ASTM D4236-94(2016)e1
(Practice)Standard Practice for Labeling Art Materials for Chronic Health Hazards
Standard Practice for Labeling Art Materials for Chronic Health Hazards
ABSTRACT
This practice describes the standard procedure for developing precautionary labels for art materials to provide chronic health hazard and precautionary statements based on knowledge that exists in the scientific and medical communities. These statements concern hazards known to be associated with a product or product component(s) when it is present in a physical form, volume, or concentration that in the opinion of a toxicologist has the potential to produce a chronic adverse health effect. This practice applies exclusively to art materials packaged in sizes intended for individual users of any age or those participating in a small group, and does not apply to products appropriately labeled for known chronic health hazards. Also, this practice does not specify test methods for determining whether a substance or product presents adverse chronic health effects. Labels should include the signal word WARNING, list of potentially chronic hazards, name of chronically hazardous component(s), safe handling instructions, list of sensitizing components, information sources, labeling content and product size, and other supplementary information.
SCOPE
1.1 This practice describes a procedure for developing precautionary labels for art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This practice concerns those chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see 2.1.11) has the potential to produce a chronic adverse health effect(s).
1.2 This practice applies exclusively to art materials packaged in sizes intended for individual users of any age or those participating in a small group.
1.3 Labeling determinations shall consider reasonable foreseeable use or misuse. The responsibility for precautionary labeling rests with the producer or repackager who markets the materials for art or craft use.
1.4 This practice does not specify test methods for determining whether a substance or product presents chronic health hazards.
1.5 This practice does not apply to products appropriately labeled for known chronic health hazards in accordance with chemical substance labeling standards and practices, such as another national consensus standard, existing labeling statutes, regulations, or guidelines.
1.6 Since knowledge about chronic health hazards is incomplete and warnings cannot cover all uses of any product, it is not possible for precautionary labeling to ensure completely safe use of an art product.
1.7 Manufacturers or repackagers may wish to determine individually or collectively precautionary labeling for art materials in accordance with this practice. Compliance may be certified by a certifying organization. Guidelines for a certifying organization are given in Appendix X1.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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´1
Designation: D4236 − 94 (Reapproved 2016)
Standard Practice for
Labeling Art Materials for Chronic Health Hazards
This standard is issued under the fixed designation D4236; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—Footnote 2 was corrected editorially in July 2018.
INTRODUCTION
Uninformed or careless use of some art material products can give rise to health hazards, either
acute or chronic, or both. Specific and readily available warnings are needed to help protect users of
any age. One way to disseminate such information is to provide appropriate precautionary labeling on
art material products.
Labeling for acute health hazards, including those associated with art materials, is being addressed
by such requirements as the U.S. Consumer Product Safety Act (CPSC) , the Federal Hazardous
Substances Act, and the like. There are presently no specific national standards for labeling art
materials with respect to chronic health hazards.
This practice is intended to provide a standard for developing precautionary labels concerning
chronic health hazards related to the use of art materials. It is further intended to have the adaptability
necessary to keep labels current with existing scientific and medical knowledge, as well as in
conformity with other precautionary labeling requirements, both acute and chronic, thereby avoiding
unnecessary confusion by users with respect to other precautionary labeling.
1. Scope labeling rests with the producer or repackager who markets the
materials for art or craft use.
1.1 This practice describes a procedure for developing
precautionary labels for art materials and provides hazard and
1.4 This practice does not specify test methods for deter-
precautionary statements based upon knowledge that exists in
mining whether a substance or product presents chronic health
the scientific and medical communities. This practice concerns
hazards.
those chronic health hazards known to be associated with a
1.5 This practice does not apply to products appropriately
product or product component(s), when the component(s) is
labeled for known chronic health hazards in accordance with
present in a physical form, volume, or concentration that in the
chemical substance labeling standards and practices, such as
opinion of a toxicologist (see 2.1.11) has the potential to
another national consensus standard, existing labeling statutes,
produce a chronic adverse health effect(s).
regulations, or guidelines.
1.2 This practice applies exclusively to art materials pack-
aged in sizes intended for individual users of any age or those
1.6 Since knowledge about chronic health hazards is incom-
participating in a small group. plete and warnings cannot cover all uses of any product, it is
not possible for precautionary labeling to ensure completely
1.3 Labeling determinations shall consider reasonable fore-
safe use of an art product.
seeable use or misuse. The responsibility for precautionary
1.7 Manufacturers or repackagers may wish to determine
individually or collectively precautionary labeling for art
This practice is under the jurisdiction of ASTM Committee D01 on Paint and
materials in accordance with this practice. Compliance may be
Related Coatings, Materials, and Applications and is the direct responsibility of
certified by a certifying organization. Guidelines for a certify-
Subcommittee D01.57 on Artist Paints and Related Materials.
Current edition approved Dec. 1, 2016. Published December 2016. Originally ing organization are given in Appendix X1.
approved in 1983. Last previous edition approved in 2011 as D4236 – 94 (2011).
1.8 This standard does not purport to address all of the
DOI: 10.1520/D4236-94R16E01.
ASTM Practice D4236 has been codified into U.S. law as part of the Federal
safety concerns, if any, associated with its use. It is the
HazardousSubstancesAct,15USCS1277.Usersofthisstandardshouldbefamiliar
responsibility of the user of this standard to establish appro-
with the law and its regulations. Under this law and its regulations (16 CFR 1500),
priate safety, health, and environmental practices and deter-
manufacturers must submit to the CPSC (Washington DC 20207) written criteria
used by the toxicologist to recommend labeling. mine the applicability of regulatory limitations prior to use.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
D4236 − 94 (2016)
1.9 This international standard was developed in accor- 2.1.12 users, n—artists or crafts people of any age who
dance with internationally recognized principles on standard- create, or recreate in a limited number, largely by hand, works
ization established in the Decision on Principles for the which may or may not have a practical use, but in which
Development of International Standards, Guides and Recom- aesthetic considerations are paramount.
mendations issued by the World Trade Organization Technical
3. Requirements
Barriers to Trade (TBT) Committee.
3.1 To conform to this voluntary practice the producer or
2. Terminology
repackager of art materials shall submit art material product
formulation(s) or reformulation(s) to a toxicologist for review,
2.1 Definitions of Terms Specific to This Standard:
such review to be in accordance with Section 4of this practice.
2.1.1 analytical laboratory, n—a laboratory having person-
The toxicologist shall be required to keep product formula-
nel and apparatus capable of performing quantitative or quali-
tion(s) confidential.
tative analyses of art materials, which may yield information
3.1.1 Unless otherwise agreed in writing by the producer or
that is used by a toxicologist for evaluation of potentially
repackager,nooneotherthanthetoxicologistshallhaveaccess
hazardous materials.
to the formulation(s); except that the toxicologist shall furnish
2.1.2 art material or art material product, n—any raw or
a patient’s physician, on a confidential basis, the information
processed material, or manufactured product, marketed or
necessary to diagnose or treat cases of exposure or accidental
represented by the producer or repackager as intended for and
ingestion.
suitable for users as defined herein.
3.2 To conform to this practice, the producer or repackager,
2.1.3 bioavailability, n—the extent that a substance can be
upon advice given by a toxicologist in accordance with Section
absorbed in a biologically active form.
4 of this practice, shall adopt precautionary labeling in accor-
2.1.4 chronic adverse health effect(s), n—a persistent toxic
dance with Section 5 of this practice and based upon generally
effect(s) that develops over time from a single, prolonged, or
accepted, well-established evidence that a component sub-
repeated exposure to a substance. This effect may result from
stance(s) is known to cause chronic adverse health effects.
exposure(s) to a substance that can, in humans, cause sterility,
3.3 To conform to this practice, labeling shall be parallel to,
birth defects, harm to a developing fetus or to a nursing infant,
conform to, and minimally include any labeling practices
cancer, allergenic sensitization, damage to the nervous system,
prescribed by U.S. federal and state statutes or regulations and
or a persistent adverse effect to any other organ system.
shall not diminish the effect of required acute toxicity warn-
2.1.5 chronic health hazard(s) (hereafter referred to as
ings.
“chronic hazard”), n—a health risk to humans, resultant from
3.4 To conform to this practice, the producer or repackager
exposure to a substance that may cause a chronic adverse
shall supply a poison exposure management information
health effect.
source the generic formulation information required for dis-
2.1.6 label, n—a display of written, printed, or graphic
seminationtopoisoncontrolcentersorprovidea24-hcost-free
matter upon the immediate container of any art material
telephone number to poison control centers.
product.Whentheproductisunpackaged,orisnotpackagedin
an immediate container intended or suitable for delivery to 3.5 To conform to this practice, the producer or repackager
shall have a toxicologist review as necessary, but at least every
users, the label can be a display of such matter directly upon
the article involved or upon a tag or other suitable labeling 5 years, art material product formulation(s) and associated
label(s) based upon the then current, generally accepted,
device attached to the art material.
well-established scientific knowledge. If an art material pro-
2.1.7 producer, n—the person or entity who manufactures,
ducer or repackager becomes newly aware of any significant
processes, or imports an art material.
information regarding the chronic hazards of an art material or
2.1.8 repackager, n—the person or entity who obtains ma-
ways to protect against the chronic hazard, this new informa-
terials from producers and without making changes in such
tion must be incorporated into the labels of such art materials
materials puts them in containers intended for sale as art
that are manufactured after 12 months from the date of
materials to users.
discovery. If a producer or repackager reformulates an art
2.1.9 sensitizer, n—a substance known to cause, through an
material, the new information must be evaluated and labeled in
allergicprocess,achronicadversehealtheffectwhichbecomes
accordance with Section 5 of this practice.
evident in a significant number of people on re-exposure to the
3.6 Statement of Conformance—“Conforms toASTM Prac-
same substance.
ticeD4236,”or“ConformstoASTMD4236,”or“Conformsto
2.1.10 toxic, n—applies to any substance that is likely to
the health requirements ofASTM D4236.”This statement may
produce personal injury or illness to humans through ingestion,
be combined with other conformance statements. The purpose
inhalation, or skin contact.
of the conformance statement is to inform the purchaser, at the
2.1.11 toxicologist, n—an individual who through
education, training, and experience has expertise in the field of
Two of the larger poison exposure management information sources are: The
toxicology, as it relates to human exposure, and is either a
Rocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO
toxicologist or physician certified by a nationally recognized
80204; and the National Poison Center Network, 125 De Soto St., Pittsburgh, PA
certification board. 15213.
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D4236 − 94 (2016)
time of purchase, of the product’s compliance with the stan- ments listed in Annex A1 of this practice. Potentially chronic
dard. To accomplish this purpose the conformance statement hazards noted shall be those that are clinically significant and
should appear whenever practical on the product; however, it that might be expected with any reasonably foreseeable use of
shall also be acceptable to place the statement on one or more the art material. The hazards should be grouped in the order of
of the following: (a) the individual product package, (b)a relative descending severity.
display or sign at the point of purchase, (c) separate explana-
5.3 Name of Chronically Hazardous Component(s)—All
tory literature available on request at the point of purchase, (d)
components and known decomposition products of the formu-
a response to a formal request for bid or proposal.
lationwithapotentialforchronichazards,asdeterminedunder
the procedures of Section 4, shall be listed prominently.
4. Determination of Labeling
Generically equivalent names may be used.
4.1 An art material is considered to have the potential for
producing chronic adverse health effects if any customary or 5.4 Safe Handling Instructions—Appropriate precautionary
reasonably foreseeable use can result in a chronic hazard. statements as to work practices, personal protection, and
ventilation requirements shall be used substantially conform-
4.2 In making the determination a toxicologist(s) shall take
ing with those listed in Annex A2 of this practice.
into account the following:
4.2.1 Current chemical composition of the art material,
5.5 List of Sensitizing Components—To protect users from
supplied by an analytical laboratory or by an industrial chemist
known sensitizers found within art materials, each label shall
on behalf of a manufacturer or repackager.
contain a list of those sensitizers present in sufficient amounts
4.2.2 Current generally accepted, well-established scientific
to contribute significantly to a known skin or respiratory
knowledge of the chronic toxic potential of each component
sensitization.
and the total formulation.
5.6 Combined Statements—If an art material contains more
4.2.3 Specificphysicalandchemicalformoftheartmaterial
than one component capable of causing a chronic adverse
product, bioavailability, concentration, and the amount of each
health effect, or if a single chemical can cause several different
potentially chronic toxic component found in the formulation.
chronic adverse health effects, the potential effects may be
4.2.4 Reasonably foreseeable uses of the art material prod-
combined into one statement.
uct as determined by consultation with users and other indi-
5.7 Information Sources—In addition to an appropriate
viduals who are experienced in use of the material(s), such as
teachers, or by market studies, unless such use information has telephone number, the precautionary label shall contain a
statementidentifyingasourceforadditionalhealthinformation
previously been determined with respect to the specific art
material(s) under review. substantially in conformance with one of the phrases listed
4.2.5 Potential for known synergism and antagonism of the below:
various components of the formulation.
5.7.1 For more health information—(24-h cost-free tele-
4.2.6 Potentially chronic adverse health effects of decom-
phone number), or
position or combustion products, if known, from any reason-
5.7.2 For further health information call a poison control
ably foreseeable use of the hazardous art material product.
center.
4.2.7 Opinions of various regulatory agencies and scientific
5.8 Labeling Content, Product Size—An art material prod-
bodies, including the International Agency for Research on
uct(s) in a container larger in size than one fluid ounce (30 mL)
Cancer and the National Cancer Institute, on the potential for
(if the product is sold by volume) or one ounce net weight (28
chronic adverse health effects of the various components of the
g) (if the product is sold by weight) shall
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: D4236 − 94 (Reapproved 2016) D4236 − 94 (Reapproved 2016)
Standard Practice for
Labeling Art Materials for Chronic Health Hazards
This standard is issued under the fixed designation D4236; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—Footnote 2 was corrected editorially in July 2018.
INTRODUCTION
Uninformed or careless use of some art material products can give rise to health hazards, either
acute or chronic, or both. Specific and readily available warnings are needed to help protect users of
any age. One way to disseminate such information is to provide appropriate precautionary labeling on
art material products.
Labeling for acute health hazards, including those associated with art materials, is being addressed
by such requirements as the U.S. Consumer Product Safety Act (CPSC) , the Federal Hazardous
Substances Act, and the like. There are presently no specific national standards for labeling art
materials with respect to chronic health hazards.
This practice is intended to provide a standard for developing precautionary labels concerning
chronic health hazards related to the use of art materials. It is further intended to have the adaptability
necessary to keep labels current with existing scientific and medical knowledge, as well as in
conformity with other precautionary labeling requirements, both acute and chronic, thereby avoiding
unnecessary confusion by users with respect to other precautionary labeling.
1. Scope
1.1 This practice describes a procedure for developing precautionary labels for art materials and provides hazard and
precautionary statements based upon knowledge that exists in the scientific and medical communities. This practice concerns those
chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a
physical form, volume, or concentration that in the opinion of a toxicologist (see 2.1.11) has the potential to produce a chronic
adverse health effect(s).
1.2 This practice applies exclusively to art materials packaged in sizes intended for individual users of any age or those
participating in a small group.
1.3 Labeling determinations shall consider reasonable foreseeable use or misuse. The responsibility for precautionary labeling
rests with the producer or repackager who markets the materials for art or craft use.
1.4 This practice does not specify test methods for determining whether a substance or product presents chronic health hazards.
1.5 This practice does not apply to products appropriately labeled for known chronic health hazards in accordance with chemical
substance labeling standards and practices, such as another national consensus standard, existing labeling statutes, regulations, or
guidelines.
1.6 Since knowledge about chronic health hazards is incomplete and warnings cannot cover all uses of any product, it is not
possible for precautionary labeling to ensure completely safe use of an art product.
1.7 Manufacturers or repackagers may wish to determine individually or collectively precautionary labeling for art materials in
accordance with this practice. Compliance may be certified by a certifying organization. Guidelines for a certifying organization
are given in Appendix X1.
This practice is under the jurisdiction of ASTM Committee D01 on Paint and Related Coatings, Materials, and Applications and is the direct responsibility of
Subcommittee D01.57 on Artist Paints and Related Materials.
Current edition approved Dec. 1, 2016. Published December 2016. Originally approved in 1983. Last previous edition approved in 2011 as D4236 – 94 (2011). DOI:
10.1520/D4236-94R16.10.1520/D4236-94R16E01.
ASTM Practice D4236 has been codified into U.S. law as part of the Federal Hazardous Substances Act, 15 USC S1277. Users of this standard should be familiar with
the law and its regulations. Under this law and its regulations (16 CRFCFR 1500), manufacturers must submit to the CPSC (Washington DC 20207) written criteria used
by the toxicologist to recommend labeling.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
D4236 − 94 (2016)
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Terminology
2.1 Definitions of Terms Specific to This Standard:
2.1.1 analytical laboratory, n—a laboratory having personnel and apparatus capable of performing quantitative or qualitative
analyses of art materials, which may yield information that is used by a toxicologist for evaluation of potentially hazardous
materials.
2.1.2 art material or art material product, n—any raw or processed material, or manufactured product, marketed or represented
by the producer or repackager as intended for and suitable for users as defined herein.
2.1.3 bioavailability, n—the extent that a substance can be absorbed in a biologically active form.
2.1.4 chronic adverse health effect(s), n—a persistent toxic effect(s) that develops over time from a single, prolonged, or
repeated exposure to a substance. This effect may result from exposure(s) to a substance that can, in humans, cause sterility, birth
defects, harm to a developing fetus or to a nursing infant, cancer, allergenic sensitization, damage to the nervous system, or a
persistent adverse effect to any other organ system.
2.1.5 chronic health hazard(s) (hereafter referred to as “chronic hazard”), n—a health risk to humans, resultant from exposure
to a substance that may cause a chronic adverse health effect.
2.1.6 label, n—a display of written, printed, or graphic matter upon the immediate container of any art material product. When
the product is unpackaged, or is not packaged in an immediate container intended or suitable for delivery to users, the label can
be a display of such matter directly upon the article involved or upon a tag or other suitable labeling device attached to the art
material.
2.1.7 producer, n—the person or entity who manufactures, processes, or imports an art material.
2.1.8 repackager, n—the person or entity who obtains materials from producers and without making changes in such materials
puts them in containers intended for sale as art materials to users.
2.1.9 sensitizer, n—a substance known to cause, through an allergic process, a chronic adverse health effect which becomes
evident in a significant number of people on re-exposure to the same substance.
2.1.10 toxic, n—applies to any substance that is likely to produce personal injury or illness to humans through ingestion,
inhalation, or skin contact.
2.1.11 toxicologist, n—an individual who through education, training, and experience has expertise in the field of toxicology,
as it relates to human exposure, and is either a toxicologist or physician certified by a nationally recognized certification board.
2.1.12 users, n—artists or crafts people of any age who create, or recreate in a limited number, largely by hand, works which
may or may not have a practical use, but in which aesthetic considerations are paramount.
3. Requirements
3.1 To conform to this voluntary practice the producer or repackager of art materials shall submit art material product
formulation(s) or reformulation(s) to a toxicologist for review, such review to be in accordance with Section 4of this practice. The
toxicologist shall be required to keep product formulation(s) confidential.
3.1.1 Unless otherwise agreed in writing by the producer or repackager, no one other than the toxicologist shall have access to
the formulation(s); except that the toxicologist shall furnish a patient’s physician, on a confidential basis, the information necessary
to diagnose or treat cases of exposure or accidental ingestion.
3.2 To conform to this practice, the producer or repackager, upon advice given by a toxicologist in accordance with Section 4
of this practice, shall adopt precautionary labeling in accordance with Section 5 of this practice and based upon generally accepted,
well-established evidence that a component substance(s) is known to cause chronic adverse health effects.
3.3 To conform to this practice, labeling shall be parallel to, conform to, and minimally include any labeling practices prescribed
by U.S. federal and state statutes or regulations and shall not diminish the effect of required acute toxicity warnings.
3.4 To conform to this practice, the producer or repackager shall supply a poison exposure management information source the
generic formulation information required for dissemination to poison control centers or provide a 24-h cost-free telephone number
to poison control centers.
Two of the larger poison exposure management information sources are: The Rocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO 80204; and
the National Poison Center Network, 125 De Soto St., Pittsburgh, PA 15213.
´1
D4236 − 94 (2016)
3.5 To conform to this practice, the producer or repackager shall have a toxicologist review as necessary, but at least every 5
years, art material product formulation(s) and associated label(s) based upon the then current, generally accepted, well-established
scientific knowledge. If an art material producer or repackager becomes newly aware of any significant information regarding the
chronic hazards of an art material or ways to protect against the chronic hazard, this new information must be incorporated into
the labels of such art materials that are manufactured after 12 months from the date of discovery. If a producer or repackager
reformulates an art material, the new information must be evaluated and labeled in accordance with Section 5 of this practice.
3.6 Statement of Conformance—“Conforms to ASTM Practice D4236,” or “Conforms to ASTM D4236,” or “Conforms to the
health requirements of ASTM D4236.” This statement may be combined with other conformance statements. The purpose of the
conformance statement is to inform the purchaser, at the time of purchase, of the product’s compliance with the standard. To
accomplish this purpose the conformance statement should appear whenever practical on the product; however, it shall also be
acceptable to place the statement on one or more of the following: (a) the individual product package, (b) a display or sign at the
point of purchase, (c) separate explanatory literature available on request at the point of purchase, (d) a response to a formal request
for bid or proposal.
4. Determination of Labeling
4.1 An art material is considered to have the potential for producing chronic adverse health effects if any customary or
reasonably foreseeable use can result in a chronic hazard.
4.2 In making the determination a toxicologist(s) shall take into account the following:
4.2.1 Current chemical composition of the art material, supplied by an analytical laboratory or by an industrial chemist on behalf
of a manufacturer or repackager.
4.2.2 Current generally accepted, well-established scientific knowledge of the chronic toxic potential of each component and
the total formulation.
4.2.3 Specific physical and chemical form of the art material product, bioavailability, concentration, and the amount of each
potentially chronic toxic component found in the formulation.
4.2.4 Reasonably foreseeable uses of the art material product as determined by consultation with users and other individuals
who are experienced in use of the material(s), such as teachers, or by market studies, unless such use information has previously
been determined with respect to the specific art material(s) under review.
4.2.5 Potential for known synergism and antagonism of the various components of the formulation.
4.2.6 Potentially chronic adverse health effects of decomposition or combustion products, if known, from any reasonably
foreseeable use of the hazardous art material product.
4.2.7 Opinions of various regulatory agencies and scientific bodies, including the International Agency for Research on Cancer
and the National Cancer Institute, on the potential for chronic adverse health effects of the various components of the formulation.
4.3 Based upon the conclusion reached in conformance with review determinations set forth herein the toxicologist(s) shall
recommend precautionary labeling consistent with Section 5 of this practice.
5. Labeling Practices
5.1 Signal Word:
5.1.1 When a signal word for an acute hazard(s) is mandated and a chronic hazard(s) exists, the signal word shall be that for
the acute hazard.
5.1.2 When only a chronic hazard(s) exists, the signal word WARNING shall be used.
5.1.3 The signal word shall be prominently visible and set in bold capitals in a size equal to or greater than the statement of
potential chronic hazards.
5.2 List of Potentially Chronic Hazards—Potentially chronic hazards, as determined under the procedures of Section 4, shall be
stated substantially in accordance with the statements listed in Annex A1 of this practice. Potentially chronic hazards noted shall
be those that are clinically significant and that might be expected with any reasonably foreseeable use of the art material. The
hazards should be grouped in the order of relative descending severity.
5.3 Name of Chronically Hazardous Component(s)—All components and known decomposition products of the formulation
with a potential for chronic hazards, as determined under the procedures of Section 4, shall be listed prominently. Generically
equivalent names may be used.
5.4 Safe Handling Instructions—Appropriate precautionary statements as to work practices, personal protection, and ventilation
requirements shall be used substantially conforming with thos
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