ASTM D4236-1994(2016)e1 Standard Practice for Labeling Art Materials for Chronic Health Hazards.pdf

1、Designation: D4236 94 (Reapproved 2016)1Standard Practice forLabeling Art Materials for Chronic Health Hazards1This standard is issued under the fixed designation D4236; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of l

2、ast revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEFootnote 2 was corrected editorially in July 2018.INTRODUCTIONUninformed or careless use of some art material products can giv

3、e rise to health hazards, eitheracute or chronic, or 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

4、 those associated with art materials, is being addressedby 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 pr

5、actice is intended to provide a standard for developing 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 w

6、ith other precautionary labeling requirements, both acute 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

7、 statements based upon knowledge that exists inthe scientific 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

8、 toxicologist (see 2.1.11) has the potential toproduce 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 fo

9、re-seeable use or misuse. The responsibility for precautionarylabeling 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

10、does not apply to products appropriatelylabeled for known 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 i

11、s incom-plete and warnings cannot cover all uses of any 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 t

12、his practice. Compliance may becertified by a certifying 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

13、establish appro-priate safety, health, and environmental practices and deter-mine the applicability 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 ofSubco

14、mmittee D01.57 on Artist Paints and Related Materials.Current edition approved Dec. 1, 2016. Published December 2016. Originallyapproved in 1983. Last previous edition approved in 2011 as D4236 94 (2011).DOI: 10.1520/D4236-94R16E01.2ASTM Practice D4236 has been codified into U.S. law as part of the

15、FederalHazardous SubstancesAct, 15 USC S1277. Users of this standard should be familiarwith the law and its regulations. Under this law and its regulations (16 CFR 1500),manufacturers must submit to the CPSC (Washington DC 20207) written criteriaused by the toxicologist to recommend labeling.Copyrig

16、ht ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of Internationa

17、l Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.11.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDev

18、elopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 analytical laboratory, na laboratory having person-nel and apparatus capable of pe

19、rforming quantitative or quali-tative analyses of art materials, which may yield informationthat is used by a toxicologist for evaluation of potentiallyhazardous materials.2.1.2 art material or art material product, nany raw orprocessed material, or manufactured product, marketed orrepresented by th

20、e producer or repackager as intended for andsuitable for users as defined herein.2.1.3 bioavailability, nthe extent that a substance can beabsorbed in a biologically active form.2.1.4 chronic adverse health effect(s), na persistent toxiceffect(s) that develops over time from a single, prolonged, orr

21、epeated exposure to a substance. This effect may result fromexposure(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 orga

22、n system.2.1.5 chronic health hazard(s) (hereafter referred to as“chronic hazard”), na health risk to humans, resultant fromexposure to a substance 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 mate

23、rialproduct. When the product is unpackaged, or is not packaged inan immediate container intended or suitable for delivery tousers, the label 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,

24、nthe person or entity who manufactures,processes, or imports an art material.2.1.8 repackager, nthe person or entity who obtains ma-terials from producers and without making changes in suchmaterials puts them in containers intended for sale as artmaterials to users.2.1.9 sensitizer, na substance kno

25、wn to cause, through anallergic process, a chronic adverse health effect which becomesevident in a significant number of people on re-exposure 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 s

26、kin contact.2.1.11 toxicologist, nan individual who througheducation, training, and experience has expertise in the field oftoxicology, as it relates to human exposure, and is either atoxicologist or physician certified by a nationally recognizedcertification board.2.1.12 users, nartists or crafts p

27、eople of any age whocreate, or recreate in a limited number, largely by hand, workswhich may or may not have a practical use, but in whichaesthetic considerations are paramount.3. Requirements3.1 To conform to this voluntary practice the producer orrepackager of art materials shall submit art materi

28、al productformulation(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 formula-tion(s) confidential.3.1.1 Unless otherwise agreed in writing by the producer orrepackager, no one other

29、 than the toxicologist shall have accessto the formulation(s); except that the toxicologist shall furnisha patients physician, on a confidential basis, the informationnecessary to diagnose or treat cases of exposure or accidentalingestion.3.2 To conform to this practice, the producer or repackager,u

30、pon advice given by a toxicologist in accordance with Section4 of this practice, shall adopt precautionary labeling in accor-dance with Section 5 of this practice and based upon generallyaccepted, well-established evidence that a component sub-stance(s) is known to cause chronic adverse health effec

31、ts.3.3 To conform to this practice, labeling shall be parallel to,conform to, and minimally include any labeling practicesprescribed by U.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 o

32、r repackagershall supply a poison exposure management informationsource3the generic formulation information required for dis-semination to 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 hav

33、e a toxicologist review as necessary, but at least every5 years, art material product formulation(s) and associatedlabel(s) based upon the then current, generally accepted,well-established scientific knowledge. If an art material pro-ducer or repackager becomes newly aware of any significantinformat

34、ion regarding the chronic hazards of an art material orways to protect against the chronic hazard, this new informa-tion must be incorporated into the labels of such art materialsthat are manufactured after 12 months from the date ofdiscovery. If a producer or repackager reformulates an artmaterial,

35、 the new information must be evaluated and labeled inaccordance with Section 5 of this practice.3.6 Statement of Conformance“Conforms to ASTM Prac-tice D4236,” or “Conforms toASTM D4236,” or “Conforms tothe health requirements of ASTM D4236.” This statement maybe combined with other conformance stat

36、ements. The purposeof the conformance statement is to inform the purchaser, at the3Two of the larger poison exposure management information sources are: TheRocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO80204; and the National Poison Center Network, 125 De Soto St., Pittsburg

37、h, PA15213.D4236 94 (2016)12time of purchase, of the products compliance with the stan-dard. To accomplish this purpose the conformance statementshould appear whenever practical on the product; however, itshall also be acceptable to place the statement on one or moreof the following: (a) the individ

38、ual product package, (b)adisplay or sign at the point of purchase, (c) separate explana-tory literature available on request at the point of purchase, (d)a response to a formal request for bid or proposal.4. Determination of Labeling4.1 An art material is considered to have the potential forproducin

39、g chronic adverse health effects if any customary orreasonably foreseeable use can result in a chronic hazard.4.2 In making the determination 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 in

40、dustrial chemiston behalf of a manufacturer or repackager.4.2.2 Current generally accepted, well-established scientificknowledge of the chronic toxic potential of each componentand the total formulation.4.2.3 Specific physical and chemical form of the art materialproduct, bioavailability, concentrat

41、ion, and the amount of eachpotentially chronic toxic component found in the formulation.4.2.4 Reasonably foreseeable uses of the art material 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,

42、 unless such use information haspreviously been determined with respect to the specific artmaterial(s) under review.4.2.5 Potential for known synergism and antagonism of thevarious components of the formulation.4.2.6 Potentially chronic adverse health effects of decom-position or combustion products

43、, if known, from any reason-ably foreseeable use of the hazardous art material product.4.2.7 Opinions of various regulatory agencies and scientificbodies, including the International Agency for Research onCancer and the National Cancer Institute, on the potential forchronic adverse health effects of

44、 the various components of theformulation.4.3 Based upon the conclusion reached in conformance withreview determinations set forth herein 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

45、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 chronic 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 greate

46、r than the statement ofpotential chronic hazards.5.2 List of Potentially Chronic HazardsPotentiallychronic hazards, as determined under the procedures of Section4, shall be stated substantially in accordance with the state-ments listed in Annex A1 of this practice. Potentially chronichazards noted s

47、hall be those that are clinically significant andthat might be expected with any reasonably foreseeable use ofthe art material. The hazards should be grouped in the order ofrelative descending severity.5.3 Name of Chronically Hazardous Component(s)Allcomponents and known decomposition products of th

48、e formu-lation with a potential for chronic hazards, as determined underthe procedures of Section 4, shall be listed prominently.Generically equivalent names may be used.5.4 Safe Handling InstructionsAppropriate precautionarystatements as to work practices, personal protection, andventilation requir

49、ements shall be used substantially conform-ing with those listed in Annex A2 of this practice.5.5 List of Sensitizing ComponentsTo protect 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 causing a chronic adversehealth effect, or if a single chemical can cause several differentchronic adverse health effects, the potenti