CosmeticIngredientReview課前回顧與預習Task1化妝品成分評估CIR學習查找化妝品成分評估文件化妝品成分的安全評估報告1PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]2PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]3PART3[SafetyAssessmentofCosmeticIngredients化妝品成分的安全評估報告]02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]CIRFindingsarelistedatawebsite(/cir-findings).CIRFindingsareclassifiedintofourcategoriesasshowninAppendixXX:SafeAsUsed,SafewithQualifications,Unsafe,UseNotSupported.AbouttheCosmeticIngredientReviewTheCosmeticIngredientReviewwasestablishedin1976bytheindustrytradeassociation(thentheCosmetic,Toiletry,andFragranceAssociation,nowthePersonalCareProductsCouncil),withthesupportoftheU.S.FoodandDrugAdministrationandtheConsumerFederationofAmerica.AlthoughfundedbytheCouncil,CIR,theExpertPanelforCosmeticIngredientSafety,andthereviewprocessareindependentfromtheCouncilandthecosmeticsindustry.CIRandtheExpertPanelforCosmeticIngredientSafetyoperateunderasetofprocedures.02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]Generalpolicyanddirectionaregivenbya7-memberSteeringCommitteechairedbythePresidentandCEOoftheCouncil,withadermatologistrepresentingtheAmericanAcademyofDermatology,atoxicologistrepresentingtheSocietyofToxicology,aconsumerrepresentativerepresentingtheConsumerFederationofAmerica,anindustryscientist(thecurrentchairoftheCouncil'sCIRCommittee),ChairoftheExpertPanelforCosmeticIngredientSafety,andtheCouncil’sExecutiveVicePresidentforScience.ExpertPanelforCosmeticIngredientSafety40YearsofCIRFor40yearstheCosmeticIngredientReviewhasworkedwithFDA,thecosmeticsindustry,andconsumerstohelpkeepcosmeticssafe.FindIngredientReviewsandDocumentsSelectaletterofthealphabettobrowseingredientsbynameorenteraningredientnameinthesearchfieldbelow.02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]Ingredientsofinterestmaybefoundonthelabelofapersonalcareproductandsearchedusingthisdatabase.IngredientsareoftenreferredtoonthelabelofapersonalcareproductbytheingredientnameasitappearsintheInternationalNomenclatureofCosmeticIngredients(INCI),knownastheINCIName.CIRreviewsingredients,notproducts.Furthermore,asamatterofpractice,CIRdoesnotusuallyreviewfragrances,colors,orflavorings.CIRperformsanextensivesearchoftheworldliteratureaspartofitspreparationofasafetyassessment.ThewebsitesandsourcesthatCIRroutinelysearchesforinformationthatcouldbeapplicabletothepreparationofasafetyassessmentareidentifiedhere.Othersourcesmayalsobesearched,asappropriate.TypicalSearchTermsINCInamesCASnumberschemical/technicalnamesadditionaltermswillbeusedasappropriateSearchEnginesPubmed(-/pubmed)02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]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學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]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學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]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學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]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學習查找化妝品成分評估文件]CONTENT1[FullText全文閱讀]InrodentfeedingstudiesconductedfortheNationalCancerInstitute,1,4-dioxanewasfoundtoproducecanceroftheliverandthenasalturbinates.Italsocausedsystemiccancerinaskinpaintingstudy.Skinabsorptionstudiesdemonstratedthatdioxanereadilypenetratesanimalandhumanskinfromvarioustypesofvehicles.However,itwasalsodeterminedthatmostofthedioxaneappliedtotheskininavehicleevaporatesintotheenvironmentandmaynotbeavailableforskinabsorption.Thecontaminationofethoxylatedsurface-activeagentswithdioxanewasfirstreportedin1978.Manyoftherawmaterialsanalyzedsincethenhavebeenfoundtocontaindioxane;somecontainedasmuchas,ormorethan,100ppm.Infinishedcosmeticproductscontainingethoxylatedsurface-activeagents,theincidenceandlevelofdioxanecontaminationwassignificantlylower.polymerizationn.英[?p?lim?ra??ze??n]聚合;多項式agentn.英[?e?d??nt]代理人，經(jīng)紀人02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT

2[KeyWords&Phrases重點單詞和短語]agentinvestigatev.英[?n?vest?ɡe?t]偵查，調(diào)查，研究Rodentn.英[?r??dnt]嚙齒動物contaminationn.[k?n?t?m??ne??n]聚合;多項式02PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT

2[KeyWords&Phrases重點單詞和短語]01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

2[KeyWords&Phrases重點單詞和短語]WordandPhraserodent[?r??dnt]n.嚙齒動物contamination[k?n?t?m??ne??n]n.污染;污穢;(語言的)交感polymerization[?p?lim?ra??ze??n]n.聚合;多項式agent[?e?d??nt]n.(企業(yè)、政治等的)代理人，經(jīng)紀人investigate[?n?vest?ɡe?t]v.偵查(某事);調(diào)查(某人);研究;調(diào)查ExpertPanel專家小組general[?d?en?r?l]n.總的，普遍的，一般的，通用的establish[is?t?bli?]vt.建立，建造institute[?institju?t]n.學會，協(xié)會contamination[k?n?t?mi?nei??n]n.污染，污穢absorption[?b?s??p??n]n.吸收01PART2[LearntocheckCIRFindings學習查找化妝品成分評估文件]CONTENT

3[SentenceParsing句子解析]CIRFindingsarelistedatawebsite(/cir-findings).CIRFindingsareclassifiedintofourcategoriesasshowninAppendixXX:SafeAsUsed,SafewithQualifications,Unsafe,UseNotSupported.化妝品成分查找的網(wǎng)頁(/cir-findings)，上面有調(diào)查結果。結果分為四類，如附錄xx所示:安全使用，安全與資格，不安全，不建議使用。TheCosmeticIngredientReviewwasestablishedin1976bytheindustrytradeassociation(thentheCosmetic,Toiletry,andFragranceAssociation,nowthePersonalCareProductsCouncil),withthesupportoftheU.S.化妝品成分審查于1976年由工業(yè)貿(mào)易協(xié)會(當時是化妝品，化妝品和香水協(xié)會，現(xiàn)在是個人護理產(chǎn)品委員會)在美國的支持下建立。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]FoodandDrugAdministrationandtheConsumerFederationofAmerica.AlthoughfundedbytheCouncil,CIR,theExpertPanelforCosmeticIngredientSafety,andthereviewprocessareindependentfromtheCouncilandthecosmeticsindustry.CIRandtheExpertPanelforCosmeticIngredientSafetyoperateunderasetofprocedures.食品藥品管理局和美國消費者聯(lián)合會。雖然由委員會資助，但是化妝品成分安全專家小組和審查過程是獨立于委員會和化妝品行業(yè)的。中情局局長和化妝品成分安全專家小組根據(jù)一套程序進行操作。accordingto根據(jù)01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]Generalpolicyanddirectionaregivenbya7-memberSteeringCommitteechairedbythePresidentandCEOoftheCouncil,withadermatologistrepresentingtheAmericanAcademyofDermatology,atoxicologistrepresentingtheSocietyofToxicology,aconsumerrepresentativerepresentingtheConsumerFederationofAmerica,anindustryscientist(thecurrentchairoftheCouncil'sCIRCommittee),ChairoftheExpertPanelforCosmeticIngredientSafety,andtheCouncil’sExecutiveVicePresidentforScience.總體政策和方向由委員會主席兼首席執(zhí)行官主持的7人指導委員會提供，一名皮膚科醫(yī)生代表美國皮膚病學會，一名毒理學家代表美國毒理學年會，一名消費者代表代表美國消費者聯(lián)合會，一名行業(yè)科學家(CIR委員會現(xiàn)任主席)，化妝品成分安全專家小組主席，以及委員會科學執(zhí)行副主席。begivenby由...提供；ChairoftheExpertPanel專家小組主席01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]ExpertPanelforCosmeticIngredientSafety40YearsofCIRFor40yearstheCosmeticIngredientReviewhasworkedwithFDA,thecosmeticsindustry,andconsumerstohelpkeepcosmeticssafe.FindIngredientReviewsandDocumentsSelectaletterofthealphabettobrowseingredientsbynameorenteraningredientnameinthesearchfieldbelow.化妝品成分安全專家小組CIR的40年40年來CIR與美國食品藥品監(jiān)督管理局、化妝品行業(yè)和消費者合作，幫助保護化妝品安全。查找成分審查文件選擇字母表中的一個字母，按名稱瀏覽成分，或在下面的搜索欄中輸入成分名稱。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]CIRperformsanextensivesearchoftheworldliteratureaspartofitspreparationofasafetyassessment.ThewebsitesandsourcesthatCIRroutinelysearchesforinformationthatcouldbeapplicabletothepreparationofasafetyassessmentareidentifiedhere.Othersourcesmayalsobesearched,asappropriate.TypicalSearchTermsINCInamesCASnumberschemical/technicalnamesadditionaltermswillbeusedasappropriateSearchEnginesPubmed(-/pubmed)Acetylethyltetramethyltetralin(AETT)-Inasubchronictoxicitystudyinratsconductedin1977,AETTwasfoundtocauseseriousneurotoxicdisordersanddiscolorationofinternalorgans.Itwasalsodeterminedtopenetratehumanskin.ThefragranceindustryvoluntarilydiscontinuedtheuseofAETTin1978.InvestigateanddocumentanyuseofAETTinfragranceformulationsandfinishedcosmeticproducts,usuallythoseclaimingtobefragrancefree.作為安全評估準備工作的一部分，CIR對世界文獻進行了廣泛的搜索。定期搜尋可用于準備安全評估的資料的網(wǎng)站和來源，并列出。如有需要，亦可搜尋其他資料來源。在1977年對大鼠進行的一項亞慢性毒性研究中發(fā)現(xiàn)，AETT會導致嚴重的神經(jīng)毒性疾病和內(nèi)臟器官變色。還能穿透人體皮膚。1978年香水行業(yè)自愿停止在香水中使用AETT。調(diào)查并記錄在香料配方和成品化妝品中使用AETT的情況，通常是那些致力于無香料的產(chǎn)品。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估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是一種香料成分，是一種強有力的光敏劑，在陽光下接觸可能會導致一些消費者嚴重的皮膚和系統(tǒng)疾病。在1976年和1978年之間，F(xiàn)DA收到了許多關于使用含有6-MC的suntan制劑的不良反應的報告。6-MC的光接觸過敏性隨后在臨床研究中得到證實。1978年，F(xiàn)DA要求防曬霜和防曬產(chǎn)品的生產(chǎn)商停止使用6-MC。兩家公司自愿從市場上召回含有防曬霜的6-MC產(chǎn)品。調(diào)查并記錄陽光照射產(chǎn)品的香味中是否使用了6-MC。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估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)是一種香料成分，可能會引起光接觸敏感，即皮膚在接觸到麝香和陽光后會產(chǎn)生過敏反應。動物實驗表明，麝香可能會引起神經(jīng)毒性反應。美國國際香料協(xié)會協(xié)會建議，麝香不應該用于皮膚護理產(chǎn)品，尤其是那些習慣性地暴露在陽光下的皮膚護理產(chǎn)品。調(diào)查和記錄任何使用麝香在陽光暴曬產(chǎn)品的香味使用。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估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.亞硝胺-含有胺和氨基衍生物成分的化妝品，特別是二三乙醇胺(DEA&TEA)，如果它們還含有一種起硝化作用的成分，例如2-溴-2-硝基丙烷-1,3-二醇(bronopol，onyxide500)，5-溴-5-硝基-1,3-二氧六環(huán)(bronc)或三(羥甲基)硝基甲烷(trihydroxymethylnitro-methane)，則可形成亞硝胺;或如果它們受到硝化劑的污染，例如亞硝酸鈉。胺及其衍生物大多存在于霜、乳液、洗發(fā)水和護發(fā)素中。亞硝化反應可能發(fā)生在生產(chǎn)和產(chǎn)品儲存過程中。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估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.許多亞硝胺已被確定會導致實驗室動物的癌癥。它們也能穿透皮膚。亞硝胺污染的化妝品成為一個問題，在1977年初。在對29種化妝品和乳液的研究中，測定了27種化妝品中的n-亞硝基二乙醇胺(ndela)。Ndela污染水平介乎百萬分之10至50之間。1978年、1979年和1980年初，美國食品藥品監(jiān)督管理局實驗室對300多份化妝品樣品進行了分析，其中7%的樣品含有30ppb-2ppm，26%的樣品含有30ppb-2ppm，7%的樣品含有2ppm-150ppm。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估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.許多亞硝胺已被確定會導致實驗室動物的癌癥。它們也能穿透皮膚。亞硝胺污染的化妝品成為一個問題，在1977年初。在對29種化妝品和乳液的研究中，測定了27種化妝品中的n-亞硝基二乙醇胺(NDELA)。NDELA污染水平介乎百萬分之10至50之間。1978年、1979年和1980年初，美國食品藥品監(jiān)督管理局實驗室對300多份化妝品樣品進行了分析，其中7%的樣品含有30ppb，26%的樣品含有30ppb-2ppm，7%的樣品含有2ppm-150ppm。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]TheFDAexpresseditsconcernaboutthecontaminationofcosmeticswithnitrosaminesinaFederalRegisternoticedatedApril10,1979,whichstatedthatcosmeticscontainingnitrosaminesmaybeconsideredadulteratedandsubjecttoenforcementaction.Insurveysofcosmeticproductsconductedin1991-92,NDELAwasfoundin65%ofthesamplesatlevelsupto3ppm.InvestigatewhetherDEAorTEAcontainingproductscontainasingredientsoneoftheaforementionednitrosatingagents,andreportanycosmeticcontainingthesetwotypesofingredients.Whencollectingsurveillancesamples,selectsuchproductsforchemicalanalysis.美國食品及藥物管理局在1979年4月10日的聯(lián)邦注冊公告中，表達對亞硝胺污染化妝品的關注。該公告指出，含有亞硝胺的化妝品可能被視為摻假，并須采取執(zhí)法行動。在1991-1992年進行的化妝品調(diào)查中，發(fā)現(xiàn)65%的樣本含有NDELA，含量高達百萬分之三。調(diào)查毒品管制局或含茶產(chǎn)品是否含有上述其中一種硝化劑成分，并舉報任何含有這兩種成分的化妝品。收集監(jiān)察樣本時，應選擇有關產(chǎn)品進行化學分析。01PART1[IntroductionofCosmeticIngredientReview化妝品成分評估CIR]CONTENT

3[SentenceParsing句子解析]Dioxane-Cosmeticscontainin