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首页 OPPTS 830.6313 Stability to Normal and Elevated …

OPPTS 830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions.pdf

OPPTS 830.6313 Stability to Nor…

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2013-02-19 0人阅读 举报 0 0 暂无简介

简介:本文档为《OPPTS 830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ionspdf》,可适用于人文社科领域

UnitedStatesEnvironmentalProtectionAgencyPrevention,PesticidesandToxicSubstances()EPA–C––AugustProductPropertiesTestGuidelinesOPPTSStabilitytoNormalandElevatedTemperature,Metals,andMetalIonsiINTRODUCTIONThisguidelineisoneofaseriesoftestguidelinesthathavebeendevelopedbytheOfficeofPrevention,PesticidesandToxicSubstances,UnitedStatesEnvironmentalProtectionAgencyforuseinthetestingofpesticidesandtoxicsubstances,andthedevelopmentoftestdatathatmustbesubmittedtotheAgencyforreviewunderFederalregulationsTheOfficeofPrevention,PesticidesandToxicSubstances(OPPTS)hasdevelopedthisguidelinethroughaprocessofharmonizationthatblendedthetestingguidanceandrequirementsthatexistedintheOfficeofPollutionPreventionandToxics(OPPT)andappearedinTitle,ChapterI,SubchapterRoftheCodeofFederalRegulations(CFR),theOfficeofPesticidePrograms(OPP)whichappearedinpublicationsoftheNationalTechnicalInformationService(NTIS)andtheguidelinespublishedbytheOrganizationforEconomicCooperationandDevelopment(OECD)ThepurposeofharmonizingtheseguidelinesintoasinglesetofOPPTSguidelinesistominimizevariationsamongthetestingproceduresthatmustbeperformedtomeetthedatarequirementsoftheUSEnvironmentalProtectionAgencyundertheToxicSubstancesControlAct(USC)andtheFederalInsecticide,FungicideandRodenticideAct(USC,etseq)FinalGuidelineRelease:ThisdocumentisavailablefromtheUSGovernmentPrintingOffice,Washington,DConTheFederalBulletinBoardBymodemdial––,telnetandftp:fedbbsaccessgpogov(IP),internet:http:fedbbsaccessgpogov,orcall––fordisksorpapercopiesThisguidelineisavailableinASCIIandPDF(portabledocumentformat)fromtheEPAPublicAccessGopher(gopherepagov)undertheheading‘‘EnvironmentalTestMethodsandGuidelines’’OPPTSStabilitytonormalandelevatedtemperature,metals,andmetalions(a)Scope()ApplicabilityThisguidelineisintendedtomeettestingrequirementsoftheFederalInsecticide,Fungicide,andRodenticideAct(FIFRA)(USC,etseq)()BackgroundThesourcematerialusedindevelopingthisharmonizedOPPTStestguidelineisOPPguideline–Stability(PesticideAssessmentGuidelines,SubdivisionD:ProductChemistry,EPAReport––,October)andCFRPhysicalandchemicalcharacteristics(b)Testmethod()Objective(i)DataonthephysicalandchemicalcharacteristicsofpesticideactiveingredientsandproductsareusedtoconfirmorprovidesupportiveinformationontheiridentitySuchdataarealsousedinreviewingtheproductionorformulatingprocessusedtoproducethepesticideorproduct(ii)Theobjectiveofthisguidelineistodeterminehowstabletheactiveingredientisinthepresenceofnormalandelevatedtemperatures,metals,andmetalionsDataregardingstabilitytometalandmetalionsisrequiredonlyifthereisalikelihoodthatthetechnicalgradeoftheactiveingredient(TGAI)willcomeintocontactwithmetalsduringitsstorageanduse()Testdetails(i)Inordertofullycharacterizethestabilityofthepesticidechemical,standardmethodsmaybeusedSubjectivejudgementsbyachemistfamiliarwiththechemicalanditsintendeduseareneededinselectingappropriatetests(ii)TheagencyrecommendstheCIPACmethod‘‘MTAcceleratedStorageTestsbyHeating’’todeterminestabilityofapesticidewhensubjectedtoelevatedtemperature(seeparagraph(d)()ofthisguideline)(A)TestprocedureDispersiblepowders:AgsampleofthepesticideisplacedinabeakerandspreadinasmoothevenlayerofconstantthicknessAplasticcoatedmetaldiskoftheapproximatediameterofthebeakerisplacedontopofthesampleandthebeakerisplacedinanovenThesampleismaintainedintheovenat°CfordaysUponremovalfromtheoven,thespecimenisallowedtocoolinadessicatorwithoutdessicantandsamplesofthehardcakearesubmittedforappropriatetestingandanalysis(B)Reserved(iii)Todeterminestabilityinthepresenceofmetalsandmetalions,thefollowingtestmethodisrecommended(A)TestmethodAfinemetalistypicallyuniformlydispersedinasolidmixtureorsunkinliquidformulationsandanalyzedforactiveingredientattimeandafterdaysofexposureorbydifferentialscanningcalorimetrydifferentialthermalanalysis(DSCDTA)bycomparisontoanonexposedtestsampleTwometalsintheirnaturalstateandintheirionicformaretypicallytestedOventestingisusuallyperiodic,typicallyanalyzingafter,,anddaysofexposuretocollectmorethansinglepointdataforexposuretoeachmaterialTypicallythemetalandsaltofaweakacid,suchasanacetateorcarbonate(eg,ironfilingsandferricacetate,aluminumrodsandaluminumacetate,leadshotandleadacetate)areusedSinceexposuretometalsisusuallyofshortduration,especiallyifreactive,testingatambienttemperaturecanbeusedasacontrol,asmeasuredagainstelevatedtemperature(B)Reserved(iv)ConsultationwiththeAgencyisrecommendediftherearequestionsaboutappropriatemethodsfortheotherdeterminations(v)Ifanalternativemethodisused,itisrecommendedthattheregistrantconsultwiththeAgencypriortoadoptingthetestmethod(c)Reporting()DescriptionsandresultsofalltestsshouldbereportedTheinformationonstabilityshallincludeconsiderationanddiscussionofthesensitivityoftheactiveingredienttometalsandmetalionsitmaycomeincontactwith,atnormalandelevatedtemperatures()AnymethodsusedtocharacterizethephysicalpropertiesofapesticideshallbereferencedordescribedintheapplicationforregistrationIfthemethodsusedarelistedinthisguideline,referencetothemethodwillsufficeIfothermethodsareused,copiesofsuchmethodsmustbesubmittedwiththeapplication()Referencesdenoting‘‘CIPAC’’refertostandardizedmethodsoftheCollaborativeInternationalPesticideAnalyticalCouncil,Ltd,HatchingGreen,Harpenden,Hertfordshire,England()Theapplicantshallsubmithisownstatisticalevaluationoftheprecisionandaccuracyofthesemeasurements(eg,standarddeviationsorconfidenceintervals)whenappropriate(d)ReferencesThefollowingreferencesshouldbeconsultedforadditionalbackgroundmaterialonthistestguideline()CollaborativeInternationalPesticideAnalyticalCouncilLtd(CIPAC)Handbook,‘‘MTAcceleratedStorageTestsbyHeating,’’CIPAC,HatchingGreen,Harpenden,Hertfordshire,England()()Reserved

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OPPTS 830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions

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