基因毒性试验基因毒性试验

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1、基因毒性試驗基因毒性試驗(毒性試驗規範)¢目的:偵測化合物直接或間接引發之基因傷害與程度¢基因突變,廣泛性的染色體缺失或重組,或染色體數量改變等基因損害皆可能會導致遺傳疾病或體細胞之變性.¢試驗物質會導致上述傷害,則該產品可能為人體致癌物或致突變原,可能會導致癌症或遺傳缺陷¢基因毒性試驗有助於預測試驗物質的致癌性,且有助於致癌性試驗的結果分析¢基因毒性試驗可分為活體與體外測試,測試指標包括基因突變,染色體變異或基因損害等1基因毒性測試方法（毒性試驗規範）參考指標測試方法基因突變1.Genemutationtestwithbacteria2.Genemutati

2、ontestwithmammaliancellsinculture3.TestwithDrosophilamelanogaster4.Spottestwithmice5.Specificlocustestwithmice染色體變異1.Chromosomalaberrationtestwithmammaliancellsinculture2.Chromosomalaberrationtestwithbonemarrowcellsorrodents3.micronucleustestwithrodents4.Chromosomalaberrationtestwit

3、hgenotypesofrodents5.Dominantlethaltestwithrodent6.Reciprocaltranslocationtestwithmice基因受損1.Phageinductiontestwithbacteria2.DNArepairtestwithbacteria3.UnscheduledDNAsynthesistest(UDS)withmammaliancells4.Sisterchromatidexchange(SCE)testwithmammaliancells其他測試1.Mitoticrecombinationandg

4、eneconversiontestwithyeast2.Spermabnormalitytest綜合基因毒性試驗（毒性試驗規範）測試項目測試方法微生物突變分析1.細菌基因突變測試法（Amestest）體外哺乳類細胞遺傳毒1.體外哺乳類細胞的染色體異常分析性分析法(Invitrochromosomalaberrationtestwithmammaliancellsinculture)2.體外鼷鼠淋巴瘤tk分析法(Invitromouselymphomatkassay)動物活體基因毒性分析1.囓齒類骨髓細胞染色體異常測試法(Chromosomalaberratio

5、nsinbonemarrowcellsofrodents)2.囓齒類骨髓細胞之微核測試法(Micronucleiinbonemarrowcellsofrodents)3.囓齒類周邊血液之微核測試法(Micronucleiinperipheralbloodofrodents)2OfficeofFoodAdditiveSafetyRedbook2000ToxicologicalPrinciplesfortheSafetyAssessmentofFoodIngredientsJuly7,2000Short-TermTestsforGeneticToxicityGen

6、eticchangesknowntobeassociatedwithadversehumanhealtheffectsincludegenemutations,chromosomalrearrangementsordeletions,andlossorgainofwholechromosomes(aneuploidy染色體不正常)orchromosomalsegments.Genotoxicitytestsareinvitroandinvivotestsdesignedtodetectcompoundsthatinducegeneticdamage.3Reco

7、mmendedTests1.Atestforgenemutationsinbacteria2.Aninvitrotestwithcytogeneticevaluationofchromosomaldamageusingmammaliancellsoraninvitromouselymphomathymidinekinase+/-genemutationassay3.Aninvivotestforchromosomaldamageusingmammalianhematopoieticcells.¢Themutationassaysspecifiedinthest

8、andardbatteryarecap