized test
modified to comply with paragraph yields ‘‘valid’’ data for defining the hazard
(f)(1) of this section. class of concern.
(ii) All employers shall, as necessary, A.0.2.4 Existing test data are acceptable
update any alternative workplace la- for classifying chemicals, although expert
judgment also may be needed for classifica-
beling used under paragraph (f)(6) of tion purposes.
this section, update the hazard commu- A.0.2.5 The effect of a chemical on bio-
nication program required by para- logical systems is influenced, by the physico-
graph (h)(1), and provide any additional chemical properties of the substance and/or
employee training in accordance with ingredients of the mixture and the way in
paragraph (h)(3) for newly identified which ingredient substances are biologically
physical or health hazards no later available. A chemical need not be classified
than June 1, 2016. when it can be shown by conclusive experi-
(3) Chemical manufacturers, import- mental data from scientifically validated
test methods that the chemical is not bio-
ers, distributors, and employers may logically available.
comply with either § 1910.1200 revised as A.0.2.6 For classification purposes, epide-
of October 1, 2011, or the current miological data and experience on the effects
version of this standard, or both during of chemicals on humans (e.g., occupational
the transition period. data, data from accident databases) shall be
taken into account in the evaluation of
APPENDIX A TO § 1910.1200—HEALTH HAZARD human health hazards of a chemical.
CRITERIA (MANDATORY)
A.0.3 CLASSIFICATION BASED ON WEIGHT OF
A.0 GENERAL CLASSIFICATION
EVIDENCE
CONSIDERATIONS
A.0.3.1 For some hazard classes, classi-
A.0.1 CLASSIFICATION fication results directly when the data sat-
A.0.1.1 The term ‘‘hazard classification’’ isfy the criteria. For others, classification of
is used to indicate that only the intrinsic a chemical shall be determined on the basis
hazardous properties of chemicals are con- of the total weight of evidence using expert
sidered. Hazard classification incorporates judgment. This means that all available in-
three steps: formation bearing on the classification of
(a) Identification of relevant data regard- hazard shall be considered together, includ-
ing the hazards of a chemical; ing the results of valid in vitro tests, relevant
(b) Subsequent review of those data to as- animal data, and human experience such as
certain the hazards associated with the epidemiological and clinical studies and
chemical; well-documented case reports and observa-
(c) Determination of whether the chemical tions.
will be classified as hazardous and the degree A.0.3.2 The quality and consistency of the
of hazard. 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 clas- mixture (e.g., application of cut-off values/
sified shall be considered as appropriate, as concentration limits).
well as site of action and mechanism or A.0.4.2 An exception to the above order or
mode of action study results. Both positive precedence is made for Carcinogenicity,
and negative results shall be considered to- Germ Cell Mutagenicity, and Reproductive
gether in a single weight-of-evidence deter- Toxicity. For these three hazard classes,
mination. mixtures shall be classified based upon infor-
A.0.3.3 Positive effects which are con-
mation on the ingredient substances, unless
sistent with the criteria for classification,
whether seen in humans or animals, shall on a case-by-case basis, justification can be
normally justify classification. Where evi- provided for classifying based upon the mix-
dence is available from both humans and ani- ture as a whole. See chapters A.5, A.6, and
mals and there is a conflict between the find- A.7 for further information on case-by-case
ings, the quality and reliability of the evi- bases.
dence from both sources shall be evaluated A.0.4.3 Use of cut-off values/concentration
in order to resolve the question of classifica- limits.
tion. Reliable, good quality human data A.0.4.3.1 When classifying an untested
shall generally have precedence over other mixture based on the hazards of its ingredi-
data. However, even well-designed and con- ents, cut-off values/concentration limits for
ducted epidemiological studies may lack a the classified ingredients of the mixture are
sufficient number of subjects to detect rel- used for several hazard classes. While the
atively rare but still significant effects, or to adopted cut-off values/concentration limits
assess potentially confounding factors.
adequately identify the hazard for most mix-
Therefore, positive results from well-con-
tures, there may be some that contain haz-
ducted animal studies are not necessarily ne-
gated by the lack of positive human experi- ardous ingredients at lower concentrations
ence but require an assessment of the than the specified cut-off values/concentra-
robustness, quality and statistical power of tion limits that still pose an identifiable
both the human and animal data. hazard. There may also be cases where the
A.0.3.4 Route of exposure, mechanistic in- cut-off value/concentration limit is consider-
formation, and metabolism studies are perti- ably lower than the established non-haz-
nent to determining the relevance of an ef- ardous level for an ingredient.
fect in humans. When such information A.0.4.3.2 If the classifier has information
raises doubt about relevance in humans, a that the hazard of an ingredient will be evi-
lower classification may be warranted. When dent (i.e., it presents a health risk) below the
there is scientific evidence demonstrating specified cut-off value/concentration limit,
that the mechanism or mode of action is not the mixture containing that ingredient shall
relevant to humans, the chemical should not be classified accordingly.
be classified.
A.0.3.5 Both positive and negative results A.0.4.3.3 In exceptional cases, conclusive
are considered together in the weight of evi- data may demonstrate that the hazard of an
dence determination. However, a single posi- ingredient will not be evident (i.e., it does
tive study performed according to good sci- not present a health risk) when present at a
entific principles and with statistically and level above the specified cut-off value/con-
biologically significant positive results may centration limit(s). In these cases the mix-
justify classification. ture may be classified according to those
data. The data must exclude the possibility
A.0.4 CONSIDERATIONS FOR THE that the ingredient will behave in the mix-
CLASSIFICATION OF MIXTURES ture in a manner that would increase the
A.0.4.1 For most hazard classes, the rec- hazard over that of the pure substance. Fur-
ommended process of classification of mix- thermore, the mixture must not contain in-
tures is based on the following sequence: gredients that would affect that determina-
(a) Where test data are available for the tion.
complete mixture, the classification of the A.0.4.4 Synergistic or antagonistic effects.
mixture will always be based on those data; When performing an assessment in accord-
(b) Where test data are not available for
ance with these requirements, the evaluator
the mixture itself, the bridging principles
must take into account all available infor-
designated in each health hazard chapter of
this appendix shall be considered for classi- mation about the potential occurrence of
fication of the mixture; synergistic effects among the ingredients of
(c) If test data are not available for the the mixture. Lowering classification of a
mixture itself, and the available information mixture to a less hazardous category on the
is not sufficient to allow application of the basis of antagonistic effects may be done
above-mentioned bridging principles, then only if the determination is supported by
the method(s) described in each chapter for sufficient data.
estimating the hazards based on the informa-
tion known will be applied to classify the
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Occupational Safety and Health Admin., Labor § 1910.1200
A.0.5 BRIDGING PRINCIPLES FOR THE CLASSI- B have been tested and are in the same tox-
FICATION OF MIXTURES WHERE TEST DATA icity category, and where untested mixture
ARE NOT AVAILABLE FOR THE COMPLETE C has the same toxicologically active ingre-
MIXTURE dients as mixtures A and B but has con-
centrations of toxicologically active ingredi-
A.0.5.1 Where the mixture itself has not
ents intermediate to the concentrations in
been tested to determine its toxicity, but
mixtures A and B, then mixture C is assumed
there are sufficient data on both the indi-
to be in the same toxicity category as A and
vidual ingredients and similar tested mix-
B.
tures to adequately characterize the hazards
A.0.5.1.5 Substantially similar mixtures.
of the mixture, these data shall be used in
For mixtures classified in accordance with
accordance with the following bridging prin-
A.1 through A.10 of this Appendix, given the
ciples, subject to any specific provisions for
following set of conditions:
mixtures for each hazard class. These prin-
(a) Where there are two mixtures:
ciples ensure that the classification process
uses the available data to the greatest ex- (i) A + B;
tent possible in characterizing the hazards of (ii) C + B;
the mixture. (b) The concentration of ingredient B is es-
A.0.5.1.1 Dilution. sentially the same in both mixtures;
For mixtures classified in accordance with (c) The concentration of ingredient A in
A.1 through A.10 of this Appendix, if a tested mixture (i) equals that of ingredient C in
mixture is diluted with a diluent that has an mixture (ii);
equivalent or lower toxicity classification (d) And data on toxicity for A and C are
than the least toxic original ingredient, and available and substantially equivalent; i.e.,
which is not expected to affect the toxicity they are in the same hazard category and are
of other ingredients, then: not expected to affect the toxicity of B; then
(a) The new diluted mixture shall be classi- If mixture (i) or (ii) is already classified
fied as equivalent to the original tested mix- based on test data, the other mixture can be
ture; or assigned the same hazard category.
(b) For classification of acute toxicity in A.0.5.1.6 Aerosols.
accordance with A.1 of this Appendix, para- For mixtures classified in accordance with
graph A.1.3.6 (the additivity formula) shall A.1, A.2, A.3, A.4, A.8, or A.9 of this Appen-
be applied. dix, an aerosol form of a mixture shall be
A.0.5.1.2 Batching. classified in the same hazard category as the
For mixtures classified in accordance with tested, non-aerosolized form of the mixture,
A.1 through A.10 of this Appendix, the tox- provided the added propellant does not affect
icity of a tested production batch of a mix- the toxicity of the mixture when spraying.
ture can be assumed to be substantially
A.1 ACUTE TOXICITY
equivalent to that of another untested pro-
duction batch of the same mixture, when A.1.1 DEFINITION
produced by or under the control of the same
chemical manufacturer, unless there is reason Acute toxicity refers to those adverse effects
to believe there is significant variation such occurring following oral or dermal adminis-
that the toxicity of the untested batch has tration of a single dose of a substance, or
changed. If the latter occurs, a new classi- multiple doses given within 24 hours, or an
fication is necessary. inhalation exposure of 4 hours.
A.0.5.1.3 Concentration of mixtures.
A.1.2 CLASSIFICATION CRITERIA FOR
For mixtures classified in accordance with
SUBSTANCES
A.1, A.2, A.3, A.8, A.9, or A.10 of this Appen-
dix, if a tested mixture is classified in Cat- A.1.2.1 Substances can be allocated to one
egory 1, and the concentration of the ingre- of four toxicity categories based on acute
dients of the tested mixture that are in Cat- toxicity by the oral, dermal or inhalation
egory 1 is increased, the resulting untested route according to the numeric cut-off cri-
mixture shall be classified in Category 1. teria as shown in Table A.1.1. Acute toxicity
A.0.5.1.4 Interpolation within one toxicity values are expressed as (approximate) LD50
category. (oral, dermal) or LC50 (inhalation) values or
For mixtures classified in accordance with as acute toxicity estimates (ATE). See the
A.1, A.2, A.3, A.8, A.9, or A.10 of this Appen- footnotes following Table A.1.1 for further
dix, for three mixtures (A, B and C) with explanation on the application of these val-
identical ingredients, where mixtures A and ues.
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
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TABLE A.1.1—ACUTE TOXICITY HAZARD CATEGORIES AND ACUTE TOXICITY ESTIMATE (ATE) VALUES
DEFINING THE RESPECTIVE CATEGORIES—Continued
Exposure route Category 1 Category 2 Category 3 Category 4
see: Note (a) ................... ≤5 >5 and ≤ 50 ................ >50 and ≤ 300 ............ >300 and ≤ 2000.
Note (b)
Dermal (mg/kg bodyweight)
see: Note (a) ................... ≤ 50 >50 and ≤ 200 ............ >200 and ≤ 1000 ........ >1000 and ≤ 2000.
Note (b)
Inhalation—Gases (ppmV)
see: Note (a) ................... ≤ 100 >100 and ≤ 500 .......... >500 and ≤ 2500 ........ >2500 and ≤ 20000.
Note (b)
Note (c)
Inhalation—Vapors (mg/l)
see: Note (a) ................... ≤ 0.5 >0.5 and ≤ 2.0 ............ >2.0 and ≤ 10.0 .......... >10.0 and ≤ 20.0.
Note (b)
Note (c)
Note (d)
Inhalation—Dusts and Mists (mg/l)
see: Note (a) ................... ≤ 0.05 >0.05 and ≤ 0.5 .......... >0.5 and ≤ 1.0 ............ >1.0 and ≤ 5.0.
Note (b)
Note (c)
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 eval- value from among scientifically validated
uation of acute toxicity by the oral and in- tests.
halation routes is the rat, while the rat or
rabbit are preferred for evaluation of acute A.1.3 CLASSIFICATION CRITERIA FOR
dermal toxicity. Test data already generated MIXTURES
for the classification of chemicals under ex-
isting systems should be accepted when re- A.1.3.1 The approach to classification of
classifying these chemicals under the har- mixtures for acute toxicity is tiered, and is
monized system. When experimental data for dependent upon the amount of information
acute toxicity are available in several ani- available for the mixture itself and for its in-
mal species, scientific judgment should be gredients. The flow chart of Figure A.1.1 in-
used in selecting the most appropriate LD50 dicates the process that must be followed:
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Occupational Safety and Health Admin., Labor § 1910.1200
A.1.3.2 Classification of mixtures for within the same category, then the mixture
acute toxicity may be carried out for each should be classified in that category.
route of exposure, but is only required for (d) When only range data (or acute toxicity
one route of exposure as long as this route is hazard category information) are available
followed (estimated or tested) for all ingredi- for ingredients in a mixture, they may be
ents and there is no relevant evidence to sug- converted to point estimates in accordance
gest acute toxicity by multiple routes. When with Table A.1.2 when calculating the classi-
there is relevant evidence of acute toxicity fication of the new mixture using the for-
by multiple routes of exposure, classification mulas in A.1.3.6.1 and A.1.3.6.2.4.
is to be conducted for all appropriate routes
of exposure. All available information shall A.1.3.4 CLASSIFICATION OF MIXTURES WHERE
be considered. The pictogram and signal ACUTE TOXICITY TEST DATA ARE AVAILABLE
word used shall reflect the most severe haz- FOR THE COMPLETE MIXTURE
ard category; and all relevant hazard state-
Where the mixture itself has been tested to
ments shall be used.
determine its acute toxicity, it is classified
A.1.3.3 For purposes of classifying the
according to the same criteria as those used
hazards of mixtures in the tiered approach:
for substances, presented in Table A.1.1. If
(a) The ‘‘relevant ingredients’’ of a mixture
test data for the mixture are not available,
are those which are present in concentra-
the procedures presented below must be fol-
tions ≥1% (weight/weight for solids, liquids,
lowed.
dusts, mists and vapors and volume/volume
for gases). If there is reason to suspect that A.1.3.5 CLASSIFICATION OF MIXTURES WHERE
an ingredient present at a concentration <1% ACUTE TOXICITY TEST DATA ARE NOT
will affect classification of the mixture for AVAILABLE FOR THE COMPLETE MIXTURE:
acute toxicity, that ingredient shall also be BRIDGING PRINCIPLES
considered relevant. Consideration of ingre-
dients present at a concentration <1% is par- A.1.3.5.1 Where the mixture itself has not
ticularly important when classifying untest- been tested to determine its acute toxicity,
ed mixtures which contain ingredients that but there are sufficient data on both the in-
are classified in Category 1 and Category 2; dividual ingredients and similar tested mix-
(b) Where a classified mixture is used as an tures to adequately characterize the hazards
ingredient of another mixture, the actual or of the mixture, these data will be used in ac-
derived acute toxicity estimate (ATE) for cordance with the following bridging prin-
that mixture is used when calculating the ciples as found in paragraph A.0.5 of this Ap-
classification of the new mixture using the pendix: Dilution, Batching, Concentration of
formulas in A.1.3.6.1 and A.1.3.6.2.4. mixtures, Interpolation within one toxicity
(c) If the converted acute toxicity point es- category, Substantially similar mixtures,
timates for all ingredients of a mixture are and Aerosols.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.1.3.6 CLASSIFICATION OF MIXTURES BASED (c) Ignore ingredients if the data available
ON INGREDIENTS OF THE MIXTURE are from a limit dose test (at the upper
(ADDITIVITY FORMULA) threshold for Category 4 for the appropriate
route of exposure as provided in Table A.1.1)
A.1.3.6.1 Data available for all ingredi- and do not show acute toxicity.
ents. Ingredients that fall within the scope of
The acute toxicity estimate (ATE) of in- this paragraph are considered to be ingredi-
gredients is considered as follows: ents with a known acute toxicity estimate
(a) Include ingredients with a known acute (ATE). See note (b) to Table A.1.1 and para-
toxicity, which fall into any of the acute graph A.1.3.3 for appropriate application of
toxicity categories, or have an oral or der- available data to the equation below, and
mal LD50 greater than 2000 but less than or paragraph A.1.3.6.2.4.
equal to 5000 mg/kg body weight (or the The ATE of the mixture is determined by
equivalent dose for inhalation); calculation from the ATE values for all rel-
(b) Ignore ingredients that are presumed evant ingredients according to the following
not acutely toxic (e.g., water, sugar); formula below for oral, dermal or inhalation
toxicity:
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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 Converted
Exposure routes acute acute toxicity
toxicity range estimate point estimate
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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 ani-
mals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scal-
ing; or
(3) In some cases where there is pronounced variability of response among animals, with very defi-
nite 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 the death of the animals. When observations
a test can be quite variable, as they are with are made of skin corrosion/irritation in
corrosion. A separate irritant criterion ac- acute toxicity studies and are observed up
commodates cases when there is a signifi- through the limit dose, these data may be
cant irritant response but less than the used for classification provided that the dilu-
mean score criterion for a positive test. For tions used and species tested are equivalent.
example, a substance might be designated as In vitro alternatives that have been scientif-
an irritant if at least 1 of 3 tested animals ically validated shall be used to make classi-
shows a very elevated mean score through- fication decisions. Solid substances (pow-
out the study, including lesions persisting at ders) may become corrosive or irritant when
the end of an observation period of normally moistened or in contact with moist skin or
14 days. Other responses could also fulfil this mucous membranes. Likewise, pH extremes
criterion. However, it should be ascertained like ≤2 and ≥11.5 may indicate skin effects,
that the responses are the result of chemical especially when associated with significant
exposure. Addition of this criterion increases buffering capacity. Generally, such sub-
the sensitivity of the classification system. stances are expected to produce significant
A.2.2.2.3 Reversibility of skin lesions is effects on the skin. In the absence of any
another consideration in evaluating irritant other information, a substance is considered
responses. When inflammation persists to corrosive (Skin Category 1) if it has a pH ≤2
the end of the observation period in 2 or or a pH ≥11.5. However, if consideration of al-
more test animals, taking into consideration kali/acid reserve suggests the substance or
alopecia (limited area), hyperkeratosis, mixture may not be corrosive despite the low
hyperplasia and scaling, then a chemical or high pH value, then further evaluation
should be considered to be an irritant. may be necessary. In some cases enough in-
formation may be available from struc-
A.2.3 CLASSIFICATION CRITERIA FOR turally related compounds to make classi-
SUBSTANCES USING OTHER DATA ELEMENTS fication decisions.
A.2.3.2 A tiered approach to the evaluation
A.2.3.1 Existing human and animal data of initial information shall be used (Figure
including information from single or re- A.2.1) recognizing that all elements may not
peated exposure should be the first line of be relevant in certain cases.
analysis, as they give information directly A.2.3.3 The tiered approach explains how
relevant to effects on the skin. If a substance to organize information on a substance and
is highly toxic by the dermal route, a skin to make a weight-of-evidence decision about
corrosion/irritation study may not be prac- hazard assessment and hazard classification.
ticable since the amount of test substance to A.2.3.4 All the above information that is
be applied would considerably exceed the available on a substance shall be evaluated.
toxic dose and, consequently, would result in Although information might be gained from
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Occupational Safety and Health Admin., Labor § 1910.1200
the evaluation of single parameters within a eters. Emphasis shall be placed upon existing
tier, there is merit in considering the total- human experience and data, followed by ani-
ity of existing information and making an mal experience and testing data, followed by
overall weight of evidence determination. other sources of information, but case-by-
This is especially true when there is infor- case determinations are necessary.
mation available on some but not all param-
483
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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Occupational Safety and Health Admin., Labor § 1910.1200
containing corrosive or irritant ingredients ingredient will not be evident when present
that cannot be classified based on the at a level above the generic concentration
additivity approach shown in Table A.2.3, cut-off values mentioned in Tables A.2.3 and
due to chemical characteristics that make A.2.4. In these cases the mixture could be
this approach unworkable, should be classi- classified according to those data (See Use of
fied as Skin Category 1 if it contains ≥1% of cut-off values/concentration limits, paragraph
a corrosive ingredient and as Skin Category A.0.4.3 of this Appendix).
2 when it contains ≥3% of an irritant ingre- A.2.4.3.6 If there are data showing that
dient. Classification of mixtures with ingre- (an) ingredient(s) may be corrosive or irri-
dients for which the approach in Table A.2.3 tant at a concentration of <1% (corrosive) or
does not apply is summarized in Table A.2.4 <3% (irritant), the mixture shall be classified
below. accordingly (See Use of cut-off values/con-
A.2.4.3.5 On occasion, reliable data may centration limits, paragraph A.0.4.3 of this Ap-
show that the skin corrosion/irritation of an pendix).
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]
Category 1 Category 2
Mixture
Ingredient: Concentration: classified as:
Skin
A.3 SERIOUS EYE DAMAGE/EYE criteria in this section. In case the criteria
IRRITATION cannot be directly applied, classification of a
substance or a mixture is made on the basis
A.3.1 DEFINITIONS AND GENERAL of the total weight of evidence (See A.0.3.1).
CONSIDERATIONS This means that all available information
A.3.1.1 Serious eye damage is the produc- bearing on the determination of serious eye
tion of tissue damage in the eye, or serious damage/eye irritation is considered together,
physical decay of vision, following applica- including the results of appropriate scientif-
tion of a test substance to the anterior sur- ically validated in vitro tests, relevant ani-
face of the eye, which is not fully reversible mal data, and human data such as epidemio-
within 21 days of application. logical and clinical studies and well-docu-
Eye irritation is the production of changes mented case reports and observations.
in the eye following the application of test A.3.2 CLASSIFICATION CRITERIA FOR
substance to the anterior surface of the eye, SUBSTANCES USING ANIMAL TEST DATA
which are fully reversible within 21 days of
application. A.3.2.1 Irreversible effects on the eye/seri-
A.3.1.2 Serious eye damage/eye irritation ous damage to eyes (Category 1).
shall be classified using a tiered approach as A single hazard category is provided in
detailed in Figure A.3.1. Emphasis shall be Table A.3.1, for substances that have the po-
placed upon existing human data (See tential to seriously damage the eyes. Cat-
A.0.2.6), followed by animal data, followed by egory 1, irreversible effects on the eye, in-
other sources of information. Classification cludes the criteria listed below. These obser-
results directly when the data satisfy the vations 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. de- are not fully reversible within an observa-
struction of cornea) observed at any time tion period of normally 21 days. Category 1
during the test, as well as persistent corneal also contains substances fulfilling the cri-
opacity, discoloration of the cornea by a dye teria of corneal opacity ≥3 and/or iritis >1.5
substance, adhesion, pannus, and inter- detected in a Draize eye test with rabbits,
ference with the function of the iris or other because severe lesions like these usually do
effects that impair sight. In this context, not reverse within a 21-day observation pe-
persistent lesions are considered those which riod.
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 nor-
mally 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 (Cat- A single category is provided in Table A.3.2
egory 2). for substances that have the potential to in-
duce reversible eye irritation.
A.3.2.3 For those chemicals where there is cially when associated with significant
pronounced variability among animal re- buffering capacity. Generally, such sub-
sponses, this information may be taken into stances are expected to produce significant
account in determining the classification. effects on the eyes. In the absence of any
other information, a mixture/substance is
A.3.3 CLASSIFICATION CRITERIA FOR
considered to cause serious eye damage (Eye
SUBSTANCES USING OTHER DATA ELEMENTS
Category 1) if it has a pH ≤2 or ≥11.5. How-
A.3.3.1 Existing human and animal data ever, if consideration of acid/alkaline reserve
should be the first line of analysis, as they suggests the substance may not have the po-
give information directly relevant to effects tential to cause serious eye damage despite
on the eye. Possible skin corrosion shall be the low or high pH value, then further eval-
evaluated prior to consideration of serious uation may be necessary. In some cases
eye damage/eye irritation in order to avoid enough information may be available from
testing for local effects on eyes with skin structurally related compounds to make
corrosive substances. In vitro alternatives classification decisions.
that have been scientifically validated and A.3.3.2 A tiered approach to the evalua-
accepted shall be used to make classification
tion of initial information shall be used
decisions. Likewise, pH extremes like ≤2 and
≥11.5, may indicate serious eye damage, espe-
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Occupational Safety and Health Admin., Labor § 1910.1200
where applicable, recognizing that all ele- Although information might be gained from
ments may not be relevant in certain cases the evaluation of single parameters within a
(Figure A.3.1). tier, consideration should be given to the to-
A.3.3.3 The tiered approach explains how tality of existing information and making an
to organize existing information on a sub- overall weight-of-evidence determination.
stance and to make a weight-of-evidence de- This is especially true when there is conflict
cision, where appropriate, about hazard as- in information available on some param-
sessment and hazard classification. eters.
A.3.3.4 All the above information that is
available on a substance shall be evaluated.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.3.4 CLASSIFICATION CRITERIA FOR to the eye or eye irritant when data are
MIXTURES available on the ingredients, but not on the
mixture as a whole, is based on the theory of
A.3.4.1 CLASSIFICATION OF MIXTURES WHEN additivity, such that each corrosive or irri-
DATA ARE AVAILABLE FOR THE COMPLETE tant ingredient contributes to the overall ir-
MIXTURE ritant or corrosive properties of the mixture
A.3.4.1.1 The mixture will be classified in proportion to its potency and concentra-
using the criteria for substances. tion. A weighting factor of 10 is used for cor-
A.3.4.1.2 Unlike other hazard classes, rosive ingredients when they are present at a
there are alternative tests available for skin concentration below the concentration limit
corrosivity of certain types of chemicals for classification with Category 1, but are at
that can give an accurate result for classi- a concentration that will contribute to the
fication purposes, as well as being simple and classification of the mixture as an irritant.
relatively inexpensive to perform. When con- The mixture is classified as seriously dam-
sidering testing of the mixture, chemical aging to the eye or eye irritant when the
manufacturers are encouraged to use a tiered sum of the concentrations of such ingredi-
weight of evidence strategy as included in ents exceeds a threshold cut-off value/con-
the criteria for classification of substances centration limit.
for skin corrosion and serious eye damage A.3.4.3.3 Table A.3.3 provides the cut-off
and eye irritation to help ensure an accurate value/concentration limits to be used to de-
classification, as well as avoid unnecessary termine if the mixture should be classified as
animal testing. In the absence of any other seriously damaging to the eye or an eye irri-
information, a mixture is considered to tant.
cause serious eye damage (Eye Category 1) if A.3.4.3.4 Particular care must be taken
it has a pH ≤2 or ≥11.5. However, if consider- when classifying certain types of chemicals
ation of acid/alkaline reserve suggests the such as acids and bases, inorganic salts,
substance or mixture may not have the po- aldehydes, phenols, and surfactants. The ap-
tential to cause serious eye damage despite proach explained in A.3.4.3.1 and A.3.4.3.2
the low or high pH value, then further eval- might not work given that many of such sub-
uation may be necessary. stances are corrosive or irritant at con-
centrations <1%. For mixtures containing
A.3.4.2 CLASSIFICATION OF MIXTURES WHEN
strong acids or bases, the pH should be used
DATA ARE NOT AVAILABLE FOR THE COM-
as classification criteria (See A.3.4.1) since
PLETE MIXTURE: BRIDGING PRINCIPLES
pH will be a better indicator of serious eye
A.3.4.2.1 Where the mixture itself has not damage than the concentration limits of
been tested to determine its skin corrosivity Table A.3.3. A mixture containing corrosive
or potential to cause serious eye damage or or irritant ingredients that cannot be classi-
eye irritation, but there are sufficient data fied based on the additivity approach applied
on both the individual ingredients and simi- in Table A.3.3 due to chemical characteris-
lar tested mixtures to adequately charac- tics that make this approach unworkable,
terize the hazards of the mixture, these data should be classified as Eye Category 1 if it
will be used in accordance with the following contains ≥1% of a corrosive ingredient and as
bridging principles, as found in paragraph Eye Category 2 when it contains ≥3% of an
A.0.5 of this Appendix: Dilution, Batching, irritant ingredient. Classification of mix-
Concentration of mixtures, Interpolation tures with ingredients for which the ap-
within one toxicity category, Substantially proach in Table A.3.3 does not apply is sum-
similar mixtures, and Aerosols. marized in Table A.3.4.
A.3.4.3.5 On occasion, reliable data may
A.3.4.3 CLASSIFICATION OF MIXTURES WHEN show that the reversible/irreversible eye ef-
DATA ARE AVAILABLE FOR ALL INGREDIENTS fects of an ingredient will not be evident
OR ONLY FOR SOME INGREDIENTS OF THE
when present at a level above the generic
MIXTURE cut-off values/concentration limits men-
A.3.4.3.1 For purposes of classifying the tioned in Tables A.3.3 and A.3.4. In these
eye corrosion/irritation hazards of mixtures cases the mixture could be classified accord-
in the tiered approach: ing to those data (See also A.0.4.3 Use of cut-
The ‘‘relevant ingredients’’ of a mixture off values/concentration limits’’). On occasion,
are those which are present in concentra- when it is expected that the skin corrosion/
tions ≥1% (weight/weight for solids, liquids, irritation or the reversible/irreversible eye
dusts, mists and vapors and volume/volume effects of an ingredient will not be evident
for gases.) If the classifier has reason to sus- when present at a level above the generic
pect that an ingredient present at a con- concentration/cut-off levels mentioned in
centration <1% will affect classification of Tables A.3.3 and A.3.4, testing of the mixture
the mixture for eye corrosion/irritation, that may be considered. In those cases, the tiered
ingredient shall also be considered relevant. weight of evidence strategy should be ap-
A.3.4.3.2 In general, the approach to clas- plied as referred to in section A.3.3, Figure
sification of mixtures as seriously damaging A.3.1 and explained in detail in this chapter.
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A.3.4.3.6 If there are data showing that <3% (irritant), the mixture should be classi-
(an) ingredient(s) may be corrosive or irri- fied accordingly (See also paragraph A.0.4.3,
tant at a concentration of <1% (corrosive) or 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 Category 2
Mixture
Ingredient Concentration classified as:
Eye
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
quality evidence from human cases or epide- A.4.2.1.1.2 Where data are not sufficient
miological studies and/or observations from for sub-categorization, respiratory sensi-
appropriate studies in experimental animals. tizers shall be classified in Category 1.
TABLE A.4.1—HAZARD CATEGORY AND SUB-CATEGORIES FOR RESPIRATORY SENSITIZERS
Category 1 Respiratory sensitizer
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A.4.2.2.1.1 Effects seen in either humans miological studies and/or observations from
or animals will normally justify classifica- appropriate studies in experimental animals
tion in a weight of evidence approach for according to the guidance values provided in
skin sensitizers. Substances may be allo- A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A
cated to one of the two sub-categories 1A or and in A.4.2.2.2.2 and A.4.2.2.3.3 for sub-cat-
1B using a weight of evidence approach in ac- egory 1B.
cordance with the criteria given in Table A.4.2.2.1.2 Where data are not sufficient
A.4.2 and on the basis of reliable and good for sub-categorization, skin sensitizers shall
quality evidence from human cases or epide- be classified in Category 1.
TABLE A.4.2—HAZARD CATEGORY AND SUB-CATEGORIES FOR SKIN SENSITIZERS
Category 1 Skin sensitizer
4 Test methods for skin sensitization are de- Mouse Ear Swelling Test (MEST), appears to be
scribed in OECD Guideline 406 (the Guinea Pig a reliable screening test to detect moderate to
Maximization test and the Buehler guinea pig strong sensitizers, and can be used, in accord-
test) and Guideline 429 (Local Lymph Node ance with professional judgment, as a first stage
Assay). Other methods may be used provided in the assessment of skin sensitization potential.
that they are scientifically validated. The
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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-cat-
egory 1B can include data with values indi-
cated in Table A.4.4 below:
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Occupational Safety and Health Admin., Labor § 1910.1200
from human experience or appropriate stud- bridging principles as found in paragraph
ies in experimental animals, is available for A.0.5 of this Appendix: Dilution, Batching,
the mixture, then the mixture shall be clas- Concentration of mixtures, Interpolation,
sified by weight of evidence evaluation of Substantially similar mixtures, and
these data. Care must be exercised in evalu- Aerosols.
ating data on mixtures that the dose used
does not render the results inconclusive. A.4.3.3 CLASSIFICATION OF MIXTURES WHEN
DATA ARE AVAILABLE FOR ALL INGREDIENTS
A.4.3.2 CLASSIFICATION OF MIXTURES WHEN
OR ONLY FOR SOME INGREDIENTS OF THE
DATA ARE NOT AVAILABLE FOR THE COM-
PLETE MIXTURE: BRIDGING PRINCIPLES
MIXTURE
A.4.3.2.1 Where the mixture itself has not The mixture shall be classified as a res-
been tested to determine its sensitizing prop- piratory or skin sensitizer when at least one
erties, but there are sufficient data on both ingredient has been classified as a res-
the individual ingredients and similar tested piratory or skin sensitizer and is present at
mixtures to adequately characterize the haz- or above the appropriate cut-off value/con-
ards of the mixture, these data will be used centration limit for the specific endpoint as
in accordance with the following agreed shown in Table A.4.5.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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 com-
bination with some evidence that the substance has potential to cause mutations to
germ cells. This supporting evidence may, for example, be derived from mutage-
nicity/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 posi-
tive results from in vitro mutagenicity assays.
Note: Substances which are positive in in vitro mammalian muta-
genicity 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 classi- ducted test is used for classification, it shall
fication of substances as germ cell mutagens: provide clear and unambiguously positive re-
A.5.2.2.1 To arrive at a classification, test sults. The relevance of the route of exposure
results are considered from experiments de- used in the study of the substance compared
termining mutagenic and/or genotoxic ef- to the route of human exposure should also
fects in germ and/or somatic cells of exposed be taken into account.
animals. Mutagenic and/or genotoxic effects
determined in in vitro tests shall also be con- A.5.3 CLASSIFICATION CRITERIA FOR
sidered. MIXTURES 5
A.5.2.2.2 The system is hazard based,
classifying chemicals on the basis of their A.5.3.1 CLASSIFICATION OF MIXTURES WHEN
intrinsic ability to induce mutations in germ DATA ARE AVAILABLE FOR ALL INGREDIENTS
cells. The scheme is, therefore, not meant for OR ONLY FOR SOME INGREDIENTS OF THE
the (quantitative) risk assessment of chem- MIXTURE
ical substances.
A.5.2.2.3 Classification for heritable ef- A.5.3.1.1 Classification of mixtures shall
fects in human germ cells is made on the be based on the available test data for the in-
basis of scientifically validated tests. Eval- dividual ingredients of the mixture using
uation of the test results shall be done using cut-off values/concentration limits for the
expert judgment and all the available evi- ingredients classified as germ cell mutagens.
dence shall be weighed for classification. A.5.3.1.2 The mixture will be classified as
A.5.2.2.4 The classification of substances a mutagen when at least one ingredient has
shall be based on the total weight of evi- been classified as a Category 1A, Category 1B
dence available, using expert judgment. In or Category 2 mutagen and is present at or
those instances where a single well-con-
5 It should be noted that the classification cri- sider the cut-off values/concentration limits as
teria for health hazards usually include a tiered the primary tier and allow the classification to
scheme in which test data available on the com- be modified only on a case-by-case evaluation
plete mixture are considered as the first tier in based on available test data for the mixture as
the evaluation, followed by the applicable bridg- a whole.
ing principles, and lastly, cut-off values/con-
centration limits or additivity. However, this ap-
proach is not used for Germ Cell Mutagenicity.
These criteria for Germ Cell Mutagenicity con-
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Occupational Safety and Health Admin., Labor § 1910.1200
above the appropriate cut-off value/con-
centration 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
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.6.2 CLASSIFICATION CRITERIA FOR one of two categories based on strength of
SUBSTANCES 6 evidence and additional weight of evidence
considerations. In certain instances, route-
A.6.2.1 For the purpose of classification for
specific classification may be warranted.
carcinogenicity, substances are allocated to
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Occupational Safety and Health Admin., Labor § 1910.1200
be stated. Limited evidence in animals is (i) Comparison of absorption, distribution,
provided when data suggest a carcinogenic metabolism and excretion between test ani-
effect, but are less than sufficient. (Guidance mals and humans;
on consideration of important factors in the (j) The possibility of a confounding effect
classification of carcinogenicity and a more of excessive toxicity at test doses; and,
detailed description of the terms ‘‘limited’’ (k) Mode of action and its relevance for hu-
and ‘‘sufficient’’ have been developed by the mans, such as mutagenicity, cytotoxicity
International Agency for Research on Cancer with growth stimulation, mitogenesis,
(IARC) and are provided in non-mandatory immunosuppression.
Appendix F). Mutagenicity: It is recognized that genetic
A.6.2.5 Weight of evidence: Beyond the de- events are central in the overall process of
termination of the strength of evidence for cancer development. Therefore evidence of
carcinogenicity, a number of other factors mutagenic activity in vivo may indicate that
should be considered that influence the over- a substance has a potential for carcinogenic
all likelihood that an agent may pose a car- effects.
cinogenic hazard in humans. The full list of A.6.2.5.3 A substance that has not been
factors that influence this determination is tested for carcinogenicity may in certain in-
very lengthy, but some of the important stances be classified in Category 1A, Cat-
ones are considered here. egory 1B, or Category 2 based on tumor data
A.6.2.5.1 These factors can be viewed as ei- from a structural analogue together with
ther increasing or decreasing the level of substantial support from consideration of
concern for human carcinogenicity. The rel- other important factors such as formation of
ative emphasis accorded to each factor de- common significant metabolites, e.g., for
pends upon the amount and coherence of evi- benzidine congener dyes.
dence bearing on each. Generally there is a A.6.2.5.4 The classification should also
requirement for more complete information take into consideration whether or not the
to decrease than to increase the level of con- substance is absorbed by a given route(s); or
cern. Additional considerations should be whether there are only local tumors at the
used in evaluating the tumor findings and site of administration for the tested route(s),
the other factors in a case-by-case manner. and adequate testing by other major route(s)
A.6.2.5.2 Some important factors which show lack of carcinogenicity.
may be taken into consideration, when as- A.6.2.5.5 It is important that whatever is
sessing the overall level of concern are: known of the physico-chemical,
toxicokinetic and toxicodynamic properties
(a) Tumor type and background incidence;
of the substances, as well as any available
(b) Multisite responses;
relevant information on chemical analogues,
(c) Progression of lesions to malignancy; i.e., structure activity relationship, is taken
(d) Reduced tumor latency; into consideration when undertaking classi-
Additional factors which may increase or fication.
decrease the level of concern include:
(e) Whether responses are in single or both A.6.3 CLASSIFICATION CRITERIA FOR
sexes; MIXTURES 7
(f) Whether responses are in a single spe- A.6.3.1 The mixture shall be classified as a
cies or several species; carcinogen when at least one ingredient has
(g) Structural similarity or not to a sub- been classified as a Category 1 or Category 2
stance(s) for which there is good evidence of carcinogen and is present at or above the ap-
carcinogenicity; propriate cut-off value/concentration limit
(h) Routes of exposure; 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 Category 2
Ingredient classified as: carcinogen carcinogen
7 It should be noted that the classification cri- proach is not used for Carcinogenicity. These
teria for health hazards usually include a tiered criteria for Carcinogenicity consider the cut-off
scheme in which test data available on the com- values/concentration limits as the primary tier
plete mixture are considered as the first tier in and allow the classification to be modified only
the evaluation, followed by the applicable bridg- on a case-by-case evaluation based on available
ing principles, and lastly, cut-off values/con- test data for the mixture as a whole.
centration limit or additivity. However, this ap-
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
Category 1 Category 2
Ingredient classified as: carcinogen carcinogen
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Occupational Safety and Health Admin., Labor § 1910.1200
shall be considered. In addition, effects on or hazard category in accordance with Figure
via lactation shall be classified in a separate A.7.1(b).
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
specific property to produce an adverse ef- property will not be expressed in humans
fect on reproduction and substances should then a chemical which produces an adverse
not be so classified if such an effect is pro- effect on reproduction in experimental ani-
duced solely as a non-specific secondary con- mals should not be classified.
sequence of other toxic effects. A.7.2.3.3 In some reproductive toxicity
A.7.2.2.2 In the evaluation of toxic effects studies in experimental animals the only ef-
on the developing offspring, it is important fects recorded may be considered of low or
to consider the possible influence of mater- minimal toxicological significance and clas-
nal toxicity. sification may not necessarily be the out-
A.7.2.2.3 For human evidence to provide come. These effects include, for example,
the primary basis for a Category 1A classi- small changes in semen parameters or in the
fication there must be reliable evidence of an incidence of spontaneous defects in the fetus,
adverse effect on reproduction in humans. small changes in the proportions of common
Evidence used for classification shall be from fetal variants such as are observed in skel-
well conducted epidemiological studies, if etal examinations, or in fetal weights, or
available, which include the use of appro- small differences in postnatal developmental
priate controls, balanced assessment, and assessments.
due consideration of bias or confounding fac- A.7.2.3.4 Data from animal studies shall
tors. Less rigorous data from studies in hu- provide sufficient evidence of specific repro-
mans may be sufficient for a Category 1A ductive toxicity in the absence of other sys-
classification if supplemented with adequate temic toxic effects. However, if develop-
data from studies in experimental animals, mental toxicity occurs together with other
but classification in Category 1B may also be toxic effects in the dam (mother), the poten-
considered. tial influence of the generalized adverse ef-
fects should be assessed to the extent pos-
A.7.2.3 WEIGHT OF EVIDENCE sible. The preferred approach is to consider
A.7.2.3.1 Classification as a reproductive adverse effects in the embryo/fetus first, and
toxicant is made on the basis of an assess- then evaluate maternal toxicity, along with
ment of the total weight of evidence using any other factors which are likely to have
expert judgment. This means that all avail- influenced these effects, as part of the
able information that bears on the deter- weight of evidence. In general, develop-
mination of reproductive toxicity is consid- mental effects that are observed at mater-
ered together. Included is information such nally toxic doses should not be automati-
as epidemiological studies and case reports cally discounted. Discounting developmental
in humans and specific reproduction studies effects that are observed at maternally toxic
along with sub-chronic, chronic and special doses can only be done on a case-by-case
study results in animals that provide rel- basis when a causal relationship is estab-
evant information regarding toxicity to re- lished or refuted.
productive and related endocrine organs. A.7.2.3.5 If appropriate information is
Evaluation of substances chemically related available it is important to try to determine
to the material under study may also be in- whether developmental toxicity is due to a
cluded, particularly when information on the specific maternally mediated mechanism or
material is scarce. The weight given to the to a non-specific secondary mechanism, like
available evidence will be influenced by fac- maternal stress and the disruption of homeo-
tors such as the quality of the studies, con- stasis. Generally, the presence of maternal
sistency of results, nature and severity of ef- toxicity should not be used to negate find-
fects, level of statistical significance for ings of embryo/fetal effects, unless it can be
intergroup differences, number of endpoints clearly demonstrated that the effects are
affected, relevance of route of administra- secondary non-specific effects. This is espe-
tion to humans and freedom from bias. Both cially the case when the effects in the off-
positive and negative results are considered spring are significant, e.g., irreversible ef-
together in a weight of evidence determina- fects such as structural malformations. In
tion. However, a single, positive study per- some situations it is reasonable to assume
formed according to good scientific prin- that reproductive toxicity is due to a sec-
ciples and with statistically or biologically ondary consequence of maternal toxicity and
significant positive results may justify clas- discount the effects, for example if the chem-
sification (See also A.7.2.2.3). ical is so toxic that dams fail to thrive and
A.7.2.3.2 Toxicokinetic studies in animals there is severe inanition; they are incapable
and humans, site of action and mechanism or of nursing pups; or they are prostrate or
mode of action study results may provide dying.
relevant information, which could reduce or
A.7.2.4 MATERNAL TOXICITY
increase concerns about the hazard to human
health. If it is conclusively demonstrated A.7.2.4.1 Development of the offspring
that the clearly identified mechanism or throughout gestation and during the early
mode of action has no relevance for humans postnatal stages can be influenced by toxic
or when the toxicokinetic differences are so effects in the mother either through non-spe-
marked that it is certain that the hazardous cific mechanisms related to stress and the
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Occupational Safety and Health Admin., Labor § 1910.1200
disruption of maternal homeostasis, or by A.7.2.4.4 Some of the endpoints used to as-
specific maternally-mediated mechanisms. sess maternal toxicity are provided below.
So, in the interpretation of the develop- Data on these endpoints, if available, shall
mental outcome to decide classification for be evaluated in light of their statistical or
developmental effects it is important to con- biological significance and dose-response re-
sider the possible influence of maternal tox- lationship.
icity. This is a complex issue because of un- (a) Maternal mortality: An increased inci-
certainties surrounding the relationship be- dence of mortality among the treated dams
tween maternal toxicity and developmental over the controls shall be considered evi-
outcome. Expert judgment and a weight of dence of maternal toxicity if the increase oc-
evidence approach, using all available stud- curs in a dose-related manner and can be at-
ies, shall be used to determine the degree of tributed to the systemic toxicity of the test
influence to be attributed to maternal tox- material. Maternal mortality greater than
icity when interpreting the criteria for clas- 10% is considered excessive and the data for
sification for developmental effects. The ad- that dose level shall not normally be consid-
verse effects in the embryo/fetus shall be ered to need further evaluation.
first considered, and then maternal toxicity, (b) Mating index (Number of animals with
along with any other factors which are like- seminal plugs or sperm/Number of mated ×
ly to have influenced these effects, as weight 100)
of evidence, to help reach a conclusion about (c) Fertility index (Number of animals
classification. with implants/Number of matings × 100)
A.7.2.4.2 Based on pragmatic observation, (d) Gestation length (If allowed to deliver)
it is believed that maternal toxicity may, (e) Body weight and body weight change:
depending on severity, influence develop- Consideration of the maternal body weight
ment via non-specific secondary mecha- change and/or adjusted (corrected) maternal
nisms, producing effects such as depressed body weight shall be included in the evalua-
fetal weight, retarded ossification, and pos- tion of maternal toxicity whenever such data
sibly resorptions and certain malformations are available. The calculation of an adjusted
in some strains of certain species. However, (corrected) mean maternal body weight
the limited numbers of studies which have change, which is the difference between the
investigated the relationship between devel- initial and terminal body weight minus the
opmental effects and general maternal tox- gravid uterine weight (or alternatively, the
icity have failed to demonstrate a con- sum of the weights of the fetuses), may indi-
sistent, reproducible relationship across spe- cate whether the effect is maternal or intra-
cies. Developmental effects which occur even uterine. In rabbits, the body weight gain
in the presence of maternal toxicity are con- may not be a useful indicator of maternal
sidered to be evidence of developmental tox- toxicity because of normal fluctuations in
icity, unless it can be unequivocally dem- body weight during pregnancy.
onstrated on a case by case basis that the de- (f) Food and water consumption (if rel-
velopmental effects are secondary to mater- evant): The observation of a significant de-
nal toxicity. Moreover, classification shall crease in the average food or water consump-
be considered where there is a significant tion in treated dams (mothers) compared to
toxic effect in the offspring, e.g., irreversible the control group may be useful in evalu-
effects such as structural malformations, ating maternal toxicity, particularly when
embryo/fetal lethality, or significant post- the test material is administered in the diet
natal functional deficiencies. or drinking water. Changes in food or water
A.7.2.4.3 Classification shall not auto- consumption must be evaluated in conjunc-
matically be discounted for chemicals that tion with maternal body weights when deter-
produce developmental toxicity only in asso- mining if the effects noted are reflective of
ciation with maternal toxicity, even if a spe- maternal toxicity or more simply,
cific maternally-mediated mechanism has unpalatability of the test material in feed or
been demonstrated. In such a case, classifica- water.
tion in Category 2 may be considered more (g) Clinical evaluations (including clinical
appropriate than Category 1. However, when signs, markers, and hematology and clinical
a chemical is so toxic that maternal death or chemistry studies): The observation of in-
severe inanition results, or the dams (moth- creased incidence of significant clinical signs
ers) are prostrate and incapable of nursing of toxicity in treated dams (mothers) rel-
the pups, it is reasonable to assume that de- ative to the control group is useful in evalu-
velopmental toxicity is produced solely as a ating maternal toxicity. If this is to be used
secondary consequence of maternal toxicity as the basis for the assessment of maternal
and discount the developmental effects. Clas- toxicity, the types, incidence, degree and du-
sification is not necessarily the outcome in ration of clinical signs shall be reported in
the case of minor developmental changes, the study. Clinical signs of maternal intoxi-
e.g., a small reduction in fetal/pup body cation include, but are not limited to: coma,
weight or retardation of ossification when prostration, hyperactivity, loss of righting
seen in association with maternal toxicity. 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 an adverse effect on reproduction in experi-
and/or severity of post-mortem findings may mental animals should not be classified.
be indicative of maternal toxicity. This can A.7.2.5.6 Studies involving routes of ad-
include gross or microscopic pathological ministration such as intravenous or
findings or organ weight data, including ab- intraperitoneal injection, which may result
solute organ weight, organ-to-body weight in exposure of the reproductive organs to un-
ratio, or organ-to-brain weight ratio. When realistically high levels of the test sub-
supported by findings of adverse stance, or elicit local damage to the repro-
histopathological effects in the affected ductive organs, e.g., by irritation, must be
organ(s), the observation of a significant interpreted with extreme caution and on
change in the average weight of suspected their own are not normally the basis for
target organ(s) of treated dams (mothers), classification.
compared to those in the control group, may A.7.2.5.7 There is general agreement about
be considered evidence of maternal toxicity. the concept of a limit dose, above which the
A.7.2.5 ANIMAL AND EXPERIMENTAL DATA production of an adverse effect may be con-
sidered to be outside the criteria which lead
A.7.2.5.1 A number of scientifically vali- to classification. Some test guidelines speci-
dated test methods are available, including fy a limit dose, other test guidelines qualify
methods for developmental toxicity testing the limit dose with a statement that higher
(e.g., OECD Test Guideline 414, ICH Guide- doses may be necessary if anticipated human
line S5A, 1993), methods for peri- and post- exposure is sufficiently high that an ade-
natal toxicity testing (e.g., ICH S5B, 1995), quate margin of exposure would not be
and methods for one or two-generation tox- achieved. Also, due to species differences in
icity testing (e.g., OECD Test Guidelines 415, toxicokinetics, establishing a specific limit
416) dose may not be adequate for situations
A.7.2.5.2 Results obtained from screening where humans are more sensitive than the
tests (e.g., OECD Guidelines 421—Reproduc- animal model.
tion/Developmental Toxicity Screening Test, A.7.2.5.8 In principle, adverse effects on
and 422—Combined Repeated Dose Toxicity reproduction seen only at very high dose lev-
Study with Reproduction/Development Tox- els in animal studies (for example doses that
icity Screening Test) can also be used to jus- induce prostration, severe inappetence, ex-
tify classification, although the quality of cessive mortality) do not normally lead to
this evidence is less reliable than that ob- classification, unless other information is
tained through full studies. available, for example, toxicokinetics infor-
A.7.2.5.3 Adverse effects or changes, seen mation indicating that humans may be more
in short- or long-term repeated dose toxicity susceptible than animals, to suggest that
studies, which are judged likely to impair re- classification is appropriate.
productive function and which occur in the A.7.2.5.9 However, specification of the ac-
absence of significant generalized toxicity, tual ‘‘limit dose’’ will depend upon the test
may be used as a basis for classification, e.g., method that has been employed to provide
histopathological changes in the gonads. the test results.
A.7.2.5.4 Evidence from in vitro assays, or
non-mammalian tests, and from analogous A.7.3 CLASSIFICATION CRITERIA FOR
substances using structure-activity relation- MIXTURES 9
ship (SAR), can contribute to the procedure
for classification. In all cases of this nature, A.7.3.1 CLASSIFICATION OF MIXTURES WHEN
expert judgment must be used to assess the DATA ARE AVAILABLE FOR ALL INGREDIENTS
adequacy of the data. Inadequate data shall OR ONLY FOR SOME INGREDIENTS OF THE
not be used as a primary support for classi- MIXTURE
fication.
A.7.2.5.5 It is preferable that animal stud- A.7.3.1.1 The mixture shall be classified as
ies are conducted using appropriate routes of a reproductive toxicant when at least one in-
administration which relate to the potential gredient has been classified as a Category 1
route of human exposure. However, in prac-
tice, reproductive toxicity studies are com- 9 It should be noted that the classification cri-
monly conducted using the oral route, and teria for health hazards usually include a tiered
such studies will normally be suitable for scheme in which test data available on the com-
evaluating the hazardous properties of the plete mixture are considered as the first tier in
substance with respect to reproductive tox- the evaluation, followed by the applicable bridg-
icity. However, if it can be conclusively dem- ing principles, and lastly, cut-off values/con-
onstrated that the clearly identified mecha- centration limits or additivity. However, this ap-
nism or mode of action has no relevance for proach is not used for Reproductive Toxicity.
humans or when the toxicokinetic dif- These criteria for Reproductive Toxicity con-
ferences are so marked that it is certain that sider the cut-off values/concentration limits as
the hazardous property will not be expressed the primary tier and allow the classification to
in humans then a substance which produces be modified only on a case-by-case evaluation
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Occupational Safety and Health Admin., Labor § 1910.1200
or Category 2 reproductive toxicant and is one ingredient has been classified for effects
present at or above the appropriate cut-off on or via lactation and is present at or above
value/concentration limit specified in Table the appropriate cut-off value/concentration
A.7.1 for Category 1 and 2, respectively. limit specified in Table A.7.1 for the addi-
A.7.3.1.2 The mixture shall be classified tional category for effects on or via lacta-
for effects on or via lactation when at least tion.
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 CLASSIFICA-
TION OF THE MIXTURE
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.8.2 CLASSIFICATION CRITERIA FOR the use of expert judgment on the basis of
SUBSTANCES the weight of all evidence available, includ-
ing the use of recommended guidance values
A.8.2.1 SUBSTANCES OF CATEGORY 1 AND (See A.8.2.1.9). Substances shall then be clas-
CATEGORY 2 sified in Category 1 or 2, depending upon the
A.8.2.1.1 Substances shall be classified for nature and severity of the effect(s) observed,
immediate or delayed effects separately, by 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 poten-
tial 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 ani-
mals, 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 ap-
propriate 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 classifica-
tion.
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 classi-
fied 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 rea-
sonable period without leaving significant alteration of structure or function. This category
only includes narcotic effects and respiratory tract irritation. Substances are classified spe-
cifically 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 eval-
uated 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 experimental animals. The standard animal
by which the classified substance produces studies in rats or mice that provide this in-
damage shall be identified. formation are acute toxicity studies which
A.8.2.1.3 Classification is determined by can include clinical observations and de-
expert judgment, on the basis of the weight tailed macroscopic and microscopic exam-
of all evidence available including the guid- ination to enable the toxic effects on target
ance presented below. tissues/organs to be identified. Results of
A.8.2.1.4 Weight of evidence of all avail- acute toxicity studies conducted in other
able data, including human incidents, epide- species may also provide relevant informa-
miology, and studies conducted in experi- tion.
mental animals is used to substantiate spe-
A.8.2.1.6 In exceptional cases, based on ex-
cific target organ toxic effects that merit
pert judgment, it may be appropriate to
classification.
A.8.2.1.5 The information required to place certain substances with human evi-
evaluate specific target organ toxicity comes dence of target organ toxicity in Category 2:
either from single exposure in humans (e.g., (a) when the weight of human evidence is not
exposure at home, in the workplace or envi- sufficiently convincing to warrant Category
ronmentally), or from studies conducted in
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Occupational Safety and Health Admin., Labor § 1910.1200
1 classification, and/or (b) based on the na- number) in vital organs incapable of regen-
ture and severity of effects. Dose/concentra- eration.
tion levels in humans shall not be considered A.8.2.1.8 Effects considered not to support
in the classification and any available evi- classification for Category 1 and 2
dence from animal studies shall be con- Effects may be seen in humans and/or ani-
sistent with the Category 2 classification. In mals that do not justify classification. Such
other words, if there are also animal data effects include, but are not limited to:
available on the substance that warrant Cat- (a) Clinical observations or small changes
egory 1 classification, the chemical shall be in bodyweight gain, food consumption or
classified as Category 1. water intake that may have some toxi-
A.8.2.1.7 Effects considered to support cological importance but that do not, by
classification for Category 1 and 2 themselves, indicate ‘‘significant’’ toxicity;
A.8.2.1.7.1 Classification is supported by (b) Small changes in clinical biochemistry,
evidence associating single exposure to the hematology or urinalysis parameters and/or
substance with a consistent and identifiable transient effects, when such changes or ef-
toxic effect. fects are of doubtful or of minimal toxi-
A.8.2.1.7.2 Evidence from human experi-
cological importance;
ence/incidents is usually restricted to re-
(c) Changes in organ weights with no evi-
ports of adverse health consequences, often
dence of organ dysfunction;
with uncertainty about exposure conditions,
and may not provide the scientific detail (d) Adaptive responses that are not consid-
that can be obtained from well-conducted ered toxicologically relevant; and,
studies in experimental animals. (e) Substance-induced species-specific
A.8.2.1.7.3 Evidence from appropriate mechanisms of toxicity, i.e., demonstrated
studies in experimental animals can furnish with reasonable certainty to be not relevant
much more detail, in the form of clinical ob- for human health, shall not justify classi-
servations, and macroscopic and microscopic fication.
pathological examination and this can often A.8.2.1.9 Guidance values to assist with
reveal hazards that may not be life-threat- classification based on the results obtained
ening but could indicate functional impair- from studies conducted in experimental ani-
ment. Consequently all available evidence, mals for Category 1 and 2
and evidence relevance to human health, A.8.2.1.9.1 In order to help reach a deci-
must be taken into consideration in the clas- sion about whether a substance shall be clas-
sification process. Relevant toxic effects in sified or not, and to what degree it shall be
humans and/or animals include, but are not classified (Category 1 vs. Category 2), dose/
limited to: concentration ‘‘guidance values’’ are pro-
(a) Morbidity resulting from single expo- vided for consideration of the dose/con-
sure; centration which has been shown to produce
(b) Significant functional changes, more significant health effects. The principal ar-
than transient in nature, in the respiratory gument for proposing such guidance values is
system, central or peripheral nervous sys- that all chemicals are potentially toxic and
tems, other organs or other organ systems, there has to be a reasonable dose/concentra-
including signs of central nervous system de- tion above which a degree of toxic effect is
pression and effects on special senses (e.g., acknowledged.
sight, hearing and sense of smell); A.8.2.1.9.2 Thus, in animal studies, when
(c) Any consistent and significant adverse significant toxic effects are observed that in-
change in clinical biochemistry, hematology, dicate classification, consideration of the
or urinalysis parameters; dose/concentration at which these effects
(d) Significant organ damage that may be were seen, in relation to the suggested guid-
noted at necropsy and/or subsequently seen ance values, provides useful information to
or confirmed at microscopic examination; help assess the need to classify (since the
(e) Multi-focal or diffuse necrosis, fibrosis toxic effects are a consequence of the haz-
or granuloma formation in vital organs with ardous property(ies) and also the dose/con-
regenerative capacity; centration).
(f) Morphological changes that are poten- A.8.2.1.9.3 The guidance value (C) ranges
tially reversible but provide clear evidence for single-dose exposure which has produced
of marked organ dysfunction; and, a significant non-lethal toxic effect are those
(g) Evidence of appreciable cell death (in- applicable to acute toxicity testing, as indi-
cluding cell degeneration and reduced cell cated in Table A.8.1.
TABLE A.8.1—GUIDANCE VALUE RANGES FOR SINGLE-DOSE EXPOSURES
Guidance value ranges for:
Route of exposure Units
Category 1 Category 2 Category 3
Oral (rat) ...................... mg/kg body weight ....... C ≤300 ......................... 2000 ≥C >300 .............. Guidance values do not
apply.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
Dermal (rat or rabbit) ... mg/kg body weight ....... C ≤1,000 ...................... 2000 ≥C >1,000.
Inhalation (rat) gas ....... ppmV/4h ....................... C ≤2,500 ...................... 20,000 ≥C >2,500.
Inhalation (rat) vapor ... mg/1/4h ........................ C ≤10 ........................... 20 ≥C >10.
Inhalation (rat) dust/ mg/l/4h ......................... C ≤1.0 .......................... 5.0 ≥C >1.0.
mist/fume.
A.8.2.1.9.4 The guidance values and ranges consideration of other important factors
mentioned in Table A.8.1 are intended only such as formation of common significant me-
for guidance purposes, i.e., to be used as part tabolites.
of the weight of evidence approach, and to
assist with decisions about classification. A.8.2.2 SUBSTANCES OF CATEGORY 3
They are not intended as strict demarcation
A.8.2.2.1 Criteria for respiratory tract ir-
values. Guidance values are not provided for
ritation
Category 3 since this classification is pri-
marily based on human data; animal data The criteria for classifying substances as
may be included in the weight of evidence Category 3 for respiratory tract irritation
evaluation. are:
A.8.2.1.9.5 Thus, it is feasible that a spe- (a) Respiratory irritant effects (character-
cific profile of toxicity occurs at a dose/con- ized by localized redness, edema, pruritis
centration below the guidance value, e.g., and/or pain) that impair function with symp-
<2000 mg/kg body weight by the oral route, toms such as cough, pain, choking, and
however the nature of the effect may result breathing difficulties are included. It is rec-
in the decision not to classify. Conversely, a ognized that this evaluation is based pri-
specific profile of toxicity may be seen in marily on human data;
animal studies occurring at above a guidance (b) Subjective human observations sup-
value, e.g., ≥2000 mg/kg body weight by the ported by objective measurements of clear
oral route, and in addition there is supple- respiratory tract irritation (RTI) (e.g.,
mentary information from other sources, electrophysiological responses, biomarkers
e.g., other single dose studies, or human case of inflammation in nasal or bronchoalveolar
experience, which supports a conclusion lavage fluids);
that, in view of the weight of evidence, clas- (c) The symptoms observed in humans
sification is the prudent action to take. shall also be typical of those that would be
A.8.2.1.10 Other considerations produced in the exposed population rather
A.8.2.1.10.1 When a substance is character- than being an isolated idiosyncratic reaction
ized only by use of animal data the classi- or response triggered only in individuals
fication process includes reference to dose/ with hypersensitive airways. Ambiguous re-
concentration guidance values as one of the ports simply of ‘‘irritation’’ should be ex-
elements that contribute to the weight of cluded as this term is commonly used to de-
evidence approach. scribe a wide range of sensations including
A.8.2.1.10.2 When well-substantiated those such as smell, unpleasant taste, a tick-
human data are available showing a specific ling sensation, and dryness, which are out-
target organ toxic effect that can be reliably side the scope of classification for res-
attributed to single exposure to a substance, piratory tract irritation;
the substance shall be classified. Positive (d) There are currently no scientifically
human data, regardless of probable dose, pre- validated animal tests that deal specifically
dominates over animal data. Thus, if a sub- with RTI; however, useful information may
stance is unclassified because specific target be obtained from the single and repeated in-
organ toxicity observed was considered not halation toxicity tests. For example, animal
relevant or significant to humans, if subse- studies may provide useful information in
quent human incident data become available terms of clinical signs of toxicity (dyspnoea,
showing a specific target organ toxic effect, rhinitis etc) and histopathology (e.g., hyper-
the substance shall be classified. emia, edema, minimal inflammation, thick-
A.8.2.1.10.3 A substance that has not been ened mucous layer) which are reversible and
tested for specific target organ toxicity may be reflective of the characteristic clin-
shall, where appropriate, be classified on the ical symptoms described above. Such animal
basis of data from a scientifically validated studies can be used as part of weight of evi-
structure activity relationship and expert dence evaluation; and,
judgment-based extrapolation from a struc- (e) This special classification will occur
tural analogue that has previously been clas- only when more severe organ effects includ-
sified together with substantial support from ing the respiratory system are not observed
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Occupational Safety and Health Admin., Labor § 1910.1200
as those effects would require a higher clas- ating data on mixtures, that the dose, dura-
sification. tion, observation or analysis, do not render
A.8.2.2.2 Criteria for narcotic effects the results inconclusive.
The criteria for classifying substances in
Category 3 for narcotic effects are: A.8.3.3 CLASSIFICATION OF MIXTURES WHEN
(a) Central nervous system depression in- DATA ARE NOT AVAILABLE FOR THE COM-
cluding narcotic effects in humans such as PLETE MIXTURE: BRIDGING PRINCIPLES
drowsiness, narcosis, reduced alertness, loss
of reflexes, lack of coordination, and vertigo A.8.3.3.1 Where the mixture itself has not
are included. These effects can also be mani- been tested to determine its specific target
fested as severe headache or nausea, and can organ toxicity, but there are sufficient data
lead to reduced judgment, dizziness, irrita- on both the individual ingredients and simi-
bility, fatigue, impaired memory function, lar tested mixtures to adequately charac-
deficits in perception and coordination, reac- terize the hazards of the mixture, these data
tion time, or sleepiness; and, shall be used in accordance with the fol-
(b) Narcotic effects observed in animal lowing bridging principles as found in para-
studies may include lethargy, lack of coordi- graph A.0.5 of this Appendix: Dilution,
nation righting reflex, narcosis, and ataxia. Batching, Concentration of mixtures, Inter-
If these effects are not transient in nature, polation within one toxicity category, Sub-
then they shall be considered for classifica- stantially similar mixtures, or Aerosols.
tion as Category 1 or 2.
A.8.3.4 CLASSIFICATION OF MIXTURES WHEN
A.8.3 CLASSIFICATION CRITERIA FOR DATA ARE AVAILABLE FOR ALL INGREDIENTS
MIXTURES OR ONLY FOR SOME INGREDIENTS OF THE
MIXTURE
A.8.3.1 Mixtures are classified using the
same criteria as for substances, or alter- A.8.3.4.1 Where there is no reliable evi-
natively as described below. As with sub- dence or test data for the specific mixture
stances, mixtures may be classified for spe- itself, and the bridging principles cannot be
cific target organ toxicity following single used to enable classification, then classifica-
exposure, repeated exposure, or both. tion of the mixture is based on the classifica-
tion of the ingredient substances. In this
A.8.3.2 CLASSIFICATION OF MIXTURES WHEN
case, the mixture shall be classified as a spe-
DATA ARE AVAILABLE FOR THE COMPLETE
cific target organ toxicant (specific organ
MIXTURE
specified), following single exposure, re-
When reliable and good quality evidence peated exposure, or both when at least one
from human experience or appropriate stud- ingredient has been classified as a Category
ies in experimental animals, as described in 1 or Category 2 specific target organ toxicant
the criteria for substances, is available for and is present at or above the appropriate
the mixture, then the mixture shall be clas- cut-off value/concentration limit specified in
sified by weight of evidence evaluation of Table A.8.2 for Categories 1 and 2, respec-
this data. Care shall be exercised in evalu- tively.
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
Ingredient classified as: a mixture as:
Category 1 Category 2
A.8.3.4.2 These cut-off values and con- cause certain substances can cause target
sequent classifications shall be applied organ toxicity at <1% concentration when
equally and appropriately to both single- and other ingredients in the mixture are known
repeated-dose target organ toxicants. to potentiate its toxic effect.
A.8.3.4.3 Mixtures shall be classified for A.8.3.4.5 Care shall be exercised when ex-
either or both single and repeated dose tox- trapolating the toxicity of a mixture that
icity independently. contains Category 3 ingredient(s). A cut-off
A.8.3.4.4 Care shall be exercised when value/concentration limit of 20%, considered
toxicants affecting more than one organ sys- as an additive of all Category 3 ingredients
tem are combined that the potentiation or for each hazard endpoint, is appropriate;
synergistic interactions are considered, be- 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 a potential for adverse health effects in peo-
the Category 3 ingredient(s) involved and the ple who are exposed to it.
fact that some effects such as respiratory A.9.1.3 These adverse health effects pro-
tract irritation may not occur below a cer- duced by repeated exposure include con-
tain concentration while other effects such sistent and identifiable toxic effects in hu-
as narcotic effects may occur below this 20% mans, or, in experimental animals,
value. Expert judgment shall be exercised. toxicologically significant changes which
Respiratory tract irritation and narcotic ef- have affected the function or morphology of
fects are to be evaluated separately in ac- a tissue/organ, or have produced serious
cordance with the criteria given in A.8.2.2. changes to the biochemistry or hematology
When conducting classifications for these of the organism and these changes are rel-
hazards, the contribution of each ingredient evant for human health. Human data will be
should be considered additive, unless there is the primary source of evidence for this haz-
evidence that the effects are not additive. ard class.
A.9.1.4 Assessment shall take into consid-
A.9 SPECIFIC TARGET ORGAN TOXICITY eration not only significant changes in a sin-
REPEATED OR PROLONGED EXPOSURE gle organ or biological system but also gen-
eralized changes of a less severe nature in-
A.9.1 DEFINITIONS AND GENERAL volving several organs.
CONSIDERATIONS
A.9.1.5 Specific target organ toxicity can
A.9.1.1 Specific target organ toxicity—re- occur by any route that is relevant for hu-
peated exposure (STOT–RE) means specific mans, e.g., principally oral, dermal or inha-
target organ toxicity arising from repeated lation.
exposure to a substance or mixture. All sig-
nificant health effects that can impair func- A.9.2 CLASSIFICATION CRITERIA FOR
SUBSTANCES
tion, both reversible and irreversible, imme-
diate and/or delayed and not specifically ad- A.9.2.1 Substances shall be classified as
dressed in A.1 to A.7 and A.10 of this Appen- STOT–RE by expert judgment on the basis of
dix are included. Specific target organ tox- the weight of all evidence available, includ-
icity following a single-event exposure is ing the use of recommended guidance values
classified in accordance with SPECIFIC TAR- which take into account the duration of ex-
GET ORGAN TOXICITY—SINGLE EXPOSURE posure and the dose/concentration which pro-
(A.8 of this Appendix) and is therefore not in- duced the effect(s), (See A.9.2.9). Substances
cluded here. shall be placed in one of two categories, de-
A.9.1.2 Classification identifies the sub- pending upon the nature and severity of the
stance or mixture as being a specific target effect(s) observed, in accordance with Figure
organ toxicant and, as such, it may present 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 poten-
tial 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 gen-
erally low exposure concentrations. Guidance dose/concentration values are pro-
vided 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 ani-
mals can be presumed to have the potential to be harmful to human health following re-
peated 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 pro-
duced at generally moderate exposure concentrations. Guidance dose/concentra-
tion 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 Cat-
egory 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 A.9.2.7.2 Evidence from human experience/
which the classified substance produces dam- incidents is usually restricted to reports of
age shall be identified. adverse health consequences, often with un-
A.9.2.3 Classification is determined by ex- certainty about exposure conditions, and
pert judgment, on the basis of the weight of may not provide the scientific detail that
all evidence available including the guidance can be obtained from well-conducted studies
presented below. in experimental animals.
A.9.2.4 Weight of evidence of all data, in- A.9.2.7.3 Evidence from appropriate stud-
cluding human incidents, epidemiology, and ies in experimental animals can furnish
studies conducted in experimental animals, much more detail, in the form of clinical ob-
is used to substantiate specific target organ servations, hematology, clinical chemistry,
toxic effects that merit classification. macroscopic and microscopic pathological
A.9.2.5 The information required to evalu- examination and this can often reveal haz-
ate specific target organ toxicity comes ei- ards that may not be life-threatening but
ther from repeated exposure in humans, e.g., could indicate functional impairment. Con-
exposure at home, in the workplace or envi-
sequently all available evidence, and rel-
ronmentally, or from studies conducted in
evance to human health, must be taken into
experimental animals. The standard animal
consideration in the classification process.
studies in rats or mice that provide this in-
formation are 28 day, 90 day or lifetime stud- Relevant toxic effects in humans and/or ani-
ies (up to 2 years) that include mals include, but are not limited to:
hematological, clinico-chemical and detailed (a) Morbidity or death resulting from re-
macroscopic and microscopic examination to peated or long-term exposure. Morbidity or
enable the toxic effects on target tissues/or- death may result from repeated exposure,
gans to be identified. Data from repeat dose even to relatively low doses/concentrations,
studies performed in other species may also due to bioaccumulation of the substance or
be used. Other long-term exposure studies, its metabolites, or due to the overwhelming
e.g., for carcinogenicity, neurotoxicity or re- of the de-toxification process by repeated ex-
productive toxicity, may also provide evi- posure;
dence of specific target organ toxicity that (b) Significant functional changes in the
could be used in the assessment of classifica- central or peripheral nervous systems or
tion. other organ systems, including signs of cen-
A.9.2.6 In exceptional cases, based on ex- tral nervous system depression and effects
pert judgment, it may be appropriate to on special senses (e.g., sight, hearing and
place certain substances with human evi- sense of smell);
dence of specific target organ toxicity in
(c) Any consistent and significant adverse
Category 2: (a) when the weight of human
change in clinical biochemistry, hematology,
evidence is not sufficiently convincing to
or urinalysis parameters;
warrant Category 1 classification, and/or (b)
based on the nature and severity of effects. (d) Significant organ damage that may be
Dose/concentration levels in humans shall noted at necropsy and/or subsequently seen
not be considered in the classification and or confirmed at microscopic examination;
any available evidence from animal studies (e) Multi-focal or diffuse necrosis, fibrosis
shall be consistent with the Category 2 clas- or granuloma formation in vital organs with
sification. In other words, if there are also regenerative capacity;
animal data available on the substance that (f) Morphological changes that are poten-
warrant Category 1 classification, the sub- tially reversible but provide clear evidence
stance shall be classified as Category 1. of marked organ dysfunction (e.g., severe
fatty change in the liver); and,
A.9.2.7 EFFECTS CONSIDERED TO SUPPORT
(g) Evidence of appreciable cell death (in-
CLASSIFICATION
cluding cell degeneration and reduced cell
A.9.2.7.1 Classification is supported by re- number) in vital organs incapable of regen-
liable evidence associating repeated exposure eration.
to the substance with a consistent and iden-
tifiable toxic effect.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.9.2.8 EFFECTS CONSIDERED NOT TO that all chemicals are potentially toxic and
SUPPORT CLASSIFICATION there has to be a reasonable dose/concentra-
tion above which a degree of toxic effect is
Effects may be seen in humans and/or ani-
acknowledged. Also, repeated-dose studies
mals that do not justify classification. Such
effects include, but are not limited to: conducted in experimental animals are de-
(a) Clinical observations or small changes signed to produce toxicity at the highest
in bodyweight gain, food consumption or dose used in order to optimize the test objec-
water intake that may have some toxi- tive and so most studies will reveal some
cological importance but that do not, by toxic effect at least at this highest dose.
themselves, indicate ‘‘significant’’ toxicity; What is therefore to be decided is not only
(b) Small changes in clinical biochemistry, what effects have been produced, but also at
hematology or urinalysis parameters and/or what dose/concentration they were produced
transient effects, when such changes or ef- and how relevant is that for humans.
fects are of doubtful or of minimal toxi- A.9.2.9.3 Thus, in animal studies, when
cological importance; significant toxic effects are observed that in-
(c) Changes in organ weights with no evi- dicate classification, consideration of the du-
dence of organ dysfunction; ration of experimental exposure and the
(d) Adaptive responses that are not consid- dose/concentration at which these effects
ered toxicologically relevant; were seen, in relation to the suggested guid-
(e) Substance-induced species-specific ance values, provides useful information to
mechanisms of toxicity, i.e., demonstrated help assess the need to classify (since the
with reasonable certainty to be not relevant toxic effects are a consequence of the haz-
for human health, shall not justify classi- ardous property(ies) and also the duration of
fication. exposure and the dose/concentration).
A.9.2.9.4 The decision to classify at all can
A.9.2.9 GUIDANCE VALUES TO ASSIST WITH be influenced by reference to the dose/con-
CLASSIFICATION BASED ON THE RESULTS OB- centration guidance values at or below which
TAINED FROM STUDIES CONDUCTED IN EX- a significant toxic effect has been observed.
PERIMENTAL ANIMALS
A.9.2.9.5 The guidance values refer to ef-
A.9.2.9.1 In studies conducted in experi- fects seen in a standard 90-day toxicity study
mental animals, reliance on observation of conducted in rats. They can be used as a
effects alone, without reference to the dura- basis to extrapolate equivalent guidance val-
tion of experimental exposure and dose/con- ues for toxicity studies of greater or lesser
centration, omits a fundamental concept of duration, using dose/exposure time extrapo-
toxicology, i.e., all substances are poten- lation similar to Haber’s rule for inhalation,
tially toxic, and what determines the tox- which states essentially that the effective
icity is a function of the dose/concentration dose is directly proportional to the exposure
and the duration of exposure. In most studies concentration and the duration of exposure.
conducted in experimental animals the test The assessment should be done on a case-by-
guidelines use an upper limit dose value. case basis; for example, for a 28-day study
A.9.2.9.2 In order to help reach a decision the guidance values below would be in-
about whether a substance shall be classified creased by a factor of three.
or not, and to what degree it shall be classi- A.9.2.9.6 Thus for Category 1 classifica-
fied (Category 1 vs. Category 2), dose/con- tion, significant toxic effects observed in a
centration ‘‘guidance values’’ are provided in 90-day repeated-dose study conducted in ex-
Table A.9.1 for consideration of the dose/con- perimental animals and seen to occur at or
centration which has been shown to produce below the (suggested) guidance values (C) as
significant health effects. The principal ar- indicated in Table A.9.1 would justify classi-
gument for proposing such guidance values is fication:
TABLE A.9.1—GUIDANCE VALUES TO ASSIST IN CATEGORY 1 CLASSIFICATION
[Applicable to a 90-day study]
Guidance values
Route of exposure Units (dose/concentration)
A.9.2.9.7 For Category 2 classification, mental animals and seen to occur within the
significant toxic effects observed in a 90-day
repeated-dose study conducted in experi-
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Occupational Safety and Health Admin., Labor § 1910.1200
(suggested) guidance value ranges as indi-
cated in Table A.9.2 would justify classifica-
tion:
TABLE A.9.2—GUIDANCE VALUES TO ASSIST IN CATEGORY 2 CLASSIFICATION
[Applicable to a 90-day study]
Guidance values
Route of exposure Units (dose/concentration)
A.9.2.9.8 The guidance values and ranges classified on the basis of data from a sci-
mentioned in A.2.9.9.6 and A.2.9.9.7 are in- entifically validated structure activity rela-
tended only for guidance purposes, i.e., to be tionship and expert judgment-based extrapo-
used as part of the weight of evidence ap- lation from a structural analogue that has
proach, and to assist with decisions about previously been classified together with sub-
classification. They are not intended as stantial support from consideration of other
strict demarcation values. important factors such as formation of com-
A.9.2.9.9 Thus, it is possible that a specific mon significant metabolites.
profile of toxicity occurs in repeat-dose ani-
mal studies at a dose/concentration below A.9.3 CLASSIFICATION CRITERIA FOR
the guidance value, e.g., <100 mg/kg body MIXTURES
weight/day by the oral route, however the
nature of the effect, e.g., nephrotoxicity seen A.9.3.1 Mixtures are classified using the
only in male rats of a particular strain same criteria as for substances, or alter-
known to be susceptible to this effect, may natively as described below. As with sub-
result in the decision not to classify. Con- stances, mixtures may be classified for spe-
versely, a specific profile of toxicity may be cific target organ toxicity following single
seen in animal studies occurring at above a exposure, repeated exposure, or both.
guidance value, e.g., ≥100 mg/kg body weight/
day by the oral route, and in addition there A.9.3.2 CLASSIFICATION OF MIXTURES WHEN
is supplementary information from other DATA ARE AVAILABLE FOR THE COMPLETE
sources, e.g., other long-term administration MIXTURE
studies, or human case experience, which
supports a conclusion that, in view of the When reliable and good quality evidence
weight of evidence, classification is prudent. from human experience or appropriate stud-
ies in experimental animals, as described in
A.9.2.10 OTHER CONSIDERATIONS the criteria for substances, is available for
A.9.2.10.1 When a substance is character- the mixture, then the mixture shall be clas-
ized only by use of animal data the classi- sified by weight of evidence evaluation of
fication process includes reference to dose/ these data. Care shall be exercised in evalu-
concentration guidance values as one of the ating data on mixtures, that the dose, dura-
elements that contribute to the weight of tion, observation or analysis, do not render
evidence approach. the results inconclusive.
A.9.2.10.2 When well-substantiated human
data are available showing a specific target A.9.3.3 CLASSIFICATION OF MIXTURES WHEN
organ toxic effect that can be reliably attrib- DATA ARE NOT AVAILABLE FOR THE COM-
uted to repeated or prolonged exposure to a PLETE MIXTURE: BRIDGING PRINCIPLES
substance, the substance shall be classified.
A.9.3.3.1 Where the mixture itself has not
Positive human data, regardless of probable
been tested to determine its specific target
dose, predominates over animal data. Thus,
if a substance is unclassified because no spe- organ toxicity, but there are sufficient data
cific target organ toxicity was seen at or on both the individual ingredients and simi-
below the dose/concentration guidance value lar tested mixtures to adequately charac-
for animal testing, if subsequent human inci- terize the hazards of the mixture, these data
dent data become available showing a spe- shall be used in accordance with the fol-
cific target organ toxic effect, the substance lowing bridging principles as found in para-
shall be classified. graph A.0.5 of this Appendix: Dilution;
A.9.2.10.3 A substance that has not been Batching; Concentration of mixtures; Inter-
tested for specific target organ toxicity may polation within one toxicity category; Sub-
in certain instances, where appropriate, be stantially similar mixtures; and Aerosols.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
A.9.3.4 CLASSIFICATION OF MIXTURES WHEN tion of the ingredient substances. In this
DATA ARE AVAILABLE FOR ALL INGREDIENTS case, the mixture shall be classified as a spe-
OR ONLY FOR SOME INGREDIENTS OF THE cific target organ toxicant (specific organ
MIXTURE specified), following single exposure, re-
peated exposure, or both when at least one
A.9.3.4.1 Where there is no reliable evi- ingredient has been classified as a Category
dence or test data for the specific mixture 1 or Category 2 specific target organ toxicant
itself, and the bridging principles cannot be and is present at or above the appropriate
used to enable classification, then classifica- cut-off value/concentration limit specified in
tion of the mixture is based on the classifica- 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
Ingredient classified as: mixture as:
Category 1 Category 2
A.9.3.4.2 These cut-off values and con- A.10.1.2 Aspiration toxicity includes se-
sequent classifications shall be applied vere acute effects such as chemical pneu-
equally and appropriately to both single- and monia, varying degrees of pulmonary injury
repeated-dose target organ toxicants. or death following aspiration.
A.9.3.4.3 Mixtures shall be classified for A.10.1.3 Aspiration is initiated at the mo-
either or both single- and repeated-dose tox- ment of inspiration, in the time required to
icity independently. take one breath, as the causative material
lodges at the crossroad of the upper res-
A.9.3.4.4 Care shall be exercised when
piratory and digestive tracts in the
toxicants affecting more than one organ sys-
laryngopharyngeal region.
tem are combined that the potentiation or
A.10.1.4 Aspiration of a substance or mix-
synergistic interactions are considered, be- ture can occur as it is vomited following in-
cause certain substances can cause specific gestion. This may have consequences for la-
target organ toxicity at <1% concentration beling, particularly where, due to acute tox-
when other ingredients in the mixture are icity, a recommendation may be considered
known to potentiate its toxic effect. to induce vomiting after ingestion. However,
if the substance/mixture also presents an as-
A.10 ASPIRATION HAZARD piration toxicity hazard, the recommenda-
tion to induce vomiting may need to be
A.10.1 DEFINITIONS AND GENERAL AND
modified.
SPECIFIC CONSIDERATIONS
A.10.1.1 Aspiration means the entry of a A.10.1.5 SPECIFIC CONSIDERATIONS
liquid or solid chemical directly through the A.10.1.5.1 The classification criteria refer
oral or nasal cavity, or indirectly from vom- to kinematic viscosity. The following pro-
iting, into the trachea and lower respiratory vides the conversion between dynamic and
system. kinematic viscosity:
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Occupational Safety and Health Admin., Labor § 1910.1200
containers, trigger and pump sprayers. Clas- the mist produced by trigger and pump
sification for these products shall be consid- sprayers is coarse and therefore, a pool may
ered if their use may form a pool of product be formed that then may be aspirated. When
in the mouth, which then may be aspirated. the pump mechanism may be removed and
If the mist or aerosol from a pressurized con- contents are available to be swallowed then
tainer is fine, a pool may not be formed. On the classification of the products should be
the other hand, if a pressurized container considered.
dispenses product in a stream, a pool may be A.10.2 CLASSIFICATION CRITERIA FOR
formed that may then be aspirated. Usually, SUBSTANCES
TABLE A.10.1—CRITERIA FOR ASPIRATION TOXICITY
Category Criteria
Category 1: Chemicals known to cause human aspiration tox- A substance shall be classified in Category 1:
icity hazards or to be regarded as if they cause human aspi- (a) If reliable and good quality human evidence indicates
ration toxicity hazard. 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.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
B.1.2 CLASSIFICATION CRITERIA solid (See B.14) is determined by Test Series
8 tests.
Chemicals and items of this class shall be
classified as unstable explosives or shall be NOTE: Classification of solid chemicals
assigned to one of the following six divisions shall be based on tests performed on the
depending on the type of hazard they chemical as presented. If, for example, for
present: the purposes of supply or transport, the same
(a) Division 1.1—Chemicals and items chemical is to be presented in a physical
which have a mass explosion hazard (a mass form different from that which was tested
explosion is one which affects almost the en- and which is considered likely to materially
tire quantity present virtually instanta- alter its performance in a classification test,
neously); classification must be based on testing of the
(b) Division 1.2—Chemicals and items chemical in the new form.
which have a projection hazard but not a B.1.3.2 Explosive properties are associated
mass explosion hazard; with the presence of certain chemical groups
(c) Division 1.3—Chemicals and items in a molecule which can react to produce
which have a fire hazard and either a minor very rapid increases in temperature or pres-
blast hazard or a minor projection hazard or sure. The screening procedure in B.1.3.1 is
both, but not a mass explosion hazard: aimed at identifying the presence of such re-
(i) Combustion of which gives rise to con- active groups and the potential for rapid en-
siderable radiant heat; or ergy release. If the screening procedure iden-
(ii) Which burn one after another, pro- tifies the chemical as a potential explosive,
ducing minor blast or projection effects or the acceptance procedure (See section 10.3 of
both; the UN ST/SG/AC.10 (incorporated by ref-
(d) Division 1.4—Chemicals and items erence; See § 1910.6)) is necessary for classi-
which present no significant hazard: chemi- fication.
cals and items which present only a small NOTE: Neither a Series 1 type (a) propaga-
hazard in the event of ignition or initiation. tion of detonation test nor a Series 2 type (a)
The effects are largely confined to the pack- test of sensitivity to detonative shock is nec-
age and no projection of fragments of appre- essary if the exothermic decomposition en-
ciable size or range is to be expected. An ex- ergy of organic materials is less than 800 J/
ternal fire shall not cause virtually instanta- g.
neous explosion of almost the entire con- B.1.3.3 If a mixture contains any known
tents of the package; explosives, the acceptance procedure is nec-
(e) Division 1.5—Very insensitive chemi- essary for classification.
cals which have a mass explosion hazard: B.1.3.4 A chemical is not classified as ex-
chemicals which have a mass explosion haz- plosive if:
ard but are so insensitive that there is very (a) There are no chemical groups associ-
little probability of initiation or of transi- ated with explosive properties present in the
tion from burning to detonation under nor- molecule. Examples of groups which may in-
mal conditions; dicate explosive properties are given in
(f) Division 1.6—Extremely insensitive Table A6.1 in Appendix 6 of the UN ST/SG/
items which do not have a mass explosion AC.10 (incorporated by reference; See
hazard: items which contain only extremely § 1910.6); or
insensitive detonating chemicals and which (b) The substance contains chemical
demonstrate a negligible probability of acci- groups associated with explosive properties
dental initiation or propagation. which include oxygen and the calculated ox-
ygen balance is less than ¥200.
B.1.3 ADDITIONAL CLASSIFICATION
CONSIDERATIONS The oxygen balance is calculated for the
chemical reaction:
B.1.3.1 Explosives shall be classified as un- CXHyOz + [x + (y/4) ¥ (z/2)] O2 → x. CO2 + (y/
stable explosives or shall be assigned to one 2) H2O
of the six divisions identified in B.1.2 in ac-
cordance with the three step procedure in using the formula:
Part I of the UN ST/SG/AC.10 (incorporated oxygen balance = ¥1600 [2x +(y/2) ¥z]/molec-
by reference; See § 1910.6). The first step is to ular weight;
ascertain whether the substance or mixture or
has explosive effects (Test Series 1). The sec- (c) The organic substance or a homogenous
ond step is the acceptance procedure (Test mixture of organic substances contains
Series 2 to 4) and the third step is the assign- chemical groups associated with explosive
ment to a hazard division (Test Series 5 to 7). properties but the exothermic decomposition
The assessment whether a candidate for energy is less than 500 J/g and the onset of
‘‘ammonium nitrate emulsion or suspension exothermic decomposition is below 500 °C
or gel, intermediate for blasting explosives (932 °F). The exothermic decomposition en-
(ANE)’’ is insensitive enough for inclusion as ergy may be determined using a suitable
an oxidizing liquid (See B.13) or an oxidizing calorimetric technique; or
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Occupational Safety and Health Admin., Labor § 1910.1200
(d) For mixtures of inorganic oxidizing B.2 FLAMMABLE GASES
substances with organic material(s), the con-
centration of the inorganic oxidizing sub- B.2.1 DEFINITION
stance is: Flammable gas means a gas having a flam-
(i) Less than 15%, by mass, if the oxidizing mable range with air at 20 °C (68 °F) and a
substance is assigned to Category 1 or 2; standard pressure of 101.3 kPa (14.7 psi).
(ii) Less than 30%, by mass, if the oxidizing
B.2.2 CLASSIFICATION CRITERIA
substance is assigned to Category 3.
A flammable gas shall be classified in one
of the two categories for this class in accord-
ance 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 flam-
mable limit.
2 ................................. 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.
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
2 ................................. 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
NOTE: Aerosols not submitted to the flam- Appendix shall be classified as extremely
mability classification procedures in this flammable (Category 1).
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
B.3.3 ADDITIONAL CLASSIFICATION B.3.3.2 The chemical heat of combustion
CONSIDERATIONS (DHc), in kilojoules per gram (kJ/g), is the
product of the theoretical heat of combus-
B.3.3.1 To classify a flammable aerosol, tion (DHcomb), and a combustion efficiency,
data on its flammable components, on its usually less than 1.0 (a typical combustion
chemical heat of combustion and, if applica- efficiency is 0.95 or 95%).
ble, the results of the aerosol foam flamma- For a composite aerosol formulation, the
bility test (for foam aerosols) and of the igni- chemical heat of combustion is the summa-
tion distance test and enclosed space test tion of the weighted heats of combustion for
(for spray aerosols) are necessary. the individual components, as follows:
1 ................................. Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other ma-
terial more than air does.
B.4.3 ADDITIONAL CLASSIFICATION kPa (29 psi) (gauge) or more, or which are
CONSIDERATIONS liquefied or liquefied and refrigerated.
Classification shall be in accordance with They comprise compressed gases, liquefied
tests or calculation methods as described in gases, dissolved gases and refrigerated lique-
ISO 10156 (incorporated by reference; See fied gases.
§ 1910.6) and ISO 10156–2 (incorporated by ref-
erence; See § 1910.6). B.5.2 CLASSIFICATION CRITERIA
Gases under pressure shall be classified in
B.5 GASES UNDER PRESSURE
one of four groups in accordance with Table
B.5.1 DEFINITION B.5.1:
Gases under pressure are gases which are
contained in a receptacle at a pressure of 200
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Occupational Safety and Health Admin., Labor § 1910.1200
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).
Liquefied gas ......................... 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).
Refrigerated liquefied gas ..... A gas which is made partially liquid because of its low temperature.
Dissolved gas ........................ A gas which when under pressure is dissolved in a liquid phase solvent.
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 mixture with air near the surface of the liq-
uid, as determined by a method identified in
B.6.1 DEFINITION Section B.6.3.
Flammable liquid means a liquid having a
B.6.2 CLASSIFICATION CRITERIA
flash point of not more than 93 °C (199.4 °F).
Flash point means the minimum tempera- A flammable liquid shall be classified in
ture at which a liquid gives off vapor in suffi- one of four categories in accordance with
cient concentration to form an ignitable Table B.6.1:
TABLE B.6.1—CRITERIA FOR FLAMMABLE LIQUIDS
Category Criteria
1 ....................................... Flash point <23 °C (73.4 °F) and initial boiling point ≤35 °C (95 °F).
2 ....................................... Flash point <23 °C (73.4 °F) and initial boiling point >35 °C (95 °F).
3 ....................................... Flash point ≥23 °C (73.4 °F) and ≤60 °C (140 °F).
4 ....................................... Flash point >60 °C (140 °F) and ≤93 °C (199.4 °F).
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
NOTE: Classification of solid chemicals mentioned in B.8.2.1 (a), (c), (d) or (e), shall
shall be based on tests performed on the be subjected to the self-reactive chemicals
chemical as presented. If, for example, for classification procedure in B.8.2.3. Such a
the purposes of supply or transport, the same mixture showing the properties of a self-re-
chemical is to be presented in a physical active chemical type B to F shall be classi-
form different from that which was tested fied as a self-reactive chemical.
and which is considered likely to materially B.8.2.3 Self-reactive chemicals shall be
alter its performance in a classification test, classified in one of the seven categories of
classification must be based on testing of the ‘‘types A to G’’ for this class, according to
chemical in the new form. the following principles:
(a) Any self-reactive chemical which can
B.8 SELF-REACTIVE CHEMICALS detonate or deflagrate rapidly, as packaged,
will be defined as self-reactive chemical
B.8.1 DEFINITIONS
TYPE A;
Self-reactive chemicals are thermally unsta- (b) Any self-reactive chemical possessing
ble liquid or solid chemicals liable to under- explosive properties and which, as packaged,
go a strongly exothermic decomposition neither detonates nor deflagrates rapidly,
even without participation of oxygen (air). but is liable to undergo a thermal explosion
This definition excludes chemicals classified in that package will be defined as self-reac-
under this section as explosives, organic per- tive chemical TYPE B;
oxides, oxidizing liquids or oxidizing solids. (c) Any self-reactive chemical possessing
A self-reactive chemical is regarded as pos- explosive properties when the chemical as
sessing explosive properties when in labora- packaged cannot detonate or deflagrate rap-
tory testing the formulation is liable to det- idly or undergo a thermal explosion will be
onate, to deflagrate rapidly or to show a vio- defined as self-reactive chemical TYPE C;
lent effect when heated under confinement. (d) Any self-reactive chemical which in
laboratory testing meets the criteria in
B.8.2 CLASSIFICATION CRITERIA (d)(i), (ii), or (iii) will be defined as self-reac-
B.8.2.1 A self-reactive chemical shall be tive chemical TYPE D:
considered for classification in this class un- (i) Detonates partially, does not deflagrate
less: rapidly and shows no violent effect when
(a) It is classified as an explosive according heated under confinement; or
to B.1 of this appendix; (ii) Does not detonate at all, deflagrates
(b) It is classified as an oxidizing liquid or slowly and shows no violent effect when
an oxidizing solid according to B.13 or B.14 of heated under confinement; or
this appendix, except that a mixture of oxi- (iii) Does not detonate or deflagrate at all
dizing substances which contains 5% or more and shows a medium effect when heated
of combustible organic substances shall be under confinement;
classified as a self-reactive chemical accord- (e) Any self-reactive chemical which, in
ing to the procedure defined in B.8.2.2; laboratory testing, neither detonates nor
(c) It is classified as an organic peroxide deflagrates at all and shows low or no effect
according to B.15 of this appendix; when heated under confinement will be de-
(d) Its heat of decomposition is less than fined as self-reactive chemical TYPE E;
300 J/g; or (f) Any self-reactive chemical which, in
(e) Its self-accelerating decomposition laboratory testing, neither detonates in the
temperature (SADT) is greater than 75 °C cavitated state nor deflagrates at all and
(167 °F) for a 50 kg (110 lb) package. shows only a low or no effect when heated
B.8.2.2 Mixtures of oxidizing substances, under confinement as well as low or no ex-
meeting the criteria for classification as oxi- plosive power will be defined as self-reactive
dizing liquids or oxidizing solids, which con- chemical TYPE F;
tain 5% or more of combustible organic sub- (g) Any self-reactive chemical which, in
stances and which do not meet the criteria laboratory testing, neither detonates in the
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Occupational Safety and Health Admin., Labor § 1910.1200
cavitated state nor deflagrates at all and (a) There are no chemical groups present in
shows no effect when heated under confine- the molecule associated with explosive or
ment nor any explosive power, provided that self-reactive properties; examples of such
it is thermally stable (self-accelerating de- groups are given in Tables A6.1 and A6.2 in
composition temperature is 60 °C (140 °F) to the Appendix 6 of the UN ST/SG/AC.10 (incor-
75 °C (167 °F) for a 50 kg (110 lb) package), porated by reference; See § 1910.6); or
and, for liquid mixtures, a diluent having a (b) For a single organic substance or a ho-
boiling point greater than or equal to 150 °C mogeneous mixture of organic substances,
(302 °F) is used for desensitization will be de- the estimated SADT is greater than 75 °C
fined as self-reactive chemical TYPE G. If (167 °F) or the exothermic decomposition en-
the mixture is not thermally stable or a dil- ergy is less than 300 J/g. The onset tempera-
uent having a boiling point less than 150 °C ture and decomposition energy may be esti-
(302 °F) is used for desensitization, the mix- mated using a suitable calorimetric tech-
ture shall be defined as self-reactive chem- nique (See 20.3.3.3 in Part II of the UN ST/SG/
ical TYPE F. AC.10 (incorporated by reference; See
B.8.3 ADDITIONAL CLASSIFICATION § 1910.6)).
CONSIDERATIONS
B.9 PYROPHORIC LIQUIDS
B.8.3.1 For purposes of classification, the
properties of self-reactive chemicals shall be B.9.1 DEFINITION
determined in accordance with test series A
Pyrophoric liquid means a liquid which,
to H as described in Part II of the UN ST/SG/
even in small quantities, is liable to ignite
AC.10 (incorporated by reference; See
within five minutes after coming into con-
§ 1910.6).
tact with air.
B.8.3.2 Self-accelerating decomposition
temperature (SADT) shall be determined in B.9.2 CLASSIFICATION CRITERIA
accordance with the UN ST/SG/AC.10, Part
II, section 28 (incorporated by reference; See A pyrophoric liquid shall be classified in a
§ 1910.6). single category for this class using test N.3
B.8.3.3 The classification procedures for in Part III, sub-section 33.3.1.5 of the UN ST/
self-reactive substances and mixtures need SG/AC.10 (incorporated by reference; See
not be applied if: § 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.
1 ............................................. The solid ignites within 5 min of coming into contact with air.
NOTE: Classification of solid chemicals the purposes of supply or transport, the same
shall be based on tests performed on the chemical is to be presented in a physical
chemical as presented. If, for example, for 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 out energy supply, is liable to self-heat; this
alter its performance in a classification test, chemical differs from a pyrophoric liquid or
classification must be based on testing of the solid in that it will ignite only when in large
chemical in the new form. amounts (kilograms) and after long periods
of time (hours or days).
B.10.3 ADDITIONAL CLASSIFICATION NOTE: Self-heating of a substance or mix-
CONSIDERATIONS ture is a process where the gradual reaction
The classification procedure for pyrophoric of that substance or mixture with oxygen (in
solids need not be applied when experience in air) generates heat. If the rate of heat pro-
production or handling shows that the chem- duction exceeds the rate of heat loss, then
ical does not ignite spontaneously on coming the temperature of the substance or mixture
into contact with air at normal tempera- will rise which, after an induction time, may
tures (i.e., the chemical is known to be sta- lead to self-ignition and combustion.
ble at room temperature for prolonged peri-
B.11.2 CLASSIFICATION CRITERIA
ods of time (days)).
B.11.2.1 A self-heating chemical shall be
B.11 SELF-HEATING CHEMICALS classified in one of the two categories for
this class if, in tests performed in accordance
B.11.1 DEFINITION
with test method N.4 in Part III, sub-section
A self-heating chemical is a solid or liquid 33.3.1.6 of the UN ST/SG/AC.10 (incorporated
chemical, other than a pyrophoric liquid or by reference; See § 1910.6), the result meets
solid, which, by reaction with air and with- the criteria shown in Table B.11.1.
TABLE B.11.1—CRITERIA FOR SELF-HEATING CHEMICALS
Category Criteria
1 ................................. A positive result is obtained in a test using a 25 mm sample cube at 140 °C (284 °F).
2 ................................. 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 of the fire and explosion risks in drying pow-
spontaneous combustion higher than 50 °C ders, Plant Operations Progress, 4 (3), 181–
(122 °F) for a volume of 27 m3 shall not be 189, 1985) with an onset temperature 60°K
classified as self-heating chemicals. above the reference temperature for a vol-
B.11.2.3 Chemicals with a spontaneous ig- ume of 1 l.
nition temperature higher than 50 °C (122 °F)
for a volume of 450 liters shall not be classi- B.12 CHEMICALS WHICH, IN CONTACT
fied in Category 1 of this class. WITH WATER, EMIT FLAMMABLE GASES
B.11.3 ADDITIONAL CLASSIFICATION B.12.1 DEFINITION
CONSIDERATIONS
Chemicals which, in contact with water, emit
B.11.3.1 The classification procedure for flammable gases are solid or liquid chemicals
self-heating chemicals need not be applied if which, by interaction with water, are liable
the results of a screening test can be ade- to become spontaneously flammable or to
quately correlated with the classification give off flammable gases in dangerous quan-
test and an appropriate safety margin is ap- tities.
plied.
B.11.3.2 Examples of screening tests are: B.12.2 CLASSIFICATION CRITERIA
(a) The Grewer Oven test (VDI guideline
2263, part 1, 1990, Test methods for the Deter- B.12.2.1 A chemical which, in contact with
mination of the Safety Characteristics of water, emits flammable gases shall be classi-
Dusts) with an onset temperature 80°K above fied in one of the three categories for this
the reference temperature for a volume of 1 class, using test N.5 in Part III, sub-section
l; 33.4.1.4 of the UN ST/SG/AC.10 (incorporated
(b) The Bulk Powder Screening Test (Gib- by reference; See § 1910.6), in accordance with
son, N. Harper, D. J. Rogers, R. Evaluation 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.
2 ................................. 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.
3 ................................. 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.
1 ................................. Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, spontaneously ig-
nites; 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;
2 ................................. 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;
3 ................................. 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.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
UN ST/SG/AC.10 (incorporated by reference; generally by yielding oxygen, cause, or con-
See § 1910.6) shall be repeated with an inert tribute to, the combustion of other material.
substance (e.g., diatomite (kieselguhr)) in
place of the cellulose in order to clarify the B.14.2 CLASSIFICATION CRITERIA
nature of the reaction.
An oxidizing solid shall be classified in one
B.14 OXIDIZING SOLIDS of the three categories for this class using
test O.1 in Part III, sub-section 34.4.1 of the
B.14.1 DEFINITION UN ST/SG/AC.10 (incorporated by reference;
Oxidizing solid means a solid which, while See § 1910.6), in accordance with Table B.14.1:
in itself is not necessarily combustible, may,
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 burn-
ing time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cel-
lulose.
2 ................................. Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burn-
ing time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bro-
mate and cellulose and the criteria for Category 1 are not met.
3 ................................. Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burn-
ing time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bro-
mate and cellulose and the criteria for Categories 1 and 2 are not met.
NOTE 1: Some oxidizing solids may present shows them to be oxidizing, judgements
explosion hazards under certain conditions based on known experience shall take prece-
(e.g., when stored in large quantities). For dence over test results.
example, some types of ammonium nitrate
may give rise to an explosion hazard under B.15 ORGANIC PEROXIDES
extreme conditions and the ‘‘Resistance to
detonation test’’ (IMO: Code of Safe Practice B.15.1 DEFINITION
for Solid Bulk Cargoes, 2005, Annex 3, Test 5) B.15.1.1 Organic peroxide means a liquid or
may be used to assess this hazard. When in- solid organic chemical which contains the
formation indicates that an oxidizing solid bivalent –0–0– structure and as such is con-
may present an explosion hazard, it shall be sidered a derivative of hydrogen peroxide,
indicated on the Safety Data Sheet. where one or both of the hydrogen atoms
NOTE 2: Classification of solid chemicals have been replaced by organic radicals. The
shall be based on tests performed on the term organic peroxide includes organic per-
chemical as presented. If, for example, for oxide mixtures containing at least one or-
the purposes of supply or transport, the same ganic peroxide. Organic peroxides are ther-
chemical is to be presented in a physical mally unstable chemicals, which may under-
form different from that which was tested go exothermic self-accelerating decomposi-
and which is considered likely to materially tion. In addition, they may have one or more
alter its performance in a classification test, of the following properties:
classification must be based on testing of the
(a) Be liable to explosive decomposition;
chemical in the new form.
(b) Burn rapidly;
B.14.3 ADDITIONAL CLASSIFICATION (c) Be sensitive to impact or friction;
CONSIDERATIONS (d) React dangerously with other sub-
stances.
B.14.3.1 For organic chemicals, the classi-
fication procedure for this class shall not be B.15.1.2 An organic peroxide is regarded as
applied if: possessing explosive properties when in lab-
oratory testing the formulation is liable to
(a) The chemical does not contain oxygen,
detonate, to deflagrate rapidly or to show a
fluorine or chlorine; or
violent effect when heated under confine-
(b) The chemical contains oxygen, fluorine
ment.
or chlorine and these elements are chemi-
cally bonded only to carbon or hydrogen. B.15.2 CLASSIFICATION CRITERIA
B.14.3.2 For inorganic chemicals, the clas-
sification procedure for this class shall not B.15.2.1 Any organic peroxide shall be
be applied if the chemical does not contain considered for classification in this class, un-
oxygen or halogen atoms. less it contains:
B.14.3.3 In the event of divergence be- (a) Not more than 1.0% available oxygen
tween test results and known experience in from the organic peroxides when containing
the handling and use of chemicals which 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 NOTE: The available oxygen content (%) of
from the organic peroxides when containing an organic peroxide mixture is given by the
more than 1.0% but not more than 7.0% hy- formula:
drogen peroxide.
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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 togram shall not appear where it is used for
or aluminium indicates the chemical being acute toxicity;
tested is corrosive, the follow-up test on the C.2.1.3 If the corrosive pictogram is in-
other metal is not necessary. cluded, the exclamation mark pictogram
shall not appear where it is used for skin or
B.16.3 ADDITIONAL CLASSIFICATION eye irritation;
CONSIDERATIONS C.2.1.4 If the health hazard pictogram is
The specimen to be used for the test shall included for respiratory sensitization, the
be made of the following materials: exclamation mark pictogram shall not ap-
pear where it is used for skin sensitization or
(a) For the purposes of testing steel, steel
for skin or eye irritation.
types S235JR+CR (1.0037 resp.St 37–2),
S275J2G3+CR (1.0144 resp.St 44–3), ISO 3574, C.2.2 HAZARD STATEMENT TEXT
Unified Numbering System (UNS) G 10200, or
SAE 1020; C.2.2.1 The text of all applicable hazard
(b) For the purposes of testing aluminium: statements shall appear on the label, except
Non-clad types 7075–T6 or AZ5GU–T6. as otherwise specified. The information in
italics shall be included as part of the hazard
APPENDIX C TO § 1910.1200—ALLOCATION OF statement as provided. For example: ‘‘causes
LABEL ELEMENTS (MANDATORY) damage to organs (state all organs affected)
through prolonged or repeated exposure
C.1 The label for each hazardous chemical (state route of exposure if no other routes of ex-
shall include the product identifier used on posure cause the hazard)’’. Hazard statements
the safety data sheet. may be combined where appropriate to re-
C.1.1 The labels on shipped containers duce the information on the label and im-
shall also include the name, address, and prove readability, as long as all of the haz-
telephone number of the chemical manufac- ards are conveyed as required.
turer, importer, or responsible party. C.2.2.2 If the chemical manufacturer, im-
C.2 The label for each hazardous chemical porter, or responsible party can demonstrate
that is classified shall include the signal that all or part of the hazard statement is
word, hazard statement(s), pictogram(s), and inappropriate to a specific substance or mix-
precautionary statement(s) specified in C.4 ture, the corresponding statement may be
for each hazard class and associated hazard omitted from the label.
category, except as provided for in C.2.1
through C.2.4. C.2.3 PICTOGRAMS
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
C.2.4 PRECAUTIONARY STATEMENT TEXT ets is not appropriate in every case and
should be used only in certain cir-
C.2.4.1 There are four types of pre- cumstances. In these cases, conditions for
cautionary statements presented, ‘‘preven- use explaining when the text should be used
tion,’’ ‘‘response,’’ ‘‘storage,’’ and ‘‘dis- are provided. For example, one pre-
posal.’’ The core part of the precautionary cautionary statement states: ‘‘[In case of in-
statement is presented in bold print. This is adequate ventilation] wear respiratory pro-
the text, except as otherwise specified, that tection.’’ This statement is given with the
shall appear on the label. Where additional condition for use ‘‘– text in square brackets
information is required, it is indicated in may be used if additional information is pro-
plain text. vided with the chemical at the point of use
C.2.4.2 When a backslash or diagonal that explains what type of ventilation would
mark (/) appears in the precautionary state- be adequate for safe use’’. This means that,
ment text, it indicates that a choice has to if additional information is provided with
be made between the separated phrases. In the chemical explaining what type of ven-
such cases, the chemical manufacturer, im- tilation would be adequate for safe use, the
porter, or responsible party can choose the text in square brackets should be used and
most appropriate phrase(s). For example, the statement would read: ‘‘In case of inad-
‘‘Wear protective gloves/protective clothing/ equate ventilation wear respiratory protec-
eye protection/face protection’’ could read tion.’’ However, if the chemical is supplied
‘‘wear eye protection’’. without such ventilation information, the
C.2.4.3 When three full stops (* * *) appear text in square brackets should not be used,
in the precautionary statement text, they and the precautionary statement should
indicate that all applicable conditions are read: ‘‘Wear respiratory protection.’’
not listed. For example, in ‘‘Use explosion- C.2.4.6 Precautionary statements may be
proof electrical/ventilating/lighting/* * */ combined or consolidated to save label space
equipment’’, the use of ‘‘* * *’’ indicates that and improve readability. For example, ‘‘Keep
other equipment may need to be specified. In away from heat, sparks and open flame,’’
such cases, the chemical manufacturer, im- ‘‘Store in a well-ventilated place’’ and ‘‘Keep
porter, or responsible party can choose the cool’’ can be combined to read ‘‘Keep away
other conditions to be specified. from heat, sparks and open flame and store
C.2.4.4 When text in italics is used in a pre- in a cool, well-ventilated place.’’
cautionary statement, this indicates specific C.2.4.7 In most cases, the precautionary
conditions applying to the use or allocation statements are independent (e.g., the phrases
of the precautionary statement. For exam- for explosive hazards do not modify those re-
ple, ‘‘Use explosion-proof electrical/ven- lated to certain health hazards, and products
tilating/lighting/* * */equipment’’ is only re- that are classified for both hazard classes
quired for flammable solids ‘‘if dust clouds shall bear appropriate precautionary state-
can occur’’. Text in italics is intended to be ments for both). Where a chemical is classi-
an explanatory, conditional note and is not fied for a number of hazards, and the pre-
intended to appear on the label. cautionary statements are similar, the most
C.2.4.5 Where square brackets ([ ]) appear stringent shall be included on the label (this
around text in a precautionary statement, will be applicable mainly to preventive
this indicates that the text in square brack- measures). An order of precedence may be
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Occupational Safety and Health Admin., Labor § 1910.1200
imposed by the chemical manufacturer, im- wide variation or undermine the required in-
porter or responsible party in situations formation, supplementary information on
where phrases concern ‘‘Response.’’ Rapid the label is limited to when it provides fur-
action may be crucial. For example, if a ther detail and does not contradict or cast
chemical is carcinogenic and acutely toxic, doubt on the validity of the standardized
rapid action may be crucial, and first aid hazard information.
measures for acute toxicity will take prece- C.3.2 Where the chemical manufacturer,
dence over those for long-term effects. In ad-
importer, or distributor chooses to add sup-
dition, medical attention to delayed health
plementary information on the label, the
effects may be required in cases of incidental
exposure, even if not associated with imme- placement of supplemental information shall
diate symptoms of intoxication. not impede identification of information re-
C.2.4.8 If the chemical manufacturer, im- quired by this section.
porter, or responsible party can demonstrate C.3.3 Where an ingredient with unknown
that a precautionary statement is inappro- acute toxicity is used in a mixture at a con-
priate to a specific substance or mixture, the centration ≥1%, and the mixture is not clas-
precautionary statement may be omitted sified based on testing of the mixture as a
from the label. whole, a statement that X% of the mixture
consists of ingredient(s) of unknown acute
C.3 SUPPLEMENTARY HAZARD INFORMATION toxicity is required on the label.
C.3.1 To ensure that non-standardized in-
formation does not lead to unnecessarily
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
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Occupational Safety and Health Admin., Labor § 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
585
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Occupational Safety and Health Admin., Labor § 1910.1200
Secrecy. The subject matter of a trade se- ther use of it and is required to account for
cret must be secret. Matters of public knowl- the profits derived from his past use. If, on
edge or of general knowledge in an industry the other hand, the secret consists of me-
cannot be appropriated by one as his secret. chanical improvements that a good me-
Matters which are completely disclosed by chanic can make without resort to the se-
the goods which one markets cannot be his cret, the wrongdoer’s liability may be lim-
secret. Substantially, a trade secret is ited to damages, and an injunction against
known only in the particular business in future use of the improvements made with
which it is used. It is not requisite that only the aid of the secret may be inappropriate.
the proprietor of the business know it. He
may, without losing his protection, commu- APPENDIX F TO § 1910.1200—GUIDANCE FOR
nicate it to employees involved in its use. He HAZARD CLASSIFICATIONS RE: CARCINO-
may likewise communicate it to others GENICITY (NON-MANDATORY)
pledged to secrecy. Others may also know of
The mandatory criteria for classification
it independently, as, for example, when they
of a chemical for carcinogenicity under HCS
have discovered the process or formula by
(§ 1910.1200) are found in Appendix A.6 to this
independent invention and are keeping it se-
section. This non-mandatory Appendix pro-
cret. Nevertheless, a substantial element of
secrecy must exist, so that, except by the vides additional guidance on hazard classi-
use of improper means, there would be dif- fication for carcinogenicity. Part A of Ap-
ficulty in acquiring the information. An pendix F includes background guidance pro-
exact definition of a trade secret is not pos- vided by GHS based on the Preamble of the
sible. Some factors to be considered in deter- International Agency for Research on Cancer
mining whether given information is one’s (IARC) ‘‘Monographs on the Evaluation of
trade secret are: (1) The extent to which the Carcinogenic Risks to Humans’’ (2006). Part
information is known outside of his business; B provides IARC classification information.
(2) the extent to which it is known by em- Part C provides background guidance from
ployees and others involved in his business; the National Toxicology Program (NTP)
(3) the extent of measures taken by him to ‘‘Report on Carcinogens’’ (RoC), and Part D
guard the secrecy of the information; (4) the is a table that compares GHS carcinogen
value of the information to him and his com- hazard categories to carcinogen classifica-
petitors; (5) the amount of effort or money tions under IARC and NTP, allowing classi-
expended by him in developing the informa- fiers to be able to use information from
tion; (6) the ease or difficulty with which the IARC and NTP RoC carcinogen classifica-
information could be properly acquired or tions to complete their classifications under
duplicated by others. the GHS, and thus the HCS.
Novelty and prior art. A trade secret may be
a device or process which is patentable; but PART A: BACKGROUND GUIDANCE 1
it need not be that. It may be a device or As noted in Footnote 6 of Appendix A.6. to
process which is clearly anticipated in the this section, the GHS includes as guidance
prior art or one which is merely a mechan- for classifiers information taken from the
ical improvement that a good mechanic can Preamble of the International Agency for
make. Novelty and invention are not req- Research on Cancer (IARC) ‘‘Monographs on
uisite for a trade secret as they are for pat- the Evaluation of Carcinogenic Risks to Hu-
entability. These requirements are essential mans’’ (2006), providing guidance on the eval-
to patentability because a patent protects uation of the strength and evidence of car-
against unlicensed use of the patented device cinogenic risks to humans. This guidance
or process even by one who discovers it prop- also discusses some additional consider-
erly through independent research. The pat- ations in classification and an approach to
ent monopoly is a reward to the inventor. analysis, rather than hard-and-fast rules.
But such is not the case with a trade secret. Part A is consistent with Appendix A.6, and
Its protection is not based on a policy of re- should help in evaluating information to de-
warding or otherwise encouraging the devel- termine carcinogenicity.
opment of secret processes or devices. The Carcinogenicity in humans:
protection is merely against breach of faith The evidence relevant to carcinogenicity
and reprehensible means of learning an- from studies in humans is classified into one
other’s secret. For this limited protection it of the following categories:
is not appropriate to require also the kind of
novelty and invention which is a requisite of
patentability. The nature of the secret is, 1 The text of Appendix F, Part A, on the IARC
however, an important factor in determining Monographs, is paraphrased from the 2006 Pre-
the kind of relief that is appropriate against amble to the ‘‘Monographs on the Evaluation of
one who is subject to liability under the rule Carcinogenic Risks to Humans’’; the Classifier is
stated in this Section. Thus, if the secret referred to the full IARC Preamble for the com-
consists of a device or process which is a plete text. The text is not part of the agreed
novel invention, one who acquires the secret GHS text on the harmonized system developed
wrongfully is ordinarily enjoined from fur- by the OECD Task Force-HCL.
587
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
(a) Sufficient evidence of carcinogenicity: ysis. The IPCS ‘‘Conceptual Framework for
A causal relationship has been established Evaluating a Mode of Action for Chemical Car-
between exposure to the agent and human cinogenesis’’ (2001), International Life
cancer. That is, a positive relationship has Sciences Institute (ILSI) ‘‘Framework for
been observed between the exposure and can- Human Relevance Analysis of Information on
cer in studies in which chance, bias and con- Carcinogenic Modes of Action’’ (Meek, et al.,
founding could be ruled out with reasonable 2003; Cohen et al., 2003, 2004), and Preamble to
confidence. the IARC Monographs (2006; Section B.6.
(b) Limited evidence of carcinogenicity: A (Scientific Review and Evaluation; Evalua-
positive association has been observed be- tion and Rationale)) provide a basis for sys-
tween exposure to the agent and cancer for tematic assessments that may be performed
which a causal interpretation is considered in a consistent fashion. The IPCS also con-
by the Working Group to be credible, but vened a panel in 2004 to further develop and
chance, bias or confounding could not be clarify the human relevance framework.
ruled out with reasonable confidence. However, the above documents are not in-
In some instances, the above categories tended to dictate answers, nor provide lists
may be used to classify the degree of evi- of criteria to be checked off.
dence related to carcinogenicity in specific
organs or tissues. Mode of Action
Carcinogenicity in experimental animals: Various documents on carcinogen assess-
The evidence relevant to carcinogenicity ment all note that mode of action in and of
in experimental animals is classified into itself, or consideration of comparative me-
one of the following categories: tabolism, should be evaluated on a case-by-
(a) Sufficient evidence of carcinogenicity: case basis and are part of an analytic evalua-
A causal relationship has been established tive approach. One must look closely at any
between the agent and an increased inci- mode of action in animal experiments, tak-
dence of malignant neoplasms or of an appro- ing into consideration comparative
priate combination of benign and malignant toxicokinetics/toxicodynamics between the
neoplasms in two or more species of animals animal test species and humans to determine
or two or more independent studies in one the relevance of the results to humans. This
species carried out at different times or in may lead to the possibility of discounting
different laboratories or under different pro- very specific effects of certain types of sub-
tocols. An increased incidence of tumors in
stances. Life stage-dependent effects on cel-
both sexes of a single species in a well-con-
lular differentiation may also lead to quali-
ducted study, ideally conducted under Good
tative differences between animals and hu-
Laboratory Practices, can also provide suffi-
mans. Only if a mode of action of tumor de-
cient evidence.
velopment is conclusively determined not to
Exceptionally, a single study in one species
be operative in humans may the carcino-
and sex might be considered to provide suffi-
genic evidence for that tumor be discounted.
cient evidence of carcinogenicity when ma-
However, a weight of evidence evaluation for
lignant neoplasms occur to an unusual de-
gree with regard to incidence, site, type of a substance calls for any other tumorigenic
tumor or age at onset, or when there are activity to be evaluated, as well.
strong findings of tumors at multiple sites. Responses in Multiple Animal Experiments
(b) Limited evidence of carcinogenicity:
The data suggest a carcinogenic effect but Positive responses in several species add to
are limited for making a definitive evalua- the weight of evidence that a substance is a
tion because, e.g. the evidence of carcino- carcinogen. Taking into account all of the
genicity is restricted to a single experiment; factors listed in A.6.2.5.2 and more, such
there are unresolved questions regarding the chemicals with positive outcomes in two or
adequacy of the design, conduct or interpre- more species would be provisionally consid-
tation of the studies; the agent increases the ered to be classified in GHS Category 1B
incidence only of benign neoplasms or le- until human relevance of animal results are
sions of uncertain neoplastic potential; or assessed in their entirety. It should be noted,
the evidence of carcinogenicity is restricted however, that positive results for one species
to studies that demonstrate only promoting in at least two independent studies, or a sin-
activity in a narrow range of tissues or or- gle positive study showing unusually strong
gans. evidence of malignancy may also lead to
Category 1B.
Guidance on How To Consider Important Fac-
tors in Classification of Carcinogenicity (See Responses Are in One Sex or Both Sexes
Reference Section)
Any case of gender-specific tumors should
The weight of evidence analysis called for be evaluated in light of the total
in GHS and the HCS (§ 1910.1200) is an inte- tumorigenic response to the substance ob-
grative approach that considers important served at other sites (multi-site responses or
factors in determining carcinogenic poten- incidence above background) in determining
tial along with the strength of evidence anal- the carcinogenic potential of the substance.
588
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Occupational Safety and Health Admin., Labor § 1910.1200
If tumors are seen only in one sex of an Group 1: The agent is carcinogenic to hu-
animal species, the mode of action should be mans
carefully evaluated to see if the response is This category is used when there is suffi-
consistent with the postulated mode of ac- cient evidence of carcinogenicity in humans.
tion. Effects seen only in one sex in a test Exceptionally, an agent may be placed in
species may be less convincing than effects this category when evidence of carcino-
seen in both sexes, unless there is a clear genicity in humans is less than sufficient but
patho-physiological difference consistent there is sufficient evidence of carcinogenicity
with the mode of action to explain the single in experimental animals and strong evidence
sex response. in exposed humans that the agent acts
through a relevant mechanism of carcino-
Confounding Effects of Excessive Toxicity or genicity.
Localized Effects
Group 2:
Tumors occurring only at excessive doses This category includes agents for which, at
associated with severe toxicity generally one extreme, the degree of evidence of car-
have doubtful potential for carcinogenicity cinogenicity in humans is almost sufficient,
in humans. In addition, tumors occurring as well as those for which, at the other ex-
only at sites of contact and/or only at exces- treme, there are no human data but for
sive doses need to be carefully evaluated for which there is evidence of carcinogenicity in
human relevance for carcinogenic hazard. experimental animals. Agents are assigned
For example, forestomach tumors, following to either Group 2A (probably carcinogenic to
administration by gavage of an irritating or humans) or Group 2B (possibly carcinogenic to
corrosive, non-mutagenic chemical, may be humans) on the basis of epidemiological and
of questionable relevance. However, such de- experimental evidence of carcinogenicity
terminations must be evaluated carefully in and mechanistic and other relevant data.
justifying the carcinogenic potential for hu- The terms probably carcinogenic and possibly
mans; any occurrence of other tumors at dis- carcinogenic have no quantitative signifi-
tant sites must also be considered. cance and are used simply as descriptors of
different levels of evidence of human car-
Tumor Type, Reduced Tumor Latency cinogenicity, with probably carcinogenic sig-
Unusual tumor types or tumors occurring nifying a higher level of evidence than pos-
with reduced latency may add to the weight sibly carcinogenic.
of evidence for the carcinogenic potential of Group 2A: The agent is probably carcino-
a substance, even if the tumors are not sta- genic to human.
tistically significant. This category is used when there is limited
Toxicokinetic behavior is normally as- evidence of carcinogenicity in humans and suf-
sumed to be similar in animals and humans, ficient evidence of carcinogenicity in experi-
at least from a qualitative perspective. On mental animals. In some cases, an agent may
the other hand, certain tumor types in ani- be classified in this category when there is
mals may be associated with toxicokinetics inadequate evidence of carcinogenicity in hu-
or toxicodynamics that are unique to the mans and sufficient evidence of carcinogenicity
animal species tested and may not be pre- in experimental animals and strong evidence
dictive of carcinogenicity in humans. Very that the carcinogenesis is mediated by a
few such examples have been agreed inter- mechanism that also operates in humans.
nationally. However, one example is the lack Exceptionally, an agent may be classified in
of human relevance of kidney tumors in this category solely on the basis of limited
male rats associated with compounds caus- evidence of carcinogenicity in humans. An
ing a2u-globulin nephropathy (IARC, Sci- agent may be assigned to this category if it
entific Publication N° 147 2). Even when a clearly belongs, based on mechanistic con-
particular tumor type may be discounted, siderations, to a class of agents for which
expert judgment must be used in assessing one or more members have been classified in
the total tumor profile in any animal experi- Group 1 or Group 2A.
ment. Group 2B: The agent is possibly carcinogenic
to humans.
PART B: INTERNATIONAL AGENCY FOR This category is used for agents for which
RESEARCH ON CANCER (IARC) 3 there is limited evidence of carcinogenicity in
IARC Carcinogen Classification Categories: humans and less than sufficient evidence of
carcinogenicity in experimental animals. It
2 While most international agencies do not
may also be used when there is inadequate
evidence of carcinogenicity in humans but
consider kidney tumors coincident with α2u- there is sufficient evidence of carcinogenicity
globulin nephropathy to be a predictor of risk in in experimental animals. In some instances,
humans, this view is not universally held. (See:
Doi et al., 2007).
3 Preamble of the International Agency for Re- Evaluation of Carcinogenic Risks to Humans’’
search on Cancer (IARC) ‘‘Monographs on the (2006).
589
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§ 1910.1200 29 CFR Ch. XVII (7–1–13 Edition)
an agent for which there is inadequate evi- there is less than sufficient evidence of car-
dence of carcinogenicity in humans and less cinogenicity in humans or laboratory ani-
than sufficient evidence of carcinogenicity in mals; however, the agent, substance, or mix-
experimental animals together with sup- ture belongs to a well-defined, structurally-
porting evidence from mechanistic and other related class of substances whose members
relevant data may be placed in this group. are listed in a previous Report on Carcino-
An agent may be classified in this category gens as either known to be a human car-
solely on the basis of strong evidence from cinogen or reasonably anticipated to be a
mechanistic and other relevant data. human carcinogen, or there is convincing
PART C: NATIONAL TOXICOLOGY PROGRAM relevant information that the agent acts
(NTP), ‘‘REPORT ON CARCINOGENS’’, BACK- through mechanisms indicating it would
GROUND GUIDANCE likely cause cancer in humans.
Conclusions regarding carcinogenicity in
NTP Listing Criteria 4: humans or experimental animals are based
The criteria for listing an agent, sub- on scientific judgment, with consideration
stance, mixture, or exposure circumstance in given to all relevant information. Relevant
the Report on Carcinogens (RoC) are as fol- information includes, but is not limited to,
lows: dose response, route of exposure, chemical
Known To Be A Human Carcinogen: There structure, metabolism, pharmacokinetics,
is sufficient evidence of carcinogenicity from sensitive sub-populations, genetic effects, or
studies in humans 5 that indicates a causal other data relating to mechanism of action
relationship between exposure to the agent, or factors that may be unique to a given sub-
substance, or mixture, and human cancer. stance. For example, there may be sub-
Reasonably Anticipated To Be A Human stances for which there is evidence of car-
Carcinogen: There is limited evidence of car- cinogenicity in laboratory animals, but
cinogenicity from studies in humans that in- there are compelling data indicating that
dicates that a causal interpretation is cred- the agent acts through mechanisms that do
ible, but that alternative explanations, such not operate in humans and would therefore
as chance, bias, or confounding factors, could not reasonably be anticipated to cause can-
not adequately be excluded, cer in humans.
or
PART D: TABLE RELATING APPROXIMATE
there is sufficient evidence of carcino-
EQUIVALENCES AMONG IARC, NTP ROC, AND
genicity from studies in experimental ani-
GHS CARCINOGENICITY CLASSIFICATIONS
mals that indicates there is an increased in-
cidence of malignant and/or a combination of The following table may be used to per-
malignant and benign tumors in multiple form hazard classifications for carcino-
species or at multiple tissue sites, or by mul- genicity under the HCS (§ 1910.1200). It re-
tiple routes of exposure, or to an unusual de- lates the approximated GHS hazard cat-
gree with regard to incidence, site, or type of egories for carcinogenicity to the classifica-
tumor, or age at onset, tions provided by IARC and NTP, as de-
or scribed in Parts B and C of this Appendix.
4 See:
http://ntp.niehs.nih.gov/go/15209. cells from humans exposed to the substance in
5 This
evidence can include traditional cancer question that can be useful for evaluating
epidemiology studies, data from clinical studies, whether a relevant cancer mechanism is oper-
and/or data derived from the study of tissues or ating in people.
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Occupational Safety and Health Admin., Labor § 1910.1450
b. There is convincing relevant information § 1910.1201 Retention of DOT mark-
that the agent acts through mechanisms indi- ings, placards and labels.
cating it would likely cause cancer in humans.
(a) Any employer who receives a
*REFERENCES package of hazardous material which is
Cohen, S.M., J. Klaunig, M.E. Meek, R.N. required to be marked, labeled or plac-
Hill, T. Pastoor, L. Lehman-McKeeman, arded in accordance with the U. S. De-
J. Bucher, D.G. Longfellow, J. Seed, V. partment of Transportation’s Haz-
Dellarco, P. Fenner-Crisp, and D. Patton. ardous Materials Regulations (49 CFR
2004. Evaluating the human relevance of Parts 171 through 180) shall retain
chemically induced animal tumors. those markings, labels and placards on
Toxicol. Sci. 78(2):181–186. the package until the packaging is suf-
Cohen, S.M., M.E. Meek, J.E. Klaunig, D.E.
ficiently cleaned of residue and purged
Patton, P.A. Fenner-Crisp. 2003. The
human relevance of information on car-
of vapors to remove any potential haz-
cinogenic modes of action: Overview. ards.
Crit. Rev. Toxicol. 33(6):581–9. (b) Any employer who receives a
Meek, M.E., J.R. Bucher, S.M. Cohen, V. freight container, rail freight car,
Dellarco, R.N. Hill, L. Lehman- motor vehicle, or transport vehicle
McKeeman, D.G. Longfellow, T. Pastoor, that is required to be marked or plac-
J. Seed, D.E. Patton. 2003. A framework arded in accordance with the Haz-
for human relevance analysis of informa- ardous Materials Regulations shall re-
tion on carcinogenic modes of action. tain those markings and placards on
Crit. Rev. Toxicol. 33(6):591–653.
the freight container, rail freight car,
Sonich-Mullin, C., R. Fielder, J. Wiltse, K.
Baetcke, J. Dempsey, P. Fenner-Crisp, D.
motor vehicle or transport vehicle
Grant, M. Hartley, A. Knapp, D. Kroese, until the hazardous materials which re-
I. Mangelsdorf, E. Meek, J.M. Rice, and quire the marking or placarding are
M. Younes. 2001. The conceptual frame- sufficiently removed to prevent any po-
work for evaluating a mode of action for tential hazards.
chemical carcinogenesis. Reg. Toxicol. (c) Markings, placards and labels
Pharm. 34:146–152. shall be maintained in a manner that
International Programme on Chemical Safe- ensures that they are readily visible.
ty Harmonization Group. 2004. Report of
(d) For non-bulk packages which will
the First Meeting of the Cancer Working
Group. World Health Organization. Re- not be reshipped, the provisions of this
port IPCS/HSC–CWG–1/04. Geneva. section are met if a label or other ac-
International Agency for Research on Can- ceptable marking is affixed in accord-
cer. IARC Monographs on the Evaluation ance with the Hazard Communication
of Carcinogenic Risks to Human. Pre- Standard (29 CFR 1910.1200).
ambles to Volumes. World Health Orga- (e) For the purposes of this section,
nization. Lyon, France. the term ‘‘hazardous material’’ and
Cohen, S.M., P.A. Fenner-Crisp, and D.E. any other terms not defined in this sec-
Patton. 2003. Special Issue: Cancer Modes
tion have the same definition as in the
of Action and Human Relevance. Critical
Reviews in Toxicology, R.O. McClellan,
Hazardous Materials Regulations (49
ed., Volume 33/Issue 6. CRC Press. CFR Parts 171 through 180).
Capen, C.C., E. Dybing, and J.D. Wilbourn. [59 FR 36700, July 19, 1994]
1999. Species differences in thyroid, kid-
ney and urinary bladder carcinogenesis. § 1910.1450 Occupational exposure to
International Agency for Research on hazardous chemicals in labora-
Cancer, Scientific Publication N° 147. tories.
Doi, A.M., G. Hill, J. Seely, J.R. Hailey, G.
Kissling, and J.R. Buchera. 2007. a2u- (a) Scope and application. (1) This sec-
Globulin nephropathy and renal tumors tion shall apply to all employers en-
in National Toxicology Program studies. gaged in the laboratory use of haz-
Toxicol. Pathol. 35:533–540. ardous chemicals as defined below.
[59 FR 6170, Feb. 9, 1994, as amended at 59 FR (2) Where this section applies, it shall
17479, Apr. 13, 1994; 59 FR 65948, Dec. 22, 1994; supersede, for laboratories, the require-
61 FR 9245, Mar. 7. 1996; 77 FR 17785, Mar. 26, ments of all other OSHA health stand-
2012; 78 FR 9313, Feb. 8, 2013] ards in 29 CFR part 1910, subpart Z, ex-
cept as follows:
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