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FileNo:NA/6921May2000

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME

FULLPUBLICREPORT

CP 7077

ThisAssessmenthasbeen compiled in accordance with the provisions of theIndustrialChemicals(NotificationandAssessment)Act1989(theAct) and Regulations. Thislegislation isan ActoftheCommonwealthofAustralia.TheNationalIndustrialChemicalsNotificationandAssessmentScheme (NICNAS)is administered bythe NationalOccupationalHealthandSafetyCommissionwhichalsoconductstheoccupationalhealthsafetyassessment.Theassessmentofenvironmentalhazard isconducted bytheDepartmentofthe Environmentandtheassessment ofpublic health isconductedbytheDepartmentofHealthandAgedCare.

Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybe inspectedbythepublicattheLibrary,NationalOccupationalHealthandSafetyCommission,92-94ParramattaRoad,CamperdownNSW2050,betweenthefollowinghours:

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Director

ChemicalsNotificationandAssessment

NA/692

FULLPUBLICREPORT

CP 7077

1.APPLICANT

ChevronChemicalAustraliaofLevel22,385BurkeStreet,MelbourneVictoria3000hassubmittedastandardnotificationstatementin supportoftheir application foranassessmentcertificateforCP7077.

2.IDENTITYOFTHECHEMICAL

Thechemicalname,othername,CASnumber,molecularandstructuralformulae,molecularweightandspectral datahavebeen exemptedfrompublication inthe Full Public ReportandtheSummaryReport.

TradeName:OLOA 271(containingamaximumof 70 % of thenotifiedchemical)

ThenotifiedchemicalisaUVCB.

3.PHYSICALANDCHEMICALPROPERTIES

Appearance at 20°Cand101.3 kPa:

darkbrown,viscousliquid

MeltingPoint:notprovided(pourpoint15°C)

SpecificGravity:0.982g/cm3at20oC

VapourPressure:nodata presented; notifier claims that it should be

negligible for this chemical, and the MSDS states0.000013kPaat20C

WaterSolubility:39mg/L

PartitionCo-efficient(n-octanol/water):

expectedtobe>3;seecommentsbelow

HydrolysisasaFunctionofpH:

nodatapresented;seecommentsbelow

Adsorption/Desorption:nodatapresented;seecommentsbelow

DissociationConstant:nodatapresented

ParticleSize:notapplicableasthenotifiedchemicalisliquid

FlashPoint:212°C

FlammabilityLimits:nodatapresented;expectedtobeflammable

AutoignitionTemperature:nodatapresented

ExplosiveProperties:notexplosive

Reactivity/Stability:notreactive;stableundernormalconditions

CommentsonPhysico-ChemicalProperties

Measurementsofpourpoint,specificgravity,watersolubilityandflashpointwereperformedbyAnalyticalSciencesattheChevronResearchTechnologyCompany,Richmond,California.Afulltestreportwassubmittedforwatersolubilityonly.

Accordingtothenotifier,noboilingpointcouldbedeterminedforCP7077.Atabout215oC,componentsbegintodistillaway.Atabout420oC thefinalcomponentsbegintodecompose.Thenotifierhasalsoindicatedthat thevapourpressure isnegligibleduetothenotifiedchemical’sionicnature.

Concentrationsofthenotifiedsubstanceinwaterweredeterminedbythetotalorganiccarbon(TOC)analysisoftheequilibratedsolutionsbasedonpercentcarboninformation.

Thenotifiedchemicaldoesnotcontainanyhydrolysablefunctionalgroupsthoughstrongacidwillneutralisethecalciumsalt.Hence,thereactionsofthesubstancewillbeverylimitedanditwillbestableinwaterwithrespecttotheenvironmentalpHrange5–9.

Thenotifierhasestimatedthepartitioncoefficienttobe3.Thoughtherearenotestreportsto support thisclaim,the estimatedvalue seemsappropriatedue the highmolecularweightandhighhydrocarboncontentofthesubstance.Thisvalueisrelativelyhighandthechemicalcan be expected to bindstronglyto, orbe associatedwith, soil and sediment. Hence, due tothedetergentnatureofOLOA271(strongsurfaceactivity)andmicelleformationtendencies,theOLOA271willtendtopartitionfromwatertosolidsororganicmatter.

Thenotifiedchemicalwillnotdissociate.Althoughthechemicalcontainscalciumsalts,the

complexnatureofthissubstanceandthetendencytoformmicellesindicatesdissociationisunlikely.

4.PURITYOFTHECHEMICAL

DegreeofPurity:99%(typicalrange97-100%)

ToxicorHazardousImpurities: none

Non-hazardous Impurities(>1%by weight):

Chemicalname:DilutionOil100N

Synonyms:heavyparaffinicpetroleumdistillate

Weightpercentage:1(range0-3)

CASNo.:64741-88-4and64742-54-7

:The dilutionoilsarenotclassifiedas hazardous basedontheresultsoftheDMSOextractionprocedureasdefinedby IP 346. The DMSO extract is routinely wellbelow3%.

Additives/Adjuvants:none

5.USE,VOLUMEANDFORMULATION

CP7077isadetergent,addedtoalubricatingoilformulationformarinedieselenginesinlargeocean-goingvessels.Itspurpose istopreventdeposits, butalsoactsasanacidneutraliserandantioxidant.Itreduces depositson pistons andin theengine crankcaseandcontrolsoxidation inthe lubricantathightemperatures.

Itisto beimportedas part of alubricatingoil additivepreparation, comprising amaximum 70%ofthepreparation.Thepreparationwillbeblendedinto thefinallubricatingoilinAustralia.TheconcentrationofCP7077inthefinallubricatingoilwillrangefrom10to40%.

Anestimated400tonnesofadditive,containingapproximately280tonnesofthenotifiedchemical,willbeimportedannuallyforthefirstfiveyears.

6.OCCUPATIONALEXPOSURE

CP7077 will be importedas a component(70 %) of alubricatingoil additiveand will be shipped in200litresteeldrums,orinbulk.TheadditivewillbereformulatedintothefinallubricatingoilatvariouscustomersitescomprisingthemajoroilcompaniesaroundAustralia,foruseindieselenginesofocean-goingvessels.

SincethenotifiedchemicalwillalwaysbehandledinsolutioninAustralia,themostlikelymeansofexposure willbeviaskinandeyecontact. Inhalationexposuremayoccurifmistsoraerosols aregeneratedatanytime(e.g.duringmixingofsolutions).

Thenumberandcategoriesofworkersthatmaybeexposedtothenotifiedchemicalareestimatedasfollows:

watersideworkers / 2-4
transportdrivers(percustomer) / 1-2
warehouseworkers(percustomer) / 2-4
QCtechnicians(percustomersite) / 1-2
blendingandpackagingworkers(percustomersite) / 2-4
marineenginemechanics / 10-20.

Thetotalnumberofworkersinvolvedintransportation,reformulationanddrumminginAustralia isexpectedtobelessthan100.

Transportand storage(1-2hours/day;10days/year)

Uponreceiptat thewatersidedocks,thecontainers (drumsor bulk)willbeconveyedto thevariouscustomersites(blendingplants).TransportwithinAustraliawillbebyrailcarortanktruck.

Attheblendingplant,the contentsofthe importedcontainers willbetransferred toa bulk storagetankthrougha 10cm diameterhose.Thereis potentialforworkerexposurefromspillsandsplashesduringthecouplinganduncouplingofthehose.Workerswillweargloves,coverallsandeyeprotection.Aspecialair-backflushsystemisincorporatedtopreventsuchlossesandtheareaisbundedtocontainspills.Workerexposuremayalsooccurduringthecleaningofcontainers aftertransfertostoragetanks.

Theblendingprocess(1-2hours/day;20days/year)

Theadditiveisblendedwithmotoroilandvariousotheringredients(e.g.dispersants,anti-foam,zincdithiophosphate)bypumpingthelubricantoilandadditivesthroughcomputercontrolledvalvesthatmetertheprecisedeliveryofthecomponentsintoablendingtank.Mixingtakesplaceat60oC.

Afterblending,theproductissampledfromthetankbyqualitycontrolworkerswhotestthephysico-chemicalpropertiesoftheblend.Thefinisheddieselenginelubricantisthenpackagedinto200litre drums,or as bulkin tanktrucks.The drummingfacility uses automatedweigh scalesto fillthedrums.Bungsandlabelsareappliedbytheoperators.TheCP7077ispresentatamaximumconcentrationof40%.Atypicalbatchsizewillbesufficientforoneship(i.e.6000kgofthenotifiedchemical).

Exposuretothenotifiedchemicalispossibleduringthedrumfillingandqualitycontrolwork.However,allworkersareequippedwithstandardprotectiveclothing,aswellasstandardsafetygoggles/glassesandhandprotection.WorkerswillreceivetraininginallaspectsofoccupationalhealthandsafetyrelevanttoCP7077.Facilitiesarestatedtobewellventilated,whilethetransfer ofnotifiedchemicalbetweencontainersandtheblendingprocessarefullyautomatedandperformedinenclosedsystems.Exposureintheeventofaccidentalspillagewillbecontrolledbylocalbundingandbarriers,whilespillsaretobecollectedbysuctionandsenttoon-site wastetreatmentfacilitiesutilisingAmericanPetroleumInstitute(API)oil-waterseparationandsandfiltration.

Workerexposuremayalsooccurduringthecleaningandmaintenanceoftheblendingtankandequipment.

EndUse

Attheship,theoilistransferredfromthebulkcontainerstostoragetanksviahoses.Thenotifierstatesthatprocedures(notdescribed)areinplacetoensurethatspillageisminimisedduringtransfer.However,skincontact withthe notifiedchemical mayoccur duringcouplinganduncouplingthetransferhoses.

During itsuse inthe dieselengine, the majority ofthe notifiedchemical willbe combusted (98 %).Thebalancewillconsistofcalciumdeposits.

Marineenginemechanicsmaybeexposedtothenotifiedchemicalduringmaintenanceandoverhauloftheships’engines.Theseworkersarestatedtowearprotectiveclothingbutnotnormallysafetygogglesandglassesorgloves.

7.PUBLICEXPOSURE

Asthenotifiedchemicalisintendedtobeusedinanindustrialenvironmentduringallphasesofitslifecycle,includingtransport,reformulation,useanddisposal,thepotentialforpublicexposuretothenotifiedchemicalisconsideredtobenegligible.

8.ENVIRONMENTALEXPOSURERelease

TheOLOA271containingadditivepackagewillarriveatthecustomer'sblendingplantbyrailcaror tank truck. The oil is transferredto a storage tank througha hose and an air back flushsystempreventsanyspillages.Thenotifierestimatesthat10kgperannumofthenewsubstancewouldbereleasedduringthisprocess.Thehoseendiskeptinanoilydrain whennotinuseandthecontentsofthedrainaretreatedonsite.Therailcarsortanktrucksaregenerally cleaned with steam and the waste water treatedon site and it isestimatedthat 100kgperannumwillbereleasedduringthisprocess.

WastewatercontainingOLOA271issenttoanon-sitechemicalwastewatersystemthatincludesanAPIwaterandoilseparator,airflotationandsandfiltration.AsaresultofAPIoilseparationnomorethan5%oftheOLOA271isexpectedtobeemulsifiedinthewater.Thewastewaterisfurthertreatedwithpondaerationandsandfiltrationbeforeitissenttothesewer.Theremainingoilywasteisincinerated.Thenotifierestimatesthat20kgperannumofthenewsubstancewouldbereleasedduringtheunloadingprocess.

Theoilblendingprocessinvolvescombininglubricatingoilblendstocks,pourpointdepressants,foaminhibitorsandadditivepackageinablendingtank.Itisestimatedthat20kg perannumofthenotifiedsubstancewillbereleasedduringthisprocess.Theblendtank isperiodically cleaned withlube oilthat is eitherrecycled intofuture blends orisincineratedafterseparationfromwastewater.Thenotifierestimates that100kgperannumofthe newsubstanceisfurtherreleasedduringthisprocess.

Afterblending,thefinishedmarineproductsarepackagedinto200Ldrumsorsoldasbulkintanktrucks.Thenotifierestimatesthatanother20kgperannumofthenewchemicalisreleasedduringthisprocess.Afterfilling,thedeliverylinesareplacedoveroilydrainswhichcatch any spiltproduct. The lines are cleanedwithlube oil whichis recycled during futureblending operationsorincinerated. Thenotifier estimates that20kgperannum ofthe newsubstanceisreleasedduringtheproductloadingprocess.

Theselossesaresummarisedinthefollowingtable:

PossibleSourceofReleaseAnnualQuantityExpectedtobereleased

Transferfromtransporttostoragecontainers10 kgResidueinstoragecontainers/cleaningbysteam 100 kgTransfertoblendingtanks 20 kg

Cleaningofblendingtank100 kg

Transfertodrums20 kg

Chargingofships20 kg

Overall,270kgofwasteOLOA271isreleased/annum/customersitesinAustralia.AssumingthatAPIoilseparationresultsin95%removaloftheoilfromwastewater(asclaimedbythenotifier),thenapproximately13.5kgofOLOA271perannumislikelytoenterthesewersfromeachoftheblendingsites.

Spills attheblending sites arecontained by plantbarriers. As lube blending facilities haveconcrete floors,most ofthespiltproductcould besuckedupwiththeremainingproduct intheon-sitewastewatersystem.Thefinishedlubricant willbesoldindrumsorbulktoownersoflargeoceangoingdieselpoweredvessels.

During use, OLOA 271isnot substantially alteredanddoesnotdecomposein thecrankcase

duetoits highthermalstability.However, thismaterial isburnedin theengine oilduringoilconsumption.TheinsolublesandparticulatematterbecomecoatedwithOLOA271detergentandcan be filteredout of theoil. Thelost detergent propertiesin the oilare replaced asfreshoilisadded.Generally,usedoilsfromoildrainsarenotgeneratedfrommarineservice.Fresh oiliscontinuouslyaddedduringengineoperationunlesstheengineisbroughtinformaintenanceoroverhaul.Usedoilfromthesemaintenanceoperationsislikelytobeincineratedorsenttoausedoilrecycler.

Fate

TheamountofwasteOLOA271disposedoftosewerisexpectedtobeminimalaswastewaterfromtheblendingoperationsistreatedon-siteandthehydrocarbonfractionisseparatedand incinerated.Anyremaining OLOA 271 presentin waste waterdisposed oftosewerisexpectedtopartitionfromthewatertosuspendedmatterandbecomeassociatedwithsludgeatseweragetreatmentplants.Therefore,theprospectofOLOA271enteringreceivingwatersisremote.

Biodegradation

A studywasperformedto assess the ready biodegradabilityof OLOA271 using the ClosedBottle Test(OECDTG301D).Sealedbottlescontaining thetestsubstance(6.5mg/L) andinorganicnutrientmediumwereinoculatedwithactivatedseweragesludgebacteriaandincubatedforupto28daysat20C.BiodegradationwasassessedbythedeterminationofCO2produced.Thetestsubstance attained 2 % degradationafter28days.Therefore,OLOA271maynotbetermedreadilybiodegradable.

Bioaccumulation

Nostudieswereprovided. Giventhe expectedhighpartitionco-efficientofthe notifiedsubstanceanditslowbiodegradationpotential,thenotifiedsubstancewouldhavethepotentialtobioaccumulateshouldthesubstancebespilttowaterwaysorontosoils.However,thelargemolecularsizeofthechemicalanditsexpectedlimitedexposuretowaterislikelytoinhibitthebioaccumulationpotentialofOLOA271.

9.EVALUATIONOFTOXICOLOGICALDATA

9.1AcuteToxicity

SummaryoftheacutetoxicityofCP 7077

TestSpeciesOutcomeReferenceacuteoraltoxicity rat LD50>5g/kg Driscoll,1998aacutedermaltoxicity rat LD50>2g/kg Driscoll,1998b

skinirritationrabbitmoderateirritantDriscoll,1998c

eyeirritationrabbitslighttomoderateirritant

Driscoll,1998d

skinsensitisationguineapigweaksensitiserDriscoll,1998e;

Morris,1998

9.1.1OralToxicity(Driscoll,1998a)

Species/strain:rat/Sprague-DawleyCD

Number/sexofanimals:5/sex

Observationperiod:14days

Methodofadministration:singlelimitdoseof5000mg/kg;administeredbygavageasa

dispersioninarachisoilBP

Testmethod:limit test, as in EC Annexto Directive 92/69/EEC and

OECDTG401

Clinicalobservations:hunched posture was common,with additional signs of

diarrhoeaandpilo-erection;isolatedsignsofataxia,lethargy,ptosis,decreasedrespiratoryrate,labouredrespirationandred-brownstainingaroundeyes;allanimalsrecoveredbyday4afterdosing

Mortality:onefemaledied2daysafterdosing–notrelatedtotreatment

Morphologicalfindings:noabnormalitiesobserved

LD50:5000mg/kg

Result:the notifiedchemical wasofverylowacute oraltoxicity inrats

9.1.2DermalToxicity(Driscoll,1998b)

Species/strain:rat/Sprague-DawleyCD

Number/sexofanimals:five/sex

Observationperiod:14days

Methodofadministration:single,24-hoursemi-occluded,dermalapplicationto intact

skin(shornflank)atadoselevelof2000mg/kgbodyweight

Testmethod:accordingtoOECDTG402

Clinicalobservations:no signs of systemic toxicity observed; signs of dermal

irritation,includingslighttomoderateerythema,desquamation,leatheringandfissuring

Mortality:nodeathsobservedduringthestudy

Morphologicalfindings:noabnormalitiesobserved

LD50:2000mg/kg

Result:thenotifiedchemicalwasoflowacutedermaltoxicityinrats

9.1.3SkinIrritation(Driscoll,1998c)

Species/strain:rabbit/NewZealandWhite

Number/sexofanimals:6males

Observationperiod:72hoursfordeterminationofPrimaryIrritationIndex

14daysfordeterminationofreversibilityofchanges

Methodofadministration:single four hour, semi-occluded application (0.5mL of

notifiedchemical,pH5.5)tointactskinofshorndorsalflank

Testmethod:OECDTG404

Draizescores(Driscoll,1998c):

Timeaftertreatment(days)

Erythema/eschar

Animal#

123456

aseeAttachment1forDraizescales

?indicateswhereadversereactionspreventedaccurateevaluationoferythema/oedema

Comment:Thenotifiedchemicalproducedwelldefinederythemaandslighttomoderateoedema(meanscoresof2forerythema/escharformation and 2for oedema for24, 48 and72 hours);

otherreactionsincludedlightbrown discolourationoftheepidermis,lossofskinelasticityandflexibility,crustformation,desquamation,scabbingandreducedorincreasedfurgrowth;nocorrosiveeffectsobserved;

after14 days the reactions inducedby the notified chemicalwerenotfullyreversible;

PrimaryIrritationIndex=3.9

Result:thenotifiedchemicalwasmoderatelyirritatingtotheskinofrabbits

9.1.4EyeIrritation(Driscoll,1998d)

Species/strain:rabbit/NewZealandWhite

Number/sexofanimals:Group1:1female,5males

Group2:3males

Observationperiod:14days

Methodofadministration:Group1(unirrigated):0.1mLofnotifiedchemical,pH 5.5

instilledintotheconjunctivalsacofthelefteye(righteye =control)

Group2(irrigated):sameasGroup1,exceptthechemicalwaswashed outafter 30seconds

Testmethod:accordingtoOECDTG405

Draizescoresofunirrigatedeyes:

Timeafterinstillation

Animal1day2days3days4days7daysCornea o

1(female)11

20

31

40

50

61

Iris

1(female)

2

3

4

5

6

1seeAttachment1forDraizescales

o=opacitya= arear=rednessc =chemosisd =discharge

-indicatesobservationnotrequired

Comments:all eyes demonstrated positive effects, with all effectsreversedwithinthe14dayobservationperiod;

diffusetotranslucentcornealopacityobservedin3eyes,iridialinflammationin twoandconjunctivalirritationin alltreatedeyes;

meanscoresforcornealopacity,irislesion,conjunctivalrednessandconjunctivalchemosiswere0.6,0.2,1.7and1.8,

respectively(for24,48and72hours);

themaximumindividualscoreinirrigatedeyes(24–72hours)was1forconjunctivalrednessandchemosis;

conjunctivalirritationnotedinallthreeirrigatedeyes,however,nocornealoriridialeffectswerenoted;

noeffectswereobservedafter72hours

Result:thenotifiedchemicalwas aslighttomoderateirritanttotheeyesofrabbits

9.1.5SkinSensitisation–MaximisationTest(Driscoll,1998e)

Species/strain:albinoguineapig/Dunkin-Hartley

Numberofanimals:20testand10controlsinthemainstudy;allfemales

Inductionprocedure:Day 1intradermalinjectionsto a clipped area(40mm x

60mm)oftheshoulderregion,eachanimalreceived3pairsofintradermalinjections(0.1mL/site)asfollows:

• Freund’sCompleteAdjuvant(FCA):distilledwater(1:1v/v)
• 5%w/vofnotifiedchemicalinarachisoilBP
• 5%w/vof notifiedchemicalina1:1mixtureofFCAanddistilledwater



forthenegativecontrolgroup,thenotifiedchemicalwasreplacedwitharachisoilBP

Day 7sameshoulderareawas re-clippedand subsequentlytreatedwithatopicalapplicationof75%v/vnotifiedchemical(occludedfor48hours);arachisoilBPwassubstitutedinthenegativecontrolgroup

Challengeprocedure:Day21occluded24hourapplicationof25%v/vnotified

chemicalinarachisoilBPtoaclippedarea(50mmx70mm)ontheleftflankofeachanimal

RechallengeprocedureDay 42 test group animals rechallenged on previously

untreatedskinwith10%and25 %v/vnotified chemical inarachisoilBP;similartreatmenttoacontrolgroupnotpreviously exposedtothenotifiedchemical butwhich hadreceivedintradermalinjectionsofFCA

Testmethod:Magnusson and Kligman maximisation test, according to

OECDGuidelineNo.406

Challengeoutcome:

Challengeconcentration

TestanimalsControlanimals

24hours*48hours*24 hours48 hours

25%1/20**0/200/100/10

*timeafterpatchremoval

**numberofanimalsexhibitingpositiveresponse

Rechallengeoutcome:

Challengeconcentration

TestanimalsControlanimals

24hours*48hours*24 hours48 hours

25%1/20**0/200/100/10

*timeafterpatchremoval

**numberofanimalsexhibitingpositiveresponse

Comment:therewerenodermalreactionsineithergroupwiththe10% challenge;forthe25%challenge,differentanimalsexhibitedskinreactionsafterthefirstchallengeandtherechallenge

Result:therewas slightevidence that the notified chemical wassensitisingtotheskinofguineapigs

9.1.6SkinSensitisation–BuehlerTest(Morris, 1998)

Species/strain:albinoguineapig/Dunkin-Hartley

Numberofanimals:20testanimals,10naivecontrolsandeight pilot animals;

equalnumbersofmalesandfemalesincludedineachgroup

Inductionprocedure:the leftshoulderofeachanimalwas clipped and treated

epidermallywith0.3mLof25%w/vnotified chemicalinmineraloilusingaHillTopChamber;

threeinductionexposuresof six hours duration,atintervalsof6or7days,wereappliedtotheonesite;

forthe negativecontrolgroup,the notifiedchemical wasreplacedwithmineraloil

Challengeprocedure:twoweeksafterthelastinduction,inducedanimalsexposed

to5%w/vnotifiedchemicalinmineraloilonapreviouslyuntreatedsite;

similar treatment toan additionalgroup of 10 naivecontrolanimals,notpreviouslyexposedtothenotifiedchemical

Testmethod:anadaptationofthemethodofRitzandBuehler(1980)

Challengeoutcome:

Challengeconcentration

TestanimalsControlanimals

24hours*48hours*24 hours48 hours

5%6/20**0/201/100/10

* timeafterpatchremoval

**numberofanimalsexhibitingpositiveresponse

Comments:6outof20testanimalsand1outof10controlanimalsshowed slightbutconfluent, ormoderatepatchy erythema(ratedasapositiveresponse),at24hours;all othertest and

controlanimalsrespondingtothechallengeexhibitedslight,patchyerythema;

alltestanimalsand9outof10controlsexhibitedslight,patchyerythemaat48hours;

overalltheseverityofresponseswascomparableat24hours betweenthe test and control groups (mean scores of 0.7 and0.6,respectively),buttheincidenceofclearpositiveresponseswashigherinthe testgroup(30%)comparedwiththecontrols(10%)

Result:thenotifiedchemicalwasaweaksensitisertothe skinofguineapigs

9.228-Day OralRepeatedDoseToxicity(Jones,1998)Species/strain:Rat/Crl:CDBRNumber/sexofanimals: 5/sex/group

Methodofadministration: gavage

Dose/Studyduration::0,100,500or1000mg/kg incornoil;oncedailyfor28

consecutivedays

Testmethod:asinECAnnextoDirective92/69/EEC,PartB,MethodB.7

Clinicalobservations:

Nomortalitieswererecorded.Formuchofthedosingperiod,salivation andwetcoatwereseenpost-dosingforupto2hoursinbothsexesreceiving1000mg/kg/dayandtoa lesserextentat500mg/kg/day.Hunchedposturepost-dosing,forupto5hoursduration,wasobservedforallmalesandfemalesreceiving 1000mg/kg/day,particularly duringweeks3and4.Hairlosswasseenforallmalesandfemalesreceiving1000mg/kg/dayandtoaslightlylesserextentforfemalesreceiving500mg/kg/day.Malesreceiving100or500mg/kg/dayalsoshowedslighthairloss.

Throughoutthe treatmentperiod,astatistically significantreduction inbodyweightgainandfoodconsumptionwasobservedformalesreceiving1000mg/kg/day.

Clinicalchemistry/Haematology

Malesreceiving 1000 mg/kg/dayshowed a statisticallysignificantincrease in totalwhiteblood cellcountduetohighernumbersof lymphocytes, basophils,monocytes andlargeunstainedcellscomparedwithcontrols.

Reducedcholesterolwasseenforallmaleandfemaletreatedgroups,theeffectbeingdose- relatedtoadegree,butmostmarkedat500and1000mg/kg/day.Increasedglutamicpyruvictransaminase(GTP)valueswerenotedforbothsexesreceiving1000mg/kg/dayandfemalesreceiving500mg/kg/day.

Reducedcalciumlevelswereseenforfemalesreceiving500and1000mg/kg/day.Increasedureawasnotedformalesreceiving1000mg/kg/day.Therewerenocorroborativemicroscopicchangestoaccountfortheseobservations.

Bothsexesdisplayedincreasedalkalinephosphatase(AP)valuesatalldosesandalthoughtherewasnostrictdosagerelationship,thehighestvalueswereseenat500and1000mg/kg/day.Therewas,however,ahighdegreeofindividualvariationandthisfindingwasconsideredunlikelytohavebeentreatment-relatedbythestudyauthors.

Pathology:

Astatisticallysignificantincreaseinliverweightwasseenforbothsexesreceiving500and1000mg/kg/day,theeffectforfemalesatthehighestdosagealsobeingobservedmacroscopically.Centrilobularhepatocytehypertrophywasseenmicroscopicallyintheliver ofbothsexesreceiving500and1000mg/kg/day, theeffectbeingdose-related.Formostanimalsreceivingthehighestdose,aswellasonefemaleon500mg/kg/day,thisfindingwasaccompaniedbyslightvacuolationoftheperiportalhepatocytes.

Malesreceiving1000mg/kg/dayshowedastatisticallysignificantdecreaseinweightsofthesexual organs (e.g. prostate, testes, seminalvesiclesandepididymides).Femalesonthesame dosage showedslightlyreduced uterus weights.For the seminalvesicles /prostate,slightlyreducedcolloidwasseenmicroscopicallyinthemajorityofanimalsreceiving1000 mg/kg/dayandonemaleat500mg/kg/day.Thestudyauthorsstatedthatthisfindingwasofuncertaintoxicologicalsignificance.

Females at alldosesand malesreceiving1000mg/kg/dayshowed statistically significantincreasesinadrenalweightcomparedwithcontrols.Femalesalsorecordedkidneyweightincreasesat500and1000mg/kg/day.Slight adrenalcorticalhypertrophywasfoundatalldosesforfemalesandfortwomalesreceiving1000andonemaleat500mg/kg/day. Thefinding correlatedwith changesobserved in adrenal weight; however,the effect wasnotdoserelated.Thesignificanceofthisfindingisuncertain.

Conclusions:

Pathologicalchanges(statisticallysignificant),includingeffectsonbodyweight(males),organweights(malesandfemales),haematology(males),biochemistry(malesandfemales)andhistopathology(males and females) wereseen at 500 mg/kg/day. Adrenal weight changesandhypertrophywerefoundatalldoses,butnotalwaysinbothsexes.Theauthorsdidnotconsidertheseeffectsweretoxicologicallyimportant.Clinicalsigns(salivationandhairloss)wereseenatalldoses.Consideringthesefindings,aNoObservedEffectLevel(NOEL)cannotbeestablished.ThestudyauthorsconcludedaNoObservedAdverseEffectLevel(NOAEL)of100mg/kg/day.

Comment

Theauthorsstatedthatthe28daystudywasconductedinordertoselectsuitabledosesfora13weekstudy.Basedontheresultsofthisstudy,the13weekinvestigationiswarranted.

9.3Genotoxicity

9.3.1Salmonellatyphimurium/EscherichiacoliReverseMutationAssay

(Thompson,1998)

Strains: / Salmonellatyphimurium
TA1535,TA1537,TA98andTA100
Escherichiacoli
WP2uvrA-
Concentrationrange: / 15-5000g/mL,inabsenceandpresenceofS9
Testmethod: / accordingtoOECDTG471and472
Comment: / Preliminarytoxicitystudy
Thenotifiedchemicalwasnon-toxicto / Salmonella

typhimuriumTA100andEscherichiacoliWP2uvrA-atthetestedconcentrationsupto5000g/plate

Range-findingandmainmutationassays

Inthetwo experiments,all bacterialstrainswereusedat sixconcentrationsup to5000g/plate,withandwithout S9metabolicactivation. Precipitation occurred at thetop dosebutdidnotinterferewithscoringofrevertantcolonies. Notoxicitywasobserved.

Thenotifiedchemicalcausednovisiblereductioninthegrowthofthebacterialbackgroundlawnatanydose level.Nosignificantincreasesinthe frequencyofrevertantcolonieswererecorded forany of thebacterialstrains, withanydoseofthenotifiedchemical,eitherwithorwithoutmetabolicactivation.

Allofthepositivecontrolchemicalsusedinducedmarkedincreases inthefrequencyofrevertantcolonies,both withandwithoutmetabolicactivation;

Conclusion:the notifiedchemicalwas not mutagenic to the bacterialstrainstested

9.3.2InvivoMicronucleus Assay inthe BoneMarrow Cellsof the Mouse

(Durward, 1998)

Species/strain:mouse/albinoCrl:CD-1TM(ICR)BR

Numberand sex ofanimals:2/sex/groupintherange-findingstudy

7males/groupforthemainstudy

Doses:0,500,750,1000and2000mg/kgintherange-findingstudy

0,187.5,375and750mg/kgforthemainstudy;

positiveandnegativecontrolswereadministeredcyclophosphamideandarachisoil,respectively;

ineachtreatedgroup,animalswerekilledafter24hours,exceptforthe 750mg/kggroupsome micewerekilled after48 hours

Methodofadministration:singleintraperitonealinjection

Testmethod:accordingtoOECDTG474

Results:

In therange-finding study,there was no marked difference in toxicity between the sexes,somalesonlywereusedinthemainstudy.Prematuredeathsoccurredatthetwotopdoses,1000and 2000mg/kg/day.

Inthemainstudy, animalsweretreatedwith187.5,375mg/kg/day,or themaximumtolerateddosefromtherangefindingstudyof750mg/kg/day.Therewasasmallbutstatisticallysignificantincreaseintheincidenceofmicronucleatedpolychromaticerythrocytesinanimalsreceivingthe187.5and375mg/kgdosesat24hourswhencomparedwiththeconcurrentvehiclecontrolgroup.The responseobservedwasinverselydose-relatedanddidnotexceedtheupper limitofthecurrenthistoricalbackgroundrangefor vehiclecontrolvalues.Therefore,itwasconsideredthatthe increaseshad notoxicologicalsignificance.

NostatisticallysignificantdecreasesinthePCE/NCEratiowereobservedinthe 24or48hournotifiedchemicaldosegroupswhencomparedtotheirconcurrentcontrolgroups.Theobservationofclinicalsignsat750mg/kgwastakentoindicatethatsystemicabsorptionhadoccurred.

Thepositivecontrolsproducedamarkedincreaseinthefrequencyofmicronucleatedpolychromaticerythrocytes.

Conclusion:

thenotifiedchemicalwasnotgenotoxicinbonemarrowcellsofthemouseinvivo

9.4 Overall AssessmentofToxicologicalData

Thenotifiedchemicaldisplayedverylowacuteoralandlowdermaltoxicityintherat(LD505000mg/kgandLD50 2000 mg/kg, respectively).No acute inhalationtoxicitydata were presented.Thenotifierstatedthatnostudyhasbeenconductedandthatduetothehighmolecularweight,expectedlowvapourpressureandviscousnature,thenotifiedchemicalisunlikelytogeneratevapoursduringuseandisnotlikelytoposeamajorhazardviainhalation.

Thenotifiedchemicalproducedmoderateirritationtotheskinofrabbits,sufficienttowarrantclassification asaskinirritantbasedonthepersistenceoftheadverse reactions,according totheNOHSCApprovedCriteriaforClassifyingHazardous Substances(NOHSC,1994a)(ApprovedCriteria).

Thenotifiedchemicalwasslightlyirritatingtotheeyesofrabbits.SomeevidenceofskinsensitisationwasnotedinaMagnussonandKligmanguineapigmaximisationtest.InaBuehlertest,thechemicalalsogaveequivocalresults,indicatingweak sensitisingpotential.Theresponse isnotsufficienttowarrantclassificationasaskinsensitiserundertheApprovedCriteria.

Ina28dayrepeatdoseoralratstudy,thenotifiedchemicalcausedpathologicalandbiochemicalchangesat the mid and high dose, and clinical signs of salivationand hair loss at all doses. Adrenaleffects seenatalldoseswerenotbelievedtobe toxicologically importantbythestudyauthors.ANOELcouldnotbeestablished.Onthebasisoftheresultsofthis28-daystudy,theproposed90-daystudyforthenotifiedchemical(forwhichthe28daystudyisstatedtoberange-finding)iswarranted.

ThenotifiedchemicalwasnotmutagenictothebacterialstrainstestedinreversemutationassaysinSalmonellatyphimuriumandEscherichiacoli,with andwithout S9 metabolicactivation. It alsodidnotproducegenotoxiceffectsintheinvivomousemicronucleusassay.

Based on thetoxicological dataprovided,thenotified chemical is a hazardoussubstance due toitsskinirritationpropertiesandshouldcarrytheriskphraseR38,“Irritatingtoskin”.

10.ASSESSMENTOFENVIRONMENTALEFFECTS

Thenotifierprovidedthefollowingecotoxicitydatainsupportoftheirapplication.

TestSpeciesResult

AcutetoxicityRainbowtrout(Oncorhynchusmykiss)

NOEC>1000mg/L(asWAF)

AcutetoxicityDaphniamagnaNOEC=0.56mg/L(asWAF)**

NOEC=22mg/L(asWAF)

GrowthinhibitionGreenalgae(Pseudokirchneriellasubcapitata)

NOEC=1000mg/L(asWAF)

SludgeinhibitionNOEC1000mg/L(asWAF)

*NOEC-noobservableeffectconcentration

**FirststudyundertakenforDaphniaMagna.

The ecotoxicity tests wereperformedinaccordance withOECDTestGuidelines.The testsubstanceusedin theabovestudies waspreparedby mixingthetestoil:watersolution for24hoursandthenallowedtosettleforapproximatelyonehour.The wateraccommodatedfraction(WAF)wasthenwithdrawnviaasiphonpriortotesting.

RainbowTrout(Oncorhynchusmykiss):

Thetestsonrainbowtroutwereperformedusingasemi-statictest methodology.Threegroupsof10fishwereexposedtoanominalconcentrationof1000mg/LofthetestsubstanceastheWAF.Thecumulativemortalitywasrecordedafter3,6,24,48,72and96hours.Therewerenosub-lethaleffectsormortalitiesrecordedinthe30fishexposedforaperiodof96hours.TheLethalLoadingRate(LLR)andNoObservableEffectConcentration(NOEC)weregreaterthan1000mg/LWAF.

Daphniamagna:

ThetestsonDaphniamagnawereperformedusinga48hourstaticacuteimmobilisationstudy.Two groups of 10 daphnids wereexposed tonominal loading (WAF) rates of 0, 0.10,0.18,0.32,0.56,1.0,1.8.3.2,5.6and10mg/L.Thepercentimmobilisationwasrecordedafter24and48hours.TheNOECwasdeterminedtobe0.56mg/Landconsideredtobeverytoxic.

Theabove wasrepeateddue to the unexpectedtoxicity found in the first study.The secondtestwasspecificallydevelopedforthetestingofpetroleumadditives.Thetestwasperformedunderstaticconditionsusingtwogroupsof10daphnidsexposedatnominalconcentrationsof0,13,22,36,60and100mg/L,for48hours.The48hourmedianEC50was39mg/LWAF,basedonnominalconcentrations.The48hourNOECwas22mg/L.

AlgalGrowthInhibition(Pseudokirchneriellasubcapitata):

PseudokirchneriellasubcapitatawereexposedtoaWAFofthetestmaterialataloadingrate

of1000mg/L(intriplicateflasks)for96hours.Samplesofthealgalpopulationswereremoveddailyandcellconcentrationsdeterminedforeachcontrolandtreatmentgroup.TheNOECwasdeterminedtobegreaterthan1000mg/LWAFloadingrate.

ActivatedSludgeInhibition:

TheeffectofCP7077wasinvestigated ontherespirationofactivatedsewagesludge.Thetestinvolvedusing1000mg/LofCP7077intriplicateandaeratingfor3hoursat21Cinthepresenceofactivatedsludgeplussyntheticsewageasarespiratorysubstrate.Therateofrespirationwasmeasuredafter30minutesand3hours.Thepositivecontrolwas3,5-dichlorophenol.The3hourEC50andNOECweregreaterthan1000mg/L.

ResultsbasedonnominalconcentrationsindicatethatOLOA271isnon-toxictotheorganismstestedtothelimitofitswater solubility.Daphnia magnawasanexceptiontotheabovefindingswiththeWAFbeingconsiderablymoretoxic.

11.ASSESSMENTOFENVIRONMENTALHAZARD

Environmentalexposurefrom theoil blending sitesisexpected tobe low as themajorityofthewastefromtheprocessisincineratedorrecycledintotheblendingprocess.Overall,approximately270kgofwasteOLOA271willbegeneratedperannumateachofthesixpotentialblendingsitesinAustralia.Assumingthat APIoilseparationresultsin95%removal of the oil fromwaste water (as claimed bythe notifier), approximately13.5 kg perannumofOLOA271islikelytoenterthesewerfromeachoftheblendingsites.OLOA 271isexpectedtobeassociatedwiththesludgeatseweragetreatmentworksanditsultimatefatewilleitherbeinlandfillorincineration.

Theecotoxicitydataforthenotifiedchemicalindicatethatitisnottoxictofish,algaeorsludgegrowth.Thetoxiclevelsfordaphniaarehighbutduetothelowamountsreleasedintothe aquaticcompartmentandthedispersionofthenotifiedsubstanceamongstthesixpotentialblendingsites,theexposurewillbelow.Hencetheoverallenvironmentalhazardofthenotifiedchemicalwillbelowwhenusedinmarinedieselengineoils.

12.ASSESSMENTOFPUBLICANDOCCUPATIONALHEALTHANDSAFETYEFFECTS

Thenotifiedchemicalisoflowacuteoralanddermaltoxicity.Thenotifiedchemicalproducedmoderateandpersistentirritationtotheskinofrabbits,sufficienttowarrantclassificationasaskinirritant,accordingtotheApprovedCriteria.TheriskphraseR38‘Irritatingtoskin’shouldbeapplied.Thenotifiedchemicalwasslightlyirritatingtotheeyesofrabbits.InMagnussonandKligmanandBuehlertests,thechemicalwasaweaksensitisertoguineapigskin,however,theresponsewasinsufficienttowarrant classificationasaskinsensitiserundertheApprovedCriteria.Theresultsare,however,sufficient toindicatethatprecautionsshouldbetakentoavoidskincontactwiththenotifiedchemical.

Ina28dayrepeatdoseoralratstudy,thenotifiedchemicalcausedpathologicalandbiochemicalchangesatthemidandhighdose,andclinicalsignsofsalivationandhairlossatall doses. The toxicological significanceofadrenal effects seenatall doses is uncertain.ANOELcouldnotbeestablished.Onthebasisoftheresultsofthis28-daystudy,theproposed90-daystudyforthenotifiedchemical(forwhichthe28daystudyisstatedtoberange-finding)iswarranted.

Thenotifiedchemicalwasnotmutagenicininvivoandinvitrotestsystems.TheparaffinicpetroleumdistillatelistedasanimpurityinthenotifiedchemicalisaCategory2carcinogen,withaconcentration cutoffof0.1%,unlessthepetroleumdistillateisshowntosatisfy theconditionthatitcontainslessthan3%DMSOextractasmeasuredbyIP346.Thenotifierhasprovidedinformationwhichshowsthat theconditionissatisfiedinthiscase,andaccordinglyclassificationwillnotberequired.

OccupationalHealthandSafety

Thenotifiedchemicalwillbeimportedinbulkvesselsor200Ldrumsasacomponent(upto70%(w/w))ofalubricant additive package.Theadditivepackagewill bereformulated inAustralia,byblendingwithengineoil.Thefinalproductisthenrepackagedintocontainersfortransporttotheindustrialenduser,generallyin200Ldrumsorbulktanks.

Dermal exposure wouldbethe predominantrouteof occupationalexposure tothe notifiedchemical.Inhalationexposureisexpectedtobeminimalbecausethenotifiedchemicalandthefinishedoilareviscousandthereforehavereducedpotentialtogenerateaerosols.Inaddition,thenotifiedchemicalhasaverylowvapourpressure,sovapouraccumulationintheworkplaceairisnotlikely.Thenotifiedchemicalisaskinirritantandpossibleskinsensitiser,andsoprotectiveglovesandclothingshouldbewornwhenthepossibilityofexposuretodripsandspillsexists.

Workersinvolvedintransferringtheimportedoiladditivecontainingthenotifiedchemicalandblendingtheadditiveintooilmaybeexposedtodripsandspillsoftheadditivepackage,containing70%notified chemical.Occupational exposuretothedripsandspills ofthefinallubricatingoilcontainingupto40%notifiedchemicalispossibleforworkershandlingofthefinallubricatingoil and during disposal. Workersinvolved incleaningandmaintenanceoftanksandblendingequipment,andoftheenginesusingthefinallubricatingoil,mayalsohavegeneraldermalexposuretooilresidues.Itisrecommendedthat allworkershandlingthenotifiedchemicalandthelubricatingoilcontainingthenotifiedchemical,includingshipsengineers,weargloveswhenpotentiallyexposed.

Watersideworkersareunlikelytobeexposedtothenotifiedchemicalundernormalworkingconditions,unlesscontaminationoccursviadamagedpackaging.Withintactpackaging,theoccupationalhealthriskposedtotheseworkersisconsiderednegligible.

PublicHealth

Basedonthenegligibleexposuretothepublic,itisconsideredthatthenotifiedchemicalwillnotposeasignificanthazardtopublichealthwhenusedintheproposedmanner.

13.RECOMMENDATIONS

• Thatthe90dayrepeateddosestudyreportbeforwardedtoNICNASwhencompletedtodeterminewhetherfurtherregulatoryactionisrequired;

• Thattheadditivepackageandtheoilcontainingtheadditivebelabelledwiththefollowingriskphrases

R38‘Irritatingtoskin’R45(2)‘Causescancer’

unlessitcanbedemonstratedthatR45(2)isnotrequired;

• ThenotifiedchemicalmayberecommendedtotheNationalOccupationalHealthandSafetyCommissionforconsiderationforinclusionintheNOHSCListofDesignatedHazardousSubstances.

To minimiseoccupational exposure to notified chemical thefollowingguidelinesandprecautionsshouldbeobserved:

• SafetygogglesshouldbeselectedandfittedinaccordancewithAustralianStandardAS1336(StandardsAustralia, 1994)andcomplywithAustralian/New ZealandStandardAS/NZS1337(StandardsAustralia/StandardsNewZealand,1992);industrialclothingshouldconformtothespecificationsdetailedinAS2919(StandardsAustralia,1987)andAS3765.1(StandardsAustralia,1990);impermeableglovesshouldconform toAS/NZS2161.2(StandardsAustralia/StandardsNewZealand,1998);alloccupationalfootwearshouldconformtoAS/NZS2210(StandardsAustralia/StandardsNewZealand,1994);

• Spillageofthenotifiedchemicalshouldbeavoided.Spillagesshouldbecleaneduppromptlywithabsorbentswhichshouldbeputintocontainersfordisposal;

• Goodpersonalhygieneshouldbepractisedtominimisethepotentialforingestion;

• Workersshouldbeadvisedtoreportanyskinchangestotheoccupationalhealthandsafetyofficerattheirworkplace;and

• AcopyoftheMSDSshouldbeeasilyaccessibletoemployees.

14.MATERIALSAFETYDATASHEET

TheMSDSforthenotifiedchemical wasprovidedinaformatconsistent withtheNationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets(NationalOccupationalHealthandSafetyCommission,1994b).

ThisMSDSwasprovidedbytheapplicantaspartofthenotificationstatement.Itisreproducedhereasa matterofpublicrecord.The accuracy ofthis information remains theresponsibilityoftheapplicant.

15.REQUIREMENTSFORSECONDARYNOTIFICATION

Undersubsection64(1)oftheAct,secondarynotificationwillberequirediftheresultsofthe90 dayrepeat dosetoxicity studymentioned inthereport ofthe 28day repeatdose toxicitystudybecomesavailabletothenotifier,andifevidenceofhumanskinsensitisation isfound.Secondarynotificationofthenotifiedchemicalshallberequiredifanyofthecircumstancesstipulatedundersubsection64(2)oftheActarise.Nootherspecificconditionsareprescribed.

16.REFERENCES

DriscollR(1998a)SP7077(C1829-49):AcuteOralToxicityStudyintheRat.SPLProject Number:703/088.SafepharmLaboratoriesLimited,Derby,UK.

DriscollR(1998b)SP7077(C1829-49):AcuteDermalToxicityStudyintheRat.SPLProjectNumber:703/089.SafepharmLaboratoriesLimited,Derby,UK.

DriscollR(1998c)SP7077(C1829-49):AcuteDermalIrritationTestintheRabbit.SPLProjectNumber:703/090.SafepharmLaboratoriesLimited,Derby,UK.

DriscollR(1998d)SP7077(C1829-49):PrimaryEyeIrritationTestintheRabbit.SPLProjectNumber:703/091.SafepharmLaboratoriesLimited,Derby,UK.

DriscollR(1998e)SP7077(C1829-49):MagnussonKligmanMaximisationStudyintheGuineaPig.SPLProjectNumber:703/092.SafepharmLaboratoriesLimited,Derby,UK.

DurwardR(1998)SP7077(C1829-49):MicronucleustestintheMouse.SPLProjectNumber:703/093.SafepharmLaboratoriesLimited,Derby,UK.

EuropeanCommission(1992a)EEC Methods for the Determinationof Toxicity,Part B,AnnextoCommissionDirective92/69/EEC.OfficialJournalofthe EuropeanCommunitiesNo.L383A,December1992.

EuropeanCommission(1992b)EECMethodsfortheDeterminationofPhysico-ChemicalProperties,PartA,CommissionDirective92/69/EEC.OfficialJournalofthe EuropeanCommunitiesNo.L383A,December1992.

JonesK(1998)SP7077(C1829-49).ToxicityStudybyOralAdministrationtoCDRatsfor4Weeks.HuntingdonLifeSciencesLtd.,Cambridgeshire,UK.

MorrisTD(1998)DelayedContactHypersensitivityStudywith SP7077inGuineaPigs (BuehlerTechnique).HillTopProjectNumber:97-8517-21.HillTopResearch,Inc.,Miamiville,OH.

NationalOccupationalHealthandSafety Commission(NOHSC,1994a)ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008(1994)].AustralianGovernmentPublishingService,Canberra.

NationalOccupational HealthandSafetyCommission(NOHSC,1994b)NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets [NOHSC:2011(1994)].AustralianGovernmentPublishingService,Canberra.

RitzHLandBuehlerEV(1980).In,CurrentConceptsinCutaneousToxicity(VA Drilland T Lazar,eds.).Academic Press.Pp. 25-40.

StandardsAustralia(1987)AustralianStandard2919-1987,AustralianStandardIndustrialClothing.StandardsAustralia,Sydney.

StandardsAustralia(1990)AustralianStandard3765.1-1990,AustralianStandardClothingforProtectionAgainstHazardousChemicalsPart1:ProtectionAgainstGeneralorSpecificChemicals.StandardsAustralia,Sydney.

StandardsAustralia(1994)AustralianStandard1336-1994,AustralianStandardEyeProtectionintheIndustrialEnvironment.StandardsAustralia,Sydney.

StandardsAustralia/Standards NewZealand(1992)Australian/NewZealandStandard1337-1992,Australian/NewZealandStandardEyeProtectorsforIndustrialApplications.Standards AustraliaandStandardsNewZealand,Sydney/Wellington.

StandardsAustralia/Standards NewZealand(1994)Australian/NewZealandStandard2210-1994,Australian/NewZealandStandardOccupationalProtectiveFootwear.StandardsAustraliaandStandardsNewZealand,Sydney/Wellington.

StandardsAustralia/StandardsNewZealand(1998)Australian/NewZealandStandard2161.2-1998,Australian/NewZealandStandardOccupationalProtectiveGlovesPart2:GeneralRequirements.StandardsAustraliaandStandardsNewZealand,Sydney/Wellington.

Thompson,PW(1998)SP7077(C1829-49):SalmonellatyphimuriumandEscherichiacoli/Mammalian–MicrosomeReverseMutationAssay.SPLProjectNumber:703/083.SafepharmLaboratoriesLimited,Derby,UK.

Attachment 1

TheDraizeScaleforevaluationofskinreactionsisasfollows:

ErythemaFormationRatingOedemaFormationRating

Noerythema0Nooedema0

Veryslight erythema (barelyperceptible)

1Veryslightoedema(barelyperceptible)1

Well-definederythema2Slightoedema(edgesofareawell-2

defined bydefinite raising

Moderatetosevereerythema3Moderateoedema(raisedapprox.1mm)3

Severeerythema(beetredness)4Severeoedema(raisedmorethan1mm4

and extendingbeyondareaofexposure)

TheDraizescaleforevaluationofeyereactionsisasfollows:

CORNEA

OpacityRatingAreaof Cornea involvedRating

No opacity0none25%orless(notzero)1

Diffusearea,detailsof iris clearlyvisible

Easilyvisibletranslucentareas,detailsofirisslightlyobscure

Opalescentareas,nodetailsof irisvisible,sizeofpupilbarelydiscernible

1slight25%to50%2

2mild50%to75%3

3 moderateGreaterthan75%4

Opaque,iris invisible4severe

CONJUNCTIVAE
Redness / Rating / Chemosis / Rating / Discharge / Rating
Vessels normal / 0none / Noswelling / 0none / Nodischarge / 0none
Vesselsdefinitely / 1slight / Any swelling above / 1slight / Any amountdifferent / 1slight
injectedabovenormal / normal / fromnormal
Morediffuse,deeper / 2mod. / Obvious swelling / 2mild / Dischargewith / 2mod.
crimsonredwith / withpartialeversion / moisteningoflidsand
individualvesselsnot / oflids / adjacenthairs
easilydiscernible / Swelling withlids / 3mod. / Dischargewith / 3severe
Diffuse beefy red / 3severe / half-closed / moisteningoflidsand
Swelling withlids / 4severe / hairsandconsiderableareaaroundeye
half-closedto
completelyclosed

IRIS

ValuesRating

Normal0none

Folds abovenormal,congestion,swelling,circumcorneal injection, iris reactstolight1slightNo reactionto light, haemorrhage,grossdestruction 2severe

FULLPUBLICREPORT1May2000

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