the 3rs as a framework to support a 21st century approach for nanosafety assessment 2017 natalie burden资料.pdf

该【the 3rs as a framework to support a 21st century approach for nanosafety assessment 2017 natalie burden资料 】是由【小舍儿】上传分享，文档一共【4】页，该文档可以免费在线阅读，需要了解更多关于【the 3rs as a framework to support a 21st century approach for nanosafety assessment 2017 natalie burden资料 】的内容，可以使用淘豆网的站内搜索功能，选择自己适合的文档，以下文字是截取该文章内的部分文字，如需要获得完整电子版，请下载此文档到您的设备，方便您编辑和打印。GModelNANTOD-525;(2016)xxx–xxxContentslistsavailableatScienceDirectNanoTodayjournalhomepage:ate/nanotodayNewsandopinionsThe3Rsasaframeworktosupporta21stcenturyapproachfornanosafetyassessmenta,?bcd,1NatalieBurden,KarinAschberger,QasimChaudhry,,,PaulFowler,HelinorJohnston,RobertLandsiedel,JoannaRowland,gVickiStoneaNC3Rs,GibbsBuilding,215EustonRoad,LondonNW12BE,UKbEUReferenceLaboratoryforAlternativestoAnimalTesting(EURLECVAM),mission—JointResearchCentre(JRC),InstituteforHealthandConsumerProtection,SystemsToxicologyUnit,,I-21027Ispra,ItalycInstituteofFoodScienceandInnovation,UniversityofChester,ParkgateRoad,ChesterCH14BJ,UKdAdolpheMerkleInstitute,UniversityofFribourg,ChemindesVerdiers4,CH-1700Fribourg,SwitzerlandeInstituteofLifeScience/CentreforNanoHealth,SwanseaUniversitySchoolofMedicine,WalesSA28PP,UKfSafety&EnvironmentalAssuranceCentre(SEAC),Unilever,ColworthSciencePark,Sharnbrook,BedfordMK441LQ,UKgSchoolofLifeSciences,Heriot-WattUniversity,EdinburghEH144AS,UKhBASFSE,GB/TB—Z470,67056Ludwigshafen,GermanyiNationalCentreforEnvironmentalToxicology,WRcplc,FranklandRoad,SwindonSN58YF,UKarticleinfoabstractArticlehistory:Duetotheplethoraofnanomaterialsbeingmanufactured,-?c,business,-traditionalmethodshasthepotentialtoimprovethehumanrelevanceofAvailableonlinexxxnanosafetyassessment,reducethenumbersofanimalsthatareused,andshifttheparadigmtoa‘21stcentury’approachthatexploitsrecentscienti?:applicationofthe3Rsprinciplescanbeusedasaframeworktosupportandguidethisparadigmshiftinthe3Rsshort,mediumandlong-??-NC-NDlicense(/licenses/by-nc-nd//).Therearenumerousadvantagesofutilisingmanufacturednano-anisms,particularlyrodents,continuetobethepre-materialsovertheirbulkchemicalcounterparts,-notableriseinnanomaterialdevelopmentandproductionwithinaistration,,concernsremainpotentiallyvastnumberofnanomaterialsbeingmarketed,regula----?eldinrecentyearsaroundwhethertraditionalmethodsare?thebestwaytoassessnanomaterialsafety,-mailaddresses:natalie.******@.uk(),.******@(),q.******@,ethicalandlegislativemotivationstore-evaluatetheuse(),.******@(),.******@,therehavebeenrecentgeo-(),@(),h.******@(),@(),andthemarketingofproductscontainingingredientsthathaveJoanna.******@(),v.******@().1Presentaddress:InstituteofLifeScience/CentreforNanoHealth,SwanseaUni-,WalesSA28PP,://dx./.-0132/?-NC-NDlicense(/licenses/by-nc-nd//).Pleasecitethisarticleinpressas:,etal.,The3Rsasaframeworktosupporta21stcenturyapproachfornanosafetyassessment,NanoToday(2016),http://dx./.-525;./NanoTodayxxx(2016)xxx–xxxTable1Opportunitiestoalignthe3Rsprincipleswithimprovedapproachesfornanosafetyassessmentintheshort,mediumandlong--term(0–5years)?Usingshort-termstudies(-terminhalationstudies,[2])--termstudiescouldalsobeusedasatooltogroupsubstancesforread-acrosspurposes,-termstudies,toinformdosesettingandre?nesubsequentchronicinvivostudiesbyensuringhighdosesareonlyadministeredwherenecessary.?()andsecondarytargetsite()icassessments,tomaximisetheamountofinformationobtainedfromeachstudy([3]).?,,whichcanbeusedtoprioritiseorwaivetesting.?Adaptationofexistinginvitrotestsystemstofacilitatenanosafetyassessmentandprogresscurrentlyavailablenano-relevantinvitroassaystowardsformalisedvalidation(.,see[4]).-term(5–10years)?-acrossapproachesandcouldprovidejusti?,particularlyfornanomaterials,.[5].Computationalmodelswouldalsobeusefultoestablishcorrelationsbetweennanomaterialproperties,,butcannotreplacethem.?Expandingtheuseofinvitroapproachesthatarespeci?callytargetedtowardstheful?,hazardandinternalexposureforuseinriskassessment(asenvisionedbytheITS-NANOframework[6]).[7].?Investingfurtherintoinnovativetechnologiesfornano-speci??tofphysiologicalrelevance,([8]).?Re?,developingshort-,-term(10years+)?Incorporationofexposurerouteandinternalexposureconsiderations,,whicharemorerealisticandphysiologicallyrelevantsystemsthantraditional2D/.?(AOPs)speci?cfornanomaterials,-animalmethodsforthepredictionofapicalendpoints[9].?odels,throughtheavailabilityofmorehazard,,thepreliminarydatacouldscienti?cally-?tsofthiswillbe(i)eselectionofdoselevels,toensurethatexcessivelyhighdosesresult-thechallengesassociatedwithmovingawayfromtraditionaltox-inginnon-speci?,andsubsequentlydecreasingthenumbersofanimalsandregulatorystudiesthenanomaterialshouldbeadministeredused,and(ii)capitalisationonallrelevantscienti?candtechno-,resultingina‘21stcentury’approachtoTraditionallythiswouldbeviainhalation,upationalnanosafetyassessment[1],whichisaspredictiveofthehumansit-(replacement,erelevant,suchasinges-re?nementandreductionofanimals)(0–5years),medium(5–10years)andlong-term(10+years)-,-term,thenumbersofnanomaterialsrequiringdeterminingeffectsatboththesiteofexposureandsecondarytar-testinginregulatoryanimalstudiescouldbereduced,andthenec--termstudiescouldalsobeusedtoinformessaryanimalstudiesre?ned(.,levelsofsufferingminimised).read-across(seebelow).The?rstquestionthatshouldbeaskedbeforeembarkingonanyWithinthemedium-term,,,thenanomaterialwouldnotposearisk,andthusassaysalreadyvalidatedforthetoxicitytestingoftraditionalchem-,anano-icals(forexample,thosetoassessgenotoxicity)withmodi?cationsmaterial’stoxicitycould?rstbeassessedinshorter,‘preliminary’whereappropriate,orassaysthathavebeenspeci?callydevelopedanimalstudies(pletedwithin28days,-daylongregulatorystudies).Thispreliminarydatacouldgiveunprotectedspecies,suchasinvertebratesandearly-lifestage?,binationwiththispointtohaltfurtherdevelopmentofthenanomaterial,putationalmodels,willavoidingthelonger,resource--alsohelptoidentifylinksbetweenstructural,biologicalorphysic-Pleasecitethisarticleinpressas:,etal.,The3Rsasaframeworktosupporta21stcenturyapproachfornanosafetyassessment,NanoToday(2016),http://dx./.-525;./NanoTodayxxx(2016)xxx–(orlackoftoxicity)ofanovelnanomaterialcouldthentheirneedsandrequirementstohelpsteerfutureacademicandbeinferredbasedonthepresenceorabsenceofspeci?cproper-,inaprocessknownasisanincreaseintargeted,-?cientcon?denceinread-acrosstechniqueswouldaspectofalltomovethingsforwardandachievethegoalssetoutobviatetheneedtoassesswhetherthenanomaterialistoxicwithinherewillbeopen,face-to-facediscussionandcollaboration,?dentlymade,incorporatescross-(providingitisnotintendedforuseinacosmeticprod-Fundinguct).Inc