1、Designation: C1023 10Standard Practice forLabeling Ceramic Art Materials for Chronic Adverse HealthHazards1This standard is issued under the fixed designation C1023; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last
2、revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONUninformed or careless use of some ceramic art material products can give rise to health hazards,either acute or chronic, o
3、r both. Specific and readily available warnings are needed to help protectusers. One way to disseminate such information is to provide appropriate precautionary labeling onceramic art material products.Labeling for acute health hazards, including those associated with ceramic art materials, areprese
4、ntly being addressed by such requirements as the U.S. Consumer Product Safety Act, the FederalHazardous SubstancesAct, and the like. There are presently no specific national standards for labelingceramic art materials with respect to chronic adverse health hazards.This practice is intended to provid
5、e a standard for developing precautionary labels concerningchronic adverse health hazards related to the use of ceramic art materials. It is further intended to havethe adaptability necessary to keep labels current with existing scientific and medical knowledge, aswell as in conformity with other pr
6、ecautionary labeling requirements, both acute and chronic, therebyavoiding unnecessary confusion by users with respect to other precautionary labeling.1. Scope1.1 This practice describes a procedure for developingprecautionary labels for ceramic art materials and provideshazard and precautionary sta
7、tements based upon knowledgethat exists in the scientific and medical communities. Thispractice concerns those chronic adverse health hazards knownto be associated with a product or product component(s), whenthe component(s) is present in a physical form, volume, orconcentration that in the opinion
8、of a toxicologist has thepotential to produce a chronic adverse health effect(s).1.2 This practice is intended to apply exclusively to ceramicart materials which are packaged in sizes intended for use byartists or crafts people, either individually, or in a small groupor class.1.3 This practice appl
9、ies to developing precautionary label-ing for ceramic art materials intended for adult usage. Con-formance to this practice does not imply that ceramic artmaterials will necessarily be labeled adequately or safe for useby children. Labeling determinations should consider reason-ably foreseeable use
10、or misuse by children and include asappropriate, in such instances, warnings to keep out of reach,or other specific precautionary statements. The responsibilityfor precautionary labeling rests with the ceramic producer orrepackager who markets the material for art or craft use.1.4 This practice does
11、 not specify test methods for deter-mining whether a substance or product presents chronicadverse health hazards.1.5 This practice does not apply to products appropriatelylabeled for known chronic adverse health hazards according tochemical substances labeling standards and practices, such asanother
12、 national consensus standard, existing labeling statutes,regulations, or guidelines.1.6 Since knowledge about chronic adverse health hazardsis incomplete and warning cannot cover all uses of anyproduct, it is not possible for precautionary labeling to assurecompletely safe use of an art product.1.7
13、Manufacturers or repackagers may wish to determineindividually or collectively precautionary labeling for ceramicart materials in accordance with this practice. Compliance maybe certified by a certifying organization. Guidelines for acertifying organization are given in Appendix X1.1This practice is
14、 under the jurisdiction of ASTM Committee C21 on CeramicWhitewares and Related Products and is the direct responsibility of SubcommitteeC21.03 on Methods for Whitewares and Environmental Concerns.Current edition approved May 1, 2010. Published June 2010. Originallyapproved in 1983. Last previous edi
15、tion approved in 2009 as C1023 09. DOI:10.1520/C1023-10.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility
16、 of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Definitions of Terms Specific to This Standard2.1 analytical laboratorya laboratory having personneland apparatus capable of performing quant
17、itative or qualitativeanalysis of ceramic art materials, which may yield informationthat is used by a toxicologist for evaluation of potentiallyhazardous materials.2.2 artists or crafts peopleindividuals who create, orrecreate in a limited number, largely by hand, works that mayor may not have a pra
18、ctical use, but in which aestheticconsiderations are paramount.2.3 bioavailabilitythe extent to which a substance can beabsorbed in a biologically active form.2.4 ceramic art material or ceramic art material productany raw or processed material, or manufactured product,marketed or represented by a c
19、eramic producer or repackageras intended for and suitable for use in a fired product producedby artists or crafts people.2.5 ceramic producerthe person or entity who manufac-tures, processes, or imports a ceramic art material.2.6 chronic adverse health effect(s)a persistent toxic ef-fect(s) that dev
20、elops over time from a single, prolonged, orrepeated exposure to a substance which can, in humans, causesterility, birth defects, harm to a developing fetus or to anursing infant, cancer, allergic sensitization, damage to thenervous system, or a persistent adverse effect to any otherorgan system.2.7
21、 chronic adverse health hazard(s)hereafter referred toas “chronic hazard”a health risk to humans, resultant fromexposure to a substance that may cause a chronic adversehealth effect.2.8 labela display of written, printed, or graphic matterupon the immediate container of any ceramic art materialprodu
22、ct. When the product is unpackaged, or is not packaged inan immediate container intended or suitable for delivery toartists or crafts people, the label can be a display of such matterdirectly upon the ceramic art material or upon a tag or othersuitable labeling device attached to the ceramic art mat
23、erial.2.9 repackagerthe person or entity who obtains materialsfrom ceramic producers and, without making changes in suchmaterials, puts them in containers intended for sale as ceramicart materials to artists or crafts people.2.10 sensitizera substance that is known to cause, throughan allergic proce
24、ss, a chronic adverse health effect whichbecomes evident in a significant number of people on re-exposure to the same substance.2.11 toxicapplies to any substance that is likely to pro-duce personal injury or illness to humans through ingestion,inhalation, or skin contact.2.12 toxicologistan individ
25、ual who through education,training and experience has expertise in the field of toxicology,as it relates to human exposure, and is either a toxicologist orphysician certified by a nationally recognized certificationboard.3. Requirements3.1 To conform to this voluntary practice, the ceramicproducer o
26、r repackager of ceramic art materials shall submitceramic art material product formulation(s) or reformulation(s)to a toxicologist for review, such review to be in accordancewith Section 4 of this practice. The toxicologist shall berequired to keep product formulation(s) confidential.3.1.1 Unless ot
27、herwise agreed in writing by the ceramicproducer or repackager, no one other than the toxicologist shallhave access to the formulation(s); except that the toxicologistshall furnish a patients physician, on a confidential basis, theinformation necessary to diagnose or treat cases of exposure oraccide
28、ntal ingestion.3.2 To conform to this practice, the ceramic producer orrepackager, upon advice given by a toxicologist in accordancewith Section 4 of this practice, shall adopt precautionarylabeling in accordance with Section 5 of this practice and basedupon generally accepted, well-established evid
29、ence that acomponent substance(s) is known to cause chronic adversehealth effects.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 re
30、quired acute toxicity warn-ings.3.4 To conform to this practice, the ceramic producer orrepackager shall supply a poison exposure management infor-mation source,2the generic formulation information requiredfor dissemination to poison control centers or provide a 24-hcost-free number to poison contro
31、l centers.3.5 To conform to this practice, the ceramic producer orrepackager shall have a toxicologist review as necessary, but atleast every five years, ceramic art material product formula-tion(s) and associated label(s) based upon the then current,generally accepted, well-established scientific k
32、nowledge.4. Determination of Labeling4.1 A ceramic art material is considered to have the poten-tial for producing chronic adverse health effects if any custom-ary or reasonably foreseeable use can result in a chronichazard.4.2 In making his determination a toxicologist(s) shall takeinto account the
33、 following:4.2.1 Current chemical composition of the ceramic artmaterial, supplied by an analytical laboratory or by an indus-trial chemist on behalf of a manufacturer or repackager.4.2.2 Current generally accepted, well-established scientificknowledge of the chronic toxic potential of each componen
34、t(s)and the total formulation.4.2.3 Specific physical and chemical form of the ceramic artmaterial product, bioavailability, concentration, and theamount of each potential chronic toxic component found in theformulation.4.2.4 Reasonably foreseeable uses of the ceramic art mate-rial product as determ
35、ined by consultation with users and other2Two of the larger poison control centers are: The Rocky Mountain PoisonControl Center, W. 8th and Cherokee, Denver, CO 80204; and the National PoisonControl Center Network, 125 De Soto St., Pittsburgh, PA 15213.C1023 102individuals, who are experienced in us
36、e of the material(s), suchas teachers, or by market studies, unless such use informationhas previously been determined with respect to the specificceramic art material(s) under review.4.2.5 Potential for known synergism and antagonism of thevarious components of the formulation.4.2.6 Potential chron
37、ic adverse health effects of decompo-sition or combustion products, if known, from any reasonablyforeseeable use of the hazardous ceramic art material product,and4.2.7 Opinions of various medical, regulatory, and scientificbodies3on the potential for chronic adverse health effects ofthe various comp
38、onents of the formulation.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 for an acute haz
39、ard(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 greater than the state
40、ment ofpotential chronic hazards.5.2 List of Potential Chronic HazardsPotential chronichazards, as determined under the procedures of Section 4, shallbe stated substantially in accordance with the statements listedin Annex A1 of this practice. Potential chronic hazards notedshall be those that are c
41、linically significant and that might beexpected with any reasonably foreseeable use of the ceramicart material. The hazards should be grouped in the order ofrelative descending severity.5.3 Name of Chronic Hazardous Component(s)All com-ponents and known decomposition products of the formulationwith
42、a potential for chronic hazards, as determined under theprocedures of Section 4, shall be listed prominently. Generi-cally equivalent names may be used.5.4 Safe Handling InstructionsAppropriate precautionarystatements as to work practices, personal protection, andventilation requirements shall be us
43、ed substantially conform-ing with those listed in Annex A2 of this practice.5.5 List of Sensitizing ComponentsTo protect artists orcrafts people from known sensitizers found within ceramic artmaterials, each label shall contain a list of those sensitizerspresent in sufficient amounts to contribute s
44、ignificantly to aknown skin or respiratory sensitization.5.6 Combined StatementsIf a ceramic art material con-tains more than one component capable of causing a chronicadverse health effect, or if a single chemical can cause severaldifferent chronic adverse effects, the potential effects may becombi
45、ned into one statement.5.7 Information SourcesThe precautionary label shallcontain a statement identifying a source for additional healthinformation substantially in conformance with one of thephrases listed below:FOR MORE HEALTH INFORMATION(24-HOUR COSTFREE NUMBER).CONTACT A PHYSICIAN FOR MORE HEAL
46、TH INFOR-MATION.CALL YOUR LOCAL POISON CONTROL CENTER FORMORE HEALTH INFORMATION.5.8 Supplemental InformationWhere appropriate, moredetailed technical information that relates to chronic hazard(s),such as physical properties, decomposition products, detailedsafety instructions or disposal recommenda
47、tions, shall beincluded in supplemental documents, such as Material SafetyData Sheets, technical brochures, technical data sheets, and thelike.6. Keywords6.1 ceramic art materials; chronic adverse health hazards;labelingANNEXES(Mandatory Information)A1. CHRONIC ADVERSE HAZARD STATEMENTSMay cause ste
48、rility.May be harmful by breathing vapors/dust.May be harmful if swallowed.May be harmful by skin contact.May produce birth defects in the developing fetus.May be excreted in human milk.May cause harm to the nursing infant.Cancer agent! Exposure may produce cancer.Cancer agent based on tests with la
49、boratory animals.Possible cancer agent based on tests with laboratory animals.May produce allergic reaction by ingestion/inhalation/skincontact.May produce numbness or weakness in the extremities.Exposure may cause (specify the organ(s) damage.Heating/combustion may cause hazardous decompositionproducts.3Such as: International Agency for Research on Cancer, National CancerInstitute, World Health Organization, American Lung Association, and the Interna-tional Lead Zinc Research Organization.C1023 103A2. PRECAUTIONARY STATEMENTSKeep out of reach of children.When
