Detailed review document on classification in OECD member countries of substances and mixtures which cause respiratory tract irritation and corrosion [electronic resource]

2004·0.31 MB·English

by  Organisation for Economic Co-operation and Development

Unclassified ENV/JM/MON0(2003)2
OrganisationdeCooperationetdeDeveloppementEconomiques
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ENVIRONMENTDIRECTORATE English-Or.English
JOINTMEETINGOFTHECHEMICALSCOMMITTEEAND
EN THEWORKINGPARTYONCHEMICALS,PESTICIDESANDBIOTECHNOLOGY
Unclassified
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OECDSERIESONTESTINGANDASSESSMENT
Number40
DETAILEDREVIEWDOCUMENTONCLASSIFICATIONINOECDMEMBERCOUNTRIESOF
SUBSTANCESANDMIXTURESWHICHCAUSERESPIRATORYTRACTIRRITATIONAND
CORROSION
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ENV/JM/MON0(2003)2
OECDEnvironment,HealthandSafetyPublications
SeriesonTestingandAssessment
No.40
DETAILEDREVIEWDOCUMENTONCLASSIFICATIONINOECDMEMBER
COUNTRIESOFSUBSTANCESANDMIXTURESWHICHCAUSERESPIRATORY
TRACTIRRITATIONANDCORROSION
EnvironmentDirectorate
OrganisationforEconomicCo-operationandDevelopment
March2003
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ENV/JM/MONO(2003)2
ALSOPUBLISHEDINTHESERIESONTESTINGANDASSESSMENT:
No.1, GuidanceDocumentfortheDevelopmentofOECD
GuidelinesforTestingofChemicals(1993;reformatted1995)
No.2, DetailedReviewPaperonBiodegradabilityTesting
(1995)
No.3, GuidanceDocumentforAquaticEffectsAssessment
(1995)
No.4, ReportoftheOECD WorkshoponEnvironmental
Hazard/RiskAssessment(1995
No.5, Report oftheSETAC/OECD Workshop onAvian
ToxicityTesting(1996)
No.6, ReportoftheFinalRing-testoftheDaphniamagna
ReproductionTest(1997)
No.7, GuidanceDocumentonDirectPhototransformationof
ChemicalsinWater(1997)
Naboo.u8t,NewReIpnodrutstorifatlheChOeEmiCcDalsWoArsksseshsompenotn(S1h9a9r7i)ngInformation
No.9, GuidanceDocumentfortheConductofStudiesof
Occupational Exposure to Pesticides during Agricultural
Application(1997)
No.10, ReportoftheOECDWorkshoponStatisticalAnalysis
ofAquaticToxicityData(1998)
No.11, DetailedReviewPaperonAquaticTestingMethodsfor
PesticidesandindustrialChemicals(1998)
fNoor.G1e2r,mDCeetlaliMluetdagReenviiceiwtyDioncOuEmeCnDtMoenmbCelarssCiofuinctartiioens(S1y9s9t8e)ms
fNoor.Se1n3,sitiDseitnagiSluebdstRaenvcieeswinDoOcEuCmeDnMteomnbeCrlaCsosuinfitcraiteison19S9y8s)tems
fNoor.E1y4e,IrDreittaatiiloend/CRoervrioseiwonDioncOumEeCnDtMoenmbClearssCiofuicnattriioensS(y1s9t9e8m)s
fNoor.Re15p,rodDuecttaiivleedToRxiecviiteywinDOocEuCmDenMtemobnerClaCsosuinftirciaetsio(n19S9y8s)tems
fNoor.Sk16i,nIrDreittaaitlieodn/RCoervrioeswionDoincuOmEeCntDoMnemCbleasrsiCfoiucnattriionesS(y1s9t9e8m)s
3
) ) /
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NExoi.st1i7n,gEInndvuisrtornimaelntCahlemiEcxaplossurienOAsEsCesDsmeMnetmbSetrrateCgoiuenstrfioesr
(1999)
No.18, ReportoftheOECDWorkshoponImprovingtheUseof
MonitoringDataintheExposureAssessmentofIndustrial
Chemicals(2000)
No.19, Draft Guidance Document on the Recognition,
AssessmentandUseofClinicalSignsasHumaneEndpointsfor
ExperimentalAnimalsusedinSafetyEvaluation(1999)
No.20, RevisedDraftGuidanceDocumentforNeurotoxicity
Testing(inpreparation)
No.21, DetailedReviewPaper:AppraisalofTestMethodsfor
SexHormoneDisruptingChemicals(2000)
No.22, GuidanceDocumentforthePerformanceofOut-door
MonolithLysimeterStudies(2000)
No.23, GuidanceDocumentonAquaticToxicityTestingof
DifficultSubstancesandMixtures(2000)
No.24, Guidance Document on Acute Oral Toxicity
Testing(2001)
No.25, DetailedReviewDocumentonHazardClassification
SEyxsptoesmusrefoirnOSpEecCiDficMseTmabregretCoOurngtarniesSy(s2t0e0m1i)cToxicityRepeated
No.26, RevisedAnalysisofResponsesReceivedfromMember
CountriestotheQuestionnaireonRegulatoryAcuteToxicity
DataNeeds(2001)
No27, GuidanceDocumentontheuseoftheHarmonised
SystemfortheClassificationofChemicalswhichareHazardous
fortheAquaticEnvironment(2001
No28, GuidanceDocumentfortheConductofSkinAbsorption
Studies(inpreparation)
No29, Draft Guidance Document on Transformation
DissolutionofMetalsandMetalCompoundsinAqueousMedia
(2001)
No30, DetailedReviewDocumentonHazardClassification
SystemsforMixtures(2001
No31, DetailedReviewPaperonNon-GenotoxicCarcinogens
Detection:ThePerformanceofIn-VitroCellTransformation
Assays(inpreparation)
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)
ENV/JM/MONO(2003)2
No.32, GuidanceNotesforAnalysisandEvaluationofRepeat-
DoseToxicityStudies(2000)
No.33, Harmonised Integrated Classification System for
Human Health and Environmental Hazards of Chemical
SubstancesandMixtures(2001)
No.34, GuidanceDocumentontheDevelopment,Validation
andRegulatoryAcceptanceofNewandUpdatedInternationally
AcceptableTestMethodsinHazardAssessment(inpreparation
No.35, Guidancenotesforanalysisandevaluationofchronic
toxicityandcarcinogenicitystudies(2002)
No.36, ReportoftheOECD/UNEPWorkshopontheuseof
Multimedia Models for estimating overall Environmental
Presistence and long range Transport in the context of
PBTS/POPSAssessment(2002)
No.37,DetailedReviewDocumentonClassificationSystemsfor
SubstancesWhichPoseanAspirationHazard(2002)
No.38,DetailedBackgroundReviewoftheUterotrophicAssay
SthuemmOaErCyDofTtahsekAvFaoilracbeleoLnitEenrdatoucrreinineSDuipsprourptteorfsthTeesPtrionjgectanodf
Assessment(EDTA)toStandardiseandValidatetheUterotrophic
Assay(2003)
No.39,GuidanceDocumentonAcuteInhalationToxicity
Testing(inpreparation)
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DGeuciidsainocnesaDnodcuRmeecnotmsmenanddattieocnhsnic(athlerfeoprormtesr.lTeghaellybebsitndkinngowonnmoefmtbheesrecopuunbtlriiceast)i,onass,wtehlelaOsEnCuDmerToeusst
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ENV/JM/MONO(2003)2
DETAILEDREVIEWDOCUMENTONCLASSIFICATIONINOECDMEMBER
COUNTRIESOFSUBSTANCESANDMIXTURESWHICHCAUSERESPIRATORY
TRACTIRRITATIONANDCORROSION
SCOPEANDDEFINITIONS
Scope
1. Thisendpointcoverssubstances[andpreparations]thatcauseirritationoftheupperrespiratory
tractinhumans.
DESCRIPTIONOFTHECLASSIFICATIONSYSTEMSINPLACE
TheEUsystem(includingSlovenia):
2. ThedevelopmentoftheRphrase,R37,IrritatingtorespiratorysystemwithintheEUisdetailed
inAppendix1.Thecurrentcriteriaareasfollows:
R37:Irritatingtorespiratorysystem:
Isassignedtosubstancesandpreparationswhichcauseseriousirritationtotherespiratory
systembasedon:
a)practicalobservationinhumans
b)positiveresultsfromappropriateanimaltests
CommentsregardingtheuseofR37:
Ininterpretingpracticalobservationsinhumans,careshouldbetakentodistinguishbetween
effectswhichleadtoclassificationwithR48(1)fromthoseleadingtoclassificationwithR37.
ConditionsnormallyleadingtoclassificationwithR37arereversibleandusuallylimitedtothe
upperairways.
Positiveresultsfromappropriateanimaltests'21mayincludedataobtainedinageneraltoxicity
test,includinghistopathologicaldatafromtherespiratorysystem.Datafromthemeasurementof
experimentalbradypnea(3)mayalsobeusedtoassessairwayirritation.’
(1>R48=Dangerofseriousdamageafterrepeatedorprolongedexposure.
>2>Appropriateanimaltestscouldincludeanacuteinhalationtoxicitystudy,arepeated-exposure
inhalationstudy.
<3>The‘Alarieassay’.
3. Asageneralobservation,historically,forExistingSubstancesthedatathatwereusedasabasis
forclassificationwithR37weremainlybasedonhumanexperience.However,inrecentyearstherehas
beenanincreasingrelianceontheuseofinformationfromanimalstudies.ForNewSubstances,itishighly
unlikelythattherewillbehumanexperienceinformation,henceclassificationisbasedonothersourcesof
informationsuchasexperimentalstudiesinanimals,orpredictionbasedoncorrosivity(toskin/eyes).
ENV/JM/MONO(2003)2
4. Formixtures,thehealtheffectdatarequiredforclassificationandlabellingmaybeobtainedby
theapplicationoftestmethodsindicatedabove.Classificationmayalsobeobtainedbyapplicationof
methodsindicatedinPartBofDirective1999/45/EC(‘ThePreparationsDirective’),‘Concentrationlimits
tobeusedinevaluationofhealthhazards’.Thissetsoutspecificconcentrationlimitsforgaseousandnon-
gaseousmixtures(orpreparations).Inshort,amixturemaybeclassifiedas‘R37,Irritatingtothe
RespiratoryTract’ifthatmixturecontainsmorethanaspecifiedpercentageconcentrationofasubstance
thathasbeenclassifiedas‘Corrosive’(seeAppendix2).
TheUSSystem
5. IntheUSA,thereisnoclassificationspecificallyforthisendpoint;itishandledasatargetorgan
effect,basedmainlyuponhumanexperience.IntheUSA,fortheOccupationalSafetyandHealth
Administration(OSHA)andConsumerProductSafetyCommission(CPSC),targetorganeffectsleadto
identificationofthespecificorganonthelabel.Thevariousprecautionarystatementsandstatementsof
treatmentcanbeorganizedinaspecificmanner.Hence,respiratorytractirritationiscoveredinthis
manner.
TheCanadianSystem
p6.rovisionsThfeor“CcahnraondiicantoxWicorekfpfelcatcs”e.HAazcahrrodnoiucstoMxaitceerfifaelcstisIndfeofrimnaetdioasnanSyasdtveemrse(eWffHeMctISon)thienchleuadletsh
ofapersonortestanimalthatdevelopsovertime,followingasingleexposuretoatoxicsubstance,orafter
prolongedorrepeatedexposuretoatoxicsubstanceunderconditionsthatdonotproducethesameeffect
fromasingleexposure.Adversehealtheffectsinthiscategoryincludelife-threateningorserious
impairmentofbodyorgansandthecardiovascularornervoussystem. Respiratorytractirritationwould
fallintothishazardclass.
ThecriteriaforsubstancesortestedmixturesforthishazardclassaredetailedinAppendix3.
UNTransportofDangerousGoods
7. IntheUNtransportregulationsirritationoftherespiratorysystem(RTI)iscoveredindirectlyvia
thesubsidiarycorrosiveriskfortoxicgases.Toxicgasesare:
Gases
- whichareknowntobesotoxicorcorrosivetohumansastoposeahazardtohealth;or
—orwhleiscshthaarenp5r,0e0s0ummeld/mto3b(epptmo)x.icorcorrosivetohumansbecausetheyhaveanLC50valueequalto
Gasesmeetingtheabovecriteriaowingtotheircorrosivityaretobeclassifiedastoxicwitha
subsidiarycorrosiverisk.
Mixturesofgases:
Abceomgdapesosntmerinuxctttsuirvoeefhttaohsetamhiesxutbssukiirnde,iaiseryyeeqrsuiaskolrotfomcuoorcrorlouessssivtimhteaymnwb5rh,ae0nn0e0tshmelom/rimxw3th(ueprnepmit)shkewnhLoeCwnn50tbhveyaLlhCuue5m0aoifnstechxaeplcecurloiaretrneocdseibvtyeo
aformulausingmolfractionsandLC50values.
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:
ENV/JM/MONO(2003)2
APPENDIX1:DEVELOPMENTOFR37,IRRITATINGTOTHERESPIRATORYSYSTEM
WithintheEU,thefirstgeneraldefinitionof"irritating"inDirective67/548/EEC(27June1967)was
recordedas"Non-corrosivesubstancesandpreparationswhich,throughimmediate,prolongedorrepeated
contactwiththeskinormucousmembrane,maycauseinflammation".TherespectiveR-(isk)phrasewas
initiallyR84=Irritatingtoskin,eyesandrespiratorysystem.
Directive76/907(14July1976):Creationofnew(separate)Rphrase:R37=Irritatingtorespiratory
system.
Directive83/467(16Sept. 1983):Forthefirsttimeacriterionwasintroduced:"Substancesand
preparationswhichcauseseriousirritationtotherespiratorysystem,basednormallyonpractical
observation."Thismeansthatatthattimedatafromanimalexperimentswerenotregardedtobeusefulin
classificationforthisendpoint.
Directive93/21/EEC(27April1993):R37isslightlymodified.Newcriteria:"Substancesandpreparations
whichcauseseriousirritationtotherespiratorysystem,basednormallyonpracticalobservationin
humans".
Directive96/54/EEC(30July1996):
Positiveresultsfromappropriateanimaltestswereforthefirsttimeintroduced.Thus,testresultsin
inhalationtoxicitystudiesincludinghistopathologicalinvestigationscanbeusedforclassifyingpurposes.
Newexpandedcriteriawereestablishedinordertodiscriminateclassificationbetweenrespiratoryirritation
andR48=Dangerofseriousdamagetohealthbyprolongedexposure.
Furthermore,theAlarietestwasintroducedasabasisforrespiratoryirritation.
Therevisedcriteria,whicharevaliduptonoware(aslaidoutinEUguidancedocuments):
‘R37:Irritatingtorespiratorysystem
Isassignedtosubstancesandpreparationswhichcauseseriousirritationtotherespiratory
systembasedon:
-practicalobservationinhumans
-positiveresultsfromappropriateanimaltests
CommentsregardingtheuseofR37
Ininterpretingpracticalobservationsinhumans,careshouldbetakentodistinguishbetween
effectswhichleadtoclassificationwithR48(seesection3.2.4.)fromthoseleadingto
classificationwithR37.ConditionsnormallyleadingtoclassificationwithR37arereversible
andusuallylimitedtotheupperairways.
Positiveresultsfromappropriateanimaltestsmayincludedataobtainedinageneraltoxicity
test,includinghistopathologicaldatafromtherespiratorysystem.Datafromthemeasurementof
experimentalbradypneamayalsobeusedtoassessairwayirritation.’
10