ASTM D4236-94(2011)
(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 and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: D4236 − 94 (Reapproved 2011)
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.
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 1.4 This practice does not specify test methods for deter-
mining whether a substance or product presents chronic health
1.1 This practice describes a procedure for developing
hazards.
precautionary labels for art materials and provides hazard and
precautionary statements based upon knowledge that exists in
1.5 This practice does not apply to products appropriately
the scientific and medical communities. This practice concerns
labeled for known chronic health hazards in accordance with
those chronic health hazards known to be associated with a
chemical substance labeling standards and practices, such as
product or product component(s), when the component(s) is
another national consensus standard, existing labeling statutes,
present in a physical form, volume, or concentration that in the
regulations, or guidelines.
opinion of a toxicologist (see 2.1.11) has the potential to
produce a chronic adverse health effect(s).
1.6 Since knowledge about chronic health hazards is incom-
plete and warnings cannot cover all uses of any product, it is
1.2 This practice applies exclusively to art materials pack-
not possible for precautionary labeling to ensure completely
aged in sizes intended for individual users of any age or those
safe use of an art product.
participating in a small group.
1.3 Labeling determinations shall consider reasonable fore-
1.7 Manufacturers or repackagers may wish to determine
seeable use or misuse. The responsibility for precautionary
individually or collectively precautionary labeling for art
labeling rests with the producer or repackager who markets the
materials in accordance with this practice. Compliance may be
materials for art or craft use.
certified by a certifying organization. Guidelines for a certify-
ing organization are given in Appendix X1.
This practice is under the jurisdiction of ASTM Committee D01 on Paint and
1.8 This standard does not purport to address all of the
Related Coatings, Materials, and Applications and is the direct responsibility of
safety concerns, if any, associated with its use. It is the
Subcommittee D01.57 on Artist Paints and Related Materials.
responsibility of the user of this standard to establish appro-
Current edition approved Feb. 1, 2011. Published February 2011. Originally
approved in 1983. Last previous edition approved in 2010 as D4236 – 94 (2010).
priate safety and health practices and determine the applica-
DOI: 10.1520/D4236-94R11.
bility of regulatory limitations prior to use.
ASTM Practice D4236 has been codified into U.S. law as part of the Federal
HazardousSubstancesAct,15USCS1277.Usersofthisstandardshouldbefamiliar
with the law and its regulations. Under this law and its regulations (16 CRF 1500),
2. Terminology
manufacturers must submit to the CPSC (Washington DC 20207) written criteria
used by the toxicologist to recommend labeling. 2.1 Definitions of Terms Specific to This Standard:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D4236 − 94 (2011)
2.1.1 analytical laboratory, n—a laboratory having person- such review to be in accordance with Section 4 of this practice.
nel and apparatus capable of performing quantitative or quali- The toxicologist shall be required to keep product formula-
tative analyses of art materials, which may yield information tion(s) confidential.
that is used by a toxicologist for evaluation of potentially 3.1.1 Unless otherwise agreed in writing by the producer or
hazardous materials.
repackager,nooneotherthanthetoxicologistshallhaveaccess
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,
birth defects, harm to a developing fetus or to a nursing infant,
3.3 To conform to this practice, labeling shall be parallel to,
cancer, allergenic sensitization, damage to the nervous system,
conform to, and minimally include any labeling practices
or a persistent adverse effect to any other organ system.
prescribed by U.S. federal and state statutes or regulations and
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
exposure to a substance that may cause a chronic adverse
3.4 To conform to this practice, the producer or repackager
health effect.
shall supply a poison exposure management information
2.1.6 label, n—a display of written, printed, or graphic source the generic formulation information required for dis-
matter upon the immediate container of any art material seminationtopoisoncontrolcentersorprovidea24-hcost-free
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
users, the label can be a display of such matter directly upon
shall have a toxicologist review as necessary, but at least every
the article involved or upon a tag or other suitable labeling
5 years, art material product formulation(s) and associated
device attached to the art material.
label(s) based upon the then current, generally accepted,
2.1.7 producer, n—the person or entity who manufactures,
well-established scientific knowledge. If an art material pro-
processes, or imports an art material.
ducer or repackager becomes newly aware of any significant
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
same substance.
3.6 Statement of Conformance—“Conforms toASTM Prac-
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 educa-
time of purchase, of the product’s compliance with the stan-
tion, training, and experience has expertise in the field of
dard. To accomplish this purpose the conformance statement
toxicology, as it relates to human exposure, and is either a
should appear whenever practical on the product; however, it
toxicologist or physician certified by a nationally recognized
shall also be acceptable to place the statement on one or more
certification board.
of the following: (a) the individual product package, ( b)a
2.1.12 users, n—artists or crafts people of any age who
display or sign at the point of purchase, ( c) separate explana-
create, or recreate in a limited number, largely by hand, works
tory literature available on request at the point of purchase, (d)
which may or may not have a practical use, but in which
a response to a formal request for bid or proposal.
aesthetic considerations are paramount.
3. Requirements
Two of the larger poison exposure management information sources are: The
3.1 To conform to this voluntary practice the producer or
Rocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO
repackager of art materials shall submit art material product
80204; and the National Poison Center Network, 125 De Soto St., Pittsburgh, PA
formulation(s) or reformulation(s) to a toxicologist for review, 15213.
D4236 − 94 (2011)
4. Determination of Labeling the procedures of Section 4, shall be listed prominently.
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-
viduals who are experienced in use of the material(s), such as
5.7 Information Sources—In addition to an appropriate
teachers, or by market studies, unless such use information has
telephone number, the precautionary label shall contain a
previously been determined with respect to the specific art
statementidentifyingasourceforadditionalhealthinformation
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 have full precaution-
formulation.
ary labeling, as generally described in Section 5 of this
4.3 Basedupontheconclusionreachedinconformancewith
practice. An art material product(s) in a container equal to or
review determinations set forth herein the toxicologist(s) shall
smallerthanonefluidounceoroneouncenetweightshallhave
recommendprecautionarylabelingconsistentwithSection5of
a label that includes a signal word in conformance with 5.1 of
this practice.
this practice and a list of potentially harmful or sensitizing
components in conformance with 5.3 and 5.5 of this practice.
5. Labeling Practices
If the toxicologist determines that an art material in a container
5.1 Signal Word:
equal to or smaller than one fluid ounce (30 mL) or one ounce
5.1.1 Whenasignalwordforanacutehazard(s)ismandated
net weight (28 g) has the potential for producing chronic
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