Full Public Report Alkane5

Full Public Report Alkane5

File No: NA/256 Date:October 1996

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME

FULL PUBLIC REPORT ALKANE5

ThisAssessmenthasbeencompiledinaccordancewiththeprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989.Thislegislation isanActoftheCommonwealthofAustralia.TheNationalIndustrialChemicals NotificationandAssessmentScheme(NICNAS) isadministeredbyWorksafeAustraliawhichalsoconductstheoccupationalhealthsafetyassessment.TheassessmentofenvironmentalhazardisconductedbytheDepartmentoftheEnvironment,Sport,andTerritoriesandtheassessmentofpublic healthisconductedbytheDepartmentofHumanServicesandHealth.

Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybeinspectedbythepublicattheLibrary,WorksafeAustralia,92-94ParramattaRoad,Camperdown NSW2050,betweenthehoursof10.00amand12.00noonand2.00pmand4.00pmeachweekdayexceptonpublicholidays.

ForEnquiriespleasecontacttheAdministrationCoordinatorat:

Street Address: 92ParramattaRdCamperdown,NSW2050,AUSTRALIA

Postal Address:GPOBox58,Sydney2001,AUSTRALIA

Telephone:(61)(02)9565-9466FAX (61) (02) 9565-9465

Director

ChemicalsNotificationandAssessment

NA/256

FULL PUBLIC REPORT

ALKANE5

1.APPLICANT

ChevronChemicalAustraliaofLevel22385BourkeStMELBOURNEVIC3000 hasappliedforanassessmentcertificateandsubmittedastandardnotificationpackagefortheimportationofthechemical,"Alkane5",undersection23oftheIndustrialChemicals(NotificationandAssessment)Act1989.

2.IDENTITYOFTHECHEMICAL

Other name(s):Polyalphaolefin;Alkane5

Trade name(s):PAO68cSt(C12content10%)

PAO79cSt(C12content98%)

Methodofdetectionanddetermination:

1.Infraredspectroscopyanalysis

2.HighPerformanceLiquidChromatographyandGasChromatography:

ThehomopolymeristrappedonaC18reverse-phaseHPLCcolumnbeforebeingelutedoffwithhexane,andthenanalysedbyGC(detectionlimitof10ppb)

3.PHYSICALANDCHEMICALPROPERTIESAppearance at 20°C

and 101.3 kPa:clearcolourlessliquid

Odour:not provided

Boilingpoint:420-650°C

Specificgravity/density:0.8337kg/m3at 15°C

Vapour pressure:5.0 x 10-2mmHgat25°C (Reidvapourpressure)

Watersolubility:10ppb-OECD105(runtoSOPstandards)

Partitionco-efficient

(n-octanol/water):log Pow> 8.0 (HPLC)

HydrolysisasafunctionofpH:stableunderallconditions

Adsorption/desorption:thePAOhydrogenatedhomopolymerprobablywillnot

associatewitheithersoilorwater;duetoitsverylowwatersolubility,itwillmigrateslowlythroughsoilbeforebiodegrading.

Dissociationconstant:willnotdissociate

Flashpoint:180°C

Flammabilitylimits:willburninthepresenceofenoughheatandoxygen

Combustionproducts:completecombustionproductsarecarbondioxideand

water

Decompositiontemperature:300°C

Decompositionproducts:incompletecombustionproductsarecarbondioxide,

water,carbonmonoxide,olefinichydrocarbons,andoxygenatedhydrocarbonfragments.

Autoignitiontemperature:200°C

Explosiveproperties:notknowntobeexplosive

Reactivity/stability:willreactinthepresenceofstrongoxidisingagents.

Stabletoacidandbase.

Particlesizedistribution:viscousliquid;willnotformparticles.

CommentsonPhysico-ChemicalProperties

WatersolubilitywasdeterminedusingPAO4cSt(trimerfractionofthenotifiedpolyalphaolefininNA/255withasimilarmonomercomposition)followingthemethodofOECDGuideline105. AsAlkane5hasagreatermolecularweightrangethantheC10trimer,itisexpectedtohavealowersolubility(calculatingwatersolubilityusingaStructuralAnalysisRelationshipaccordingtothemethodofIrmann(1)).

NotestreportormethodwasprovidedforthedeterminationofthelogPowfor Alkane 5.However, a log Powof8wasdeterminedforPAO4cStusingreversephaseHPLC(methodgiveninChromatographia,27, 118-122,1989)byacomparisonofpolyaromatichydrocarbonstandardsrunwithPAO4cStandmeasuredusingUVspectrophotometry.ThenotifierhasusedthisvalueastheexpectedlogPowfor Alkane 5. As Alkane 5 isexpectedtohavealowerwatersolubilityandequalsolubilityinoctanolcomparedwithPAO 4 cSt, it is agreed that its log Powwillbegreaterthan8.

ThenotifierclaimsthatAlkane5willnothydrolyse Itisagreedthatthechemicalcontainsnofunctionalitiesthatwouldbesubjecttohydrolysis,ordissociate,undertheexpectedenvironmentalconditionsofuse.

Adsorption/desorptionwasnotdetermined. ThenotifierexpectsthatAlkane5willnotadsorbtosoil,norassociatewithwater,becauseofitslowwatersolubility. Further,itisexpectedtomigrateslowlythroughsoilbeforebiodegrading. Itisagreedthatmobilitythroughsoilwouldbeslow,butthiswouldbeduetoitsexpectedstrongadsorptiontosoilbecauseofitshighPow.

4.PURITYOFTHECHEMICALDegreeofpurity:100%Toxicorhazardousimpurities: noneNon-hazardousimpurities

(>1%byweight):none

Additives/Adjuvants:none

5.INDUSTRIALUSE

Theprimaryuseforthishydrogenatedpolyalpha-olefin(PAO)homopolymerisasabasefluidtoblend“synthetic”automotiveandindustriallubricants. Alkane5isproducedintheUnitedStatesandimportedintoAustralia. TheestimatedimportvolumewhichwillbeimportedintoAustraliaisapproximately300000kg/year.

6.OCCUPATIONALEXPOSURE

Thereislikelyexposureofworkersinvolvedinthetransferandtransportationofthenotifiedchemical,workerswhoblendthehydrogenatedtrimerintofinishedlubricants,andmechanicsortechnicianswhomaycomeintocontactwithPAOcontaininglubricantswhileworkingonorrepairingequipment.

Themostlikelyrouteofexposureforthistrimerisskinandeyecontactwhichwouldbeminimisedinmanufacturingandtransportationworkersbyengineeringcontrolsandprotectiveclothing. Howevermechanicsortechniciansrepairingequipmentwearprotectiveclothingbutoftenmaynotwearglovesoreyeprotection.

Alkane5willbeshippedtoAustraliainbulkorisotankerandstoredinbulkstoragetanks.Thenotifiedchemicalwill arriveatatypicalAustraliancustomer’sblendingplantbyrailcarortanktruck.Alkane5istransferredtoastoragetankthroughafourinchhose. Oneworker,wearingfullprotectiveclothing,gloves,andeyeprotection,spends10minutesfasteningtheendofthehosetothetankcarandafurther10minutesuncouplingthe

hosewhenthetransferiscomplete. Proceduresexisttoensurethatthereisnospillageduetolooseconnectionsbetweenhoseandtankcar.

Thefinishedautomotiveandindustriallubricantsarepreparedbypumpingthenotifiedchemicalandtheadditivepackagefromtheirstoragefacilitiesthroughcomputercontrolledvalveswhichmetertheprecisedeliveryofthecomponentsintoablendingtankwheremoreadditivesmaybeaddeddependingonformulationtobepreparedforspecificuses. Exposureofworkerscanoccurafterblendingduringsampleremovalforlaboratoryanalysis. Asampleoftheproductisremovedfromtheblendtankbyoneortwoworkerswearingeyeprotection,coveralls,andglovestoensurethatthespecificationsofthefinishedlubricantaremet. Workerswillbepotentiallyexposedtoan80-100%formulationfor30minutes,50daysayearatboththesamplingandanalysisstage. Duringthecleaningprocessoftheblendingtankanddrums,1workermaybeexposedtoan80-100%formulationofthenotifiedchemicalfor1hour,50daysayear.

Thisexposuremaybetolubeoilused tocleantheblendingtanksortothewastewaterfromthecleaningofthedrums. Exposuretothewastewaterwillbeminimalasthetreatmentprocessispartofengineeringcontrolprocessestominimiseexposure.

Thefinishedproducts,orthenotifiedchemicalitself,arepackagedinto1L,40L,or200Ldrums. Workerswillbepotentiallyexposedtothefinishedlubricantduringthepackagingofthedrums. Thelevelofexposureshouldbeminimalasthedrummingfacilityusesautomatedweightscalestofillthedrumsandpotentialworkerexposureoccursastheoperatorwatchesfrom1-2metresawaytoensurethedrumfillingmechanismproperlyentersthedrumbeforethedrumisfilled. Thebungsandlabelsareappliedbytheoperators. Thepackagingof1Land4Ljugsisautomatedandthereisminimalworkerexposure. Thereareapproximately20-30peopleinAustraliawhowouldbeinvolvedinthetransportationandpackagingofproductscontainingthenotifiedchemical.

Mechanicsmaybeexposedtothenotifiedchemicalataconcentrationofapproximately80%whilechangingautomobileengineoil. Dermalexposureislikelytooccur,andaccidentaleyecontactmayalsooccur,particularlywhilemechanicsareworkingundervehicles. Inhalationalexposureisunlikelyduetothelowvapourpressureofthenotifiedchemical.

7.PUBLICEXPOSURE

Thenotifiedchemicalwillbeusedasabasefluidtoblendsyntheticautomotiveandindustriallubricantsatalevelofabout80%.

Theautomotiveandindustriallubricantswillbepreparedinablendingtank. Therewillbelowpotentialforpublicexposuretothenotifiedchemicalduringblendingoperations.Theblendingequipmentiscleanedwithsteamandatypical5000kgblendingtankwouldhaveabout1kgofresiduewhichwillbesenttoawastewatertreatmentfacility.Afterfurtherseparationoftheoilfromwater,lessthanagramwillbeemulsifiedinthewaterandreleasedtothemunicipalsewer.

Industrialuseofthelubricantsinfoodpackagingandprocessingequipmentmayresultincontaminationoffoodwiththeproductwhenincidentalcontactwithfoodoccurs. This

typeofequipmentwouldbemaintainedbyskilledworkersandcontaminationshouldbeminimalandinfrequent.

Theautomotiveengineoilcontainingapproximately80%ofthenotifiedchemicalpackagedin4or1Lcontainerswillbeavailabletothegeneralpublic. Thus,thepubliccanbeexposedtothenotifiedchemicalbyskincontactduringoilchanges,buttheexposureisshortandoccursinfrequently. Accidentalsplashingintotheeyecanalsooccur. Inhalationalexposurewillbenegligiblebecauseofitslowvapourpressure.

Disposaloftheusedoilisnotexpectedtoresultinpublicexposureifitisdisposedofaccordingtogovernmentregulations.

Whenusedinautomobileengineoil,thenotifiedchemicalmaybedecomposedinthecombustionchamber,andthedecompositionproductsmaybeemittedintotheairviatheautomobiletailpipe. CompletecombustionofPAO2cStproducescarbondioxideandwater. Inthecaseofincompletecombustionordecomposition,amixtureofcarbondioxide,water,carbonmonoxide,olefinichydrocarbons,andoxygenatedhydrocarbonfragmentsareproduced. Thenotifierclaimedthatthedecompositionproductsemittedfromanautomobilewillbeverylimitedandnotdistinguishablefromthefuelderivedcombustionproducts,whichwilldominatethehydrocarbonemissions. Therefore,publicexposuretothedecompositionproductsfromincompletecombustionofthenotifiedchemicalinautomobileenginesisexpectedtobelow.

Inthecaseofaccidentalspillageduringtransport,thepublicmaybeexposedtothenotifiedchemical. However,theexposurewillbeminimalifthespillsarecontainedandcleanedupbytherecommendedpracticessuchasapplicationofabsorbentmaterialsandpumpingasoutlinedintheMaterialSafetyDataSheet(MSDS).

8.ENVIRONMENTALEXPOSURE

.Release

Theformulationofsyntheticautomotiveandindustriallubricantswillinvolveanautomatedblendingprocess. Thenotifierestimatesthatonsteam-cleaningoftheequipmentanddrums,about1kgfroma5tonnebatchoffinishedproduct(0.02%)mightbereleasedinthewastewater. Afteroilseparationofthewastewater,only5%ofthe

1kgofoil(50g)releasedisexpectedtobeleftemulsifiedinwastewater. Thewastewaterisfurthertreatedbypondaeration,inwhichoilisskimmedfromthesurface,andsandfiltration,leadingtoafurtherreductionofgreaterthan2%(ie1g). Thefillingofcontainersisalsohighlyautomatedandcleanedwithlubeoil. Anyspillageinfillingcontainerswillbecleanedupwithsawdustorrags.

Oilthatcanbereclaimedintheaboveprocesseswillberecycled,whilecontaminatedsolidswilleitherbeburntorlandfilled. Anyuseddrumswillberecycledandsteamcleanedforre-use.

.Fate

SomeAlkane5willbecombustedanddestroyedinusewhenusedasanautomotiveorindustrialoil,whilethemajoritywillsharethefateofrecycledoil. Also,aminorcomponentwillbereleasedtotheenvironmentfromspillsandleaks,butwillbewidelydispersedandexpectedtoadsorbtosoilsorsedimentsadjacenttheroadorequipment.Asmallamountmayvolatilise.

Thenotifierestimatesthatabout20%oftheexpectedvolumetobeusedinautomotiveandindustrialoils(ie20%x300tonne=60tonne)willbeusedbyhomeusersfor"do-it-your-self"purposes. IthasbeenestimatedfromanANZECreport(2)onusedlubricatingoil,that35%oftheoilusedforautomotivepurposeswillnotbecollectedandcouldbedisposedofinaninappropriatemanner1. Aworstcasescenariowouldbeifallofthisuncollectedoilwasdumpedintoasewerinsomecountrycentre. This,however,wouldgiveaconcentrationofonlyabout12mg/Lper day2. Foramajorcity,theamountwouldonlybeabout115µg/Lperday. However,withitsuseAustraliawide,andwithgoodindustrialandpublicpractice,significantaquaticexposuretothepolymerisnotexpected.

·biodegradation

Informationonbiodegradationwasprovidedbythenotifier(4). ThisindicatedthatPAO6andPAO8,unspecifiedfractionsofAlkane5,werenotreadilybiodegradablewithprimarydegradationof47%and29%achieved,althoughultimatedegradationofonly41%and7%after28dwasachieved. Italsoindicatedthatforarangeofpolyalphaolefins,theextentofdegradationofthepolyalphaolefinsdecreasedwithincreasingmolecularweight. ItwouldappearthatAlkane5wouldgenerallynotbereadilybiodegradable.

UltimatebiodegradabilityofPAO6andPAO8rangedfrom41to7%,andwhilesomemineralisationwasthereforeshown,itwasclassedasnotultimatelydegradable.

·bioaccumulation

ThebioaccumulationpotentialofAlkane5wasnotdetermined. ThenotifierclaimsthatasitslogPowisgreaterthan8,itisnotlikelytobioaccumulatebecausethematerialis

practicallywaterinsoluble.Notingtheliterature(4),itisagreedthatitslowwatersolubility(<0.002mol/m3)andhighlogPow(>6),aswellasitsreadybiodegradation,islikelytolimitbioaccumulation.

1Nofiguresareavailableforhowmuchautomotiveoilwascollectedforre-use,butanestimateofabout35%ofalloilsoldisnotcollectedandpossiblydisposedofinaninappropriatemanner.Therefore,thispercentagewillbespecificallyappliedtoautomotiveoils.

2Given35%ofoilnotcollectedandassumingonly20%oftheimportedbasefluidisusedasanautomotiveoilforhomeuse,21000kgoftheadditivewouldalsonotbecollected(ie.35%x20%x300000kg). Thiswouldbe58kg/d(ie.21000kg/365d). Thedilutionataruraltowncouldreasonablybeexpectedtobeabout5 ML,whileforamajorcity,sayMelbourne,itwouldbe500 ML. Thiswouldgivefinalconcentrationsoftheoilof12mg/Lperdayand115µg/Lperday,respectively.

9.EVALUATIONOFTOXICOLOGICALDATA

Alltheacutestudiesexceptfortheinhalationaltoxicitystudywereperformedwiththenotifiedchemical. Theacuteinhalationaltoxicity,repeateddosetoxicityandgenotoxicitystudieswereconductedwithacloselyrelatedcompoundPAO2. ThetoxicitystudiesonPAO2cStcanbeusedtoassessthetoxicityofthehomopolymer,whichhasarelativelyhighermolecularweight.

9.1AcuteToxicity

AcutestudiesonPAO8cStwereprovidedinaconferencereport. GLPstatusandqualityassurancewerenotstated.

Table 1 SummaryoftheacutetoxicityofAlkane5(PAO8cSt)

TestSpeciesOutcomeReference

OraltoxicityratLD505mL/kg(4168mg/kg)

(5,6)

Dermal toxicityrabbitLD502000mg/kg(5,7)

Inhalational toxicity*ratLC50=1170mg/m3(5,8,9)

Skin Irritationrabbitnon-irritant(5,10)

Eye irritationrabbitmildirritant(5,12)

Skinsensitisationguineapignon-irritant(5)

*StudyperformedwithacloselyrelatedcompoundPAO2cStwithalowermolecularweightthanthehomopolymer.

9.1.1OralToxicity(5,6)

FastedSpragueDawley(SD)rats(5/sex)wereadministered5mL/kgofundilutedPAO8cStbysingleoralgavageandobservedfor14days. Nodeathsoccurred. Ruffledfuranddiarrhoeawereobservedduringthefirst24hoursafterdosing,butalltheanimalsappearednormalbyday2. Necropsyexaminationrevealed3casesofmoderatehydrometraand3casesoflungswithsmallscatteredclear,firmraisedareas. Itwasnotknowniftheselesionsweretreatment-related. TheoralLD50of PAO 8 cSt was > 5 mL/kg(4168mg/kg).

Inanotherstudy(6),10fastedSDrats(5/sex)wereadministered5000mg/kgAlkane5byasingleoralgavageandobservedfor14days. Therewerenodeathsorsignsofsystemictoxicity. Necropsyfindingswerenormal. TheacuteoralLD50wasgreaterthan5000mg/kg.

9.1.2DermalToxicity(5,7)

OnegroupofyoungadultalbinoNZWrabbits(4/sex)weredermallytreatedwith2000mg/kgofPAO8cStundergauzepatchonintactskinfor24hours,andasecondgroupwassimilarlytreatedonabradedskin. Theobservationperiodwas14days. Nodeathsorsignsofsystemictoxicitywereobserved. Skinirritationincludingslighterythemaandoedemaatthetreatmentsitewasobservedduringthefirst4daysoftheobservationperiod. ThedermalLD50ofPAO8cStinrabbitswas2000mg/kg.

Inanotherstudy(7),10fastedSDrats(5/sex)weredermallytreatedwith2000mg/kgAlkane5ontheintactskinundersemi-occlusivedressingfor24hoursandobservedfor14days. Therewerenodeathsorsignsofsystemictoxicity. Necropsyfindingswerenormal. TheacutedermalLD50wasgreaterthan2000mg/kg.

9.1.3InhalationToxicity(5,8,9)

Aninhalationstudyonthenotifiedchemicalwasnotconducted,butstudiesonacloselyrelatedcompound,PAO2cSt,wasprovided.

Inonestudy(5,8)5groupsofCharlesRiverCDalbinorats(5/sex/group)wereexposedtoanaerosolofSF-0203-41(PAO2cSt)at770,940,1100,1400or5100mg/m3for

4hours.Theaverageaerosolparticlesizewas2.9±2.07mm. Acontrolgroupwassimilarlyexposedtoaironly. Theanimalswereobservedfor14daysafterexposure.

Clinicalsignsobservedduringandafterexposureincludeddyspnoeaandnasaldischarge. Deathsoccurredwithinthefirst2daysafterexposureinallfemalegroupsandthemalegroupsexposedto1100mg/m3ormoreoftestsubstance. Thehighdosegroupsgainedlessbodyweightduringthefirstweekafterexposure,butthebodyweightgainwasnormalinthesecondweekpost-exposure. Macroscopicchangeswereobservedintheanimalsthatdiedduringthestudyandincludedrednasaldischargeandcongestedlungs.

Microscopicexaminationwasnotconductedintheratsexposedto770-1400mg/m3.Inthe5100mg/m3group,pulmonarycongestionwasobservedinalltheanimals. Muralproteincastswereobservedintheterminalandrespiratorybronchioles. Thecontrolanimalswerenormal. TheLC50forthecombinedsexeswas1170mg/m3.

Inthesecondinhalationstudy(9),agroupof10CDrats(5/sex)wereexposedtoanaerosolofPAO2cStat5170mg/m3(maximumpracticalconcentration)for1hour. Acontrolgroup(5/sex)wassimilarlyexposedtoroomaironly. Theanimalswereobservedfor14daysafterexposure.

Theaverageaerosolparticlesizewas1.9mmwithastandarddeviationof1.8. Onlyonetreatedfemalesurvivedduringthestudyandothertreatedanimalsdiedorweresacrificedondays1-3afterexposure. Clinicalsignsoftoxicityincludedreducedactivity,partlyclosedeyes,hunchedback,lateralprostration,increasedrespiratoryrate,labouredandirregularbreathing,andmuzzleandabdominalstaining. Thesurvivingfemalewasclinicallynormalbyday9. Noclinicalsignswereobservedinthecontrols.

Grosspathologicalexaminationrevealedanincreasedincidenceoffluidinthetrachea,uncollapsedlungsanddiscolourationofthelungsintheanimalsthatdiedduringthestudyandincreasedlungandtracheaweightsinthesurvivingfemale. Microscopicalexaminationshowedacutepneumoniaand/orhaemorrhageinthelungs,andslightfocalormultifocaldegenerationand/ornecrosisoftheepitheliumofthenasalseptuminthetreatedanimals. Thesurvivingfemalehadmildinterstitialpneumoniaofachronicnatureandslightfocalhyperplasiaoftherespiratoryepithelium. Myocardialdegenerationand/orfibrosiswerealsoobservedinthisanimalandwasconsideredpossiblyrelatedtothetreatment.

9.1.4SkinIrritation(5,10)

SixyoungadultNZWrabbits(3/sex)weredermallytreatedwith0.5mLofPAO8cSton intactskinontheleftsideandabradedskinontherightsideandcoveredwithagauzepatchfor24hours. Attheendoftheexposure,anyresidualtestmaterialwasgentlywipedfromtheskin. Theskinwasexaminedimmediatelyafterpatchremovalandat72hoursafterapplication.

Theprimarydermalirritationindexwas0.1at24hoursand0at72hoursusingthemethodofDraize(11). Thetestsubstancewasnotaskinirritantinrabbits.

Inanotherstudy(10),6NZWrabbitsweredermallytreatedwith0.5mLofAlkane5ontotheintactskinundera2.5x2.5cmcottongauzepatchfor4hours. Theskinwasexaminedat30min,24,48and72hoursafterpatchremovalandscoredaccordingtotheDraizemethod. Noerythemaoroedemawasobservedandtheprimaryirritationindexwas0. Alkane5wasnotaskinirritantinrabbits.

9.1.5EyeIrritation(5,12)

NineyoungadultNZWrabbitsweretreatedwith0.1mLofPAO8cStbyinstillationintotheconjunctivalsacoftherighteye. Theeyesof3rabbitswerewashedwithwaterforoneminuteafter20-30secondsexposure. Theeyeswereexaminedat24,48,72and

96hoursandat7daysaftertreatmentandscoredaccordingtotheDraizemethod(13).Theprimaryeyeirritationscorewas1.3at24hoursafterinstillationinbothwashedandunwashedeyes.Noirritationwasobservedby48hoursaftertreatment.PAO8cStwasconsideredamildeyeirritantinrabbits.

Inanotherstudy(12),9NZWrabbitsreceived0.1mLofAlkane5intotheconjunctivalsacoftherighteyeand3ofthemwerewashedwithwaterat30secaftertreatment. Theeyeswereexaminedat1,24,48and72hoursafterinstillation. Conjunctivalrednesswasobservedinoneanimalat1houraftertreatmentanddisappearedby24hours. No oculareffectswereseeninotherrabbits. Alkane5wasnotaneyeirritantinrabbits.

ThenotifiedchemicalisnotconsideredaneyeirritantinrabbitsbasedonthemostrecentstudywhichwascompletedinMarch1995andwasincompliancewiththeOECDguideline(1987).

9.1.6SkinSensitisation(13)

TheskinsensitisationpotentialofPAO8cStwasstudiedinguineapigsusingamodifiedBuehlertest.

Agroupof10malealbinoHartleyguineapigswereinducedwith0.5mLofthetestmaterialeveryotherday(3times/week)for3weeks. Thesiteswereexaminedat24and48hoursaftereachapplication. Thechallengedose(0.5mL)wasapplied2weeksafterthelastinductiondose. Thereactionwasexaminedat24and48hoursafterchallenge.Apositivecontrolgroup(10animals)wassimilarlytreatedwith2,4-dinitro-1-chlorobenzenedilutedindistilledwater.

Eighttestanimalshadslighterythemaand2hadslightoedemaduringtheinductionphase. Noneofthetestanimalsrespondedtothechallengedose. Thepositivecontrolshowedthattheanimalscanbesensitisedbyaknownskinsensitiser. PAO8cStwasnotaskinsensitiseringuineapigs.

9.2RepeatedDoseToxicity(14)

Repeateddosestudyonthenotifiedchemicalwasnotconducted,butastudyonacloselyrelatedcompound,PAO2cStwasprovided.

YoungadultSDrats(6/sex/group)wereorallyadministeredOroniteXS101(PAO2cSt)at 0,200,500or1000mg/kg/dayfor29daysbygavage. Twoadditionalgroupsweresimilarlydosedwith0and1000mg/kg/day,respectively,andrecoveredfortwoweeksaftercessationofadministrationbeforebeingsacrificed.

Nodeathsortreatment-relatedclinicalsignswereobservedinthecontrolandtestanimals. Therewerenochangesinbodyweightgain,feedconsumption,haematologyorclinicalchemistry. Organweightswerenotaffectedbytreatment. Notreatment-relatedmacroscopicormicroscopicchangesweredetected. Thetestcompoundwasoflowtoxicityinratsbyrepeateddosingforupto29days.

9.3Genotoxicity

Genotoxicitystudiesonthenotifiedchemicalwerenotconducted,butstudiesonacloselyrelatedcompound,PAO2cSt,wereprovided.

9.3.1SalmonellatyphimuriumandEscherichia coliReverseMutationAssays(14)SalmonellatyphimuriumTA98,TA1537,TA100andTA1535andEscherichiacoliWP2uvrA were cultured with 0.1 - 10 mg/plate of Oronite XS 101 (PAO 2 cSt) with and without metabolicactivationusingratliverS9. Atthehighestconcentration,thetestmaterialwassuspendedinthevehicle(acetone),butatalllowerconcentrations,thetestmaterialappearedtobemisciblewiththesolvent. Alldoselevelswereplatedintriplicate. Solventandpositivecontrolswererunconcurrently. Inthepositivecontrols,2-aminoanthrocenewasusedinthepresenceofS9inallthestrains.IntheabsenceofS9,2-nitrofluorenewasusedinstrainT98,sodiumazideinstrainsTA100andTA1535,andICR-191instrains TA 1537 and WP2 uvrA.

Noreproducibleincreasesinmutantfrequencywereobservedinthetreatedgroups. Thepositivecontrolsproducedmarkedincreasesinmutantfrequencyinalltheteststrains.

Thetestconcentrationswerenotcytotoxictoanystrain. Undertheconditionoftheassay,PAO2cStwasnotmutagenicintheSalmonellatyphimuriumandEscherichiacolireversemutationassays.

9.3.2MicronucleusAssayintheBoneMarrowCellsoftheMouse(15)

YoungadultSwissalbinomice(18-21/sex/group)wereintraperitoneallyadministered1250,2500or5000mg/kg(thehighestpracticaldose)ofOroniteXS101(PAO2cSt),

suspendedinpeanutoil. Avehiclecontrolgroup(18/sex)received4000mg/kgofpeanutoilonly,andapositivecontrolgroup(5/sex)wastreatedwith0.25mg/kgoftriethylenemelamine. Bonemarrowwascollectedfrom10animals(5/sex)fromeachtreatmentandvehiclecontrolgroupatapproximately24,48and72hoursafteradministration. Positivecontrolsweresampledat24hours. Twobonemarrowsmearsweremadefromeachanimaland1000polychromaticerythrocyteswerescoredformicronuclei.

Noclinicalsignsoftoxicitywereobservedduringthestudy. Cytotoxicitywasdetectedinmalesinthepositivecontrolandatthe1250mg/kgdoselevelsampledat24hoursandinfemalesatthe2500and5000mg/kgdoselevelssampledat48hours. Nosignificantincreaseinthenumberofmicronucleatedpolychromaticerythrocyteswasobservedin thetreatedanimals. Thepositivecontrolinducedmicronucleiasexpected. PAO2cStdidnotcausechromosomaldamageinbonemarrowcellsofthemousein vivo.

9.4OverallAssessmentofToxicologicalData

Alltheacutestudiesexceptfortheinhalationaltoxicitystudywereperformedwiththenotifiedchemical. Theacuteinhalationaltoxicity,repeateddosetoxicityandgenotoxicitystudieswereconductedwithacloselyrelatedcompoundPAO2cSt. ThetoxicitystudiesonPAO2cStcanbeusedtoassessthetoxicityofthehomopolymer,whichhasarelativelyhighermolecularweight.

Basedonthestudiessubmitted,thenotifiedchemicalwasoflowacuteoraltoxicityinratsandlowdermaltoxicityinrabbits. Itwasnotaskinirritantinrabbitsoraskinsensitiseringuineapigsbutwasamildeyeirritantinrabbits. Toxicitybyinhalationisunlikelyduetothehigherviscosityofthenotifiedchemical(7-9cStat100°C)comparedtothedimer(2cSt at 100°C),theriskofaerosolsbeinggeneratedbeingnegligible. Thedatadoesdemonstratehoweverthepotentialforsignificantinjuryresultingfromanyinhalationintothe respiratory tract.Based on the study on PAO 2 cSt, it is expected that repeated administrationofupto1000mg/kg/dayfor29dayswouldnotproduceanyobservedadverseeffectsinrats. Itisnotexpectedtocausereversemutationinbacteriaorcausechromosomaldamageinmousebonemarrowcells.

Onthebasisofthetoxicitydataprovided,thenotifiedchemicalisnotclassedashazardousaccordingtoWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(16).

10.ASSESSMENTOFENVIRONMENTALEFFECTSTable2.Ecotoxicity test results for Oronite XS 101

11.Design elementSpeciesTestResult

RainbowTrout(Oncorhynchusmykiss)

96hour acute

LC501000mg/La

Water Flea (Daphniamagna)48hour

acute

EC50=230mg/La

Algae (Selenastrumcapricornutum)

72hourForgrowthstimulation(0-

72 hour): EC501000mg/La

a. Resultbasedonnominalconcentrations,althoughtestwasconductedwiththewatersolublefraction.

EcotoxicitystudieswereconductedusingOroniteXS101(aC10polyalphaolefindimerwithasimilarmonomercompositionasAlkane5)accordingtoUSEPAorOECDguidelines(Table2). Thetestconcentrationsarenominalconcentrationsonly,withthewatersolublefractionused. OroniteXS101wasaddeddirectlytothetestwatertogive thecorrectconcentrationifallwoulddissolve. Thesolution/emulsionwasthenstirredfor20hours,andallowedtosettlefor4hours. Therequiredtestsolutionwasthensiphonedoffintotestvessels,avoidinganysurfacefilm. ThedegreetowhichPAO2cStdidnotdissolvewasnotrecorded,althoughalltestsolutionsremainedclearforthedurationofthe test.

Theresultsindicatethatthepolyolefinispracticallynontoxic,withthelowestEC50of230mg/Lforwaterflea. Infact,mortalityseemedtobeassociatedwiththepresenceofanoilyfilm,presumablyfrompartitioningofthepolyolefinoutofsolutionathigherconcentrations(loadings).

ThenotifiergaveaNOELof19mg/L,althoughthesublethalandlethaleffectsobserveddidnotappeartofollowadose-responseandwereofalowlevel(mortality10%atLOELandhigherconcentrations). Algaetoxicitywasassociatedwithallnominalconcentrations,butstimulatedgrowthandwiththeEC50remainingabove1000mg/L.

Althoughthereissomeuncertaintywithactualconcentrationsusedinthetests,theEPAexpectsthatOroniteXS101wouldbepracticallynon-toxicuptothelimitofitssolubility.SincethesolubilityofAlkane5islikelytobelessthanOroniteXS101becauseofitsgreatermolecularweightandsizeitstoxicitymaybehigher(17). However,determiningwhetheritismoretoxicisproblematic(17). Thus,thetoxicitywillbeaffectedbythesolubilityandthelogPowofeachcomponent,thedegreeofbranching(branchedalkaneslesstoxicthanstraightalkanes)andthedegreeofvolatilisationofthatcomponent,andinteractionsbetweencomponents.

12.ASSESSMENTOFENVIRONMENTALHAZARD

Alkane5willbeusedasabaseforautomotiveandindustrialoilblends. Themainexposurewillbefrominappropriatedisposalofoil. Calculationsshowanextremelyhighdilutionforthepolymerisstillexpectedevenifallofthe35% ofoilnotcollectedinAustraliafromhomeuserswasdisposedoftoacountrysewer. Togetherwithits

expecteddistributionthroughretailcentresacrossAustralia(ienotconcentratedinonetownorcity),andwithgoodindustrialandpublicpractice,significantaquaticexposuretothepolymerisnotexpected.

EcotoxicitytestsshowedthatforalowmolecularpolyalphaolefinwithasimilarmonomercompositionasAlkane5(OroniteXS101),thechemicalisexpectedtobepracticallynon-toxictoaquaticorganismsuptothelimitofitssolubility.

Also,theconcentrationofAlkane5inthesoilorwatercompartmentwillbefurtherreducedasitwasshowntobereadilybiodegradable.

13.ASSESSMENTOFPUBLICANDOCCUPATIONALHEALTHANDSAFETYEFFECTS

BasedonthedatagivenforAlkane5,thereislowpotentialacuteoralanddermaltoxicitywhilethereisapotentialslightskinirritationandmoderateeyeirritation. Itmaycausemoderateacuteinhalationaltoxicityhoweverthereislittlepotentialforsensitisation,repeatdosetoxicity,mutationorchromosomaldamage.

Thereexistpotentiallysignificanthealthrisksfrominhalationandeyeexposure. ThetransferofAlkane5frombulkstoragetosteeldrums,transfertoblendingtanks, samplingandanalysisofAlkane5,cleaningandpackagingallowsthepotentialforoccupationalexposurebysplashingorspillagetoan80-100%formulationforatleast30minutes,50daysayear. Thepackagingofthefinishedblendedlubricantisperformedbyautomatedmachineryandsupervisedfromtwometresaway,therebyreducingtheriskofexposure. SomelowexposuretoresidualAlkane5mayoccurduringtheapplicationoflabelsandbungstothedrums. Thecleaningofblendingvesselsandequipmentwithlubeoilandthesamplingandanalysisoftheblendedlubricantshasalsothepotentialforoccupationalexposurefromsplashingorspillage. Adequatepersonalprotection suchasgloves,shoes,eyeprotection,protectiveclothingandrespiratoryprotectivedevicesarerequiredatthisstagetoreducetheriskofinhalationoreyecontact.

Whenlubricantscontainingthenotifiedchemicalareusedinfoodpackagingandprocessingequipment,incidentalcontactwithfoodcanoccur,butcontaminationoffoodwiththelubricantsisminimal. Animalstudiesonacloselyrelatedcompoundshowedthatthenotifiedchemicalisexpectedtobeoflowtoxicitybyrepeatedoraladministrationandisnotgenotoxic. Infrequentandslightcontaminationoffoodwiththenotifiedchemicalisnotconsideredasignificanthazardtopublichealth.

Whenusedinautomotiveengineoilwhichisavailabletothepublicthroughretailers,publicexposurecanoccur. Duringoilchanges,theusermaybedermallyexposedtothenotifiedchemical,butthecontactwouldbeshortandinfrequent. Animalstudiesshowedthatthenotifiedchemicalisoflowdermaltoxicityandnotaskinirritantinrabbits. Thus,shortdermalexposuretothenotifiedchemicalshouldnothavesignificanthealtheffects.Anyaccidentalsplashingintotheeyeisnotexpectedtoresultinseriousdamagetotheeyes. Inanimalstudies,thenotifiedchemicalwasamildirritantinrabbitsandtheeffectsdisappearedwithin48hoursaftertreatment. Therefore,publicuseoftheengineoil

containingapproximately80%ofthenotifiedchemicalisnotexpectedtoresultinsignificantadversehealtheffectsprovidedcontactwitheyescanbeavoided.

Themainoccupationalhealthriskposedtoautomobilemechanicsisskinirritation,followingrepeatedexposuretothenotifiedchemicalinengineoil. Aspreviouslydiscussed,accidentaleyecontactislikelytocausediscomfort,butnoseriousdamagetoeyes.

Theincompletecombustionproductsemittedfromautomobilesaresimilartothosefromthecombustionofgasoline,butthelevelsareverylowandnotdistinguishablefromthefuelderivedcombustionproducts,whichwilldominatethehydrocarbonemissions. Suchuseofthenotifiedchemicalisnotexpectedtoposeahealthhazardtothepublic.

Alkane5willnotposeasignificanthazardtopublichealthwhenusedintheproposedmanner.

14.RECOMMENDATIONS

TominimiseoccupationalexposuretoAlkane5thefollowingguidelinesandprecautionsshouldbeobserved:

  • TheappropriaterespiratorydeviceshouldbeselectedandusedinaccordancewithAustralian/NewZealandStandard(AS/NZS)1715(18)andshouldcomplytoAS/NZS1716(19)ifventilationisinadequate;
  • EyeprotectionshouldbeselectedandfittedinaccordancewithAustralianStandard(AS)1336(20)andusedinaccordancewithAS/NZS1337(21);
  • IndustrialclothingmustconformtothespecificationsdetailedinAS2919(22)andAS3765.1(23);
  • IndustrialglovesshouldconformtothestandardsdetailedinAS2161(24)andAS3765.1(23);
  • AlloccupationalfootwearshouldconformtothestandardsdetailedinAS/NZS2210(25);
  • Particularcareshouldbetakentoavoidspillageorsplashingofthenotifiedchemical;
  • Goodpersonalhygieneshouldbepractisedtominimisethepotentialforingestion;
  • AcopyoftheMSDSshouldbeeasilyaccessibletoemployees;
  • Automobileengineoilcontainingdecene/dodecenehydrogenatedtrimershouldcarrythefollowingwarningstatements:

Avoid contact with eyes Washhandsafteruse.

15.MATERIALSAFETYDATASHEET

TheMSDSforAlkane5wasprovidedinanacceptableformat(26).

16.REQUIREMENTSFORSECONDARYNOTIFICATION

Under theIndustrialChemicals(NotificationandAssessment)Act1989,secondarynotificationofAlkane5shallberequiredifanyofthecircumstancesstipulatedundersubsection64(2)oftheActarise. Ifconditionsofusearevaried,greaterexposureofthepublictotheproductmayoccur. Insuchcircumstancesfurtherinformationmayberequiredtoassessthehazardstopublichealth.

17.REFERENCES

1.Lyman,WJ,Reehl,WFRosenblatt,DH,1982,HandbookofChemical PropertyEstimationMethods. McGraw-HillBookCompany,NewYork.p2-39.

2.AustralianandNewZealandEnvironmentCouncil,1991,Usedlubricatingoil:Generation,recoveryandreuseinAustralia.PreparedbyTechnisearchLtdfortheWasteandResourcesCommittee(WRAC).

3.Cisson,CM,Rausina,GAStonebraker,PM,(submittedtoLubricationScience).Human health and environmental hazard characterisation of lubricating oiladditives.

4.Connel,DW,1989,GeneralCharacteristicsoforganiccompoundswhichexhibitbioaccumulation, Chapter3,inConnelDW(ed)"Bioaccumulationofxenobioticcompounds". CRCPress,BocaRaton,USA.p56.

5.Guiney, PD, 1982,Acutetoxicityassessmentofpolyalphaolefin(PAO)syntheticfluids. SymposiumOnSyntheticAndPetroleumBasedLubricants,AmericanChemicalSociety,LasVegas,,p381-391.

6.Driscoll,R,1995,Alkane5(C1527-04-5):acuteoraltoxicityintherat.

SafepharmLaboratoriesLtd(Derby,UK),ProjectNo:703/14.

7.Driscoll,R,1995,Alkane5(C1527-04-5):acutedermaltoxicityintherat.

SafepharmLaboratoriesLtd(Derby,UK),ProjectNo:703/15.

8.Ulrich, CE, 1982, SF-0203-41:Acuteinhalationtoxicity(LC50) study in rats.InternationalResearchandDevelopmentCorporation,StudyNo.107-006.

9.Salame,R,1994,:AnevaluationoftheacutetoxicityofaninhalednebulisedaerosolformulationofOroniteSynfluidPAO2cSt(C1234-01-1)inthealbinorat(safetytest). Bio-ResearchLaboratoriesLtd,ProjectNo:90907.

10Driscoll,R,1995,Alkane5(C1527-04-5):primaryskinirritationtestintherabbit. SafepharmLaboratoriesLtd(Derby,UK),ProjectNo:703/16.

11.Draize,JH,1959,Paper,Assoc.FoodDrugOfficials,US,Topeka, Kansas,p49.

12.DriscollR,1995, Alkane5(C1527-04-5):primaryeyeirritationtestintherabbit. SafepharmLaboratoriesLtd(Derby,UK),ProjectNo:703/17.

13.Cooper,PN,Rogers,BC.andWong,ZA,1989, Four-weekrepeated-dosetoxicitystudyinratswithOroniteXS101(KWA88-01217). ChevronEnvironmentalHealthandToxicology,ReportNo:CEHC3050.

14.Myers,M,Machado,MLandWong,ZA,1989,Microbial/microsomereversemutationplateincorporationassaywithOroniteXS101(KWA88-01217). ChevronEnvironmentalHealthandToxicology,ReportNo:CEHC 3048.

15.Wing,CD,Machado,MLandWong,ZA,1989,MicronucleusassayinmousebonemarrowerythrocyteswithOroniteXS101(KWA88-01217). ChevronEnvironmentalHealthandToxicology,ReportNo:CEHC3049.

16.WorksafeAustralia,1994,ApprovedCriteriaForClassifyingHazardousSubstances[NOHSC:1008(1994)],AGPS, Canberra.

17.Peterson,DR 1994. Calculatingtheaquatictoxicityofhydrocarbonmixtures.Chemosphere29,2493-2506.

18.StandardsAustralia,StandardsNewZealand,1994,Australian/NewZealandStandard1715-1994Selection,UseandMaintenanceofRespiratoryProtectiveDevices.StandardsAssociationofAustraliaPubl.,Sydney,Australia,StandardsAssociationofNewZealandPubl.Wellington,NewZealand.

19.StandardsAustralia,1991,AustralianStandard1716-1991RespiratoryProtectiveDevices,StandardsAssociationofAustraliaPubl.,Sydney,Australia.

20.StandardsAustralia,1994,AustralianStandard1336-1994,RecommendedPracticesforEyeProtectionintheIndustrialEnvironment.,StandardsAssociationof Australia Publ. Sydney, Australia.

21.StandardsAustralia,StandardsNewZealand1992,Australian/NewZealandStandard1337-1992,EyeProtectorsforIndustrialApplications,StandardsAssociationofAustraliaPubl.,Sydney,Australia,StandardsAssociationofNewZealandPubl.Wellington,NewZealand.

22.StandardsAustralia,1987,AustralianStandard2919-1987IndustrialClothing,

StandardsAssociationofAustraliaPubl.,Sydney,Australia.

23.StandardsAustralia,1990,AustralianStandard3765-1990ClothingforProtectionAgainstChemicalHazards,Part1ProtectionAgainstGeneralorSpecificChemicals,Part2LimitedProtectionAgainstSpecificChemicals,StandardsAssociationofAustraliaPubl.,Sydney,Australia.

24.StandardsAustralia,1978,AustralianStandard2161-1978,IndustrialSafetyGlovesandMittens(excludingElectricalandMedicalGloves),StandardsAssociationofAustraliaPubl.,Sydney,Australia.

25.StandardsAustralia,StandardsNewZealand1994,Australian/NewZealandStandard2210-1994OccupationalProtectiveFootwear,Part1:GuidetoSelection,CareandUse. Part2:Specifications,StandardsAssociationofAustraliaPubl.,Sydney,Australia,StandardsAssociationofNewZealandPubl.Wellington,NewZealand.

26.NationalOccupationalHealthandSafetyCommission1994,NationalCode ofPracticeforthePreparationofMaterialSafetyDataSheets[NOHSC:2011(1994)], AustralianGovernmentPublishingService,Canberra.

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