1、Designation: C1023 10 (Reapproved 2018)Standard 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,
2、 the year of last 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 a
3、cute or chronic, or 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 m
4、aterials, arepresently 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
5、intended to provide 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 confor
6、mity with other precautionary 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
7、 precautionary statements 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 th
8、at in the opinion 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
9、This practice applies to developing precautionary label-ing for ceramic art materials intended for adult usage. Confor-mance to this practice does not imply that ceramic art materialswill necessarily be labeled adequately or safe for use bychildren. Labeling determinations should consider reasonably
10、foreseeable use 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 Th
11、is practice does 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
12、, such asanother 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
13、art product.1.7 Manufacturers or repackagers may wish to determineindividually or collectively precautionary labeling for ceramicart materials in accordance with this practice. Compliance may1This practice is under the jurisdiction of ASTM Committee C21 on CeramicWhitewares and Related Productsand i
14、s the direct responsibility of SubcommitteeC21.03 on Methods for Whitewares and Environmental Concerns.Current edition approved Oct. 1, 2018. Published October 2018. Originallyapproved in 1983. Last previous edition approved in 2014 as C1023 10 (2014).DOI: 10.1520/C1023-10R18.Copyright ASTM Internat
15、ional, 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 International Standards, Gui
16、des and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1be certified by a certifying organization. Guidelines for acertifying organization are given in Appendix X1.1.8 This standard does not purport to address all of thesafety concerns, if any, ass
17、ociated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally r
18、ecognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Definitions of Terms Specific to This Standard2.1 analyti
19、cal laboratorya laboratory having personneland apparatus capable of performing quantitative 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,
20、orrecreate in a limited number, largely by hand, works that mayor may not have a practical 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 producta
21、ny raw or processed material, or manufactured product,marketed or represented by a ceramic 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 whomanufactures, processes, or imports a ceramic art m
22、aterial.2.6 chronic adverse health effect(s)a persistent toxic ef-fect(s) that develops 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
23、 to thenervous system, or a persistent adverse effect to any otherorgan system.2.7 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, print
24、ed, or graphic matterupon the immediate container of any ceramic art materialproduct. 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 mater
25、ial or upon a tag or othersuitable labeling device attached to the ceramic art material.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
26、people.2.10 sensitizera substance that is known to cause, throughan allergic process, 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 producepersonal injury or illness to
27、humans through ingestion,inhalation, or skin contact.2.12 toxicologistan 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 orphysician certified by a nationally recognized certificationboard
28、.3. Requirements3.1 To conform to this voluntary practice, the ceramicproducer or 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 toxicolog
29、ist shall berequired to keep product formulation(s) confidential.3.1.1 Unless otherwise 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
30、 basis, theinformation necessary to diagnose or treat cases of exposure oraccidental 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 Se
31、ction 5 of this practice and basedupon generally accepted, well-established evidence 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.
32、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 ceramic producer orrepackager shall supply a poison exposure management infor-mation source,2the generic formulation information requiredfor disseminat
33、ion to poison control centers or provide a 24-hcost-free number to poison control 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(
34、s) based upon the then current,generally accepted, well-established scientific knowledge.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 chronichaz
35、ard.2Two 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 10 (2018)24.2 In making his determination a toxicologist(s) shall takeinto acc
36、ount the 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
37、component(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 a
38、s determined by consultation with users and otherindividuals, who are experienced in use 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 syn
39、ergism and antagonism of thevarious components of the formulation.4.2.6 Potential chronic 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
40、scientificbodies3on the potential for chronic adverse health effects ofthe various components 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
41、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 chronic hazard(s) exists, the signal wordWARNING shall be used.5.1.3 The signal word shall be p
42、rominently visible and set inbold capitals in a size equal to or greater than the statement 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 liste
43、din Annex A1 of this practice. Potential chronic hazards notedshall be those that are clinically 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 Hazardo
44、us Component(s)All com-ponents and known decomposition products of the formulationwith 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 precautionarystatem
45、ents 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 ComponentsTo protect artists orcrafts people from known sensitizers found within ceramic artmaterials, each label
46、 shall contain a list of those sensitizerspresent in sufficient amounts to contribute significantly 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 chemica
47、l can cause severaldifferent chronic adverse effects, the potential effects may becombined 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
48、:FOR MORE HEALTH INFORMATION(24-HOUR COSTFREE NUMBER).CONTACT A PHYSICIAN FOR MORE HEALTH 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
49、 properties, decomposition products, detailedsafety instructions or disposal recommendations, 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;labeling3Such as: International Agency for Research on Cancer, National CancerInstitute, World Health Organization, American Lung Association, and the Interna-tional Lead Zinc Research Organization.C1023 10 (2018)3ANNEXES(Mandatory Information)A1. CHRONIC ADVERSE HAZA
