1、Designation: D 4236 94 (Reapproved 2005)Standard Practice forLabeling Art Materials for Chronic Health Hazards1This standard is issued under the fixed designation D 4236; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of
2、last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONUninformed or careless use of some art material products can give rise to health hazards, eitheracute or chronic, or
3、both. Specific and readily available warnings are needed to help protect users ofany age. One way to disseminate such information is to provide appropriate precautionary labeling onart material products.Labeling for acute health hazards, including those associated with art materials, is being addres
4、sedby such requirements as the U.S. Consumer Product Safety Act (CPSC)2, the Federal HazardousSubstances Act, and the like. There are presently no specific national standards for labeling artmaterials with respect to chronic health hazards.This practice is intended to provide a standard for developi
5、ng precautionary labels concerningchronic health hazards related to the use of art materials. It is further intended to have the adaptabilitynecessary to keep labels current with existing scientific and medical knowledge, as well as inconformity with other precautionary labeling requirements, both a
6、cute and chronic, thereby avoidingunnecessary confusion by users with respect to other precautionary labeling.1. Scope1.1 This practice describes a procedure for developingprecautionary labels for art materials and provides hazard andprecautionary statements based upon knowledge that exists inthe sc
7、ientific and medical communities. This practice concernsthose chronic health hazards known to be associated with aproduct or product component(s), when the component(s) ispresent in a physical form, volume, or concentration that in theopinion of a toxicologist (see 2.1.11) has the potential toproduc
8、e a chronic adverse health effect(s).1.2 This practice applies exclusively to art materials pack-aged in sizes intended for individual users of any age or thoseparticipating in a small group.1.3 Labeling determinations shall consider reasonable fore-seeable use or misuse. The responsibility for prec
9、autionarylabeling rests with the producer or repackager who markets thematerials for art or craft use.1.4 This practice does not specify test methods for deter-mining whether a substance or product presents chronic healthhazards.1.5 This practice does not apply to products appropriatelylabeled for k
10、nown chronic health hazards in accordance withchemical substance labeling standards and practices, such asanother national consensus standard, existing labeling statutes,regulations, or guidelines.1.6 Since knowledge about chronic health hazards is incom-plete and warnings cannot cover all uses of a
11、ny product, it isnot possible for precautionary labeling to ensure completelysafe use of an art product.1.7 Manufacturers or repackagers may wish to determineindividually or collectively precautionary labeling for artmaterials in accordance with this practice. Compliance may becertified by a certify
12、ing organization. Guidelines for a certify-ing organization are given in Appendix X1.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices an
13、d determine the applica-bility of regulatory limitations prior to use.1This practice is under the jurisdiction of ASTM Committee D01 on Paint andRelated Coatings, Materials, and Applications and is the direct responsibility ofSubcommittee D01.57 on Artist Paints and Related Materials.Current edition
14、 approved March 1, 2005. Published March 2005. Originallyapproved in 1983. Last previous edition approved in 2001 as D 4236 94 (2001).2ASTM Practice D 4236 has been codified into U.S. law as part of the FederalHazardous SubstancesAct, 15 USC S1277. Users of this standard should be familiarwith the l
15、aw and its regulations. Under this law and its regulations (16 CRF 1500),manufacturers must submit to the CPSC (Washington DC 20207) written criteriaused by the toxicologist to recommend labeling.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, Uni
16、ted States.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 analytical laboratory, na laboratory having person-nel and apparatus capable of performing quantitative or quali-tative analyses of art materials, which may yield informationthat is used by a toxicologist for evaluatio
17、n of potentiallyhazardous materials.2.1.2 art material or art material product, nany raw orprocessed material, or manufactured product, marketed orrepresented by the producer or repackager as intended for andsuitable for users as defined herein.2.1.3 bioavailability, nthe extent that a substance can
18、 beabsorbed in a biologically active form.2.1.4 chronic adverse health effect(s)a persistent toxiceffect(s) that develops over time from a single, prolonged, orrepeated exposure to a substance. This effect may result fromexposure(s) to a substance that can, in humans, cause sterility,birth defects,
19、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”), na health risk to humans, resultant fromexposure to a s
20、ubstance that may cause a chronic adversehealth effect.2.1.6 label, na display of written, printed, or graphicmatter upon the immediate container of any art materialproduct. When the product is unpackaged, or is not packaged inan immediate container intended or suitable for delivery tousers, the lab
21、el can be a display of such matter directly uponthe article involved or upon a tag or other suitable labelingdevice attached to the art material.2.1.7 producer, nthe person or entity who manufactures,processes, or imports an art material.2.1.8 repackager, nthe person or entity who obtainsmaterials f
22、rom producers and without making changes in suchmaterials puts them in containers intended for sale as artmaterials to users.2.1.9 sensitizer, na substance known to cause, through anallergic process, a chronic adverse health effect which becomesevident in a significant number of people on re-exposur
23、e to thesame substance.2.1.10 toxic, napplies to any substance that is likely toproduce personal injury or illness to humans through ingestion,inhalation, or skin contact.2.1.11 toxicologist, nan individual who through educa-tion, training, and experience has expertise in the field oftoxicology, as
24、it relates to human exposure, and is either atoxicologist or physician certified by a nationally recognizedcertification board.2.1.12 users, nartists or crafts people of any age whocreate, or recreate in a limited number, largely by hand, workswhich may or may not have a practical use, but in whicha
25、esthetic considerations are paramount.3. Requirements3.1 To conform to this voluntary practice the producer orrepackager of art materials shall submit art material productformulation(s) or reformulation(s) to a toxicologist for review,such review to be in accordance with Section 4 of this practice.T
26、he toxicologist shall be required to keep product formula-tion(s) confidential.3.1.1 Unless otherwise agreed in writing by the producer orrepackager, no one other than the toxicologist shall have accessto the formulation(s); except that the toxicologist shall furnisha patients physician, on a confid
27、ential basis, the informationnecessary to diagnose or treat cases of exposure or accidentalingestion.3.2 To conform to this practice, the producer or repackager,upon advice given by a toxicologist in accordance with Section4 of this practice, shall adopt precautionary labeling in accor-dance with Se
28、ction 5 of this practice and based upon generallyaccepted, well-established evidence that a component sub-stance(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 practicesprescribed by U.
29、S. federal and state statutes or regulations andshall not diminish the effect of required acute toxicity warn-ings.3.4 To conform to this practice, the producer or repackagershall supply a poison exposure management informationsource3the generic formulation information required for dis-semination to
30、 poison control centers or provide a 24-h cost-freetelephone number to poison control centers.3.5 To conform to this practice, the producer or repackagershall have a toxicologist review as necessary, but at least every5 years, art material product formulation(s) and associatedlabel(s) based upon the
31、 then current, generally accepted,well-established scientific knowledge. If an art material pro-ducer or repackager becomes newly aware of any significantinformation regarding the chronic hazards of an art material orways to protect against the chronic hazard, this new informa-tion must be incorpora
32、ted into the labels of such art materialsthat are manufactured after 12 months from the date ofdiscovery. If a producer or repackager reformulates an artmaterial, the new information must be evaluated and labeled inaccordance with Section 5 of this practice.3.6 Statement of Conformance“Conforms to A
33、STM Prac-tice D 4236,” or “Conforms to ASTM D 4236,” or “Conformsto the health requirements of ASTM D 4236.” This statementmay be combined with other conformance statements. Thepurpose of the conformance statement is to inform the pur-chaser, at the time of purchase, of the products compliancewith t
34、he standard. To accomplish this purpose the conformancestatement should appear whenever practical on the product;however, it shall also be acceptable to place the statement onone or more of the following: (a) the individual productpackage, (b) a display or sign at the point of purchase, (c)separate
35、explanatory literature available on request at the pointof purchase, (d) a response to a formal request for bid orproposal.3Two of the larger poison exposure management information sources are: TheRocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO80204; and the National Poison C
36、enter Network, 125 De Soto St., Pittsburgh, PA15213.D 4236 94 (2005)24. Determination of Labeling4.1 An art material is considered to have the potential forproducing chronic adverse health effects if any customary orreasonably foreseeable use can result in a chronic hazard.4.2 In making the determin
37、ation a toxicologist(s) shall takeinto account the following:4.2.1 Current chemical composition of the art material,supplied by an analytical laboratory or by an industrial chemiston behalf of a manufacturer or repackager.4.2.2 Current generally accepted, well-established scientificknowledge of the
38、chronic toxic potential of each componentand the total formulation.4.2.3 Specific physical and chemical form of the art materialproduct, bioavailability, concentration, and the amount of eachpotentially chronic toxic component found in the formulation.4.2.4 Reasonably foreseeable uses of the art mat
39、erial prod-uct as determined by consultation with users and other indi-viduals who are experienced in use of the material(s), such asteachers, or by market studies, unless such use information haspreviously been determined with respect to the specific artmaterial(s) under review.4.2.5 Potential for
40、known synergism and antagonism of thevarious components of the formulation.4.2.6 Potentially chronic adverse health effects of decom-position or combustion products, if known, from any reason-ably foreseeable use of the hazardous art material product.4.2.7 Opinions of various regulatory agencies and
41、 scientificbodies, including the International Agency for Research onCancer and the National Cancer Institute, on the potential forchronic adverse health effects of the various components of theformulation.4.3 Based upon the conclusion reached in conformance withreview determinations set forth herei
42、n the toxicologist(s) shallrecommend precautionary labeling consistent with Section 5 ofthis practice.5. Labeling Practices5.1 Signal Word:5.1.1 When a signal word for an acute hazard(s) is mandatedand a chronic hazard(s) exists, the signal word shall be that forthe acute hazard.5.1.2 When only a ch
43、ronic hazard(s) exists, the signal wordWARNING shall be used.5.1.3 The signal word shall be prominently visible and set inbold capitals in a size equal to or greater than the statement ofpotential chronic hazards.5.2 List of Potentially Chronic HazardsPotentiallychronic hazards, as determined under
44、the procedures of Section4, shall be stated substantially in accordance with the state-ments listed in Annex A1 of this practice. Potentially chronichazards noted shall be those that are clinically significant andthat might be expected with any reasonably foreseeable use ofthe art material. The haza
45、rds should be grouped in the order ofrelative descending severity.5.3 Name of Chronically Hazardous Component(s)Allcomponents and known decomposition products of the formu-lation with a potential for chronic hazards, as determined underthe procedures of Section 4, shall be listed prominently.Generic
46、ally equivalent names may be used.5.4 Safe Handling InstructionsAppropriate precautionarystatements as to work practices, personal protection, andventilation requirements shall be used substantially conform-ing with those listed in Annex A2 of this practice.5.5 List of Sensitizing Components To prot
47、ect users fromknown sensitizers found within art materials, each label shallcontain a list of those sensitizers present in sufficient amountsto contribute significantly to a known skin or respiratorysensitization.5.6 Combined StatementsIf an art material contains morethan one component capable of ca
48、using a chronic adversehealth effect, or if a single chemical can cause several differentchronic adverse health effects, the potential effects may becombined into one statement.5.7 Information SourcesIn addition to an appropriatetelephone number, the precautionary label shall contain astatement iden
49、tifying a source for additional health informationsubstantially in conformance with one of the phrases listedbelow:5.7.1 For more health information(24-h cost-free tele-phone number), or5.7.2 For further health information call a poison controlcenter.5.8 Labeling Content, Product Size An art material prod-uct(s) in a container larger in size than one fluid ounce (30 mL)(if the product is sold by volume) or one ounce net weight (28g) (if the product is sold by weight) shall have full precaution-ary labeling, as generally described in Section 5 of thispractice. An
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