学习查找化妆品成分评估文件

CosmeticIngredientReview课前回顾与预习Task1化妆品成分评估CIR学习查找化妆品成分评估文件化妆品成分的安全评估报告1PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]2PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]3PART3[SafetyAssessmentofCosmeticIngredients化妆品成分的安全评估报告]02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]CIRFindingsarelistedatawebsite(/cir-findings).CIRFindingsareclassifiedintofourcategoriesasshowninAppendixXX:SafeAsUsed,SafewithQualifications,Unsafe,UseNotSupported.AbouttheCosmeticIngredientReviewTheCosmeticIngredientReviewwasestablishedin1976bytheindustrytradeassociation(thentheCosmetic,Toiletry,andFragranceAssociation,nowthePersonalCareProductsCouncil),withthesupportoftheU.S.FoodandDrugAdministrationandtheConsumerFederationofAmerica.AlthoughfundedbytheCouncil,CIR,theExpertPanelforCosmeticIngredientSafety,andthereviewprocessareindependentfromtheCouncilandthecosmeticsindustry.CIRandtheExpertPanelforCosmeticIngredientSafetyoperateunderasetofprocedures.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]Generalpolicyanddirectionaregivenbya7-memberSteeringCommitteechairedbythePresidentandCEOoftheCouncil,withadermatologistrepresentingtheAmericanAcademyofDermatology,atoxicologistrepresentingtheSocietyofToxicology,aconsumerrepresentativerepresentingtheConsumerFederationofAmerica,anindustryscientist(thecurrentchairoftheCouncil'sCIRCommittee),ChairoftheExpertPanelforCosmeticIngredientSafety,andtheCouncil’sExecutiveVicePresidentforScience.ExpertPanelforCosmeticIngredientSafety40YearsofCIRFor40yearstheCosmeticIngredientReviewhasworkedwithFDA,thecosmeticsindustry,andconsumerstohelpkeepcosmeticssafe.FindIngredientReviewsandDocumentsSelectaletterofthealphabettobrowseingredientsbynameorenteraningredientnameinthesearchfieldbelow.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]Ingredientsofinterestmaybefoundonthelabelofapersonalcareproductandsearchedusingthisdatabase.IngredientsareoftenreferredtoonthelabelofapersonalcareproductbytheingredientnameasitappearsintheInternationalNomenclatureofCosmeticIngredients(INCI),knownastheINCIName.CIRreviewsingredients,notproducts.Furthermore,asamatterofpractice,CIRdoesnotusuallyreviewfragrances,colors,orflavorings.CIRperformsanextensivesearchoftheworldliteratureaspartofitspreparationofasafetyassessment.ThewebsitesandsourcesthatCIRroutinelysearchesforinformationthatcouldbeapplicabletothepreparationofasafetyassessmentareidentifiedhere.Othersourcesmayalsobesearched,asappropriate.TypicalSearchTermsINCInamesCASnumberschemical/technicalnamesadditionaltermswillbeusedasappropriateSearchEnginesPubmed(-/pubmed)02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]Acetylethyltetramethyltetralin(AETT)-Inasubchronictoxicitystudyinratsconductedin1977,AETTwasfoundtocauseseriousneurotoxicdisordersanddiscolorationofinternalorgans.Itwasalsodeterminedtopenetratehumanskin.ThefragranceindustryvoluntarilydiscontinuedtheuseofAETTin1978.InvestigateanddocumentanyuseofAETTinfragranceformulationsandfinishedcosmeticproducts,usuallythoseclaimingtobefragrancefree.Methylcoumarin(6-MC)-6-MC,afragranceingredient,isapotentphotocontactsensitizerwhichmaycauseseriousskinandsystemicdisordersinsomeconsumersoncontactinthepresenceofsunlight.Between1976&1978,theFDAreceivedmanyreportsofadversereactionsassociatedwiththeuseof6-MCcontainingsuntanpreparations.Thephotocontactallergenicityof6-MCwassubsequentlyconfirmedinclinicalstudies.In1978,theFDAaskedmanufacturersofsuntanandsunscreenproductstodiscontinuetheuseof6-MC.Twofirmsvoluntarilyrecalledtheir6-MCcontainingsuntanproductsfromthemarket.Investigateanddocumentanyuseof6-MCinthefragranceofsunexposureproducts.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]MuskAmbrette-Muskambrette,afragranceingredient,maycausephotocontactsensitization,i.e.,allergicreactionoftheskinonexposuretomuskambretteandsunlight.Animalstudiesdemonstratedthatmuskambrettemaycauseneurotoxiceffects.TheInternationalFragranceAssociationhasrecommendedthatmuskambretteshouldnotbeusedinproductsappliedtotheskin,particularlyinproductsusedonskinthatiscustomarilyalsoexposedtosunlight.Investigateanddocumentanyuseofmuskambretteinthefragranceofsunexposureproducts.Nitrosamines-Cosmeticscontainingasingredientsaminesandaminoderivatives,particularlydi-&triethanolamine(DEA&TEA)mayformnitrosamines,iftheyalsocontainaningredientwhichactsasanitrosatingagentasforexample,2-bromo-2-nitropropane-1,3-diol(Bronopol,Onyxide500),5-bromo-5-nitro-1,3-dioxane(BronidoxC)ortris(hydroxymethyl)nitro-methane(TrisNitro);oriftheyarecontaminatedwithanitrosatingagent,e.g.,sodiumnitrite.Aminesandtheirderivativesaremostlypresentincreams,creamlotions,hairshampoosandcreamhairconditioners.Thenitrosationmayoccurduringmanufactureaswellasproductstorage.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]Manynitrosamineshavebeendeterminedtocausecancerinlaboratoryanimals.Theyhavealsobeenshowntopenetratetheskin.Nitrosaminecontaminationofcosmeticsbecameanissueinearly1977.Inastudyof29cosmeticcreamsandlotions,N-Nitrosodiethanolamine(NDELA)wasdeterminedin27.ThelevelsofNDELAcontaminationrangedfromlessthan10ppbto50ppm.Ofthemorethan300cosmeticsamplesanalyzedin1978,1979andearly1980inFDAlaboratories,7%containedlessthan30ppbNDELA,26%contained30ppbto2ppm,and7%containedbetween2ppmand150ppm.TheFDAexpresseditsconcernaboutthecontaminationofcosmeticswithnitrosaminesinaFederalRegisternoticedatedApril10,1979,whichstatedthatcosmeticscontainingnitrosaminesmaybeconsideredadulteratedandsubjecttoenforcementaction.Insurveysofcosmeticproductsconductedin1991-92,NDELAwasfoundin65%ofthesamplesatlevelsupto3ppm.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]InvestigatewhetherDEAorTEAcontainingproductscontainasingredientsoneoftheaforementionednitrosatingagents,andreportanycosmeticcontainingthesetwotypesofingredients.Whencollectingsurveillancesamples,selectsuchproductsforchemicalanalysis.Dioxane-Cosmeticscontainingasingredientsethoxylatedsurfaceactiveagents,i.e.,detergents,foamingagents,emulsifiersandcertainsolventsidentifiablebytheprefix,wordorsyllable"PEG,""Polyethylene,""Polyethyleneglycol,""Polyoxyethylene,""-eth-,"or"-oxynol-,"maybecontaminatedwith1,4-dioxane.Itmayberemovedfromethoxylatedcompoundsbymeansofvacuumstrippingattheendofthepolymerizationprocesswithoutanunreasonableincreaseinrawmaterialcost.02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT1[FullText全文阅读]InrodentfeedingstudiesconductedfortheNationalCancerInstitute,1,4-dioxanewasfoundtoproducecanceroftheliverandthenasalturbinates.Italsocausedsystemiccancerinaskinpaintingstudy.Skinabsorptionstudiesdemonstratedthatdioxanereadilypenetratesanimalandhumanskinfromvarioustypesofvehicles.However,itwasalsodeterminedthatmostofthedioxaneappliedtotheskininavehicleevaporatesintotheenvironmentandmaynotbeavailableforskinabsorption.Thecontaminationofethoxylatedsurface-activeagentswithdioxanewasfirstreportedin1978.Manyoftherawmaterialsanalyzedsincethenhavebeenfoundtocontaindioxane;somecontainedasmuchas,ormorethan,100ppm.Infinishedcosmeticproductscontainingethoxylatedsurface-activeagents,theincidenceandlevelofdioxanecontaminationwassignificantlylower.polymerizationn.英[ˌpɒliməraɪˈzeɪʃn]聚合;多项式agentn.英[ˈeɪdʒənt]代理人，经纪人02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT

2[KeyWords&Phrases重点单词和短语]agentinvestigatev.英[ɪnˈvestɪɡeɪt]侦查，调查，研究Rodentn.英[ˈrəʊdnt]啮齿动物contaminationn.[kənˌtæmɪˈneɪʃn]聚合;多项式02PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT

2[KeyWords&Phrases重点单词和短语]01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

2[KeyWords&Phrases重点单词和短语]WordandPhraserodent[ˈrəʊdnt]n.啮齿动物contamination[kənˌtæmɪˈneɪʃn]n.污染;污秽;(语言的)交感polymerization[ˌpɒliməraɪˈzeɪʃn]n.聚合;多项式agent[ˈeɪdʒənt]n.(企业、政治等的)代理人，经纪人investigate[ɪnˈvestɪɡeɪt]v.侦查(某事);调查(某人);研究;调查ExpertPanel专家小组general[ˈdʒenərəl]n.总的，普遍的，一般的，通用的establish[isˈtæbliʃ]vt.建立，建造institute[ˈinstitjuːt]n.学会，协会contamination[kənˌtæmiˈneiʃən]n.污染，污秽absorption[əbˈsɔːpʃən]n.吸收01PART2[LearntocheckCIRFindings学习查找化妆品成分评估文件]CONTENT

3[SentenceParsing句子解析]CIRFindingsarelistedatawebsite(/cir-findings).CIRFindingsareclassifiedintofourcategoriesasshowninAppendixXX:SafeAsUsed,SafewithQualifications,Unsafe,UseNotSupported.化妆品成分查找的网页(/cir-findings)，上面有调查结果。结果分为四类，如附录xx所示:安全使用，安全与资格，不安全，不建议使用。TheCosmeticIngredientReviewwasestablishedin1976bytheindustrytradeassociation(thentheCosmetic,Toiletry,andFragranceAssociation,nowthePersonalCareProductsCouncil),withthesupportoftheU.S.化妆品成分审查于1976年由工业贸易协会(当时是化妆品，化妆品和香水协会，现在是个人护理产品委员会)在美国的支持下建立。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]FoodandDrugAdministrationandtheConsumerFederationofAmerica.AlthoughfundedbytheCouncil,CIR,theExpertPanelforCosmeticIngredientSafety,andthereviewprocessareindependentfromtheCouncilandthecosmeticsindustry.CIRandtheExpertPanelforCosmeticIngredientSafetyoperateunderasetofprocedures.食品药品管理局和美国消费者联合会。虽然由委员会资助，但是化妆品成分安全专家小组和审查过程是独立于委员会和化妆品行业的。中情局局长和化妆品成分安全专家小组根据一套程序进行操作。accordingto根据01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]Generalpolicyanddirectionaregivenbya7-memberSteeringCommitteechairedbythePresidentandCEOoftheCouncil,withadermatologistrepresentingtheAmericanAcademyofDermatology,atoxicologistrepresentingtheSocietyofToxicology,aconsumerrepresentativerepresentingtheConsumerFederationofAmerica,anindustryscientist(thecurrentchairoftheCouncil'sCIRCommittee),ChairoftheExpertPanelforCosmeticIngredientSafety,andtheCouncil’sExecutiveVicePresidentforScience.总体政策和方向由委员会主席兼首席执行官主持的7人指导委员会提供，一名皮肤科医生代表美国皮肤病学会，一名毒理学家代表美国毒理学年会，一名消费者代表代表美国消费者联合会，一名行业科学家(CIR委员会现任主席)，化妆品成分安全专家小组主席，以及委员会科学执行副主席。begivenby由...提供；ChairoftheExpertPanel专家小组主席01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]ExpertPanelforCosmeticIngredientSafety40YearsofCIRFor40yearstheCosmeticIngredientReviewhasworkedwithFDA,thecosmeticsindustry,andconsumerstohelpkeepcosmeticssafe.FindIngredientReviewsandDocumentsSelectaletterofthealphabettobrowseingredientsbynameorenteraningredientnameinthesearchfieldbelow.化妆品成分安全专家小组CIR的40年40年来CIR与美国食品药品监督管理局、化妆品行业和消费者合作，帮助保护化妆品安全。查找成分审查文件选择字母表中的一个字母，按名称浏览成分，或在下面的搜索栏中输入成分名称。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]CIRperformsanextensivesearchoftheworldliteratureaspartofitspreparationofasafetyassessment.ThewebsitesandsourcesthatCIRroutinelysearchesforinformationthatcouldbeapplicabletothepreparationofasafetyassessmentareidentifiedhere.Othersourcesmayalsobesearched,asappropriate.TypicalSearchTermsINCInamesCASnumberschemical/technicalnamesadditionaltermswillbeusedasappropriateSearchEnginesPubmed(-/pubmed)Acetylethyltetramethyltetralin(AETT)-Inasubchronictoxicitystudyinratsconductedin1977,AETTwasfoundtocauseseriousneurotoxicdisordersanddiscolorationofinternalorgans.Itwasalsodeterminedtopenetratehumanskin.ThefragranceindustryvoluntarilydiscontinuedtheuseofAETTin1978.InvestigateanddocumentanyuseofAETTinfragranceformulationsandfinishedcosmeticproducts,usuallythoseclaimingtobefragrancefree.作为安全评估准备工作的一部分，CIR对世界文献进行了广泛的搜索。定期搜寻可用于准备安全评估的资料的网站和来源，并列出。如有需要，亦可搜寻其他资料来源。在1977年对大鼠进行的一项亚慢性毒性研究中发现，AETT会导致严重的神经毒性疾病和内脏器官变色。还能穿透人体皮肤。1978年香水行业自愿停止在香水中使用AETT。调查并记录在香料配方和成品化妆品中使用AETT的情况，通常是那些致力于无香料的产品。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]6-Methylcoumarin(6-MC)-6-MC,afragranceingredient,isapotentphotocontactsensitizerwhichmaycauseseriousskinandsystemicdisordersinsomeconsumersoncontactinthepresenceofsunlight.Between1976&1978,theFDAreceivedmanyreportsofadversereactionsassociatedwiththeuseof6-MCcontainingsuntanpreparations.Thephotocontactallergenicityof6-MCwassubsequentlyconfirmedinclinicalstudies.In1978,theFDAaskedmanufacturersofsuntanandsunscreenproductstodiscontinuetheuseof6-MC.Twofirmsvoluntarilyrecalledtheir6-MCcontainingsuntanproductsfromthemarket.Investigateanddocumentanyuseof6-MCinthefragranceofsunexposureproducts.甲基香豆素(6-MC)-6-MC是一种香料成分，是一种强有力的光敏剂，在阳光下接触可能会导致一些消费者严重的皮肤和系统疾病。在1976年和1978年之间，FDA收到了许多关于使用含有6-MC的suntan制剂的不良反应的报告。6-MC的光接触过敏性随后在临床研究中得到证实。1978年，FDA要求防晒霜和防晒产品的生产商停止使用6-MC。两家公司自愿从市场上召回含有防晒霜的6-MC产品。调查并记录阳光照射产品的香味中是否使用了6-MC。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]MuskAmbrette-Muskambrette,afragranceingredient,maycausephotocontactsensitization,i.e.,allergicreactionoftheskinonexposuretomuskambretteandsunlight.Animalstudiesdemonstratedthatmuskambrettemaycauseneurotoxiceffects.TheInternationalFragranceAssociationhasrecommendedthatmuskambretteshouldnotbeusedinproductsappliedtotheskin,particularlyinproductsusedonskinthatiscustomarilyalsoexposedtosunlight.Investigateanddocumentanyuseofmuskambretteinthefragranceofsunexposureproducts.麝香(ambrette)-麝香(ambrette)是一种香料成分，可能会引起光接触敏感，即皮肤在接触到麝香和阳光后会产生过敏反应。动物实验表明，麝香可能会引起神经毒性反应。美国国际香料协会协会建议，麝香不应该用于皮肤护理产品，尤其是那些习惯性地暴露在阳光下的皮肤护理产品。调查和记录任何使用麝香在阳光暴晒产品的香味使用。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]Nitrosamines-Cosmeticscontainingasingredientsaminesandaminoderivatives,particularlydi-&triethanolamine(DEA&TEA)mayformnitrosamines,iftheyalsocontainaningredientwhichactsasanitrosatingagentasforexample,2-bromo-2-nitropropane-1,3-diol(Bronopol,Onyxide500),5-bromo-5-nitro-1,3-dioxane(BronidoxC)ortris(hydroxymethyl)nitro-methane(TrisNitro);oriftheyarecontaminatedwithanitrosatingagent,e.g.,sodiumnitrite.Aminesandtheirderivativesaremostlypresentincreams,creamlotions,hairshampoosandcreamhairconditioners.Thenitrosationmayoccurduringmanufactureaswellasproductstorage.亚硝胺-含有胺和氨基衍生物成分的化妆品，特别是二三乙醇胺(DEA&TEA)，如果它们还含有一种起硝化作用的成分，例如2-溴-2-硝基丙烷-1,3-二醇(bronopol，onyxide500)，5-溴-5-硝基-1,3-二氧六环(bronc)或三(羟甲基)硝基甲烷(trihydroxymethylnitro-methane)，则可形成亚硝胺;或如果它们受到硝化剂的污染，例如亚硝酸钠。胺及其衍生物大多存在于霜、乳液、洗发水和护发素中。亚硝化反应可能发生在生产和产品储存过程中。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]Manynitrosamineshavebeendeterminedtocausecancerinlaboratoryanimals.Theyhavealsobeenshowntopenetratetheskin.Nitrosaminecontaminationofcosmeticsbecameanissueinearly1977.Inastudyof29cosmeticcreamsandlotions,N-Nitrosodiethanolamine(NDELA)wasdeterminedin27.ThelevelsofNDELAcontaminationrangedfromlessthan10ppbto50ppm.Ofthemorethan300cosmeticsamplesanalyzedin1978,1979andearly1980inFDAlaboratories,7%containedlessthan30ppbNDELA,26%contained30ppbto2ppm,and7%containedbetween2ppmand150ppm.许多亚硝胺已被确定会导致实验室动物的癌症。它们也能穿透皮肤。亚硝胺污染的化妆品成为一个问题，在1977年初。在对29种化妆品和乳液的研究中，测定了27种化妆品中的n-亚硝基二乙醇胺(ndela)。Ndela污染水平介乎百万分之10至50之间。1978年、1979年和1980年初，美国食品药品监督管理局实验室对300多份化妆品样品进行了分析，其中7%的样品含有30ppb-2ppm，26%的样品含有30ppb-2ppm，7%的样品含有2ppm-150ppm。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]Manynitrosamineshavebeendeterminedtocausecancerinlaboratoryanimals.Theyhavealsobeenshowntopenetratetheskin.Nitrosaminecontaminationofcosmeticsbecameanissueinearly1977.Inastudyof29cosmeticcreamsandlotions,N-Nitrosodiethanolamine(NDELA)wasdeterminedin27.ThelevelsofNDELAcontaminationrangedfromlessthan10ppbto50ppm.Ofthemorethan300cosmeticsamplesanalyzedin1978,1979andearly1980inFDAlaboratories,7%containedlessthan30ppbNDELA,26%contained30ppbto2ppm,and7%containedbetween2ppmand150ppm.许多亚硝胺已被确定会导致实验室动物的癌症。它们也能穿透皮肤。亚硝胺污染的化妆品成为一个问题，在1977年初。在对29种化妆品和乳液的研究中，测定了27种化妆品中的n-亚硝基二乙醇胺(NDELA)。NDELA污染水平介乎百万分之10至50之间。1978年、1979年和1980年初，美国食品药品监督管理局实验室对300多份化妆品样品进行了分析，其中7%的样品含有30ppb，26%的样品含有30ppb-2ppm，7%的样品含有2ppm-150ppm。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]TheFDAexpresseditsconcernaboutthecontaminationofcosmeticswithnitrosaminesinaFederalRegisternoticedatedApril10,1979,whichstatedthatcosmeticscontainingnitrosaminesmaybeconsideredadulteratedandsubjecttoenforcementaction.Insurveysofcosmeticproductsconductedin1991-92,NDELAwasfoundin65%ofthesamplesatlevelsupto3ppm.InvestigatewhetherDEAorTEAcontainingproductscontainasingredientsoneoftheaforementionednitrosatingagents,andreportanycosmeticcontainingthesetwotypesofingredients.Whencollectingsurveillancesamples,selectsuchproductsforchemicalanalysis.美国食品及药物管理局在1979年4月10日的联邦注册公告中，表达对亚硝胺污染化妆品的关注。该公告指出，含有亚硝胺的化妆品可能被视为掺假，并须采取执法行动。在1991-1992年进行的化妆品调查中，发现65%的样本含有NDELA，含量高达百万分之三。调查毒品管制局或含茶产品是否含有上述其中一种硝化剂成分，并举报任何含有这两种成分的化妆品。收集监察样本时，应选择有关产品进行化学分析。01PART1[IntroductionofCosmeticIngredientReview化妆品成分评估CIR]CONTENT

3[SentenceParsing句子解析]Dioxane-Cosmeticscontainin