ASTM_D_4236-94-R2011.pdf

D4236-94(2011)4.Determination of Labelingthe procedures of Section 4,shall be listed prominently.4.1 An art material is considered to have the potential forGenerically equivalent names may be used.producing chronic adverse health effects if any customary or5.4 Safe Handling Instructions-Appropriate precautionaryreasonably foreseeable use can result in a chronic hazard.statements as to work practices,personal protection,and4.2 In making the determination a toxicologist(s)shall takeventilation requirements shall be used substantially conform-into account the following:ing with those listed in Annex A2 of this practice.4.2.1 Current chemical composition of the art material,5.5 List of Sensitizing Components-To protect users fromsupplied by an analytical laboratory or by an industrial chemistknown sensitizers found within art materials,each label shallon behalf of a manufacturer or repackager.contain a list of those sensitizers present in sufficient amounts4.2.2 Current generally accepted,well-established scientificto contribute significantly to a known skin or respiratoryknowledge of the chronic toxic potential of each componentsensitization.and the total formulation.4.2.3 Specific physical and chemical form of the art material5.6 Combined Statements-If an art material contains moreproduct,bioavailability,concentration,and the amount of eachthan one component capable of causing a chronic adversepotentially chronic toxic component found in the formulation.health effect,or if a single chemical can cause several different4.2.4 Reasonably foreseeable uses of the art material prod-chronic adverse health effects,the potential effects may beuct as determined by consultation with users and other indi-combined into one statement.viduals who are experienced in use of the material(s),such as5.7 Information Sources-In addition to an appropriateteachers,or by market studies,unless such use information hastelephone number,the precautionary label shall contain apreviously been determined with respect to the specific artstatement identifying a source for additional health informationmaterial(s)under review.substantially in conformance with one of the phrases listed4.2.5 Potential for known synergism and antagonism of thebelow: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),orposition or combustion products,if known,from any reason-5.7.2 For further health information call a poison controlably foreseeable use of the hazardous art material product.center.4.2.7 Opinions of various regulatory agencies and scientificbodies,including the International Agency for Research on5.8 Labeling Content,Product Size-An art material prod-Cancer and the National Cancer Institute,on the potential foruct(s)in a container larger in size than one fluid ounce(30 mL)chronic adverse health effects of the various components of the(if the product is sold by volume)or one ounce net weight(28formulation.g)(if the product is sold by weight)shall have full precaution-ary labeling,as generally described in Section 5 of this4.3 Based upon the conclusion reached in conformance withpractice.An art material product(s)in a container equal to orreview determinations set forth herein the toxicologist(s)shallsmaller than one fluid ounce or one ounce net weight shall haverecommend precautionary labeling consistent with Section 5 ofa label that includes a signal word in conformance with 5.1 ofthis practice.this practice and a list of potentially harmful or sensitizing5.Labeling Practicescomponents in conformance with 5.3 and 5.5 of this practice.If the toxicologist determines that an art material in a container5.1 Signal Word:equal to or smaller than one fluid ounce(30 mL)or one ounce5.1.1 When a signal word for an acute hazard(s)is mandatednet weight(28 g)has the potential for producing chronicand a chronic hazard(s)exists,the signal word shall be that foradverse health effects with customary or reasonably foresee-the acute hazard.able use despite its small size,the toxicologist may require the5.1.2 When only a chronic hazard(s)exists,the signal wordproduct to carry all the labeling that would be required in aWARNING shall be used.larger package.When the information cannot fit on the package5.1.3 The signal word shall be prominently visible and set inlabel,the art material shall include a package insert thatbold capitals in a size equal to or greater than the statement ofconveys all the required information.If the art material has apotential chronic hazards.package insert,the label on the product shall include a signal5.2 List of Potentially Chronic Hazards-Potentiallyword in conformance with 5.1,a list of potentially harmful orchronic hazards,as determined under the procedures of Sectionsensitizing components in conformance with 5.3 and 5.5 of this4,shall be stated substantially in accordance with the state-practice,and the statement See package insert before use.ments listed in Annex Al of this practice.Potentially chronicFor purposes of this subsection,the term package inserthazards noted shall be those that are clinically significant andmeans a display of written,printed,or graphic matter upon athat might be expected with any reasonably foreseeable use ofleaflet or suitable material accompanying the art material.the art material.The hazards should be grouped in the order of5.9 The information described in Section 5 must appear(1)relative descending severity.on the outside container or wrapper,if any,unless it is easily5.3 Name of Chronically Hazardous Component(s)-Alllegible through the outside container or wrapper and(2)on allcomponents and known decomposition products of the formu-accompanying literature where there are directions for use,lation with a potential for chronic hazards,as determined underwritten or otherwise.In a case where one or more individualCopyright by ASTM Intl(all rights reserved);Sun Sep 16 20:32:46 EDT 20123Downloaded/printed byWashington State University pursuant to License Agreement.No further reproductions authorized.