436-Acute Inhalation Toxicity - Acute Toxic Class Method

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1、OECD/OCDE436Adopted:7September2009OECDGUIDELINEFORTHETESTINGOFCHEMICALSAcuteInhalationToxicity-AcuteToxicClassMethodINTRODUCTION1.OECDGuidelinesfortheTestingofChemicalsareperiodicallyreviewedinthelightofscientificprogress,changingregulatoryneedsandanim

2、alwelfareconsiderations.ThefirstacuteinhalationTestGuideline403wasadoptedin1981,andhassincebeenrevised(1).DevelopmentofanInhalationAcuteToxicClass(ATC)method(2)(3)(4)wasconsideredappropriatefollowingtheadoptionoftherevisedoralATCmethod(TG423)(5)in2001.

3、AretrospectiveperformanceassessmentoftheATCtestmethodforacuteinhalationtoxicityshowedthatthemethodissuitableforbeingusedforClassificationandLabellingpurposes(6).TheinhalationATCTestGuidelinewillallowtheuseofserialstepsoffixedtargetconcentrationstoprovi

4、dearankingoftestarticletoxicity.Lethalityisusedaskeyendpoint,however,animalsinseverepainordistress,sufferingorimpendingdeathshouldbehumanelykilledtominimizesuffering.GuidanceonhumaneendpointsisavailableintheOECDGuidanceDocumentNo.19(7).2.Guidanceonthec

5、onductandinterpretationofthisTestGuidelinecanbefoundintheGuidanceDocumentNo.39onAcuteInhalationToxicityTesting(GD39)(8).3.DefinitionsusedinthecontextofthisGuidelineareprovidedinGD39(8).4.Themethodprovidesinformationonthehazardouspropertiesandallowsthes

6、ubstancetoberankedandclassifiedaccordingtotheUnitedNations(UN)GloballyHarmonizedSystemofClassificationandLabellingofChemicals(GHS)fortheclassificationofchemicalsthatcauseacutetoxicity(9).IncasepointestimatesofLC-valuesorconcentration-responseanalysesar

7、erequired,50TestGuideline403(1)istheappropriateTestGuidelinetouse.FurtherguidanceonTestGuidelineselectioncanbefoundinGD39(8).ThisTestGuidelineisnotspecificallyintendedforthetestingofspecializedmaterials,suchaspoorlysolubleisometricorfibrousmaterialsorm

8、anufacturednanomaterials.INITIALCONSIDERATIONS5.BeforeconsideringtestinginaccordancewiththisTestGuidelineallavailableinformationonthetestarticle,includingexistingstudieswhosedatawouldsupportnotdoingadditionaltestingshouldbeconsideredbyt