【英文标准名称】:StandardGuideforConductingtheFrogEmbryoTeratogenesisAssay-Xenopus(FETAX)
【原文标准名称】:进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南
【标准号】:ASTME1439-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E47.01
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:生物分析和试验;导则
【英文主题词】:amphibia;developmentaltoxicity;FETAX;screeningtest;short-termchronictest;teratogenicity;Xenopus
【摘要】:FETAXisarapidtestforidentifyingdevelopmentaltoxicants.Datamaybeextrapolatedtootherspeciesincludingmammals.FETAXmightbeusedtoprioritizesamplesforfurthertestswhichusemammals.Validationstudiesusingcompoundswithknownmammalianorhumandevelopmentaltoxicity,orboth,suggestthatthepredictiveaccuracywillexceed85%(2).Whenevaluatingatestmaterialformammaliandevelopmentaltoxicity,FETAXmustbeusedwithandwithoutametabolicactivationsystem(MAS).UseofthisexogenousMASshouldincreasethepredictiveaccuracyoftheassaytoapproximately95%.Theaccuracyratecomparesfavorablywithothercurrentlyavailablex201C;invitroteratogenesisscreeningassaysx201D;(3).Anyassayemployingcells,partsofembryos,orwholeembryosotherthaninvivomammalianembryosisconsideredtobeaninvitroassay.Itisimportanttomeasuredevelopmentaltoxicitybecauseembryomortality,malformation,andgrowthinhibitioncanoftenoccuratconcentrationsfarlessthanthoserequiredtoaffectadultorganisms.Becauseofthesensitivityofembryonicandearlylifestages,FETAXprovidesinformationthatmightbeusefulinestimatingthechronictoxicityofatestmaterialtoaquaticorganisms.ResultsfromFETAXmightbeusefulwhenderivingwaterqualitycriteriaforaquaticorganisms(4).FETAXresultsmightbeusefulforstudyingstructure-activityrelationshipsbetweentestmaterialsandforstudyingbioavailability.1.1Thisguidecoversproceduresforobtaininglaboratorydataconcerningthedevelopmentaltoxicityofatestmaterial.ThetestutilizesembryosoftheSouthAfricanclawedfrog,XenopuslaevisandiscalledFETAX(FrogEmbryoTeratogenesisAssay-Xenopus)().Someoftheseprocedureswillbeusefulforconductingdevelopmentaltoxicitytestswithotherspeciesoffrogsalthoughnumerousmodificationsmightbenecessary.Alistofalternativeanuransispresentedin.1.2Arenewalexposureregimenandthecollectionoftherequiredmortality,malformation,andgrowth-inhibitiondataaredescribed.Specialneedsorcircumstancesmightrequiredifferenttypesofexposureanddataconcerningothereffects.Someofthesemodificationsarelistedinalthoughothermodificationsmightalsobenecessary.Whenevertheseproceduresarealteredorotherspeciesused,theresultsoftestsmightnotbecomparablebetweenmodifiedandunmodifiedprocedures.Anytestthatisconductedusingmodifiedproceduresshouldbereportedashavingdeviatedfromtheguide.1.3Theseproceduresareapplicabletoallchemicalseitherindividuallyorinformulations,commercialproductsormixturesthatcanbemeasuredaccuratelyatthenecessaryconcentrationsinwater.Withappropriatemodificationtheseprocedurescanbeusedtoconducttestsontheeffectsoftemperature,dissolvedoxygen,pH,physicalagents,andonmaterialssuchasaqueouseffluents(seeGuideE1192),surfaceandgroundwaters,leachates,aqueousextractsofwater-insolublematerials,andsolidphasesamples,suchassoilsandsediments,particulatematter,sediment,andwholebulksoilsandsediment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A40
【国际标准分类号】:
【页数】:16P.;A4
【正文语种】: