Nationalindustrialchemicalsnotificationand Assessmentscheme

File No: NA/5502 November 2000

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONAND ASSESSMENTSCHEME

FULLPUBLICREPORT

Chemical in CAL 611

ThisAssessmenthasbeencompiledinaccordancewiththeprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989(theAct)andRegulations.ThislegislationisanActoftheCommonwealthofAustralia.TheNationalIndustrialChemicalsNotificationandAssessmentScheme(NICNAS)isadministeredbytheNationalOccupationalHealthandSafetyCommissionwhichalsoconductstheoccupationalhealthsafetyassessment.TheassessmentofenvironmentalhazardisconductedbytheDepartmentoftheEnvironmentandtheassessmentofpublichealthisconducted bythe Department of Health and Aged Care.

Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybeinspectedbythepublicattheLibrary,NationalOccupationalHealthandSafetyCommission,92-94ParramattaRoad, CamperdownNSW2050, between the followinghours:

Monday- Wednesday8.30 am - 5.00 pmThursday8.30 am - 8.00 pm

Friday8.30 am - 5.00 pm

Copiesofthisfullpublicreportmayalsoberequested,freeofcharge,bycontactingtheAdministration Coordinator on the faxnumber below.

For enquiries please contact the Administration Coordinator at:

Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW2050, AUSTRALIA

Postal Address: GPO Box58, SYDNEY NSW2001, AUSTRALIA

Telephone: (61) (02) 9577 9514 FAX(61) (02) 9577 9465

Director

Chemicals Notification and Assessment

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FULLPUBLICREPORT

Chemical in CAL 611

1.APPLICANT

Clariant(Australia)PtyLtdof675-685WarrigalRoadCHADSTONEVIC3148hassubmittedastandardnotificationstatementinsupportoftheirapplicationforanassessmentcertificate for Chemical in CAL611.

2.IDENTITY OFTHE CHEMICAL

Thechemicalname,CASnumber,molecularandstructuralformulae,detailsofexactimportvolume,purityandformulation,fullidentityofstructurallyrelatedanaloguesubstances(AnalogueA–G),specificuseandendusecustomershavebeenexemptedfrompublicationin the Full Public Reportand the SummaryReport.

Marketing Name:CAL611(productthatcontainsthenotifiedchemicalat

60 – 100%)

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MethodofDetectionand Determination:

Nuclear magnetic resonance;Infra red (IR);

Highperformance liquid chromatography.

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SpectralData:IRspectrometricdataweresubmittedfortheidentification ofthe notifiedchemical

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3.PHYSICALAND CHEMICALPROPERTIES

Dataarenotavailableforthenotifiedchemical. Unlessotherwiseindicatedthefollowingdata are for the product CAL611 or have been estimated byuse of ACD software.

Appearance at 20°C at 101.3 kPa:Slightlyyellow liquid with a characteristic odour

Boiling Point:>100°C

Specific Gravity:1.17

Vapour Pressure:2.4 kPa at 25°C

Water Solubility:100 mg/Lat 25°C (estimated)

PartitionCo-efficient

(n-octanol/water):logPow3.47 (estimated)

pH:12.5 (100 g/Lwater) (from Material SafetyData Sheet)

Hydrolysis as a Function ofpH:Stable over a wide pH range

Adsorption/Desorption:Koc1 851

DissociationConstant:pKa0.5 – 3.0

FlashPoint:>100°C

FlammabilityLimits:Notexpected to be flammableAutoignitionTemperature: Not expected to igniteExplosive Properties: Not expected to be explosive

Reactivity/Stability:Mayreleasehydrogensulphideincontactwithstrong

acids

Particle Size:Not applicable as imported as a liquid

Comments on Physico-ChemicalProperties

Thevapourpressureofthenotifiedchemicalwasnot determined.The notifier claims that theproductCAL 611hasavapourpressureof18mmHg(2.4kPa),whichisthevapourpressureofthesolventwater.ForthisassessmentusewasmadeofASTEREcotoxicityProfile(USEPA1996).Usingthissoftwareonthefreeparentacidofthenotifiedchemicaldeterminesthevapourpressurewas3.34x10-4mmHg(4.5x10-5kPa)indicatingthatthenotifiedchemicalcanbeclassifiedasveryslightlyvolatile(Mensink1995).Thesaltofthenotifiedchemical would be expected to have a lower vapour pressure.

Thewatersolubilityofthenotifiedchemicalwasnotdetermined.ThenotifierclaimsthatCAL611issolubleinwaterinallproportions.ThenotifierdeterminedthewatersolubilityofthefreeparentacidofthenotifiedchemicalbyACDSoftwaretobe100mg/L,whichiscomparableto46.3mg/LdeterminedusingASTEREcotoxicityProfile.Thenotifiersclaimthat the water solubilityof the salt would be higher is accepted.

ThehydrolysisasafunctionofpHofthenotifiedchemicalwasnotdetermined.ThenotifierclaimsthatCAL611isstableoverawidepHrangeandcanbeusedinstronglybasicandstronglyacidicmedia. Typically,thenotifiedchemicalwillbeusedwithinthepHrangeof

8.5to12.ThisassessmentnotesthatASTEREcotoxicityProfilehydrolysishalf-lifedataareunavailablefortheclassofcompoundsthat the notified chemical belongs to but would expectthe notified chemical to be stable over a wide pH range.

ThepartitioncoefficientlogPOWofCAL611wasnotdetermined.ThenotifierdeterminedthepartitioncoefficientlogPOWofthefreeparentacidofthenotifiedchemicalbyACDSoftwaretobe3.47whichisincloseagreementwith3.67obtainedbyASTEREcotoxicityProfile.Thenotifierexpectsthatthepartitioncoefficientofthesaltformwouldbelower.Thisassessmentnotesthatthevaluesaboveareconsistent(Lymanetal1982)withthefreeparentacidofthenotifiedchemicalbeinghydrophobicincharacter.Thesaltformofthenotifiedchemical,withmuchhigherwatersolubility,wouldbeexpectedtoberelativelyhydrophilic.

TheadsorptioncoefficientlogKOCofCAL 611wasnotdetermined.ThenotifierdeterminedtheadsorptioncoefficientlogKOCofthefreeparentacidofthenotifiedchemicalbyACDSoftwaretobe3.3andexpectsthattheadsorptioncoefficientofthesaltwouldbelower.ThisisequivalenttotheadsorptioncoefficientlogKOCofthefreeparentacidofthenotifiedchemicaldeterminedfromASTEREcotoxicityProfile.This is consistent (McCall et al 1980)with the free parentacid ofthe notifiedchemicalhavinglow mobilityin soil.

ThenotifiedchemicalisexpectedtobecompletelydissociatedintheenvironmentalpHrangebased on its highwater solubilityand the highpH (12.5) of CAL611.

ThenotifieralsosuppliedtheACDcalculationsofanisomerofthefreeparentacidofthenotifiedchemicalandthesecalculationsgaveidenticalpropertiesandaquatictoxicitywhencompared to the free parentacid of the notified chemical.

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4.PURITY OFTHE CHEMICAL

Degree ofPurity:Veryhigh

HazardousImpurities:None

Non-hazardous Impurities

(> 1%by weight):None

Additives/Adjuvants:None

5.USE,VOLUMEAND FORMULATION

Thenotifiedchemicalisanindustrialsurfaceactiveagentforuseinminingprocessoperations.Atpresent,useatonesitehasbeenconfirmed,althoughuseatothersitesisanticipated.

Thenotifiedchemicalwillbeimportedin200Lplasticdrumsasacomponent(60to100%)oftheproductCAL611atgreaterthan10tonnesperannumforthefirstfiveyears.Nomanufacturingof the notified chemical will take place in Australia.

AtthetimeofthisassessmentthenotifiedchemicalisinuseinAustraliaunderaNICNASCommercial Evaluation permit granted under section 21G of the Act.

Inusethenotifiedchemicaliseitherpumpedorgravityfedfromthe200L plasticdrumstoastoragetank.Anautomaticallycontrolledmainsystemisusedtoregulateflow,mixreagentsanddeliverreagentstotheadditionpointsintheprocessingoperation.Theprocessiscompletelyautomated.

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6.OCCUPATIONALEXPOSURE

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Category Number ofWorker

Maximum Potential Exposure Duration Personal Protective Equipment

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Transport and Storage,10

1hour/day; 20 days/year.Industrial standard overalls.

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ReagentHandlers,12

1hour/day; 20 days/year.

Industrial standard overalls, rubber gloves goggles, safetybootsand helmets.

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PlantOperators,6

1hour/day; 20 days/year.

Industrial standard overalls, rubber gloves goggles, safetybootsand helmets.

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Maintenance workers,4

Negligible.

Industrial standard overalls.

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QC/Lab Technicians,4

1hour/day; 20 days/year.

Industrial standard overalls, rubber gloves goggles.

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Transport and Storage

Transportandstorage workersmaybeexposed to the notifiedchemical in the event ofaspill.

Reagent Handlers

Reagenthandlersareresponsibleforconnectingpumplinesbetweentheimportcontainersandtheprocessingoperations.Thisisdonebytimingtheflowrateviaameasuringcylinder.For both activitiesthere maybe potentialfor dermalcontact to dripsand spills.

Plant Operators

Duringregularshiftinspectionsattheminesites,plantoperatorsmayhaveneedtoassistreagenthandlersinpumpingCAL611 and mayreceive dermal contact from drips and spills aspump equipment is manipulated.

Maintenance Workers

Maintenanceinvolvesservicingpumpequipmentusedinreagenttransferoperations.Thenotifier indicates that exposure is expected to be negligible duringthe operations.

QC Laboratory Technicians

Techniciansmayreceivedermalcontactfromdripsandspillsastheycollectsamplesandanalysethe contents.

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Control of Exposure

PersonalprotectiveclothingcompliantwithAustralianStandardsisrecommendedbythenotifierandislistedinthetableaboveagainsteachworkercategory.Automatedpumpingequipmentisinusetopreventdirectworkerexposure.Thenotifierstatedthatdrumsofreagents,includingCAL611arestoredinventilated,bundedareastopreventfumesfromenteringthe workplace.

Worker Education and Training

Attheminesite,workersreceiveinstructionandtraininginthehandlingofallchemicalsonsite.

Adverse EffectReporting

Thenotifieradvised that no health effects have been reported from the occupational use of thenotifiedchemical.

7.PUBLIC EXPOSURE

Itisexpectedthatduringtransport,reformulation,andstorage,exposureofthegeneralpublictothenotifiedchemicalwillbeminimal,exceptintheeventofanaccidentalspill.Thenotifiedchemicalshouldbepreventedfromenteringdrainsandwatercourses.Spillsshouldberemovedbyliquidbindingmaterials,forexample,sand,soil,anddiatomaceousearth,andtransferredtosealedcontainersforincineration.Contaminatedareasshouldbewashedwithwater anddetergent.

Astheuseofthechemicalonlyoccursatminingsites,exposureofthepublicisexpectedtobe minimal.

8.ENVIRONMENTALEXPOSURE

Release

The notifiedchemical is to be used in mining.

Thenotifierclaimsgreaterthan99%ofthenotifiedchemicalisdepositedintotailingsdamsorundergroundbackfill.Thisassessmentconsidersthatthisrateofbindingishighandthatarate of approximately70% is more typical.

Usingthenotifierestimateoflessthan1%ofreagentdisposedofwithtailings,thenforeachtonne of imported CAL611, less than 10 kgof product or 6 to 10 kgof the notified chemical.

Thisassessmentnotesthatthereagentdisposedofwiththeundergroundbackfillisassumedto be locked within the cured cementand release to the environment is notexpected.

Thenotifiedchemicaldisposedofwiththetailingsisnotexpectedtobereleasedtothewiderenvironment. Tailingsdamsaredesignedto"substantially"reducethepotentialforseepage.

Tailingdamsarelinedsoilorgeotextilematerialandtheleakageratedependson thehydraulicconductivityoftheliner.Hydraulicconductivitydependsonthesizeandfrequencyofdefectsordiscontinuityinthelinerandunderlyingbasematerial,and the length of time thehydraulicheadisappliedtotheliner(USEPA1995).Oldertailingsdamfloorsareusuallyconstructedfromsoils.Theintegrityofsoilfloorsdepends largelyupon the soil type, texture,strength,plasticityanddispersionindex.Theintegrityalsodependsuponthedegreeofmaintenanceandtheageofthetailingsdam.Regardlessoftheliningused,thereremainsariskoftailingsdamseepage,whichmayultimatelyleadtocontaminationofsurfaceandgroundwater.Thisconcernisreinforcedbyvariousenvironmentalreportsonminingoperationswhereseepagefromanewtailingsdamhascontaminatedgroundwaterbores,orperiodicdischargeofprocesswaterhasoccurredwhenstormeventscoincidewithperiodsoffullwaterstoragecapacity(NormandyMiningLimited1998),(NorthLimited1998),(Pasminco1999).AtsomeofthesesiteswaterqualitymonitoringhasbeenrequiredbythestateEnvironmentProtectionAuthority,withwaterqualitycriteriaexceededonanumberofoccasions.

Releasetotheenvironmentmayalsooccurasaresultofeitherinappropriatehandlingoraccidentalspillageduringtransport.Insuchcaseswhereliquidcontainingthenotifiedchemicalisreleasedtotheenvironment,thenotifierrecommendsthatthespilt product shouldbetakenupwithliquidabsorbingmaterial.Thewastematerialfromspillagesshouldthenbedisposed ofbyeither approvedincineration or landfill.

Fate

Thenotifierclaimsthatgreaterthan99%ofthenotifiedchemicalwillbeincorporatedduringthe process.

Lessthan1%ofthereagentwillbedisposedofintothetailingsdams.Thewaterinthetailingsdamsisexpectedtobecomeveryacidic,commonlybetweenpH1and2.Thenotifiedchemicalisexpectedtobehydrolyticallystable.However,itislikelytodegradeslowlyin the tailingsdam under the verylow pH.

TheReadyBiodegradabilityofCAL 611wasnotdetermined. However,thenotifiersuppliedalistofresultsofbetween3hoursand27daysofanunspecifiedwastewaterbiodegradationstudy(“Standtest”)onAnalogueA.AnalogueAwasfoundtobenotreadilybiodegradablewithonly 25%degradationafter27days.However,theASTEREcotoxicityProfileindicatesthatthefreeparentacidofthenotifiedchemicalhasacalculatedBODhalf-lifeof2to16days.The notified chemical may,therefore, be considered as not persistent.

Inthecaseofaccidentalreleasetowaterways,thenotifiedchemicalwouldnotbelikelytobepersistent,eitherhydrolysingordegradingslowly.Furthermore,MackayLevel1EnvironmentalPartitioningcalculationsfromtheASTEREcotoxicityProfileindicatethatapproximately40%ofthefreeparentacidofthenotifiedchemicalwouldpartitiontosoilandsedimentandapproximately56%wouldpartitiontowater.Thesaltformofthenotifiedchemicalwouldbeexpectedtoberelativelymobileandpartitiontowatertoagreaterextent.Thepartitionandadsorptioncoefficientsofapproximately3.5and3.3,respectively,forthefreeparentacidofthenotifiedchemicalindicatesthatthechemicalisrelativelyhydrophobicwithlowmobilityinsoil.Asnotifiedchemicalisasaltwithhighwatersolubilityandexpectedmobilityinsoil,itisunlikelytobioaccumulatesinceexposuretonaturalwatersis

expected to be low.

ThenotifierindicatesthatproductdrumsinwhichCAL611isimportedwillretainverylittleresidualnotifiedchemicalfollowingpumpingtothestoragetank.Emptieddrumswillberinsedinawashingareawithrinsewatertobeincludedinprocessingoperations.Alldrumswillthenberetainedonsiteinadrumholdingarea.Thenotifierindicatesthatemptydrumsare often used on site as barriers and markers for mine areas.

9.EVALUATION OFTOXICOLOGICALDATA

ThenotifierstatedthattoxicologicalstudiesarenotavailableforthenotifiedchemicalortheproductCAL611.However,tosupporttheirclaimsforvariationtotheschedulerequirementsthenotifierhassubmittedtestdataonasurrogatesubstance;AnalogueAat45%inan aqueous formulation.The notifier claims that based on structurallysimilarities, thenotifiedchemicalisexpectedtosharethesametoxicologicalprofileasthatofAnalogueA.DataforanalogueAcoveredthreeoftheeighttoxicendpointswheredataisrequiredunderParct C ofthe Schedule to the Act.

Furthersupportingtoxicitydatafromthepublishedliteraturewasprovidedbythenotifierorsourced independentlybyNICNAS on other structurallyrelated analogues identified as:

Of the surrogate data submitted, Analogue A and Analogue E are considered for thisassessment to bethemost closelyrelatedanalogues to the notifiedchemical.

Thestudiesprovidedaresummarisedandthetoxicityendpointsarecomparedwiththesupplementarydata obtained from the literature.

1(RTECS1999)

2TOXLINE,1999

3RTECS,1999;HSDB,1999.

4RTECS,1999;HSDB,1999.

5RTECS,1999;HSDB,1999.

6RTECS,1999;HSDB,1999.

7HSDB,1999,Brooks,1983,Hewstone1994.

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9.1Acute Toxicity

Summary ofthe acute toxicity ofAnalogue A:

TestSpeciesOutcomeReference

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Acute oral toxicityRatLD50>4 000 mg/kg(males)

(Pharma ResearchToxicologyandPathology1987)

(Pharma ResearchToxicologyandPathology1987)

(Pharma ResearchToxicologyandPathology1987)

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9.1.1.1Oral Toxicity (Pharma Research Toxicology and Pathology 1987)

Test Substance:AnalogueA

Species/strain:Rat/WistarNumber/sex of animals:10/sexObservation period: 14 days

Method of administration:Oralgavageof3150and4000mg/kgofbodyweightin

femaleandmalerats,respectively. Bothsexesalsoreceiveda dose of 5 000 mg/kg.

Test method:OECD TG 401

Mortality:Threefemaleandtwomalesinthe5000mg/kggroupdiedbythefirstdaypost-treatment.Allfemalesreceiving3150mg/kgand all males receiving4 000 mg/kgsurvived.

Clinical observations:The following clinical symptoms were seen in surviving

animals:reducedspontaneousactivity;squattingposture;flanksheldclose;piloerection;locomotordisturbances;abnormalbreathingnoisesandnarrowedeyelids.Thesymptoms were reversible from the second dayonwards.

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Morphological findings:At necropsy, decedents displayed the following: lung

discoloured(brightred);reddened stomach mucosa; stomachfilledwithacolourless,clearliquid;stomach/intestinaltractfilledwithreddishbrownliquid(blood);smallintestine filled with colourless,clear liquid.

Animalskilledattheendoftheobservationperiodhadnovisible macroscopic peculiarities.

Comment:Bodyweightgain of survivors was normal.

LD50:>3 150 mg/kgfor females

>4 000 mg/kgfor males

Result:AnalogueA was of verylow acute oral toxicityin rats

Acute Oral Toxicity in Rats

Test SubstanceLD50

AnalogueB694 mg/kg

Analogue C4 510 mg/kg

AnalogueD18 100 mg/kg

AnalogueE1 817 mg/kg

AnalogueF2 140 mg/kg

AnalogueG3 100 mg/kg

9.2.1. Dermal Toxicity in Rabbit

Test SubstanceLD50

AnalogueF1 250 mg/kg

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9.2.1.Inhalation Toxicity

Test SubstanceLC50 Toxic Effects

Analogue B1 700 mg/m3/4 hour;

Lacrimation,dyspnoea,changesinstructureor function of salivarygland.

Analogue C1 640 mg/m3/4 hour;

Somnolence,dyspnoea,weightlossordecreased weightgain.

Skin Irritation (Pharma Research Toxicology and Pathology 1987)

Test substance:AnalogueA

Species/strain:Rabbit/New Zealand White

Number of animals:3

Observation period:7days

Method of administration:A semi-occlusive application of 0.5 mL undiluted test

substancewasmadeonthedorsalskin. After4hours,thesubstance carefullyremoved with tap water.

Test method:OECD TG 404

Draize scores:

Time afterAnimal #

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treatment(days)

Erythema

123

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aseeAttachment1forDraizescales

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MeanIndividualScores(24,48 &72 hour observation)

Erythema and scab formation: 1.3, 2.0, 2.3;

Oedema:0.7, 0.0, 0.7.

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Comment:Bytheseventhdaypost-treatment,allsignsofirritationhaddisappearedexceptforoneanimal,whichstillhaddryandbrittle skin.

Result:Analogue A wasmoderatelyirritatingto theskin of rabbits

SkinIrritation

Test SubstanceSkin Irritancy

AnalogueBModerate

Analogue CMild

AnalogueFSevere

AnalogueGSevere

Eye Irritation (Pharma Research Toxicology and Pathology 1987)

Test substanceAnalogueA

Species/strain:Rabbit/New Zealand White

Number of animals:3

Observation period:7days

Method of administration:Asingledoseof0.1mLoftestsubstancewasappliedtothe

conjunctivalsacofthelefteyeofeachanimal,withtherightuntreatedeyeservingascontrol.Treatedeyeswererinsedthoroughlywith saline 24 hours post-treatment.

Test method:OECD TG 405

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Draize scores ofunirrigated eyes:

Time after instillation

Animal1hour1 day2 days3 days7 days

1seeAttachment1forDraizescales

o=opacity.A=areaoflighteningobservedwithfluoresceinr=redness c=chemosis d=discharge

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Individualmeanscores(24,48 72 hours)

Corneal opacity:3.0, 1.7, 2.7;

Iridial lesions:1.0, 1,0, 1.0;

Conjunctival redness:3.0, 2.3, 2.7;

Conjunctival chemosis: 2.7, 2.0, 2.3.

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Comment:Fromonehourto7daysafterapplication,allanimalsshowedslightswellingoftheconjunctivatoswellingwithhalf-closedlidsaswellasdiffusecrimsontobrightredcolouration.Thecorneahadinpartsscatteredtomother-of-pearl-likeareasofopacity,fortwoanimalsthecorneawascompletelyturbidat7daysafterapplication.Upto72hoursafterapplication,theirisesofallanimalswerereddened,7daysafterapplicationtheirisoftwoanimalscouldnotbeassessed due to the opacity.

Inaddition,upto72hoursafterapplicationthefollowingsymptomswereobservedinparts:clear,colourlesstowhiteslimydischargeandbrowndiscolouration,bleedinganddetachmentofcorneaandnictitatingmembrane.Sevendaysafterapplication,thecorneaandnictitatingmembranesofallanimalswerediscolouredwhitetobrown-white.Atthisassessmenttimepointtwoanimalsshowedadvancedvascularisation of the cornea.

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Result:Analogue A wasseverelyirritatingto theeyeof rabbits

Eye Irritation

Test SubstanceEye Irritancy

AnalogueBSevere

AnalogueCSevere

AnalogueDModerate

AnalogueFSevere

AnalogueGSevere

9.2.1. Skin Sensitisation

No data on skin sensitisationwere submitted.

Thenotifierindicatesevidenceofskinsensitivitywasnotreportedinadermalrepeatdosestudyin rabbits or rats usinganalogues (see below).

Repeated Dose Toxicity

9.2.1.28 day Repeated Dermal Dose Toxicity (Hewstone 1994)

The following is summarised from the published paper.No results were presented ortabulated.The original data was not provided for assessment.

Test SubstanceAnalogueG

Species/SexPhase 1– Rabbit (male and female);

Phase 2– Rabbits and Rats (youngand mature males).

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Concentrationand Dosing Schedule:

Phase 1

0, 1, 3, 5, 25% solutions applied topicallyat 2 mL/kg/day,

5days/week for 4 weeks;

Phase 2

25% solution applied topicallyat 2 mL/kg/day,

5days/week for 4 weeks, followed bya 28 dayrecoveryperiod.

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Findings:

Phase 1- Rabbits

No toxic effects at 1 or 3% in males or at all doses in females.

Inmalesat5%and25%,aspermatogenesisandtubularhyperplasiaandskindamage(fissuringandexfoliation)andbodyweightloss(extentofbodyweightlosswasnotreported)wasobserved.Noeffectswereseeninanyotherorgans.Theeffectsinthemalereproductivetractwerereportedtocorrelatewiththedegreeofbodyweightloss.TheNoObserved Adverse Effect Level(NOAEL) is determined at 3% (15.8 mg/kg).

Phase 2– RatsandRabbits(investigation into reproductive tract effects observed above)Rabbits–similarmalereproductivetractfindingsasobservedinphase1. Testicularatrophywasevidentinagrossreductioninsizeandweightofthetestesandinareducedtestestobodyweightratio. Intheepididymides,reductionorabsenceofspermatozoawasconsistentwiththetesticulareffects. Somereversibilityoftesticulareffectsoccurredduringrecovery. Howeverthedurationoftherecoveryperiodwasconsideredinsufficienttodetermine if reversibilitywascomplete.

Rats – no reproductive tract effects reported.

Comment:

Hewstone(1994)commentsthatthereproductivetracteffectsobservedinrabbits aregenerictothisclassofcompound.Furthermore,theseeffectsappeartobespeciesspecificbeingdemonstratedonlyintherabbit.Hewstone(1994)makesreferencetoinvestigationswhererabbitmalereproductiveeffectsmaybephysiological,aresultofreducedfoodconsumption and bodyweight loss and not as a result of a direct toxic effect.

9.2.2.Inhalation Developmental Study- (TOXLINE 1999)

ThefollowingistakenfromtheTOXLINEabstract. Theoriginaldatawerenotavailableforassessment.

Test SubstanceAnalogueB

SpeciesRat,CharlesRiver CD (SD) BR(mated)

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Concentrationand Dosing Schedule:

0,5.8,51and214mg/m36hours/dayondays6-15ofgestation.Number of animals per dose was not provided.

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Findings:

Threedamsat214mg/m3diedongestationdays15to17.At5.8and51mg/m3,clinicalsignsofmaternaltoxicitywereredstainingandencrustationoffaceandforelimbs.Inaddition,damsat214mg/m3showedurinarystaining,mattedfur,vaginaldischarge,piloerection,hunchedposture,hypoactivityandbreathingdifficulties.Bodyweightandweightgainwereunaffectedindamsat5.8mg/m3.Significantbodyweightdecreasesoccurredongestationday10,13,16,and21indamsat51mg/m3andongestationday10,13,and16at214mg/m3,relativetocontrolgroupanimals.Significantdecreasesinweightchange were reported on gestationdays 6 to 16 in dams at 214 mg/m3.

Postmortemfindingsintreatedandcontroldamswerecomparable. Mean implants,corporalutea,andpreimplantationlossintreatedgroupswerecomparabletocontrols.Uterine weights were not reported.

Totalnumberoffoetuses,livefoetuses,andmeanfoetalweight(bothmalesandfemales)decreasedsignificantlywhilethenumberofearlyresorptions,postimplantationlosesandtotalnumberwithmalformationswereincreasedinanimalsat214mg/m3.Treatmentrelatedmalformationsat214mg/m3(includedundescendedtestes,bentscapulaeand/orlimb bones and ribs).Foetal variations were similar in treated and control groups.

Comment:

Basedonthesummarydataprovidedthelowestobservedeffectlevel(LOEL)formaternaltoxicityis determined at 5.8 mg/m3and the NOAELfor developmental effects is 51 mg/m3.

9.3Genotoxicity

Test SubstanceMutagenicity

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AnalogueC(HSDB1999)

MutagenicinSalmonellastrainsTA1535andTA100inthepresence or absence of S9.

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AnalogueD(HSDB1999)

NonmutagenicinanystrainofSalmonellainthepresenceorabsence of S9.

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AnalogueG(Brooks 1983)

NonmutagenictoSalmonellastrains TA1535, TA1537, TA1538,TA98, TA100, at 12.5 to 1 000

g/plateinthepresenceorabsenceof S9.

Noincreasedcelltransformationsinmammalian(BHK21/Cl-13)cellsat500to4000g/mLinthe

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presenceorabsenceof S9.

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9.4Overall Assessment ofToxicological Data

Intheabsenceofdataonthenotifiedchemical,thenotifierprovideddataonAnalogueA.Inaddition,dataonotherstructurallyrelatedanalogues(AnaloguesB-G)werealsoprovided.FullstudydatawereonlyprovidedforAnalogueA.DataonAnaloguesB-Garetaken,without assessment, from literature abstracts or papers.

Analogue A and Analogues B-G have low acute oral toxicity, typically an oral LD50 of greater than 2 000 mg/kg (range: 694 mg/kg to 18 100 mg/kg). Analogue A is closely related to the notified chemical and it is expected that the oral toxicity of the notified chemical would be similar to that of Analogue A. Analogue F was of moderate acute dermal toxicity; the rabbit dermal LD50 is reported at 1 250 mg/kg. Analogue B and Analogue C had moderate acute inhalation toxicity, LC50 of 1 700 and 1 640 mg/L/4 hours, respectively. It is expected that the acute dermal and inhalation toxicity profile of the notified chemical would be similar to that observed with the analogues. The analogues are severely irritating to eyes and prolonged skin contact results in mild to severe skin irritation. Repeated contact results in severe skin damage characterised by fissuring and exfoliation. By analogy, the notified chemical will share the same degree of skin and eye irritancy.

A28dayrepeatdermaldosestudyonAnalogueGrevealedsignificantsystemiceffects(aspermatogenesisandtubularhypoplasia)inmalesat5%and25%butnotat1%or3%.Therewerereportedlynoeffectsinotherorgansbutexperimentaldetailswerenotprovided.Applicationat5%and25%alsoresultedinskindamageandbodyweightloss.Theeffectsinthemalereproductivetractappearedtocorrelatewiththedegreeofbodyweightlossandmaybespeciesdependentasinsubsequentinvestigationsinrabbitsandrats,reproductiveeffectswereonlyobservedinrabbits.Thisdataisinsufficienttodeterminearepeatdosehealtheffectclassification for the chemical.

Teratogenicitywasevaluatedinratsexposedbyinhalationto5.8,51and214mg/m3AnalogueBondays6to15ofgestation. TheLOELformaternaltoxicityisdeterminedat

5.8mg/m3.Treatmentrelatedmalformationswereobservedinfoetusesat214mg/m3.TheNOAELfor developmental effects was 51 mg/m3.

Analogue C was found to be mutagenic to bacteria, but not the sodium salt of this compound. Blends of Analogue G did not show evidence of genotoxic activity in a bacterial mutation assay or in a mammalian cell transformation assay. In the absence of data no determination can be made on the clastogenic potential of the class of compounds represented by Analogues A - G.

Hazard Classification

Intheabsenceofspecificdata,analoguedatawith45%ofactivechemical,andlackofstudyreportsforassessmentthisisaconservativehealtheffectsclassification.ClassificationofthehealthhazardsofthenotifiedchemicalismadebyanalogywithAnalogueAandAnaloguesB-G.TheanaloguechemicalsmeetthecriteriaforclassificationasHarmful(Xn)undertheApprovedCriteriaforClassifyingHazardousSubstances(NOHSC1999).Basedonthefindingsofsignificantskinandeyeirritationscores,AnalogueAmeetsthecriteriaforclassificationasasevereeyeirritant(R41-RiskofSeriousDamagetoEyes),andskinirritant(R38-Irritating toskin).AnalogueF isclassifiedasacutelytoxicbythe dermalroute(R21 – Harmful in Contact with Skin) based on the reported acute dermal LD50, and

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AnalogueBandAnalogueCaremoderatelyacutebytheinhalationroute(R20–HarmfulbyInhalation).

10.ASSESSMENT OFENVIRONMENTALEFFECTS

ThenotifierhassuppliedecotoxicitystudiesonAnalogueA(seeFateabove),whicharesummarised in the followingtable:

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TestSpeciesTestconcentrations(nominal) mg/L

Resultsmg/L

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Acute Toxicity9(Static Test)(OECD TG 203)

Zebra Barbel

(Brachydaniorerio)

50096 hour LC50

500

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RespirationInhibitionAerobic Waste

Water Bacteria

-3 hour EC50= 650

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10.1Acute Toxicity Fish (Pharma Research Toxicology and Pathology 1987)

TheAcuteToxicityfishtestwasperformedincompliancewithOECD/EECTestMethodsand accordingto OECD Principles of Good LaboratoryPractices.

TheacutetoxicityofAnalogueAtoZebraBarbelwasdeterminedina96hourstatictestatasinglenominalconcentrationof500mg/L.Thenotifierstatesthattherewerenomortalitiesduringtheentiretrialperiodandthatnochangesintheappearanceandbehaviourofthefishwereobservedwhencomparedwiththecontrolgroup.The96hourLC50ofthenotifiedchemicalwasdeterminedbythenotifiertobegreaterthan500 mg/Landthehighestconcentrationtestedwithouttoxiceffectswas500 mg/L.Measuredconcentrationsofthetestsampleswere not determined.

10.2Microorganisms(Hoechst 1986)

Thenotifiersuppliedaverybriefsummaryoftwounspecified24hourwastewaterbiologicaltests(saidtobeaFermentationandaConsumptionInhibitiontest)carriedoutonAnalogue

A.Nominaltestconcentrationrangeswerenotsuppliedandmeasuredconcentrationsofthetestsampleswerenotdetermined.The24hourEC50valuesofAnalogueAareclaimedbythe notifier to be 650 and 1 500 mg/L,respectively.

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TheASTEREcotoxicityProfilecalculatedforthisassessmentonthefreeparentacidofthenotifiedchemical is summarised in the followingtables:

Acute Toxicity

SpeciesDuration daysEndpointConcentration mg/L

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Water flea

Daphnia magna

Bluegill

Lepomis macrochirus

Flathead minnow

Pimephales promelas

Channelcatfish

Ictalurus punctatus

Rainbow trout

2LC503.8

4LC505.2

4LC506.3

4LC502.7

4LC502.5

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Oncorhynchusmykiss

Chronic Toxicity

SpeciesDuration daysEndpointConcentration mg/L

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Flathead minnow

32MATC1.0

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Pimephalespromelas

ThenotifieralsoprovidedcalculatedecotoxicitydataofisomersofthefreeparentacidofthenotifiedchemicalfromACDsoftware.Thedatareportedwasidenticalforbothisomersandindicatedthattheyaremoderatelytoxictofish,daphniaandalgaewitheitheranEC50or LC50range of 6 to 17 mg/L.

10.3Conclusion

TheecotoxicitydatasuppliedbythenotifierforAnalogueAindicatesthatthenotifiedchemicalispracticallynon-toxictofishandsewagemicroorganisms.TheecotoxicitydatacalculatedintheASTEREcotoxicityProfileforthefreeparentacidofthenotifiedchemicalindicatesthatitismoderatelytoxictofishanddaphnia.Thisisconfirmedbythenotifierscalculationsindicatingisomersofthefreeparentacidofthenotifiedchemicalaremoderatelytoxic to fish, daphnia and algae.

Thedataindicatesthatthesaltformofthenotifiedchemicalhashighersolubilityinwaterand a lower toxicityto aquatic organisms when compared to the free parent acid.

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11.ASSESSMENT OFENVIRONMENTAL HAZARD

Thenotifiedchemicaldisposedofinthetailingsisexpectedtobecontainedwithinthetailingsdam with minimalrelease to the environment.

Thenotifiedchemicaldisposedofwiththeundergroundbackfillwillbelockedwithinthecured cementand release to the environment is notexpected.

Basedonanannualmaximumimportvolumeof100tonnesofCAL611,600to1000kgofthenotifiedchemicalwillbereleasedtotailingsdamsandundergroundbackfillperannum.Thenotifierclaimsthattheproposedmineproducesapproximately2400000tonnesoftailingsperyearandthatthetailingsareapproximately50%solidsinwater. Therefore,1200MLofwaterwillbeconsignedtotailingsdams.Ifitisassumedthatatthesingleproposedminesiteallofthereleasednotifiedchemicalisreleasedtotailingsdamsandnottoundergroundbackfill,thenbasedonmaximumimportvolumesofCAL611thefinalconcentration of the notified chemical in the process effluent would be 0.5 to 0.8 mg/L.

Theenvironmentalsafetymarginforexposureofthemostsensitiveaquaticorganism,Rainbowtrout96hourLC50=2.5mg/Lfromcalculatedecotoxicitydataforthefreeparentacidofthenotifiedchemical,wouldbeequalto 3 to 5.However, this assessment notes that itisunlikelythatthenotifiedchemicalwillexistasthefreeparentacidwithinthetailingsdam,whichalthoughexpectedtobeveryacidic,willcontainrelativelyhighconcentrationsofdissolvedmetals.Therefore,theenvironmentalsafetymarginforexposureofthemostsensitiveaquaticorganism,ZebraBarbel96hourLC50greaterthan500mg/Lfromecotoxicitydata for structurallyrelated analogueAwould be 625 to 1 000.

Tailingsstoragedamsaredesignedtoreduce"substantially"thepotentialforseepageaswellascopewithaoneinahundred-yearflood.However,regardlessofthetypeofflooremployedthereremainssomeriskoftailingsdamseepagewhichmayleadtocontaminationofsurfaceandgroundwater.Also,periodicdischargeofprocesswaterattheminesitehasbeen known to occur when storm events coincide with periods of full water storagecapacity.

Itisassumedthatahighevaporationratefromdamsoflargesurfaceareawouldresultinaconstantvolumeofthedamwater.However,theconcentrationofthenotifiedchemicalwouldnotbeexpectedtoincrease,assome adsorption to sediment and hydrolyticdegradationarelikelytooccurinthehighlyacidicdameffluent.Intheeventofadambreachduetoheavyrainfall,highdilutionofthedamcontentswouldbeexpected.Also,themajorenvironmentalconcernofliberateddamwaterfromabreachwouldlikelybethehighacidityofthe water aswellasanydissolvedmetalscontained within the water.

Giventheabove,environmentalexposureandtheoverallenvironmentalhazardofthenotified chemical is assessed as acceptable.

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12.ASSESSMENTOFPUBLICANDOCCUPATIONALHEALTHANDSAFETYEFFECTS

NotoxicologystudiesonthenotifiedchemicalortheproductCAL611containingitweresubmitted.Analoguesofthenotifiedchemicalwereoflowacuteoraltoxicityandmoderatedermalandinhalationtoxicity.Analoguesaresevereeyeirritantsandmildtosevereskinirritantsinrabbits.Dataonskinsensitisationwerenotsubmitted.Inalimitedsummary ofarepeatdose28daydermalexposurestudyinrabbits,ananaloguecausedsevereskineffects,bodyweightlossandeffectsonthemalereproductivetractinmalesonly.Thereproductivetracteffectswerecorrelatedwiththedegreeofbodyweightloss. An inhalationdevelopmentalstudyonanotheranalogueinratscauseddevelopmentaleffectsatmaternallytoxicdoses.Onecitedstudyindicatedthatarelatedcompoundwasmutagenictobacteria,however, studies on other related compounds did not indicate this.

Intheabsenceoftoxicologicaldataonthenotifiedchemical,classificationofthehealthhazardsofthenotifiedchemicalismadebyanalogywithanalogues.TheoverallhazardclassificationisHarmful(Xn)withriskphrases:R20/21HarmfulbyInhalationandinContact with Skin; R41 – Risk of Serious Damage to Eyes; and R38 – Irritatingto Skin.

Occupational Health and Safety

Intheoccupationalenvironmentskinandeyeirritancyandsystemictoxicityarethehazardsofconcernforthenotifiedchemical.Transportandstorageofthe200Limportcontainersshould not result in worker exposure except in the event of accidental spillage.

Workerexposureduringnormaluseofthenotifiedchemicalismostlikelytooccurfromdripsandspillswhenconnectingordisconnectinglinesorcleaningpumpsandancillaryequipment.Thenotifierstatesthatplantworkersinvolvedintransferringthe notifiedchemicalduringtheprocessingphasearerequiredtowearrubbergloves,safetygogglesandoveralls.Itiscriticalthatemployersensurethatworkersweartheprotectiveclothingasspecified,tominimisethepotentialforexposuretothe60-100%solutionofchemicalandtheadverseeffectsofirritancyandtoxicity.Atthecommencementoftheprocessingphase,thenotifiedchemicaliscontainedwithinanautomatedprocessataninitialconcentrationoflessthan0.1%.Thesubsequentprocessesalsorequirelittleworkerintervention.Chemicalincorporatedduringprocessoperationsisultimatelydestroyedduringsubsequentoff-sitemetal processing.

Public Health

Asthenotifiedchemicalwillonlybeusedintheminingindustry,therewillbeminimalpublicexposure. Basedontheinformationprovided,thenotifiedchemicalisunlikelyto poseasignificanthazardtopublichealthwhenusedintheproposedmannerduetolimitedpotential for exposure.

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13.RECOMMENDATIONS

Occupational Health and Safety

TominimiseoccupationalexposuretoCAL611thefollowingguidelinesandprecautionsshould be observed:

• Developmentandimplementationofaskinandeyeexposuremanagementsystem: theworkplace,equipmentandworktasksshouldbestructuredtominimiseskinandeyeexposure and anyresultant damage to health;

• WorkersshouldbeadvisedofthepotentialforskinandeyeeffectsuponcontactwithCAL611andtopromptlyreportanyadverseeffectstotheoccupationalhealthandsafetyofficerattheirworkplace.Ifanadverseeffectoccurs,theemployershouldreviewworkpracticesandopportunitiesforcontactwiththesubstanceandinstigatepreventive measures to ensure other workers do not develop the same condition;

• SafetygogglesshouldbeselectedandfittedinaccordancewithAustralianStandard(AS)1336(StandardsAustralia1994)tocomplywithAustralian/NewZealandStandard(AS/NZS)1337(StandardsAustralia/StandardsNewZealand1992);industrialclothingshouldconformtothespecificationsdetailedinAS2919(StandardsAustralia1987)andAS3765.1(StandardsAustralia1990);impermeableglovesshouldconformtoAS/NZS2161.2(StandardsAustralia1998);alloccupationalfootwearshouldconformtoAS/NZS2210(StandardsAustralia/Standards New Zealand 1994);

• Spillageofthenotifiedchemicalshouldbeavoided.Spillagesshouldbecleaneduppromptlywith absorbents which should be put into containers for disposal;

• Good personal hygiene should be practised to minimise the potential for ingestion;

• A copyof the MSDSshould be easilyaccessible to employees.

Public Health

Iftheconditionsofusearevariedandgreaterexposureofthepublicmayoccurfurtherinformation maybe required to assess the hazards to public health.

Environment

Tominimisethepotentialforenvironmentalimpactitisrecommendedthatasmuchaspossible of the notified chemical be disposed of to underground backfill.

14.MATERIAL SAFETY DATA SHEET

TheMSDSforCAL611wasprovidedinaformatconsistentwiththeNationalCodeofPractice for the Preparation of Material Safety Data Sheets(NOHSC 1994).

ThisMSDSwasprovidedbytheapplicantaspartofthenotificationstatement.Itisreproducedhereasamatterofpublicrecord.Theaccuracyofthisinformationremainstheresponsibilityof the applicant.

15.REQUIREMENTS FOR SECONDARY NOTIFICATION

UndertheAct,secondarynotificationofthenotifiedchemicalshallberequiredifanyofthecircumstancesstipulatedunder subsection 64(2) of the Act arise.No other specific conditionsare prescribed.

16.REFERENCES

Brooks (1983).

Hewstone (1994).

Hoechst(1986)ResultsofWastewaterBiologicalTests-ReportNo. W86-081.Environmental Protection Section, Hoechst .

HSDB(1999) Hazardous Substances Database, MicromedexInc.

Lymanetal(1982)EnvironmentalBehaviourofOrganicCompounds.HandbookofChemical PropertyEstimation Methods, McGraw Hill Inc.

McCalletal(1980)EstimationofChemicalMobilityinSoilfromLiquidChromatographicRetention Times. Bull Environ Contam Toxicol, 24: 190-195.

Mensink,B.e.a.(1995)ManualforSummarisingandEvaluatingtheEnvironmentalAspectsofPesticides,July1995,ReportNo.679101022,NationalInstituteofPublicHealthandtheEnvironment, The Netherlands.

NOHSC(1994)NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets[NOHSC:2011(1994)].Canberra, Australian Government PublishingService.

NOHSC(1999)ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008(1999)].Canberra, AusInfo.

NormandyMiningLimited (1998) Environmental Report for Mt Leyshon Operations.

North Limited (1998) Environment, Safetyand Health Report.Pasminco (1999) Annual Environment Report.

PharmaResearchToxicologyandPathology(1987)TestingforAcuteOralToxicityintheWistar Rat, Report No. 87.0637, (English Translation). Frankfurt.

PharmaResearchToxicologyandPathology(1987)TestingforAcuteOralToxicityonFish,Zebra Barbel, Report No. 87.0459, (English Translation). Frankfurt.

PharmaResearchToxicologyandPathology(1987)TestingforEyeIrritationinRabbits,Report No. 87.0600 (English Translation). Frankfurt.

PharmaResearchToxicologyandPathology(1987)TestingofSkinIrritationinRabbits,Report No. 87.0582 (English Translation). Frankfurt.

RTECS (1999) Register of Toxic Effects of Chemical Substances. MicromedexInc.

StandardsAustralia(1987)AS2919-1987,AustralianStandardIndustrialClothing.Sydney,Standards Australia.

StandardsAustralia(1990)AS3765.1-1990,AustralianStandardClothingforProtectionagainstHazardousChemicalsPart1ProtectionAgainstGeneralorSpecificChemicals.Sydney,Standards Australia.

StandardsAustralia(1994)AS1336-1994,AustralianStandardEyeprotectionintheIndustrial Environment. Sydney,Standards Australia.

StandardsAustralia(1998)AS/NZS2161.2:1998,Australian/NewZealandStandardOccupationalProtectiveGlovesPart2:GeneralRequirements.Sydney/Wellington,StandardsAustralia and Standards New Zealand.

StandardsAustralia/StandardsNewZealand(1992)AS/NZS1337-1992,Australian/NewZealandStandardEyeProtectorsforIndustrialApplications.Sydney/Wellington,StandardsAustralia and Standards New Zealand.

StandardsAustralia/StandardsNewZealand(1994)AS/NZS2210-1994,Australian/NewZealandStandardOccupationalProtectiveFootwear.Sydney/Wellington,StandardsAustraliaand Standards New Zealand.

TOXLINE (1999).

US EPA (1995) Best Practice Environmental Management in Mining-TailingsContainment.

USEPA(1996)ASTEREcotoxicityProfile.Duluth,USEPANationalHealthandEnvironmental Effects Research Laboratory,Mid Continent EcologyDivision.

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Attachment 1

TheDraizeScaleforevaluationofskinreactionsisasfollows:

ErythemaFormationRatingOedemaFormationRating

Noerythema0Nooedema0Veryslighterythema (barelyperceptible) 1 Veryslightoedema (barelyperceptible) 1

Well-definederythema2Slightoedema(edges ofareawell-defined2

bydefinite raising

Moderate tosevere erythema3Moderate oedema (raisedapprox.1mm)3

Severe erythema (beetredness)4Severeoedema(raisedmorethan1mm4

and extending beyondarea ofexposure)

TheDraizescaleforevaluationofeyereactionsisasfollows:

ofirisslightlyobscure

Opalescent areas, no details of irisvisible,size ofpupilbarelydiscernible

3

moderate

Greaterthan75%4

Opaque,iris invisible4severe

Vesselsdefinitelyinjectedabove normal

Morediffuse,deepercrimsonredwithindividualvesselsnoteasilydiscernible

Diffuse beefyred

1

slight

2mod.

3severe

Anyswellingabovenormal

Obviousswellingwithpartialeversionoflids

Swellingwithlidshalf-closed

Swellingwithlidshalf-closedtocompletelyclosed

1slight

2mild

3mod.4severe

Anyamountdifferentfromnormal

Dischargewithmoisteningoflidsandadjacenthairs

Dischargewithmoisteningoflidsandhairsandconsiderablearea aroundeye

1slight

2mod.

3severe

IRIS

ValuesRating

Normal0 none

Folds above normal, congestion,swelling,circumcorneal injection,iris reacts tolight1slight

Noreactiontolight,haemorrhage,grossdestruction2severe

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