432-In Vitro 3T3 NRU phototoxicity test

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1、OECD/OCDE432Adopted:13April2004






!"#$%1.Phototoxicityisdefinedasatoxicresponsefromasubstanceappliedtothebodywhichiseitherelicitedorincreased(apparentatlowerdoselevels)aftersubsequentexposuretolight,orthatis

2、inducedbyskinirradiationaftersystemicadministrationofasubstance.2.The
3T3NRUphototoxicitytestisusedtoidentifythephototoxicpotentialofatestsubstanceinducedbytheexcitedchemicalafterexposuretolight.Thetestevaluatesphoto-cytotoxicitybytherelativereductioninviabilityofcellsexpose

3、dtothechemicalinthepresenceversusabsenceoflight.Substancesidentifiedbythistestarelikelytobephototoxic
followingsystemicapplicationanddistributiontotheskin,oraftertopicalapplication.3.DefinitionsusedareprovidedinAnnex1.4.Manytypesofchemicalshavebeenreport

4、edtoinducephototoxiceffects(1)(2)(3)(4).Theircommonfeatureistheirabilitytoabsorblightenergywithinthesunlightrange.Accordingtothefirstlawofphotochemistry(Grotthaus-DraperLaw),photoreactionrequiressufficientabsorptionoflightquanta.Thus,beforebiologicaltestingisconsidered,aUV/visabsorpt

5、ionspectrumofthetestchemicalmustbedeterminedaccordingtoOECDTestGuideline101.Ithasbeensuggestedthatifthemolar-1-1extinction/absorptioncoefficientislessthan10litrexmolxcmthechemicalisunlikelytobephotoreactive.Suchchemicalmaynotneedtobetestedinthe
3T3NRUphototoxicitytestoranyothe

6、rbiologicaltestforadversephotochemicaleffects(1)(5).SeealsoAnnex2.5.Thereliabilityandrelevanceoftheinvitro3T3NRUphototoxicitytestwasrecentlyevaluated(6)(7)(8)(9).Theinvitro3T3NRUphototoxicitytestwasshowntobepredictiveofacutephototoxicityeffectsinanimalsandhumansinvivo.Thetestisnotdes

7、ignedtopredictotheradverseeffectsthatmayarisefromcombinedactionofachemicalandlight,forexample,itdoesnotaddressphotogenotoxicity,photoallergy,orphotocarcinogenicity,nordoesitallowanassessmentofphototoxicpotency.Inaddition,thetesthasnotbeendesignedtoaddressindirectmechanismsofphototoxi

8、city,effects