ExistingChemical
Secondary NotificationAssessment NA/752S
PolymerinE7581
November 2005
NationalIndustrialChemicalsNotificationandAssessmentScheme
GPOBox58,SydneyNSW2001,Australia
©CommonwealthofAustralia2005ISBN0-9751221-9-3
Thisworkiscopyright.ApartfromanyuseaspermittedundertheCopyrightAct1968,nopartmaybereproducedbyanyprocesswithoutpriorwrittenpermissionfromtheCommonwealth.RequestsandinquiriesconcerningreproductionandrightsshouldbeaddressedtotheCommonwealthCopyrightAdministration,AttorneyGeneral’sDepartment,Robert GarranOffices,NationalCircuit,CanberraACT2600orpostedat
Polymer in E7581ii
Preface
ThisassessmentwascarriedoutundertheNationalIndustrialChemicalsNotificationandAssessmentScheme(NICNAS).ThisSchemewasestablishedbytheIndustrialChemicals(NotificationandAssessment)Act1989(theAct),whichcameintooperationon17July1990.
TheprincipalaimofNICNASistoaidintheprotectionofpeopleatwork,thepublicandtheenvironmentfromtheharmfuleffectsofindustrialchemicals.
NICNASassessmentsareconductedinconjunctionwiththeAustralianGovernmentDepartmentoftheEnvironmentandHeritage(DEH),whichcarriesouttheenvironmentalassessment.
NICNAShastwomajorprograms:theassessmentofthehealthandenvironmentaleffectsofnewindustrialchemicalspriortoimportationormanufacture;andtheotherfocussingontheassessmentofchemicalsalreadyinuseinAustraliainresponsetospecificconcernsabouttheirhealthand/orenvironmentaleffects.
Chemicalsthat have beenassessedasnew orexisting chemicalsmay require a reassessmentoftheriskofthechemicalunderthesecondarynotificationprovisionsoftheAct.
ThisassessmentreporthasbeenpreparedbytheDirectorofNICNAS,inaccordancewiththesecondarynotificationprovisionsoftheAct.UndertheActmanufacturers/importersofthechemicalarerequiredtonotifytheDirectorofnewinformationandapplyforassessment.Newinformationcanincludeanincreaseinquantityimported,thecommencementofAustralianmanufacture,increasedenvironmentalexposure,and/oradditionalinformationbecomingavailableonhazards,asisthecaseofPolymerinE7581.
Applicantsforassessmentaregivenadraftcopyofthereportand28daystoadvisetheDirectorof any errors.Followingthecorrection ofany errors,the Directorprovidesapplicantsandotherinterestedpartieswithacopyofthedraftassessmentreportforconsideration.Thisis aperiod ofpubliccomment lastingfor 28daysduringwhich requestsforvariationofthereportmaybemade.WherevariationsarerequestedtheDirector’sdecisionconcerningeachrequestismadeavailabletoeachrespondentandtootherinterestedparties(forafurtherperiodof28days).NoticesinrelationtopubliccommentanddecisionsmadeappearintheCommonwealthChemicalGazette.
InaccordancewiththeAct,publicationofthisreportrevokesthedeclarationofthischemicalforsecondaryassessment,thereforemanufacturersandimporterswishingtointroducethischemicalinthefutureneednotapplyforassessment.However,manufacturersandimportersneedtobeawareoftheirdutytoprovideanynewinformationtoNICNAS,asrequiredunderSection64oftheAct.
Polymer in E7581iii
ForthepurposesofSection78(1)oftheAct,copiesofassessmentreportsfornewandexistingchemicalassessmentsarefreelyavailablefromtheweb(CommonwealthChemicalGazette(
CopiesofthisandotherassessmentreportsareavailableontheNICNASwebsite.HardcopiesareavailablefromNICNASeitherbyusingtheprescribedapplicationformatthebackofthisreportordirectlyfromthefollowingaddress:
GPOBox58,Sydney,NSW2001,AUSTRALIATel:+61(02)85778800
Freecall:1800638528
Fax:+61(02)85778888
OtherinformationaboutNICNAS(alsoavailableonrequest)includes:
–NICNASServiceCharter;
–InformationsheetsonNICNASRegistration;
–InformationsheetsonPriorityExistingChemicalandNewChemicalsassessmentprograms;
–SafetyinformationsheetsonchemicalsthathavebeenassessedasPriorityExistingChemicals;
–DetailsfortheNICNASHandbookforNotifiers;and
–DetailsfortheCommonwealthChemicalGazette.
MoreinformationonNICNAScanbefoundattheNICNASwebsite:
Otherinformationonthemanagementofworkplacechemicalscanbefoundatthefollowingwebsite:
Polymer in E7581iv
OverviewandRecommendations
Overview
Background
PolymerinE7581wasassessedasNA/752undertheNICNASNewChemicalsprogramin1999inthelimitednotificationcategory.Asaresultofnewdataonskinandeyeirritationandreproduction/developmentaleffectsbecomingavailable,PolymerinE7581hasnowbeenreassessedundertheSecondaryNotificationprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989(theAct)relevanttoexistingchemicals,asmorethanfiveyearshaselapsedsincetheoriginalassessment.
PolymerinE7581isanamberviscousliquid,stableundernormalconditions.Forcommercialpurposes,itispreparedinsolvent,andneverisolated.Itisaflammableliquidasformulated,withoxidesofcarbon,hydrogenandnitrogenbeingproduced.Itswatersolubilityis10.0mg/Landflashpoint410C,asitexistsinsolvent.Itsboilingpointhasnotbeendetermined.
Uses
PolymerinE7581isnotmanufacturedinAustralia,butisimportedasacomponentinfueladditivepackages.ThemajoruseofPolymerinE7581isasadetergentadditiveingasoline.TheusepatterninAustraliahasnotchangedsinceitsintroductionasanewchemical.Approximately200-250tonnesofthechemicalisimportedannually.
Exposure
TheassessmentofPolymerinE7581asanewchemicalin1999indicatedthatexposurefromdripsandspillsispossiblewhentheadditivepackageisaddedtothefuel,usingautomatedprocessesanddedicateddeliverylinesandequipment.However,theexposure isexpectedtobeconfinedtoskincontaminationwhichmayoccurduringtheconnectionanddisconnectionoftransferlinesandequipment.Thepolymerisaminorcomponentinpetrol.
Thepolymerandadditivepackageisnotdirectlymarketedtothepublic,butpreblendedintothepetrolsoldatservicestations,hence,directcontactwiththepolymerbymembersofthepublicisunlikely.
Healtheffects
Notoxicologydatawereprovidedforthechemicalsubstanceduringassessmentasanewchemical.Data on acute toxicity,repeated dose toxicity, and genotoxicity were providedonapolymericsubstancesimilarincompositionandmolecularweightdistributiontoPolymerinE7581.Areassessmentofthisdatahasnotbeenconducted.Inthisreport,neweyeandskinirritationstudiesandareproduction/developmentalstudyconductedonthePolymerinE7581(withoutsolvent)areassessed.
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Theassessmentconductedin1999onasubstanceanalogoustoPolymerinE7581indicatedverylowacuteoraltoxicityinrats(LD50>5000mg/kgbw).Itisnotaskinsensitiser.Ina28-dayrepeated-dosegavagestudyinrats,theNOAELwasidentifiedas1250mg/kgbw/daybasedontheabsenceof systemic toxicityorpathologicaleffectsatthislevel.AninvitroandinvivogenotoxicitytestwereperformedwithPolymerinE7581.ThechemicalwasnegativeintheSalmonella/MammalianMicrosomePlateIncorporationMutagenicityAssayandintheinvivomousemicronucleustest.Overallthechemicalisnotconsideredgenotoxic.
AssessmentofcurrentdataindicatethatPolymerinE7581isaskinirritant,notaneyeirritant,andisnotasubstancetoxictoreproduction.
PolymerinE7581isclassifiedasa hazardouschemicalundertheNOHSCApprovedCriteriaforClassifyingHazardousSubstances(NOHSC,2004).PolymerinE7581isclassifiedas ahazardoussubstanceunderthe GloballyHarmonisedSystemof ClassificationandLabellingofChemicals(GHS),(OECD,2003)andwouldrequireappropriatelabellingwhenthissystemisadoptedinAustralia.TheclassificationofthefueladditivepackageinwhichthepolymerwillbecontainedisaClass3FlammableLiquid,PackagingGroupIIIlistedintheAustralianCodefortheTransportofDangerousGoodsbyRoadandRail(FORS,1998).
Theuseofdedicatedandautomatictransferlinesandenclosed,automatedinjectionintofuelreducestheriskofexposuretotheadditivepackage.Therisktoservicestation workersandmechanicsisexpectedtobelow,asexposurefortheseworkersisnegligiblebecauseoftheverylowconcentration(<0.1%)ofpolymerinthefuel.
Basedontheusepattern,PolymerinE7581willnotposeasignificantrisktopublichealth.
Environmentaleffects
Basedontheusepatternresultinginthemajorityofthechemicalbeingboundinapolymermatrix,environmentalexposureisexpectedtobeminimal.Potentialreleasetotheenvironmentwouldonlybethroughaccidentalspills.Theemptydrumsandtheirresiduesaresenttoacertifieddrumrecyclerwheretheyarerinsedandtherinsatedisposedinaccordancewithgovernmentregulations.Polymerreleasedtosoilthrougheitheraspillorleakfromastoragetankisexpectedtobindstronglytosoilduetoitslowwatersolubility.Polymerreleasedtoanaquaticenvironmentwouldtendtopartitionoutofwaterandintosediment.
EcotoxicologicaldataforPolymerinE7581wereobtainedfrominformationprovidedwiththeearliersubmission(NA/752).Thepolymerisunlikelytobemobilegiventheverylowwatersolubilityandhighbindingaffinitytosoil.Thepolymer’slargemolecularsizeandverylowwatersolubilityshouldpreventbioaccumulation.However,theproductcontainscomponentswhichmaybepersistentintheenvironment.Basedontheabove,environmentalexposureandriskareexpectedtobelow.
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Recommendations
ThissectionprovidestherecommendationsarisingfromtheassessmentofPolymerinE7581.RecommendationsaredirectedprincipallyatregulatorybodiesandimportersandformulatorsofPolymerinE7581.Implicitintheserecommendationsisthatbestpracticeisimplementedtominimiseoccupationalandpublicexposureandenvironmentalimpact.
RecommendationstoRegulatoryBodiesNOHSC
PolymerinE7581isclassifiedashazardousinaccordancewiththeNOHSCApproved
CriteriaforClassifyingHazardousSubstances(NOHSC,2004),withthefollowingriskphrase:
•R38–IrritatingtoSkin;
ThefollowingsafetyphraseisalsorecommendedforPolymerinE7581:
•S24–Avoidcontactwithskin
ProductscontainingPolymerinE7581atconcentrations≥20%aredeterminedtobehazardous.
ItisrecommendedthatthisclassificationbeincludedintheListofDesignatedHazardous SubstancescontainedintheHazardousSubstancesInformationSystem(HSIS).
RecommendationstoImportersandStateandTerritoryAuthorities Hazardcommunication–MaterialSafetyDataSheet
UndertheNationalModel RegulationsfortheControlofWorkplaceHazardousSubstances
(NOHSC,1994)andtheCommonwealth,StateandTerritoryregulationsintroducedinaccordancewiththesenationalmodelregulations,employeesshallhavereadyaccesstoMaterialSafetyDataSheets(MSDS)forhazardoussubstancesattheirworkplace.
InaccordancewiththeNationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets(NOHSC2003)itisrecommendedthatimportersofPolymerinE7581reviewtheirMSDSforcomplianceandpayparticularattentiontothefollowingpoints:
•risk phrases and hazard information should be updated to reflect the hazardclassificationinRecommendation12.1.1.
•safetyphrasesshouldbeincludedasnotedinRecommendation12.1.1.
Hazardcommunication–Labels
InaccordancewiththeNationalCodeofPracticefortheLabellingofWorkplaceSubstances(NOHSC1994a)itisrecommendedthatimportersofPolymerinE7581reviewtheirlabelsforcomplianceandpayparticularattentiontothefollowingpoints:
•risk phrases and hazard information should be updated to reflect the hazardclassificationinRecommendation12.1.1;and
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•safetyphrasesshouldbeincludedasnotedinRecommendation12.1.1.
ItisrecommendedthattheStateandTerritoryOccupationalHealthandSafetyauthoritiesreviewcompliancewiththeaboveinformation,intheworkplace.
RecommendationtoImportersandUsers Occupationalcontrols
TheriskofadverseefectsfromoccupationaluseofPolymerinE7581islow.This
assessmentsupportsthecontrolmeasuresrecommendedintheoriginalnewchemicalassessmentreportNA/752.ThecontrolmeasuresforPolymerinE7581areasfollows:
•localexhaustventilationattherefinery/terminalfacility,ifthepetroladditiveisblendedwithpetrolinanenclosedarea;
•avoidanceofspillageandsplashingofthechemical.Spillagesshouldbecleaneduppromptlyusingchemical-resistantimperviousgloves;
•ifengineeringcontrolsandsafeworkpracticesareinsufficienttoreduceexposure,employersshouldensurethatpersonalprotectiveequipment(PPE)suchasgloves,safetyglassesandoverallsareusedbyworkerstominimiseoccupationalexposure.ThepersonalprotectiveequipmentusedshouldbeinaccordancewithAustralian,Australian/NewZealandorotherapprovedstandards.
Disposal
Accidentalleaksandspillagesshouldbecleaneduppromptlywithabsorbentsandputintocontainersfordisposal.Theemptydrumsandtheirresiduesshouldbedisposedinaccordancewithgovernmentregulations.
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Contents
PREFACEiii
OVERVIEWAND RECOMMENDATIONSv
ACRONYMSANDABBREVIATIONSxi
GLOSSARYxii
1.INTRODUCTION1
1.1DeclarationandSecondaryNotification1
1.2Objectives1
1.3Internationalperspective2
1.4Peer review2
2.APPLICANT3
3.CHEMICALIDENTITY AND COMPOSITION4
4.PHYSICAL ANDCHEMICAL PROPERTIES5
5.MANUFACTURE,IMPORTATIONANDUSE6
5.1Manufacture and importation6
5.2Use6
6.EXPOSURE7
6.1Occupational exposure7
6.2Public exposure7
6.3Environmentalexposure7
6.3.1Release7
6.3.2Fate8
7.EVALUATIONOF ANIMAL TOXICOLOGICALDATA9
7.1
7.1.3Eye irritation (ND)10
7.2Skin sensitisation12
7.3Repeated-dose toxicity12
7.4Genotoxicity12
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7.5Reproductiveeffects(ND)13
8. / HAZARD / CLASSIFICATION / 158.1 / Skin irritation (ND) / 15
8.2 / Eye irritation (ND) / 16
8.3 / Reproductive toxicity (ND) / 16
9.ENVIRONMENTAL EFFECTS ASSESSMENT18
10.RISKCHARACTERISATIONAND MANAGEMENT19
10.1 / Occupational / 1910.2 / Public / 19
10.3 / Environmental / 20
11.DISCUSSIONAND CONCLUSIONS21
12.RECOMMENDATIONS22
12.1Recommendations toregulatory bodies22
12.1.1NOHSC22
12.2Recommendations to Importers and State andTerritory Authorities22
12.2.1Hazard communication– Material Safety Data Sheet22
12.2.2Hazard communication– Labels23
12.2.3Recommendation toimportersandusers23
13.SECONDARY NOTIFICATION24
APPENDIX 1- Classification under theGlobally Harmonized Systemof
ClassificationandLabellingof Chemicals (GHS).25
APPENDIX2– Material Safety Data Sheet26
REFERENCES32
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AcronymsandAbbreviations
CASChemicalAbstractsService
COcarbonmonoxide
DEHAustralianGovernmentDepartmentoftheEnvironmentandHeritage
FORSFederalOfficeofRoadSafety
GLPgoodlaboratorypractice
GHSGloballyHarmonizedSystemofClassificationandLabellingofChemicals
HChydrocarbon
HPLChighperformanceliquidchromatography
IPCSInternationalProgrammeonChemicalSafety
LD50medianlethaldose
MSDSMaterialSafetyDataSheet
NAMWnumberaveragemolecularweight
NDnewdata
NICNASNationalIndustrialChemicalsNotificationandAssessmentScheme
NOAELno-observed-adverse-effectlevel
NOHSCNationalOccupationalHealthandSafetyCommissionISO InternationalOrganizationforStandardization
OECDOrganisationforEconomicCooperationandDevelopment
PMNpremanufacturenotice
PPEpersonalprotectiveequipment
TGtestguidelines
USEPAUnitedStatesEnvironmentProtectionAuthorityUSTSCA UnitedStatesToxicSubstancesControlActWAMW weight-averagemolecularweight
WHOWorldHealthOrganization
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Glossary
Inthisreport,NICNASusedtheIPCSRiskAssessmentTerminology(IPCS,2004)glossarywhichincludesPart1:IPCS/OECDKeyGenericTermsusedinChemicalHazard/RiskAssessmentandPart2:IPCSGlossaryofKeyExposureAssessmentTerminology.TheIPCSTerminologycanbeaccessedat:
Adverseeffect / Changeinthemorphology,physiology,growth,development,reproduction,orlifespanofanorganism,systemor(sub)populationthatresultsinanimpairmentoffunctionalcapacity,animpairmentofthecapacitytocompensateforadditionalstress,oranincreaseinsusceptibilitytootherinfluences.Assessment / Evaluationofappraisalofananalysisoffactsandtheinferenceofpossibleconsequencesconcerningaparticularobjectorprocess.
Assessmentendpoint / Quantitative/qualitativeexpressionofaspecificfactorwithwhichariskmaybeassociatedasdeterminedthroughanappropriateriskassessment.
Concentration / Amountofamaterialoragentdissolvedorcontainedinunitquantityinagivenmediumorsystem.
Dose / Total amount of an agent administered to, taken up orabsorbedbyanorganism,systemor(sub)population.
Doserate / Doseperunittime
Dose-relatedeffect / Anyeffecttoanorganismor(sub)populationasaresultofthequantityofanagentadministeredto,takenuporabsorbedbythatorganism,systemor(sub)population.
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Dose-ResponseRelationship / Relationshipbetweentheamountofanagentadministeredto,takenuporabsorbedbyanorganism,systemor(sub)populationandthechangedevelopedinthatorganism,systemor(sub)populationinreactiontotheagent.RelatedTerms:Dose-EffectRelationship,EffectAssessment,Concentration-EffectRelationship.
Effect / Changeinthestateordynamicsofanorganism,systemor(sub)populationcausedbytheexposuretoanagent.
Exposure / Concentrationoramountofaparticularagentthatreachesatargetorganism,systemor(sub)populationinaspecificfrequencyforadefinedduration.
Exposureassessment / Evaluationoftheexposureofanorganism,systemor(sub)populationtoanagent(anditsderivatives).
Exposure Assessment is thethird step in theprocess of RiskAssessment.
Exposureperiod / Thetimeofcontinuouscontactbetweenanagentandatarget.
Exposureroute / Theway anagententersatargetaftercontact(e.g.,byingestion,inhalation,ordermalabsorption).
Fate / Patternofdistributionofanagent,itsderivativesormetabolitesinanorganism,system,compartmentor(sub)populationofconcernasaresultoftransport,partitioning,transformationordegradation.
Hazard / Inherentpropertyofanagentorsituationhavingthepotential tocause adverseeffectswhenan organism,systemor(sub)populationisexposedtothatagent.
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Hazardassessment / Aprocessdesignedtodeterminethepossibleadverseeffectsofanagentorsituationtowhichanorganism,systemor(sub)populationcouldbeexposed.Theprocessincludeshazardidentificationandhazardcharacterization.Theprocessfocusesonthehazardincontrasttoriskassessmentwhereexposureassessmentisadistinctadditionalstep.Hazardcharacterization / Thequalitativeand,whereverpossible,quantitativedescriptionoftheinherentpropertiesofanagentorsituationhavingthepotentialtocauseadverseeffects.Thisshould,wherepossible,includeadose-responseassessmentanditsattendantuncertainties.
HazardCharacterisationisthesecondstageintheprocessofHazardAssessment,andthesecondstepinRiskAssessment.
Relatedterms:Dose-EffectRelationship,EffectAssessment,Dose-Response
Relationship,Concentration-EffectRelationship.
Hazardidentification / Theidentificationofthetypeandnatureofadverseeffectsthatanagenthasinherentcapacitytocauseinanorganism,systemor(sub)population.
HazardidentificationisthefirststageinhazardassessmentandthefirststepinprocessofRiskAssessment
Riskassessment / Aprocessintendedtocalculateorestimatetherisktoagiventargetorganism,systemor(sub)population,includingtheidentificationofattendantuncertainties,followingexposuretoaparticularagent,takingintoaccounttheinherentcharacteristicsoftheagentofconcernaswellasthecharacteristicsofthespecifictargetsystem.
TheRiskAssessmentprocessincludesfoursteps:hazardidentification,hazardcharacterization(relatedterm:dose-responseassessment),exposureassessment,andriskcharacterization.Itisthefirstcomponentinariskanalysisprocess.
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Riskcharacterization / Thequalitativeand,whereverpossible,quantitativedetermination,includingattendantuncertainties,oftheprobabilityofoccurrenceofknownandpotentialadverseeffectsofanagentinagivenorganism,systemor(sub)population,underdefinedexposureconditions.RiskCharacterizationisthefourthstepintheRiskAssessmentprocess.
Riskmanagement / Decision-makingprocessinvolvingconsiderationsofpolitical,social,economic,andtechnicalfactorswithrelevantriskassessmentinformationrelatingtoahazardsoastodevelop,analyse,andcompareregulatoryandnon-regulatoryoptionsandtoselectandimplementappropriateregulatoryresponsetothathazard.
Riskmanagementcomprisesthreeelements:riskevaluation;emissionandexposurecontrol;riskmonitoring.
Toxicity / Inherentpropertyofanagenttocauseanadversebiologicaleffect.
Uptake(absorption) / The process by which an agent crosses an absorptionbarrier.
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1.Introduction
ThechemicalPolymerinE7581(CASNumbernotassigned)wasassessedasanewchemicalunderSection23oftheIndustrialChemicals(NotificationandAssessment)Act1989(theAct)underthelimitednotificationcategory.
The NewChemicalsAssessmentReport(NA/752)waspublishedinOctober1999.Fromthelimiteddataprovidedatthetime,ahazardclassificationwasconductedinaccordancewiththeNationalOccupationalHealthandSafetyCommission(NOHSC)ApprovedCriteriaforClassifyingHazardousSubstances,andPolymerinE7581wasconsideredtobenon-hazardous.Recommendationsweremaderelatingtoengineeringcontrols,useofpersonalprotectiveequipment,safeworkpracticesandMaterialSafetyDataSheet(MSDS).TheserecommendationswerebasedontheintendeduseofPolymerinE7581asadetergentadditiveinunleadedpetrol.
InSeptember2004,additionaltoxicitydataonskinandeyeirritationandreproduction/developmentaleffectswereprovidedforPolymerinE7581.Asfiveyearshave elapsed since the original assessment,thischemical is nowbeingassessedasanexistingchemical(SecondaryNotification).ThenewdatawarrantedreassessmentwhichhasbeencarriedoutunderSection68AoftheAct,coveringsecondarynotificationsofexistingchemicals.
PolymerinE7581isimportedintoAustraliaaspartofanadditivepackage.
13.1Declarationandsecondarynotification
DeclarationasaSecondaryNotificationwasinitiatedwhenNICNASreceivedfurtherstudiesconductedonPolymerinE7581withoutsolventthatwerenotavailableduringitsassessmentasanewchemical.Thestudiesare:
1.DermalIrritation/Corrosivity
2.PrimaryEyeIrritation
3.Reproduction/DevelopmentalToxicityScreeningTest
AnoticewaspublishedintheChemicalGazetteof7December2004requiringallpersonswhointroducePolymerinE7581intoAustraliaeitherbymanufactureorimport,toapplyforsecondarynotification.
13.2Objectives
Theobjectivesofthisassessmentweretoreviewthenewdatamadeavailablesincethepublicationofthe1999NewChemicalAssessment,andwhereappropriate,revisetheoriginalassessmentto:
•characterisethehazardsofPolymerinE7581tohumanhealth;
•characterisepotentialoccupational,andpublicexposuretoPolymerinE7581;
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•characterisetherisksofadverseeffectsresultingfromexposuretoworkers,andthegeneralpublic;and
•makeappropriaterecommendationstocontrolexposuresand/orreducepotentialhealthandrisksforworkersandthegeneralpublic.
13.3Internationalperspective
USA:InFebruary1999aPremanufactureNotification(PMN)forPolymerinE7581wasmadetotheUnitedStatesEnvironmentalProtectionAgency(USEPA).FollowingthePMN,theUSEPAdeterminedthatadditionalinformationwasrequiredinordertocompletetheirhumanriskassessmentonPolymerinE7581.AnoutcomeofthePMNreviewwasaConsentOrderrequiringaReproductive/DevelopmentalToxicityScreeningTesttobeconductedinaccordancewithOECDGuidelines.
Otherdatawhichbecameavailablesincetheoriginalassessmentwere:DermalIrritation/CorrosivityStudy
PrimaryEyeIrritationStudy
ThesestudieswereconductedbyAftonChemicalCorporationaspartoftheirevaluationofchemicalhazardsforemployeeandcustomerriskmanagement.
In2001,theUSEPArevokedthePMNconsentorderbasedontheresultsofthetesting.
Canada:ANewSubstanceNotificationsubmissionwasmadetotheCanadianauthoritiesin1999,andtheassessmentcommenced.NoactionwastakenbytheCanadianGovernmentpriortocompletionoftheassessment,andtheapplicantwasallowedtoimportthisproductintoCanadaforcommerce.
Korea:SubmissiontotheKoreanauthoritiesfornominationtotheKoreanInventoryofChemicalSubstanceswasmadein2000.Nocommentswerereceivedafterthe90-dayreviewperiod,andthereforetheapplicantwasallowedtoimporttheproductintoKoreaforcommercialpurposes.
13.4Peerreview
Duringallstagesofpreparation,thisreporthasbeensubjecttointernalpeerreviewbyNICNAS.
Polymer in E75812
2.Applicant
Onecompanyappliedforsecondarynotificationassessmentofthischemical.Theapplicantsuppliedadditionaltoxicitydata.UnderSection36oftheAct,theapplicantwasprovidedwithadraftcopyofthereportforcorrectionoferrorsandvariationofcontent.
Applicantdetailsare:
AFTONCHEMICALASIAPACIFICLLC
Level9,20BerryStreet(P.O.Box285)NorthSydney,NSW2059
Polymer in E75813
3.ChemicalIdentityandComposition
ChemicalName: Formaldehyde, reaction products withanalkylatedphenolandanaliphaticamine
Tradename:PolymerinE7581
USAPremanufactureNoticeNumber(PMN):
P99-531
Number-AverageMolecularWeight(NAMW):
1019
Weight-AverageMolecularWeight(WAMW):
1530
Maximumpercentageoflowmolecularweightspecies:
MolecularWeight5006
MolecularWeight100038
Maximumcontentofhazardousresidualmonomers:
No hazardous residual monomers arepresentinthepolymer
Degreeof purity:Veryhigh
Lossofmonomers,additives,impurities:
Noneexpected
Additives/Adjuvants:Petroleumsolventnaphtha;notclassifiableasahazardoussubstanceinterms of benzeneor PNAcontent ormeasuredkinematicviscosity
Polymer in E75814
4.PhysicalandChemical Properties
PolymerinE7581,asformulatedinsolvent,isanamberviscousliquid.Unlessotherwiseindicated,thedatabelowrepresentsthatofthenotifiedpolymerinpetroleumsolventnaphtha.
Boilingpoint: Notdetermined
Density: 0.908g/cm3at15.6°C
Particle size: Not applicable
Vapourpressure:Notdetermined;expectedtobelowduetohighmolecularweight
Watersolubility: 10.0mg/L(seecommentsbelow)
Partitionco-efficient(n-octanol/water):
Notdetermined
HydrolysisasafunctionofpH:
Notdetermined(inthepHrangeof4-9)
Adsorption/desorption:Notdetermined
Dissociationconstant:Notdetermined
Flashpoint:41°C(ClosedCup)Autoignitiontemperature: NotdeterminedExplosiveproperties: None
Flammabilitylimits:Combustibleasformulated.Oxidesofcarbon,
hydrogenandnitrogenareproduced
Reactivity/stability:Stableundernormalconditions
Kinematicviscosity193x10-6m2/sat40°C(target)20x10-6m2/sat100°C(typical)
Polymer in E75815
5.Manufacture,ImportationandUse
Nonewinformationwasprovidedonuseduringthesecondarynotification.Theuseofthechemicalisasoriginallynotifiedforassessmentasanewchemical.
5.1Manufactureandimportation
PolymerinE7581isnotmanufacturedinAustralia.Itisnotimportedasapolymerbutaspartofanadditivepackage.Theamountsoftheadditivepackagevariesfromyeartoyear.Ofthetotalamountimported,approximately80%isimportedinISO (International Organizationfor Standardization) containersand 20%indrums.Thecontainersaresenttothecustomerrefineriesdirectlyafterimportation.
Thevolumeimportedisintherangeof200-250tonnes/year.
5.2Use
Nonewusepatterndatahavebeenprovided.Thepolymeriscurrentlyusedasadetergentadditive inunleaded petrolwhichinconjunction witha polymericcarrierreducestheformationofdepositsincarburettors,fuelinjectorsandintakevalvesaswellasreducescombustionchamberdepositsinpetrolengines.
Attherefinery/terminalfacility,thepetroladditiveistypicallyblendedwithpetrolimmediatelyjustpriortotransportofthefueltothepetrolstation.Theadditivepackageisinjectedautomaticallyasthefuelispumpedintothedeliverytanker.Theadditiveisinjectedintounleadedpetrolonavolumetricbasisthatwillresultinlessthan0.1%w/wnotifiedpolymerinthefinalfuel.
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6.Exposure
Occupational,publicandenvironmentalexposuresareconsideredbelow.
6.1Occupationalexposure
Accordingtoinformationprovidedbytheapplicant,atotalnumberof20workersareinvolvedinimportandtransportation,24plantoperatorsandmaintenanceworkersinthestoragefacility,and100plantoperatorsandmaintenanceworkersintherefinery/terminalfacility.
Dockside andtransport
The notified polymerisimported indrumsorISO containers.Occupationalexposureisnot expectedexceptintheeventofaspill.NorepackagingofdrumsorISOcontainersisrequired,asthesearedelivereddirectlytothecustomersite.
Refinery/terminalfacility
Exposureispossiblefromdripsandspillswhentheadditivepackageisaddedtothefuel.Automatedprocessesanddedicateddeliverylinesandequipmentareusedforthisactivity.Exposureisexpectedtobeconfinedtoskincontaminationwhichmayoccurduringtheconnectionanddisconnectionoftransferlinesandequipment.Workersusechemicalgogglesandchemicalresistantgloveswhenhandlingtheadditivepackage.Engineeringcontrolsintheformofautomateddeliverysystemsalreadyinplaceattherefinerieswillminimisethepotentialforexposureduringblending.
Enduse-service stations
Exposuretoverylowconcentrationsofthenotifiedpolymerinthefinalfuelbymechanicsandservicestationpersonnelmayoccur.
6.2Publicexposure
Thepolymerisusedasaminorcomponentinpetrol.Hence,directcontactwiththepolymerbymembersofthepublicisunlikely.
6.3Environmentalexposure
6.3.1Release
Thepolymeristransportedviaroadinclosedcontainers.Potentialreleasewouldonlybethroughaccidentalspills.TheMaterialSafetyDataSheet(MSDS)detailsprocedurestoprotecttheenvironmentinthesecases.
TheISOcontainersusedtotransportandstorethefueladditivearecontinuallyreusedwithoutrinsing.Theapplicantestimatesthatamaximumof4%ofthefueladditivepackagewillremainasresiduesinemptydrums.Thiscorrespondsto
Polymer in E75817
5kgofthepolymerineach200Ldrum.Atamaximumimportvolumeof60tonnesofthepolymerindrums,1tonneofthepolymerwastewillbegeneratedperyear.Theemptydrumsandtheirresiduesaresenttoacertifieddrumrecyclerwheretheyarerinsedandtherinsatedisposedinaccordancewithgovernmentregulations.
Theapplicantexpectsthatamaximumof1500servicestationsmaystorefuelcontainingthepolymer.Theprobablenumberofspillsfor1500servicestationswouldbe4.05peryear.Ifeachspillwas200L,thiswouldresultinatotalof5kgofthepolymerbeing lost.These figuresare basedonaresearch projectcarriedoutattheUniversityofBritishColumbia,Canada,whichinvestigatedtheincidentsofpetrolspillsatservicestationsintheGreaterVancouverregion.Thesefiguresdonottakeintoaccountfrequentminorspills(<1L)thatwouldoccuratpetrolbowsersascustomersfilltheirvehicles withfuel.Giventhelowpercentageinfuel,theamountofpolymerlostinthesespillswouldbeexpectedtobeverylow.
Thepolymerandadditivepackageisnotdirectlymarketedtothepublic,butpreblendedintothepetrolsoldatservicestations.
6.3.2Fate
Polymerreleasedtosoilineitheraspillorleakfromastoragetankisexpectedtobind strongly to soil due to its lowwater solubility.Polymer released to an aquaticenvironmentwouldtendtopartitionoutofwaterandintosediment.Onceadsorbedtosoil/sediment,thefateofthepolymerisunknown.Thepolymerisnotexpectedtocrossbiologicalmembranesduetothelowsolubilityandhighmolecularweight,andshouldnotbioaccumulate(Connell,1989).
Lessthan1tonneofthepolymerwastefromdrumrecyclingentersanaqueoustreatmentplant.The polymerwaste is partofthesolidwastesfromtheplantandisconsignedtolandfill.
Theapplicanthasindicatedthattailpipeemissiondataonthenotifiedpolymerareunavailable.However,theapplicantsupplieddataonananalogue.Theonlystructuraldifferencebetweenthenotifiedpolymerandtheanalogueistheabsenceofanalkylgroup.
TestresultsprovidedshownostatisticaldifferenceinHC,COandNOxemissionsbetweentestfuelwithandwithouttheadditive.Thelongtermeffectofusingdetergentfueladditivesistoreducetheformationofenginedeposits,ie“keepclean”,and“cleanup”existingenginedepositsleadingtoreducedlevelsoftailpipeemissions.Theanalogueinconjunctionwithitspolymericcarrierhasbeenshowntoreduceportfuelinjectorpluggingafter~500milestolessthan5%fromlevelsashighas25%.
TheanalogueislistedontheUSTSCAinventoryand,incombinationwithcertaincarrier/dispersantadditives,issaidtoberegisteredforusewithUSEPAandtheCaliforniaAirResourcesBoardasafueladditive.
ThepolymerneedstomeetthecriteriaintheAustralianStandard-AS4430.2-2004-Evaluationofdevices,additivesandprocesseswhichclaimtoimprovevehicleperformance-sparkignitionenginesystem.
Polymer in E75818
7.EvaluationofAnimalToxicologicalData
Datasubmittedfortheoriginalnewchemicalassessmentincludeddataonasimilarpolymericsubstanceforacuteoral,repeated-dosetoxicityandgenotoxicitystudies.New data(denotedbyND)forskinandeyeirritationandreproductive/developmentaltoxicityconductedonthePolymerinE7581withoutsolventwasprovidedfortheSecondaryNotification.Summariesoftheoriginaldata,andassessmentofthenewstudiesarepresentedinthefollowingchapters.
7.1Acutetoxicity
7.1.1Acuteoral
PolymerinE7581hasveryloworaltoxicitywithanLD50of>5000mg/kginrats.
7.1.2Skinirritation(ND)
ADermalIrritation/CorrosivityStudyinrabbits(BonnetteKL,SpringbornLaboratories,2001),conductedonthePolymerinE7581withoutsolventwassubmittedforassessmentduringtheSecondaryNotification.Thestudywasconductedtoassessthepotentialirritantand/orcorrosiveeffectsofthetestsubstance,PolymerinE7581withoutsolvent,inNewZealandwhiterabbits,whenadministeredbyasingledermaldose.ThestudywasconductedincompliancewithGoodLaboratoryPractice(GLP),andinaccordancewiththeOECDTG404,andtheUSConsumerProductsSafetyCommission,FederalHazardousSubstancesActRegulations,1988.
SixNewZealandwhiterabbits(3maleand3female)approximately11weeksofageweighing 2.4-2.5kgand2.5kgrespectivelywerechosenforthestudy.Onthedaybeforethetest(day-1),theanimalshadthefurremovedfromthedorsalareaofthetrunkwithcarebeingtakentoavoidabradingtheskinduringtheclippingprocedure.Onthefollowingday(day-0),eachanimalreceived0.5mLofthetestsubstanceasasingledermalapplication.Thetestsubstancewasheldincontactwiththeskinunderasemi-occlusivebinderfor4h.Followingthe4-hexposureperiod,thebinderwasremovedandthetestmaterialremovedfromtheskinusingalcohol(firstrinse)andmineraloil(secondrinse).Eachrinsewasfollowedbysoap,wateranddrygauze.Testsiteswereexaminedforsignsoferythemaandoedema,andtheresponsesscoredaccordingtotheOECDTG404,1hafterpatchremovaland24,48and72h,andupto7daysafterpatchapplication.
Additionaldermalfindingsofdesquamation(scalingandflaking)werenotedinthreeanimalsat48handinallsixanimalsattheendof7days.Superficiallighteningwasnotedinfouranimalsat24h,whichresolvedinthreeoutoffouranimalsat48h,andinallanimalsat72h.Transientincidencesofdarkmaterialaroundthemouthwerenotedinthreeoutofsixanimalsduringthestudy.
Polymer in E75819
Theindividualdermalirritationscoresattheendof24,48and72harepresentedinTable7.1.Theindividualdermalirritationscoresattheendof1harenotincludedinthetable.
Table7.1:Individualdermalirritationscoresat24,48and72hafterexposuretoPolymerinE7581withoutsolvent
Animals / Erythema / Oedema24h / 48h / 72h / 24h / 48h / 72h
1 / 2 / 2 / 2 / 0 / 0 / 0
2 / 2 / 2 / 2 / 1 / 0 / 0
3 / 2 / 2 / 2 / 2 / 0 / 0
4 / 2 / 2 / 2 / 2 / 2 / 1
5 / 2 / 2 / 1 / 2 / 0 / 0
6222201
Following thegrading oferythemaand oedemaforindividual animalsatthe endof24,48and72h,themeanscoresofindividualandallanimalsforerythemaandoedemaattheendof72hweredetermined.ThesearepresentedinTable7.2.
Table7.2:Meanscoresofindividual,andallanimalsforerythemaandoedemaattheendof72h
Clinicalfindings
Meanscoresofindividualanimals*
123456
Meanscoresofallanimals**
Erythema22221.721.95
Oedema00.30.71.70.710.73
*basedonscoresforeachanimalattheendof72haccordingtotheDraizescoring method.
**after 72h for all animals
Themeanscoresofallanimalswere1.95forerythema,and0.73foroedema.
7.1.3Eyeirritation(ND)
APrimaryEyeIrritationStudyinRabbits(BonnetteKL,SpringbornLaboratories,2001),conducted withthePolymerin E7581withoutsolventwas submittedduringtheSecondaryNotification..Thestudywasconductedtoassesstheirritantand/orcorrosiveeffectsofPolymerinE7581withoutsolventwhenadministeredbyasingleoculardose.ThestudywasconductedincompliancewithGLPandinaccordancewiththeOECDTG405,andtheUSConsumerProductsSafetyCommission,FederalHazardousSubstancesActRegulations,1988.
Polymer in E758110
SixNewZealandwhiterabbits(3maleand3female)werechosen,witheachanimalreceivingadetailedpretestobservationpriortodosing.Onday0priortodosing,botheyesofeachanimalselectedforthetestwereexaminedmacroscopicallyforocularirritation.Inaddition,thecornealsurfacewasexaminedusingfluorescinsodiumdye.Followinganapproximately15secondexposure,theeyeswererinsedandthecornealsurfaceexaminedfordyeretention.Animalsexhibitingocularirritationorpre-existingcornealinjurywerenotusedinthetest.Onehourafterthepreliminaryocularexamination,0.1mLofthetestsubstancePolymerinE7581withoutsolventwasinstilledintheconjunctivalsacoftherighteyeofeachrabbit.Followinginstillation,theeyelidswereheldtogetherforapproximatelyonesecondinordertolimitthetestarticleloss. Thecontralateraleyeofeachanimalremaineduntreatedandservedasacontrol.
Followingapplicationofthetestsubstance,thetestandcontroleyeswereexaminedforsignsofirritationat1,24,48and72handupto14days,andtheeffectsonthecornea,irisandconjunctivanoted.TheresultsweregradedaccordingtotheOECDOcularGradingSystem(TG405),andthedataclassifiedaccordingto theNOHSC Approved Criteria(NOHSC, 2004).Theocular irritationscoresforallanimalsarepresentedinTable7.3.
Table7.3: OcularIrritationScoresaccordingtotheOECDOcularGrading
System
AnimalsCorneal
IrisConjuncti-
ChemosisConjunctival
opacityvalrednessdischarge
1
24h / 0 / 0 / 2 / 2 / 048h / 0 / 0 / 1 / 1 / 0
72h / 0 / 0 / 0 / 0 / 0
2
24h / 0 / 0 / 1 / 1 / 0
48h / 0 / 0 / 0 / 0 / 0
72h / 0 / 0 / 0 / 0 / 0
3
24h / 2 / 1 / 2 / 2 / 0
48h / 1 / 1 / 1 / 1 / 0
72h01110
4
24h / 0 / 0 / 1 / 1 / 048h / 0 / 0 / 1 / 1 / 0
72h / 0 / 0 / 0 / 0 / 0
5
24h / 1 / 1 / 2 / 2 / 0
48h / 0 / 0 / 1 / 1 / 0
72h / 0 / 0 / 1 / 1 / 0
6
24h / 0 / 0 / 2 / 1 / 0
48h / 0 / 0 / 1 / 1 / 0
72h / 0 / 0 / 1 / 1 / 0
Polymer in E758111
BasedontheresultsoftheOcularGradingSystem,the meanocularirritationscoreattheendof72hforallanimalsforcornealopacitywas(0.2),irislesion(0.2),conjunctivalredness(1.1)conjunctivaloedema(0.9)andconjunctivaldischarge(0).
7.2Skinsensitisation
Noskinsensitisationdatawerepresentedintheoriginalsubmission.Nonewdataweresubmittedwiththisapplication.
7.3Repeated-dosetoxicity
Inanoral(gavage)studyconductedaccordingtoOECDTG407,Sprague-Dawleyratsweregiven0,325,625and1250mg/kgofthetestsubstancefor28consecutivedaysincornoilvehicle.Nochangesinbodyweight,weightgainandfoodconsumptionwereobservedinanygroup.Notoxicologically-significantchangeswerenoted.Significantdose-relatedincreasesinabsoluteandrelativeliverweightsinbothsexeswereobserved,butnomicroscopicchangeswerenotedintheratsgiventhehighestdose.
TheNo-Observed-Adverse-Effectlevel(NOAEL)ofthesubstancewasdeterminedtobe1250mg/kgbw/d,basedontheabsenceofsystemictoxicityorpathologicaleffectsatthislevel.
7.4Genotoxicity
Oneinvitrostudyandoneinvivostudyweresubmittedwiththeoriginalapplication.
InastudyconductedaccordingtoOECDTG471usingdirectplateincorporation(SanandKruel,1989),S.typhimuriumstrainsTA98,TA100,TA1535andTA1537wereexposedtothetestsubstanceatconcentrationsofupto10000µg/platewithmetabolicactivation,andconcentrationsofupto6667µg/platewithoutmetabolicactivation.Nopositiveresponsewithanyofthetesterstrainswasnotedeitherinthepresenceorabsenceofmetabolicactivation.
Thetestsubstancedidnotinducemutationinthebacterialstrainstested.
InaninvivostudyconductedaccordingtoOECDTG474,ICRmiceweregiven0,363,1815and3630mg/kgofthetestsubstancebyasingleintraperitonealinjection.Resultsindicatedthattheratioofpolychromaticerythrocytestototalerythrocyteswasnotchangedintreatedmiceofbothsexes,indicatingthatthesubstancedidnotinducebonemarrowtoxicity.Astatisticallysignificantincreaseinmicronucleatedpolychromaticerythrocyteswasnotedatthe72hpointinmalemiceatthelowdoseonly,butwasconsideredtoberelatedtothelowbackgroundrateinthecontrolgroupatthistimepoint,ratherthanarealincreaseinthetreatedgroup.Whencomparedtothevehiclecontrolsat24or48h,nostatisticallysignificantincreaseswerenoted.Nochangeswereobservedat24and48hatalldoses.
Polymer in E758112
Thetestsubstancedidnotshowevidenceofgenotoxicactivityinvivointhemousemicronucleusassay.
7.5Reproductiveeffects(ND)
AReproduction/DevelopmentalToxicityScreeningTestintheRat(CTL/RR0844/Regulatory/Report),conductedwithPolymerinE7581withoutsolventwassubmittedduringtheSecondaryNotification.ThestudywasconductedtodeterminetheeffectsofPolymerinE7581withoutsolventonmaleandfemalereproductiveorgans.ThestudywasconductedincompliancewithGLP,andinaccordancewiththeOECDTG421.
Thestudyconsistedoffourgroups,onecontrolandthreetreatmentgroupseachcontaining10maleand10femaleWistar-derivedrats.Thetestsubstance,PolymerinE7581withoutsolvent,wasalightamberliquid,andwastestedasaformulationincornoil.Thecontrolsubstancewascornoil.Priortothestudy,theratswereexaminedtodeterminethattheywerenormal.Bodyweightsandclinicalchangeswererecordeddaily.Foodconsumptionforeachcageofratswasrecordedduringthe2-weekpre-matingperiodandcalculatedonaweeklybasis.Dosesadministeredpriortomatingandduringgestationandlactationwerebasedonindividualanimalbodyweights.
Theratsweredosedorallybygavagewith0(control),20,100or500mg/kgbw/dayPolymerinE7581 withoutsolventincornoil,withdosingcontinuingfor2weekspre-matingandduringmating.Dosingofmalescontinuedtoday30/31(aftermatingwascompleted)untiltermination,onday31ofthestudy.Dosingoffemalescontinuedthroughoutgestationuntilday4oflactation.Femaleswereterminatedonday5oflactation.
Litterswere weighedandexaminedondays1and5,postpartum.Thesexesof thepupsandanyclinicalabnormalitieswererecordedatthesametime.Deadormoribundpupsweresubjectedtoapost-mortemexamination,andabnormalitiesrecorded.
Malesdosedwith500mg/kgbw/dayshowedpoorergrowththanthecontrols(approximately11%belowthoseofthecontrolgroup).Foodconsumptioninmaleswasalsoslightlylessthanthecontrolgroupduringthepre-matingperiodinthe500mg/kgbw/daygroup.Onemaleinthisgroupwaskilledforhumanereasons,whichincludedweightlossandclinicaleffectssuchasstainednose,eyedischargeandreducedlimbfunctiononday31.TherewerenoeffectsinmalesdosedwithPolymerinE7581at20or100mg/kgbw/day.
FemalesdosedwithPolymerinE7581withoutsolventhadsimilarweightsascontrolsduringthepre-matingperiodandformostofthegestationperiod.However,inthe500mg/kgbw/daygroup,bodyweightswerelowduringlategestation,withtheoverallgestationweightgainbeing14%belowthecontrolgroup.Therewasadecreaseofbodyweightduringlactation.Onefemalefromeachofthe100and500mg/kgbw/daygroupswasfoundtohavedifficultygivingbirth(dystocia),andwerekilledtoinvestigatethisclinicaleffect.
Polymer in E758113
Therewasnoeffectonthelengthofgestation.Thenumberoflittersproducedinthe20,100and500mg/kgbw/daygroupswas9,10and8respectively,and7inthecontrolgroup.Thereweretwototallitterlossesinthe500mg/kgbw/daygroupand one inthe control group.Toxic findings indicated bylow body weights,diminishedornofoodconsumption,andclinicalfindingssuchaswetareaaroundtheanus,orurinestainingwerenotedduringthelactationperiodindamsinthe500mg/kgbw/daygroup.Therefore,thelitterlossesinthisgroupcouldberelatedtothetoxiceffectsnotedindamsatthisdose.Therewerenowholelitterlosses,andpupsurvivalwas100%and97.5%inthe20and100mg/kgbw/daygroups.
Themeanpupbodyweightsinthe500mg/kgbw/dgroupwerereduced(15%)comparedtocontrols.Therewerenoeffectsonpupsinthe20or100mg/kgbw/daygroups.
Macroscopicpost-mortemfindingsinthesinglefemaleinthe100and500mg/kgbw/daygroupswasdystocia.Thefindingsinthedeceasedmaleratinthe500mg/kg/daygroupwerenon-specific.
Macroscopicfindingsindicativeofpossiblehepatotoxicity(accentuatedlobularpattern,palespots/areas)wereobservedatterminationin1of10and4of10maleandfemaleanimalsrespectively.Nohistologicalexaminationwasconducted.
Nomicroscopicchangesintheovaries,testesor epididymis whichcouldberelatedtotreatmentwereobservedinthestudy.
Nostructuralabnormalitieswereidentifiedinthelivepupsexamined,orthepupsexaminedmacroscopicallyatpostmortem.
TheNo-Observed-Adverse-Effect-level(NOAEL)infemaleswasdeterminedtobe100mg/kgbw/day basedonanoverallreductioninbody weightgainof14%whencomparedtocontrols,andpossiblehepatotoxicityinthe500mg/kgbw/daytreatedgroup.
TheNOAELinmaleswasdeterminedtobe100mg/kgbw/daybasedonasignificantreduction(>10%)inbodyweightandfeedconsumptionat500mg/kgbw/day.
TheNOAELfordevelopmentaltoxicitywasdeterminedtobe500mg/kgbw/day.Areductioninpupweight(15%)andlitterlosseswerereportedat500mg/kgbw/d.Pupsurvivalwaslowinthe500mg/kgbw/daytreatmentgroupwithtwowholelitterlosses.Nomacroscopicstructuraldeformities,adverseclinicalsigns,litterweightchanges,oreffectsonsexdistributionwereobservedinpups,atthisdose.ThereductioninpupbodyweightandlitterlosseswereobservedatmaternallytoxicdosesandarethereforeconsideredtobesecondarytomaternaltoxicityandnotadirecteffectofPolymerinE7581.
TheNOAELforfertilitywasdeterminedtobe500mg/kgbw/daybasedontheabsenceofeffectsonreproductiveorgans,pre-coitalinterval,lengthofgestationandproductionofviablelittersatdoselevelsuptoandincluding500mg/kgbw/day.
Therewas no evidence ofdevelopmental toxicity due directly toPolymer in E7581oreffectsonreproductiveorgansinmaleandfemaleratsexposedtoPolymerinE7581atdosesupto,andincluding500mg/kg/day.
Polymer in E758114
8.Hazard Classification
ThissectiondiscussestheclassificationofthehealtheffectsofPolymerinE7581according to theNOHSC Approved Criteriafor Classifying HazardousSubstances(NOHSC,2004).TheNOHSCApprovedCriteriaarecitedintheNOHSCNationalModelRegulationsfortheControlofWorkplaceHazardousSubstances(NOHSC,1994)andprovidemandatorycriteriafordeterminingwhetheraworkplacechemicalishazardous.
Nohumandataareavailable.Theclassificationforhealtheffectsisbasedonexperimentalstudies(animalandinvitrotests).PolymerinE7581wasdeterminedtobenon-hazardousbasedonacuteoraltoxicity,repeated-dosetoxicityandgenotoxicitydataprovidedwiththeoriginalsubmission.
Thehazardclassificationforthenewdata(ND)providedfortheSecondaryNotificationforskinandeyeirritationandreproductive/developmentaleffectsarepresentedbelow.
ClassificationofPolymerinE7581inaccordancewiththeGloballyHarmonisedSystemofClassificationandLabellingofChemicals(GHS)(OECD,2003)canbefoundinAppendix 1.Thisisprovidedforguidance only,isnot mandatory andhasnolegalstatusatpresent.
8.1Skinirritation(ND)
AccordingtotheNOHSCApprovedCriteria,substancesandpreparationswhichcausesignificantinflammationoftheskin,thatpersistsforatleast24hafteranexposureperiodofupto4hareclassifiedasskinirritants.
Inflammationoftheskinissignificantifthemeanvalueofthescoresforeithererythema,escharformationoroedemaformation,calculatedoveralltheanimalstestedis2ormore.Allscoresateachofthereadingtimes(24,48and72h)foraneffectshouldbeusedincalculatingrespectivemeanvalues.Inflammationoftheskinisalsosignificantifitpersistsinatleasttwoanimalsattheendoftheobservationtime.Particulareffectse.g.,hyperplasia,scaling,discolouration,fissures,scabsandalopeciashouldbetakenintoaccount.
IntheDermalIrritation/CorrosivityStudyprovided,skininflammationwasnotedafteranexposureperiodof4hthatpersistedfor24h.Significantinflammationwasseenin5ofthe6animalswithindividualscoresforerythemaof2attheendof72h.Oneanimalhadsignificantinflammationattheendof48h(scoreof2)withslight erythema (scoreof 1) at theend of 72 hresulting in ameanscore for allanimalsof1.95attheendof72h.
Additionaldermalfindingsofdesquamation(scalingandflaking)werenotedinthreeanimalsat48handinallsixanimalsattheendof7days.
Polymer in E758115
Althoughthemeanscoreofallanimalsforerythemadidnotmeetthecriteriaforsignificantskininflammation(≥2)accordingtotheApprovedCriteria,basedontheborderlinescoreof1.95forerythema,inconjunctionwiththeadditionalfindingsof scaling and flakingnoted in allsix animals that persistedat the end of 7days,PolymerinE7581withoutsolventmeetstheApprovedCriteriaforclassificationasaskinirritant.
Classification
Polymerin E7581meetstheNOHSCApprovedCriteria(NOHSC,2004)forclassificationasaskinirritant.
8.2Eyeirritation(ND)
AccordingtotheNOHSCApprovedCriteria,substancesandpreparationswhichcausesignificantocularlesionsthatoccurwithin72hafterexposure,andwhichpersistforatleast24h,areclassifiedaseyeirritants.
Allscoresateachofthereadingtimes(24,48and72h)foraneffectshouldbeusedincalculatingtherespectivemeanvalues.
Ocularlesionsareconsideredsignificantifthe meanscoresoftheeyeirritationtestontwoormoreanimalsareequivalenttoanyofthefollowing:
•corneaopacityequaltoorgreaterthan2butlessthan3;
•irislesionequaltoorgreaterthan1butgreaterthan2;
•rednessoftheconjunctivaeequaltoorgreaterthan2.5;
•oedemaoftheconjunctivae(chemosis)equaltoorgreaterthan2.
Allscoresateachofthereadingtimes(24,48and72h)foraneffectshouldbeusedincalculatingtherespectivemeanvalues.
InthePrimaryEyeIrritationStudyinRabbits,themeanvalueofthescoresforcornealopacity,irislesionsandrednessandoedemaoftheconjunctivaeateachofthereadingtimes(24,48and 72h)were2forcorneaopacity,1foririslesions,andthan2and<2.5foroedemaandrednessoftheconjunctivaerespectively.
Classification
PolymerinE7581doesnotmeettheNOHSCApprovedCriteria(NOHSC,2004)forclassificationasaneyeirritant.
8.3Reproductivetoxicity(ND)
AccordingtotheNOHSCApprovedCriteria,reproductivetoxicityincludesimpairmentofmaleandfemalereproductivefunctionsorcapacity,andtheinductionofnon-heritableharmfuleffectsontheprogeny.Reproductivetoxicitymaybeclassifiedas:
EffectsonmaleorfemalefertilityDevelopmentaltoxicity
Polymer in E758116
IntheReproduction/DevelopmentalToxicityScreeningTestintherat,notreatment-relatedchangeswereobservedinthepre-coitalinterval,gestationlength,littersize,numberofimplantationsites,andpost-implantationlosses.Thenumberoflittersproducedinthe20,100and500mg/kgbw/daygroupswas9,10and8respectively,and7inthecontrolgroup.Therewerenowholelitterlosses,andpupsurvivalwas100%and97.5%inthe20and100mg/kgbw/daygroups.
Therewere noeffectsontestesorepididymisweights.Nomicroscopicchangesintheovaries,testesor epididymis whichcouldberelatedtotreatmentwereobservedinthestudy.
Threepupsin onelitter in the500mg/kg bw/daytreatmentgroupwere observedtobesmallonday5postpartum.Allotherpupobservationswererelatedtopupsfounddeadormissingpresumedcannibalisedbythedam.Meanindividualmaleandfemalepupbodyweightsinthisgroupwerereduced,thoughnotstatisticallysignificantascomparedtocontrols.Therewerenoeffectsonmeanindividualpupweightsinthe100mg/kgbw/daytreatmentgroupswhencomparedtocontrols.Nostructuralabnormalitieswerenotedinanyofthepupsexaminedmacroscopically,oratpostmortem.
Classification
PolymerinE7581doesnotmeettheApprovedCriteria(NOHSC,2004)forclassificationasasubstancetoxictoreproduction.
Polymer in E758117
9.EnvironmentalEffectsAssessment
Ecotoxicologicaldatawerenotprovided.Theintendedusepatternofthepolymerinthefueladditiveisnotexpectedtoresultinasignificantreleasetotheenvironment,asitisclaimedthatthepolymeriscompletelydestroyedbycombustionwithinthepetrolengine,producingoxidesofcarbonandhydrogen.Therearenodirectdatatosupporttheclaimofcompletecombustionofthepolymertooxidesofcarbonandhydrogenwhenthefuelisburntwithinthecombusionchamberofpetrolengines.However,itisevidentthatthepolymerwhichismadeupofhydrocarbon,nitrogenandoxygen,thenormalconstituentsofpetrol,willnotsurvivethetemperaturesatwhichthefuelexplodeswithintheinternalcombustionengine.Theanaloguedataindicatesthatthenotifiedpolymerwillnotincreasetailpipeemissions.
Intheeventofspills,theMSDSoftheadditivepackagecontainingthepolymercontainsinformationonprocedurestoenablecleanupoperatorstoreducereleasetotheenvironment.Minorspillsandleaksofthepolymermayoccurduringcustomerfillupsatpetrolservicestations.However,givenitslowpercentageinfuel,thelossofthepolymerinthesespillswouldbeexpectedtobelow.
Lessthan1tonneofthepolymerwastefromdrumrecyclingentersanaqueoustreatmentplant,wherepolymerwastewillbepartofthesolidwastesfromtheplantthatisconsignedtolandfill.Thepolymerisunlikelytobemobilegiventheverylowwatersolubilityandhighbindingaffinitytosoil.Thepolymer’slargemolecularsizeandverylowwatersolubilityshouldpreventbioaccumulation.
Giventheabove,environmentalexposureandriskareexpectedtobelow.
Polymer in E758118
10.RiskCharacterisationandManagement
PolymerinE7581insolventisanamberviscousliquid,stableundernormalconditions.Itiscombustibleasformulated,withoxidesofcarbon,hydrogenandnitrogenbeingproduced.Itswatersolubilityis10.0mg/Landflashpoint410Cinsolvent.Itsboilingpointhasnotbeendetermined.
ThedataprovidedintheoriginalassessmentindicatedthatPolymerinE7581hadverylowacutetoxicity(LD505000mg/kg).Itwasnotaskinsensitiser.Ina28-dayrepeat-dosetestingbygavage,a NOAELof1250 mg/kgbw/d wasestablished,basedonincreasedliverweights.Itisnotgenotoxic.
BasedonthedataprovidedfortheSecondaryNotification,PolymerinE7581isaskinirritant.Itisnotaneyeirritant,andhasnoreproductiveeffects.
PolymerinE7581isclassifiedasahazardoussubstanceaccordingtoNOHSCApprovedCriteria.
10.1Occupational
Theproductisimportedfullyformulated.Workerexposureduringtransportisunlikelyexceptintheeventofaspill.TheMSDSsuppliedbyAftonChemicalCorporationprovidesinstructionsforclean-upfollowingaspill.
Thehandlingoffuelandfuelproductsatrefineriesandterminalsingeneralmaycauseatransitoryirritationifadequateprecautionsarenottaken. However,workersat these sitesare required to wear personal protective equipmentto controlexposure.Theuseofdedicatedandautomatictransferlinesandenclosed,automated injectionintofuel,willreducethelikelihoodofexposuretotheadditivepackage.Therefore,nosignificanthealthrisksareexpectedfortheseworkers.
Exposureforservicestationworkersandmechanicsislikelytobenegligiblebecauseoftheverylowconcentration(lessthan0.1%w/w)ofpolymerpresentinthefinalfuel.Therefore,theriskofadversehealtheffects arisingfromexposuretothenotifiedpolymerisnegligible.
10.2Public
BasedonthenegligiblepotentialforpublicexposuretoPolymerinE7581arisingfromitsintendeduse,itisconsideredthatthePolymerinE7581willnotposeasignificanthazardtopublichealthwhenusedintheproposedmanner.
Polymer in E758119
10.3Environmental
Releasetotheenvironmentisnotexpectedtobesignificantasthepolymerinthefueladditiveiscompletelydestroyedbycombustionwithinthepetrolengine,producingoxidesofcarbon,nitrogen,andhydrogen.Itisalsoevidentthatthepolymerwhichismadeupofhydrocarbon,nitrogenandoxygenwhicharethenormalconstituentsofpetrolwillnotsurvivethetemperatureswithintheinternalcombustionengine.
Intheeventofspills,theMSDSoftheadditivepackagecontainingthepolymercontainsinformationoncleanupoperationswhichminimisereleasetotheenvironment.Thereleaseofthepolymer inminorspills andleaksatpetrol servicestationsisnotexpectedtobesignificant,duetothelowpercentageofthepolymerinthefuel.
Thepolymerisunlikelytobemobilegiventheverylowwatersolubilityandhighbindingaffinitytosoil.Duetothepolymer’slargemolecularsizeandverylowwatersolubility,bioaccumulationisunlikely.
Theemptydrumsandtheirresiduesaresenttoacertifieddrumrecyclerwheretheyarerinsed,andtherinsatedisposedinaccordancewithgovernmentregulations.
EcotoxicologicaldataforPolymerinE7581werenotprovided.
Polymer in E758120
11.Discussionand Conclusions
PolymerinE7581isnotmanufacturedinAustralia,andisimportedasacomponentinfueladditivepackagesat38%w/winsolventnaphtha(petroleum)withpolybuteneandotheradditives.Theadditivepackageisaddedtotheunleadedpetrolataratethatwillresultinapproximately0.005%w/wofthenotifiedpolymerinthefinalfuel.Theestimatedimportvolumeofthepolymerisintherangeof200-250tonnes/year.ThemajoruseofPolymerinE7581isasadetergentadditiveingasoline.Nonewuse/exposuredatawereprovided.
PolymerinE7581,asformulated,isanamberviscousliquid,stableundernormalconditions.Itiscombustibleasformulated,withoxidesofcarbon,hydrogenandnitrogenbeingproduced.Itswatersolubilityis10.0mg/Landflashpoint410Casformulated.Itsboilingpointhasnotbeendetermined.
PolymerinE7581hasverylowacuteoral toxicityinrats(LD50>5000mg/kgbw).Itisaskinbutnotaneyeirritantoraskinsensitiser.Ina28-dayrepeated-dosegavagestudyinrats,theNOAELwasidentifiedas1250mg/kgbw/daybasedontheabsenceofsystemictoxicityorpathologicaleffectsatthislevel.ThechemicalwasnegativeintheSalmonella/MammalianMicrosomePlateIncorporationMutagenicityAssayandintheinvivomousemicronucleustest.Thechemicalisnotconsideredgenotoxic.PolymerinE7581isnottoxictoreproduction.
Occupationalexposuremayoccurduringadditionoftheadditivepackagetothefuel.However,duetothe useofautomatedprocessesanddedicateddeliverylines,exposureisexpectedtobelow,exceptintheeventofspillsorleakages.Publicexposure isunlikelyas thepolymerwill notbedirectlymarketedtothepublic,andisalsounlikelyatpetrolservicestations.Environmentalexposureisexpectedtobeminimalfromaccidentalspillsorleaksfromstoragetanksorinlandfills,asthepolymerisexpectedtobindstronglytosoilduetoitslowwater solubility.Polymerreleasedtoanaquaticenvironmentwouldtendtopartitionoutofwaterandintosediment.
PolymerinE7581isclassifiedasahazardouschemicalundertheNOHSCApprovedCriteriaforClassifyingHazardousSubstances(NOHSC,2004).Forcomparisonpurposes,PolymerE7581isclassifiedasahazardoussubstanceundertheGloballyHarmonisedSystemforHazardClassificationandLabellingofChemicals(GHS)(OECD,2003),andwouldrequireappropriatelabellingwhenthissystemisadoptedinAustralia.PolymerinE7581isnotlistedintheAustralianCodefortheTransportofDangerousGoodsbyRoadandRail(FORS,1998).Theclassificationofthe fueladditive package inwhich thepolymerwillbecontainedisaClass3FlammableLiquid,PackagingGroupIII.
Polymer in E758121
12.Recommendations
ThissectionprovidestherecommendationsarisingfromtheassessmentofPolymerinE7581.RecommendationsaredirectedprincipallyatregulatorybodiesandimportersandformulatorsofPolymerinE7581.Implicitintheserecommendationsisthatbestpracticeisimplementedtominimiseoccupationalandpublicexposureandenvironmentalimpact.
12.1Recommendationstoregulatorybodies
12.1.1NOHSC
Polymerin E7581 isclassified as hazardousinaccordance with theNOHSCApprovedCriteriaforClassifyingHazardousSubstances(NOHSC,2004),withthefollowingriskphrase:
•R38–IrritatingtoSkin;
ThefollowingsafetyphraseisalsorecommendedforPolymerinE7581:
•S24–Avoidcontactwithskin
ProductscontainingPolymerinE7581atconcentrations≥20%aredeterminedtobehazardous.
ItisrecommendedthatthisclassificationbeincludedintheListofDesignatedHazardousSubstancescontainedintheHazardousSubstancesInformationSystem(HSIS).
12.2RecommendationstoImportersandStateandTerritoryAuthorities
12.2.1Hazardcommunication–MaterialSafetyDataSheet
UndertheNationalModelRegulationsfortheControlofWorkplaceHazardousSubstances(NOHSC,1994)andtheCommonwealth,StateandTerritoryregulationsintroducedinaccordancewiththesenationalmodelregulations,employeesshallhavereadyaccesstoMaterialSafetyDataSheets(MSDS)forhazardoussubstancesattheirworkplace.
InaccordancewiththeNationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets(NOHSC2003)itisrecommendedthatimportersofPolymerinE7581reviewtheirMSDSforcomplianceandpayparticularattentiontothefollowingpoints:
riskphrasesandhazardinformationshouldbeupdatedtoreflectthehazardclassificationinRecommendation12.1.1.
safetyphrasesshouldbeincludedasnotedinRecommendation12.1.1.
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12.2.2Hazardcommunication–Labels
InaccordancewiththeNationalCodeofPracticefortheLabellingofWorkplaceSubstances(NOHSC1994a)itisrecommendedthatimportersofPolymerinE7581reviewtheirlabelsforcomplianceandpayparticularattentiontothefollowingpoints:
riskphrasesandhazardinformationshouldbeupdatedtoreflectthehazardclassificationinRecommendation12.1.1;and
safetyphrasesshouldbeincludedasnotedinRecommendation12.1.1.
ItisrecommendedthatStateandTerritoryOccupationalHealthandSafetyauthoritiesreviewcompliancewiththeaboveinformation,intheworkplace.
12.2.3Recommendationtoimportersandusers Occupationalcontrols
TheriskofadverseefectsfromoccupationaluseofPolymerinE7581islow.This
assessmentsupportsthecontrolmeasuresrecommendedintheoriginalnewchemicalassessmentreportNA/752.ThecontrolmeasuresforPolymerinE7581areasfollows:
•localexhaustventilationattherefinery/terminal facility, if the petroladditiveisblendedwithpetrolinanenclosedarea;
•avoidanceofspillageandsplashingofthechemical.Spillagesandsplashesshouldbecleaneduppromptlyusingchemical-resistantimperviousgloves;
•ifengineeringcontrolsandsafeworkpracticesareinsufficienttoreduceexposure,employersshouldensurethatpersonalprotectiveequipment(PPE)suchasgloves,safetyglassesandoverallsareusedbyworkerstominimiseoccupationalexposure.ThepersonalprotectiveequipmentusedshouldbeinaccordancewithAustralian,Australian/NewZealandorotherapprovedstandards.
Disposal
Accidentalleaksandspillagesshouldbecleaneduppromptlywithabsorbentsandputintocontainersfordisposal.Theemptydrumsandtheirresiduesshouldbedisposedinaccordancewithgovernmentregulations.
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13.SecondaryNotification
UnderSection65oftheAct,theSecondaryNotificationofPolymerinE7581mayberequiredwhereanapplicantorotherintroducer(importer)ornewmanufacturerofPolymerinE7581,becomesawareofanycircumstancesthatmaywarrantareassessmentofitshazardsandrisks.Specificcircumstancesinclude:
a.TheuseofPolymerinE7581haschanged,orislikelytochangesignificantly.
b.TheamountofPolymerinE7581introducedintoAustraliahasincreased,orislikelytoincreasesignificantly.
c.ManufactureofPolymerinE7581hasbegun,orislikelytobeginin Australia.
d.Additionalinformationhasbecomeavailableontheadversehealthand/orenvironmentaleffectsofpolymerinE7581.
TheDirectormustbenotifiedwithin28daysoftheintroducerbecomingawareofanyoftheabovecircumstances.
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Appendix1
ClassificationundertheGloballyHarmonizedSystemofClassificationandLabellingofChemicals(GHS).
Inthis report, Polymer in E7581 has been classifiedagainst the NOHSCApproved CriteriaforClassifyingHazardousSubstances(ApprovedCriteria)(NOHSC,2004)and,inthecaseofphysicochemicalhazards,theAustralianDangerousGoodsCode(ADGCode)(FORS,1998).However,classificationundertheGloballyHarmonizedSystemofClassificationandLabellingofChemicals(GHS)(OECD,2003)willcomeintoforcewhentheGHSisadoptedbytheAustralianGovernmentandpromulgatedintoCommonwealthlegislation.GHSdocumentationisavailableat:
GHSclassificationforPolymerinE7581.
HealthHazard / Classification / HazardCommunicationSkinIrritation / Category3 / Symbol:NosymbolSignalWord:WarningHazardStatement:
Causesmildskinirritation
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Appendix2
ThisMSDSwasprovidedbyAftonChemicalCorporation.Itisreproducedhereasamatterofpublicrecord.TheformatofthisMSDSisacceptableundertheNOHSC’sNationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets(NOHSC,2003).HoweverthecontentsrequireupdatingasoutlinedinRecommendation12.1.1.Theaccuracyoftheinformationremainstheresponsibilityoftheapplicant.
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Polymer in E758128
Polymer in E758129
Polymer in E758130
Polymer in E758131
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BonnetteKL(2001)ApimaryeyeirritationstudyinrabbitswithPolymerinE7581withoutsolvent–FinalreportfromSpringbornlaboratories,Inc.,Spencerville,Ohio,USA,(SLIStudyNo.3547.21)1-29.
CTL/RR0844/Regulatory/Report(2000)PolymerinE7581withoutsolvent:reproduction/developmentaltoxicityscreeningtestintherat.CentralToxicologicalLaboratory,Cheshire.
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