1、Designation:F131390(Reapproved 2011)Standard Specification forVolatile N-Nitrosamine Levels in Rubber Nipples onPacifiers1This standard is issued under the fixed designation F1313;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the y
2、ear 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.1.Scope1.1 This specification applies to the nitrosamine content ofrubber used in the manufacture of nipples for infant pacifie
3、rs.1.2 This specification does not apply to plastic nipples(onpacifiers).1.3 The purpose of this specification is to establish amaximum level of allowed nitrosamines in rubber nipples andto outline a uniform testing method to determine such level.1.4 The values stated in SI units are to be regarded
4、asstandard.The values given in parentheses are for informationonly.1.5 The following precautionary statement pertains only tothe test method portions,Sections 5,and Appendix X4 of thisspecification.This standard does not purport to address all ofthe safety concerns,if any,associated with its use.It
5、is theresponsibility 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.Specific hazards aregiven in Appendix X2.2.Terminology2.1 Definitions:2.1.1 lotnormal production run or,in the case of impor
6、ts,a shipment of items produced in the same time frame.2.1.2 nitrosamineschemically active compounds princi-pally formed by the reaction of amines with oxides of nitrogenpresent in the environment.3.Significance and Use3.1 This specification is intended for use in reducing thenormal exposure to nitr
7、osamines.3.2 This specification refers only by way of example to theeight volatile N-nitrosamines identified below:3.2.1 N-nitrosodimethylamine,3.2.2 N-nitrosodiethylamine,3.2.3 N-nitrosodibutylamine,3.2.4 N-nitrosomorpholine,3.2.5 N-nitrosopiperidine,3.2.6 N-nitrosopyrrolidine,3.2.7 N-ethylphenylni
8、trosamine.4.Test Method4.1 Determine nitrosamine levels by using either the meth-ylene chloride extraction method described in the collaborativestudy conducted by the National Center for ToxicologicalResearch2or the Food and Drug Administration method.25.Acceptable Level5.1 A test sample of nipples,
9、drawn from a standard pro-duction lot,shall not contain more than 10 ppb(in each of 3aliquots)of any one nitrosamine.In addition,the total nitro-samines of the sample shall not exceed 20 ppb.5.2 Each manufacturer or distributor of the product shall testthe product in such a manner and at such interv
10、als to ensurecompliance in accordance with the methodology prescribed bythe test procedure utilized.Records of all testing shall beretained for a period of up to three years.6.Report6.1 Report the following information:6.1.1 Lot number,6.1.2 Date samples,6.1.3 Date tested,6.1.4 Individual nitrosamin
11、e content,and6.1.5 Total nitrosamine content.1This specification is under the jurisdiction of ASTM Committee F15 onConsumer Products and is the direct responsibility of Subcommittee F15.22 on ToySafety.Current edition approved Feb.1,2011.Published June 2011.Originally approvedin 1990.Last previous e
12、dition approved in 2005 as F1313 90(2005).DOI:10.1520/F1313-90R11.2Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocke
13、n,PA 19428-2959.United States1 APPENDIXES(Nonmandatory Information)X1.BACKGROUNDX1.1 This specification provides the rationale for the draft-ing of a voluntary product standard establishing acceptablelevels and testing procedures for nitrosamines contained inchildrens rubber pacifiers.X1.2 Some nitr
14、osamines are known to be potent animalcarcinogens and are suspected human carcinogens.In 1981,theWest German Government enacted regulations limiting theamount of preformed nitrosamine in rubber pacifiers.Nitro-samines are formed from amines used as accelerators duringvulcanization of the rubber or a
15、re unintentional trace sub-stances present in stabilizers used in the manufacturing pro-cess.X1.3 In 1982,the Consumer Product Safety Commission(CPSC)began meeting with rubber pacifier manufacturers andimporters(most are imported),drawing their attention to boththe carcinogenic potential as measured
16、 by laboratory bioassayson rodents and the results of an audit of those pacifiers on themarket.The audit revealed nitrosamine levels ranging from“non-detectable”to as much as hundreds of parts per billion(ppb).The Toy Manufacturers ofAmerica(TMA)undertook tocoordinate a program to lower the levels of nitrosamines andvalidate a single test method that could be duplicated inlaboratories worldwide.This effort was a joint,round-robinprogram with the CPSC,the National Center for ToxicologicalResearch
