Full Public Reportreactivescarletrue56

File No: NA/220 Date: 19 July 1995

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME

FULL PUBLIC REPORTREACTIVESCARLETRUE56

ThisAssessmenthasbeencompiledinaccordancewiththeprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989andRegulations.ThislegislationisanActoftheCommonwealthofAustralia.TheNationalIndustrialChemicalsNotificationandAssessmentScheme(NICNAS)isadministeredbyWorksafeAustraliawhichalsoconductstheoccupationalhealthsafetyassessment.TheassessmentofenvironmentalhazardisconductedbytheDepartmentoftheEnvironment,Sport,andTerritoriesandtheassessmentofpublic healthisconductedbytheDepartmentofHumanServicesandHealth.

Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybeinspectedbythepublicattheLibrary,WorksafeAustralia,92-94ParramattaRoad,Camperdown NSW2050,betweenthehoursof10.00a.m.and12.00noonand2.00

p.m.and4.00p.m.eachweekdayexceptonpublicholidays.

ForEnquiriespleasecontacttheAdministrationCoordinatorat:

Street Address: 92ParramattaRdCamperdown,NSW2050,AUSTRALIA

Postal Address:GPOBox58,Sydney2001,AUSTRALIA

Telephone:(61)(02)565-9466FAX (61) (02) 565-9465

Director

ChemicalsNotificationandAssessment

FULL PUBLIC REPORTREACTIVESCARLETRUE56

NA/220

1.APPLICANT

Ciba-GeigyAustraliaLtd.,140BungareeRd.,PendleHill,NSW,2145.

2.IDENTITY OF THE CHEMICAL

Basedonthenatureofthechemicalandthedataprovided,ReactiveScarletRue56isnotconsideredtobehazardous. Therefore,thechemicalname,CASNo.,molecularandstructuralformulae,molecularweightandspectraldatahavebeenexemptedfrompublicationintheFullPublicReportandtheSummaryReport.

Other names:ReactiveScarletRue56FAT45’165/A

Tradename:CIBACRONScarletLS-2G(commercialproductcontaining73.1%ReactiveScarletRue56)

3.PHYSICAL AND CHEMICAL PROPERTIESAppearance at 20°C and 101.3 kPa:Red-brownpowder.Odour: None

Point/MeltingBoilingPoint:300°C

Glass-transitionTemperature:not provided

Density:1650kg/m3

Vapour Pressure:negligiblebasedonthehighMWof thechemical

WaterSolubility:>83g/Lat20°C

FatSolubility:0.05mg/100gat37°C

PartitionCo-efficient

(n-octanol/water)logPow:< -5

SurfaceTension:52.0mN/mat20C

HydrolysisasafunctionofpH:-atpH7:hydrolyticallystableas10%

hydrolysed at 50C after 5 days, t1/2yearat 25C(estimated)

-pH 4: hydrolysis relatively fast at 25C,t1/2= 2.4 days

-atpH9:hydrolysisrelativelyslowat25C,t1/2= 193 days

Adsorption/Desorption:Notdetermined

DissociationConstantpKa:Notdetermined

FlashPoint:Not relevant

FlammabilityLimits:Notcarriedout

AutoignitionTemperature:Anexothermicreactionstartingat265°C.

At 270C,testsubstanceincreasedto

400C(selfignition). Classifiedasautoinflammable.

ExplosiveProperties:Notexplosivebythermal,mechanicalorfrictionalstresses

Reactivity/Stability:Notdetermined

Particlesizedistribution:range-<3to600 µm

< 2m0.5%

2-5m2.5%

5-10m4.6%

10-20m6.1%

20-50m8.4%

50-63m1.3%

63-250m49.3%

> 250m27.5%

Commentsonphysico-chemicalproperties:

Adsorption/desorptiondatawerenotprovidedbecausethemethodofuseofthenotifiedsubstancewillnotpresentopportunitiesforreleaseinanysignificantamountsintotheenvironment. Thedyeisexpectedtoexhibit“verystrongadsorptiononstronglysiltysandandweaksandyloam.” Thisispossiblesinceastudyofhighlysulphonatedbis(azo)dyeshasshownthatthesechemicalssorbtosediment(1)andthechemicalisconsideredtobesurfaceactive(byEECdefinition,forexample,achemicalhassurfaceactivitywhenthesurfacetensionislessthan60mN/m). However,thedegreetowhichtheywilladsorbtosoilsintheAustralianenvironmentisunknown,andwiththeirhighsolubility,lowPowandlowfatsolubilityitwouldtendtoindicatelowabsorption. Thecompound’shydrolyticstabilityindicatesthatitwouldbestableonlyatneutraltoslightlyalkalinepH. Thehalf-lifeof2.4daysat25°CandpH4isconsideredfast,whilethehalf-lifeof193daysat25°CandpHof9isconsideredslow.

Thedissociationconstanttestwasnotperformedasitisobviousthatthechemicalwilldissociateindilutesolutionfromitsstructure,functionalgroupsandbyanalogywithmembersofthesamedyefamilyalreadyassessed.

4.PURITY OF THE CHEMICAL

Thisinformationisexemptedfrompublicationinthefullpublicreport.

5.INDUSTRIAL USE

FAT45’165/AwillbeimportedinthedyestuffCIBACRONScarletLS-2G. Itwillbeused forthepurposeofcolouringofcellulosictextilesbytheexhaustdyeingmethod.

6.OCCUPATIONAL EXPOSURE

Thedyewillbe transportedtoAustraliabyshipinsturdycontainerswithantistaticlinersusedforinternationaltransport. Thecommercialformisformulatedtohaveanti-dustingproperties. Itwillbedistributedfromtwowarehousestothedyehouses.Exposureduringroadtransportispossiblebutwouldbeminimaltakingintoaccountthesubstantialpackagingandthesmallamountofsubstanceperpackage.

Repacking,ifnecessary,willbecarriedoutusingadown-flowbooth. Lessthan100kgwillbeneedtoberepackedover10days/yearfor15-20mindaily.

Occupationalexposurepotentialresultsprimarilyfrombatchingoperationsinthepreparationofdye-bathsindyehouses. Thebatchingoperationconsistsofweighingoutthepowderproductandaddingtotheblendingvesselunderlocalexhaustventilation.

Potentialexposureexistsinthedyehousefromthedyeinsolution.Thepotentialislowbecauseoftheabsenceofaerosolproduction.Alsothedye-bathsareenclosedfurtherminimizingexposurepotential.

Thereisnoevidenceofdyelossfixedtofibreafterwash-offandduringdryingorsubsequentuseinthedyedcellulose.

7.PUBLIC EXPOSURE

Undernormalcircumstancesnopublicexposuretothenotifiedchemicalisexpectedtooccurduringitsdistributiontopotentialcustomersbyroadandrail.

Nopublicexposureisexpectedtooccurduringitsindustrialusewhichwillbeconductedinalimitednumberofdyehousesunderlocalexhaustventilationorwithinaclosedsystem. Disposalofthenotifiedchemicalwasteswillbeeitherbyincinerationortosewerage. Anynotifiedchemicalinthetreatmentplanteffluentisexpectedtobeatalowconcentrationandwillbesubjecttodilutioninthecommunityseweragesystems. Hencepublicexposureisexpectedtobeminimal.

Thepublicwillbeexposedtotextilestreatedwiththenotifiedchemical. However,sincetheestimatedlevelinthetextileislessthan1.5%oftheweightofthecellulose,thechemicalisnotexpectedtopresentapublichealthproblem. Thisconclusioncanbesupportedsince,duetoitshighmolecularweightandlowfatsolubility,dermalabsorptionwouldnotbeexpectedtooccur.

8.ENVIRONMENTAL EXPOSURE

.Release

Thedyestuffwillbeusedtocolourcellulosictextilesbyexhaustdyeingmethodswithahighfixationlevel. Theremainderwillbedischargedwithwastewatertodyehouseeffluentsystems. Thenotifiedsubstanceisexpectedtoreplaceotherreactivedyestuffswithlowerratesoffixation(60-75%). Thenewtechnologyalsousesmuchlesssaltwhichgivesbotheconomicandenvironmentalbenefits.

Releasewillalsobelimitedduetotheuseinalimitednumberofsites. Thegenerationofwasteislimitedtotracesremainingfromtheclean-upofanyspill,traceresiduesinemptypackaginganddischargestodyehouseeffluents.

Thebulkofthedyewillbecomechemicallyboundtofibreandinthisstateisnotexpectedtoimpactontheenvironment. Someminorlossestotheenvironmentmightoccurfromventilationofduststoairorthroughspillsatthewarehouse,duringtransit,oratthewarehouse. Duetoitshighwatersolubility,themajorpotentiallosstotheenvironmentisfromthedyebeingreleasedintothedyehouseeffluentsystemafterwashingthefabricfreeofunfixeddye.

Anyunfixedresidues,afterenteringthesewageworks,mayberemovedthroughdegradation(chemicalorbiological)orsorptiontosludge. Inviewofthehighwatersolubility,itislikelythatsignificantproportionofunfixedresiduewillremainintheaquaticenvironment. Furthermore,reactivedyesingeneralhavebeenfoundnottoadsorbtosludgeinmodelsystems(2).

.Fate

TheMaterialSafetyDataSheet(MSDS)givesdirectionsforclean-upofminorspills,disposalofproductanddisposalofcontaminatedpackaging. Intheeventofaminorspill,theMSDSstatesthatthematerialshouldbedampeddownanddepositedinasuitablecontainerfordisposalbylandfillorincineration,anddisposedofasachemicalwaste. Also,theproductcouldbeincinerated,observinglocalregulations,andresiduescouldbeflushedawaywithwater. Incineration,withexcessair,whereavailablecouldbepreferablebecauseofthehighwatersolubilityofthematerial.

Whileazodyesaregenerallystableunderaerobicconditions,theyaresusceptibletoreductivedegradationundertheanaerobicconditionscharacteristicofsediment(3). Also,highlysulphonatedbis(azo)dyeshavebeenshowntoadsorbtosediment(1). Dyestuffcouldalsoentersedimentbyprecipitationofthecalciumsalt,asseveralcalcium saltsofsulphonicdyesareknowntobeinsolubleatmodestconcentrations(1).

Degradationofsuchdyesinsedimentwatersystemsproceededwithat1/2of2-16days.Accordingly,nosignificantincreaseindissolvedconcentrationsovertimeispredicted.

However,apartfromprecipitationasthecalciumsalt,thehydrophilicnatureandlowpartitioncoefficientofFAT45’165/Aanditssulphonatedmetabolitesmaylimittheaffinityforsoilandsedimentandthusthedyeshouldremainmainlyintheaquaticenvironment.

TheabilityofthedyestufftobebiodegradedwastestedusingtheEECC4-Etest. Thetestresultindicatednosignificantdegradationofthedyestuff. Therefore,thedyestuffisclassifiedasnotreadilybiodegradable.

ThebioaccumulationofFAT45’165Awasnotinvestigatedbecauseoftheverylowpartitioncoefficient(logPow=-5)andlipidsolubility(0.05mg/100g). Hydrophilicdyeswith log Pow=3havebeenshownnottobioaccumulate(3). Alsothelargemolecularsizeofthenotifiedchemicalwouldtendtoinhibitmembranepermeabilityanduptake(4,5).

9.EVALUATION OF TOXICOLOGICAL DATA

9.1AcuteToxicity

Table1SummaryoftheacutetoxicityofFAT45’165/A

Test / Species / Outcome / Reference
Acuteoraltoxicity / Rat / LD50 2000mg/kg / (6)
Acute dermal toxicity / Rat / LD50 2000mg/kg / (7)
Skin Irritation / Rabbit / Slightskinirritant / (8)
Eye irritation / Rabbit / Slight eye irritant / (9)
Skinsensitisation / Guinea-pig / Notaskinsensitiser / (10)

9.1.1OralToxicity(6)

ThisstudywasperformedinaccordancewithOECDguidelineNo.401(11).

FAT45’165/AwasadministeredtoWistarrats(5/sex/group)byoralgavageatasingledoseof2000mg/kg. Clinicalobservationsweremadeover15days. Necropsieswereconductedattheendofthestudy. Nomortalitiesoccurredduringthestudy. Noclinicalsignswerenotedandbodyweightgainswerenotaffectedbytreatment. Necropsyonsacrificedanimalsrevealednosignificantmacroscopiclesions.

ThestudyindicatedthatFAT45’165/AhadanoralLD502000mg/kg.

9.1.2DermalToxicity(7)

ThisstudywasperformedinaccordancewithOECDguidelineNo.402(12).

FAT45’165/AwasappliedtotheclippedbacksofWistarrats(5/sex/group)atasingledoseof2000mg/kg,coveredwithasemi-occlusivedressing,over24h. Clinicalobservationsweremadeover15days. Necropsieswereconductedattheendofthestudy. Nomortalitiesoccurredduringthestudy. Noclinicalsignswerenoted. Minorbodyweightlosses(1to3%)werenotedin4females. Thiswassuggestedtobeduetothesemi-occlusivedressing,towhichfemalesaremoresensitiveinresponseinrelationtobodyweightthanmales. Necropsyonsacrificedanimalsrevealednosignificantmacroscopiclesions.

ThestudyindicatedthatFAT45’165/AhadanoralLD502000mg/kg.

9.1.3SkinIrritation(8)

ThisstudywasperformedinaccordancewithOECDguidelineNo.404(13).

Asingledoseof0.5gFAT45’165/Aslightlymoistenedwithbi-distilledwater,wasappliedtotheclippeddorsalskin(6cm2)of3NewZealandWhiterabbits(1male/2females). Theareawascoveredbyasemi-occlusiveapplicationandexposuretimewas

4h. Skinreactionswereassessed1,24,48and72hoursafterremovalofthedressing.

Nomortalitiesorclinicalsignswerenotedduringthestudy.

Aslightreddiscolourationattheapplicationsitesdidnotpreventassessment.

Veryslighterythema(in2/3animals;meangrade=0.44outofmaximumof4over24-72hours)andnooedemawereobserved.

TheprimaryirritationscoreforFAT45’165/Awastherefore0.44(outofmax.possibleof8.0). TheresultsofthestudyindicatethatFAT45’165/Aisaslightskinirritantinrabbits.

9.1.4EyeIrritation(9)

ThisstudywasperformedinaccordancewithOECDguidelineNo.405(14).

AsingledoseofFAT45’165/Awasinstilledintotheconjunctivalsacofthelefteyeofeachof3NewZealandWhiterabbits(1male/2females). Therighteyeservedastheuntreatedcontrol. Theeyeswereexaminedforocularirritation1,24,48and72hoursafterapplication.

Nomortalitiesorclinicalsignswererecordedduringthestudy. Nostainingoftheconjunctivaeorcorneabythechemicalwasnoted. Nocorrosionwasobserved. Slightoedemawasobservedintwoanimals(1/sex)upto24h. Aprimaryirritationscoreof0.22wascalculated(outofamaxpossibleof13).

Basedupontheresultsofthestudy,FAT45’165/Aisaslighteyeirritant.

9.1.5SkinSensitisation(10)

ThisstudywasperformedinaccordancewithOECDGuidelineNo.406(15).

TheMagnusson-KligmanMaximisationTest(16)wasused. ThetestanimalsusedwerefemaleHimalayanwhitespottedguinea-pigs.

Pretest

Pretestwereperformedtoidentifyamaximallytoleratedconcentrationofchemicalfortheinductionphaseofthetest.

Basedupontheresultsofthesepretests,intradermalandepidermalinductiondosesof5%FAT45’165/Ainbi-distilledwaterand10%invaselinumalbum,respectively,werechosen. Forthechallenge,1% and0.5%dilutionsofFAT45’165/Ainvaselinumalbumwerechosen.

Induction

Onday1,20guineapigswereinjectedintradermally(oneithersideofa4x6cmclippedareaofthedorsalscapularposition)witha1:1(v/v)mixtureofFCAandphysiologicalsaline, 5% w/v FAT 45’ 165/A in bi-distilled water and 5% w/v Fat 45’ 165/A in a 1:1 (v/v) mixtureofFCAandphysiologicalsaline.

Onday8,afterclippingthescapularregionagain,afilterpaperpatchsaturatedwithFat45’165/A(10%invaselinumalbum)wasappliedovertheinjectionsitesandcoveredwithdressingfor48hours. SkinreactionswereassessedbytheDraizemethod24and48hoursafterpatchremoval.

Controlsweretreatedidenticallywiththeomissionoftestarticle.

Afterintradermalinductiontherewasnodifferenceinresponsebetweencontrolandtestanimals. Afterepidermalinduction,reddiscolourationbythetestarticlepreventeddeterminationoferythemabutnooedemawaspresent.

FirstChallenge

Onday22,filterpaperpatchessaturatedwithtestarticleateither1%and0.5%concentrationsorvaselinumalbumvehiclealonewereappliedtotheclippedleftcranialflank,leftcaudalflankandrightflanks,respectively,ofeachguineapig,andoccludedfor24hourswithdressing. Thesiteswerethendepilatedtoremoveredstainingbythetestarticleandsensitisationreactionsscored24and48hoursafterpatchremovalaccordingtotheDraizemethod. Controlsweretreatedidenticallywithoutthetestarticle.

Nopositivereactionswerenotedincontrolortreatedanimalsneitherwhentreatedwithvaselinumalbumalonenorwhentreatedwiththetestarticleat1%and0.5%invaselinumalbum.

SecondChallenge

Onday29thesecondchallengewasperformedwiththetreatmentprocedureidenticalfortestanimalsasdescribedforthefirstchallengeexcepttheapplicationsweremadetotheoppositeflanksoftheguineapigs. Thecontrolsweretreatedwiththevehiclealoneappliedtotheleftflank.

Nopositivereactionswerenotedincontrolortreatedanimalsneitherwhentreatedwithvaselinumalbumalonenorwhentreatedwiththetestarticleat1%and0.5%invaselinumalbum.

Other Data

Noclinicalsignsrelatedtotreatmentwereobservedduringthestudy. Bodyweightgainswereunaffectedbytreatment. Twodeathsoccurredduringthestudy,oneepidermalpretestanimalandonetestanimalpriortothesecondchallengeapplication. Neitherdeathwasattributedtotreatment.

Inconclusion,usingthehighestnon-irritatingconcentrationof FAT45’165/Aie.1%forthechallengeapplications,theresultsofthisstudyindicatethatFat45’165/Aisnotaskinsensitiser.

9.2RepeatedDoseToxicity

9.2.128DayOralToxicityStudyinRats(17)

ThisstudywasperformedinaccordancewithOECDGuidelineNo.407(18). GLPandQAstatementswereprovided.

Fat45’165/AwasadministeredorallytoWistarrats(10/sex/group)atdosesof0,50,200or1000mg/kg/dayfor28days. Thevehiclewasbi-distilledwater. Atterminationofthestudy5animals/sexinthecontrolandhighdose(HD)groupswereobservedforafurther14daytreatmentfreerecoveryperiodwhileallotheranimalswerenecropsiedonday29.

Nomortalitieswererecordedduringthestudy. Theonlyclinicalsignobservedwasdiscolourationoffaecesinalldosegroups,whichwouldbeduetothecolourationofthetest article.

MiminalretardationofbodyweightgainwasobservedinMDandHDmalesthroughoutthestudyandHDfemalesduringthelasttwoweeksofthestudy. MDandHDmalebodyweightswere8-9%lowerthancontrolsattheendoftreatmentincomparisontobeingsimilaratthebeginningofthestudy. DuringtherecoveryperiodbodyweightgainsofHDmaleswascomparabletothatofcontrols. Thoughthebodyweightgainsdidnotreachstatisticalsignificance,theeffectsweretreatmentrelated.

Noophthalmicabnormalitieswerenotedduringthestudy. Clinicalchemistry,haematologyandurinalysisresultsrevealednotreatment-relatedeffects.

Grossnecropsywasunremarkable. Organweights,organtobodyweightandorgantobrainweightratioswerewithinnormalranges.

Histopathologyrevealedtreatment-relatedeffectsinthestomachofprimarilyHDanimals.Theseconsistedofminimaltoslightfoveolarhyperplasiaoftheglandularmucosa(1maleand4femalesinHD)accompaniedbyhigherincidenceandseverityofinflammatorycellinfiltrationintheHDanimals. Additionallyaminimaltoslightdegreeofvacuolationwasobservedin2MDanimals(1male/1female)and4HDanimals(3males/1female). Foveolarhyperplasiaandvacuolationwerenolongerinevidenceinrecoveryanimals.

Inconclusion,theprimarytargetorganfortoxicityofFAT45’165/Awasthegastric mucosawhichwasresolvedduringarecoveryperiod.

9.3Genotoxicity

9.3.1SalmonellatyphimuriumandEscherichia coliReverseMutationAssays(19)

ThisstudywasperformedinaccordancewithOECDGuidelineNo.471and472(20,21).

StrainsusedwereSalmonellatyphimuriumstrainsTA1535,TA1537,TA98andTA100andEscherichiacolistrainsWP2andWP2uvrA. Theassayswereperformedintwoindependentexperimentsbothwithoutandwithmetabolicactivation. Eachconcentrationincludingcontrolswastestedintriplicate. Thefollowingconcentrationsweretested:33.3,100,333.3,1000,2500and5000g/plate. Positivereferencecontrolsusedwere

a)sodiumazide,4-nitro-o-phenylene-diamineandmethylmethanesulfonateintheabsenceofmetabolicinactivationandb)congoredand2-aminoanthraceneinthepresenceofmetabolicactivation.

Uptothehighestinvestigatedconcentrationnotoxiceffectswereobservedongrowthofanystrainseitherintheabsenceorpresenceofmetabolicactivation.

NoincreaseinrevertantcolonynumberswasobservedforanyofthestrainsatanydoselevelofFAT45’165/Aused,intheabsenceorpresenceofmetabolicactivation.

Thepositivecontrolsproducedtheexpectedresponses.

Inconclusion,undertheconditionsoftheseassays,FAT45’165/AdidnotinducepointmutationsbybasepairchangesorframeshiftsinanyofthefourSalmonellatyphimuriumand twoEscherichiacolistrainsused.

9.3.2ChromosomalAberrationsinChineseHamsterOvaryCells(22)

ThisstudywasperformedinaccordancewithOECDGuidelineNo.473(23).

Twoindependentexperimentswerecarriedout. Thechromosomeswereprepared18hand 28 h after initiation of treatment with FAT 45’ 165/A formulated in DSMO. The exposuretimewas4hwithmetabolicactivationand18hand28hwithoutmetabolicactivation.Cultureswithoutmetabolicactivationweretreatedwith10,30or100g/mL(experiment1)or10,50or80g/mL(experiment2)andharvestedat18h(allconcentrations)and28h(highestrespectiveconcentrationsinexperiments1and2).

Concentrationsof30,100or300g/mL wereincubatedwithmetabolicactivation(experiments1and2)andharvestedat18h(allconcentrations)and28h(300g/mlonly;experiments1and2).Allexperimentswereconductedinduplicate. Onehundredmetaphasesperculturewerescoredforstructuralchromosomalaberrations. Positive

controlsusedwereethylmethanesulfonatewithoutmetabolicactivationorcyclophosphamidewithmetabolicactivation.

Inbothindependentexperiments,therewasnobiologicallyandstatisticallyrelevantincreasesincellswithstructuralaberrationsaftertreatmentwithFAT45’165/Aatbothfixationintervalseitherwithorwithoutmetabolicactivation.

Thepositivecontrolmutagensproducedtheexpectedresponses.

Inconclusion,undertheassayconditionsdescribed,FAT45’165/Adidnotinducestructuralchromosomalaberrations.

9.4OverallAssessmentofToxicologicalData

AnimalstudiesindicatethatFAT45’165/Ahaslowacuteoralanddermaltoxicity(LD50 2000mg/kg). Itwasamildskinandeyeirritant,butaccordingtotheNOHSC

1008criteria(24)itisnotclassifiedasanirritant.FAT45’165/Aisnotaskinsensitiser. Itproducedirritationofthegastricmucosainratsatdoses200mg/kgPO,whichwasreadily resolved at the end of a 14 day recovery period. Overall, FAT 45’165/A had low toxicity.

Genotoxicitystudiesindicatedthatithadnomutagenicpotentialin vitro. Noinvivo

studieswereperformed.

10.ASSESSMENT OF ENVIRONMENTAL EFFECTS

TheecotoxicitystudieswereconductedusingFAT45’165/A(65%purity)dissolvedinwater. Actualconcentrationsoftestsolutionsinalltestsremained90%,exceptfortherespirationandbiodegradabilitytestsinwhichconcentrationswerenotmeasured. ThedyesolutionintheDaphniamagnatestdehomogenized(i.e.separatedintolayers),althoughanimalswereobservedtomovethrougheachofthedifferentlayers. TheresultsinTable2wereprovidedbythenotifier.

Table2EcotoxicityTestResults

______

SpeciesTestResult(nominalconcentration)

Carp

(Cyprinuscarpio)

Water flea (Daphniamagna)

Algae (Scenedesmussubspicatus)

96 h acuteLC50100mg/L;nodeathsathighest

concentrationused

48 h acuteEC50100mg/L;noDaphniawere

immobilizedathighestconcentrationtested.

72hgrowthForgrowthinhibition(0-72h): EC50> 100mg/L.

Activated SludgeRespiration

InhibitionTest

EC50100mg/L

TheresultsshowFat45’165/Atobenon-toxictofishanddaphnids. ThisisconsistentwiththewatersolubilityandhighMWofthesubstance.

Thecompanyperformedamodifiedalgaegrowthtesttodifferentiatebetweenreducedgrowthrateduetorealtoxiceffectsandthoseinducedbyanindirectphysicaleffecti.e.lightabsorptionbythecolouredtestsolution. TheinfluenceofthenotifiedchemicalonrespirationofactivatedsludgewastestedunderaerobicconditionsaccordingtoEECDirective67/548(amendment87/302).

Aconcentrationof100mg/Lcausednoinhibitionofbacterialrespirationprocesses.

Nofishbio-accumulationtestwasperformed,basedonthelowfatsolubilityandlowpartition coefficient of FAT 45’ 165/A.

Inconclusion,thesubstancewasnottoxictoaquaticorganismsandisnotexpectedtobioaccumulate. Thesurfaceactivityofthedyedidnotappeartohaveanysignificanteffect onaquaticorganismsunderthetestconditions.

11.ASSESSMENT OF ENVIRONMENTAL HAZARD

Asnotedabove,significantquantitiesofdyewillbedischargedintotheeffluents.Thenotifierhasclaimedthattheworstcasescenariopredictedenvironmentalconcentration(PEC)is23g/Landtheeffluentisdilutedby10:1inthereceivingwaters. Also,higherlevelsmaybeapproachedinacountrydyehouse,onthemainlandorduringdroughtconditions.

Table3EstimationofPredictedEnvironmentalConcentration

Design element

Process or dilution factorCity dyehouse

Countrydyehouse1

Countrydyehouse2

Effluentconcentrationindye-specificwash-water22.5 mg.L-122.5 mg.L-122.5 mg.L-1

Dilutionfactorindyehousebyotherwash-waters31:1(2.5

ML.d-1

effluent)

30:1(2ML.d-1

effluent)

60:1(2-4

ML.d-1

effluent)

Influentconcentration0.703 mg.L-10.725 mg.L-10.369 mg.L-1

Dilutionfactorinsewagetreatmentplant100:13:12:1

Concentrationbalanceineffluentfromsewagetreatmentplant

Noremovalofdyeinsludge:50%removalofdyeinsludge:

7µg.L-1

3.5µg.L-1

182µg.L-1

91µg.L-1

123µg.L-1

62µg.L-1

Dilutionfactorinreceivingwaters3:1to10:13:13:1

Predictedenvironmentalconcentrationinreceivingwaters

Noremovalofdyeinsludge:50%removalofdyeinsludge:

1.8-0.6µg.L-1

0.9-0.3µg.L-1

46µg.L-1

23µg.L-1

30µg.L-1

15µg.L-1

Safetyfactor*forexposureofmostsensitiveaquaticorganism(Algae,Scenedesmussubspicatus, forgrowthinhibition:EBC10=1.22mg.L-1)

677-20332741

*ThesafetyfactoristhehighestPECdividedbythelowestNOEC(EC10approximatestheaNOEC)

ThecalculationsinTable3arebasedontheinternationallyacceptedassumptionthat50%ofthedyestuffisretainedinsludgeinthebiologicaleffluenttreatmentworks.

However,assumingthatnodyestuffisretainedinsludge(asshownforthestudyinreference2)inthebiologicaleffluenttreatmentworks,thentheworstcasePECiscalculatedtobe46g/LineffluentdischargedfromCountryDyehouse1. Basedonthismostextremescenario,thePECof46g/Lgivesasafetyfactorof27toalgalspecies.

AlthoughthealgalspeciesisconsideredbytheUSEPAtobeinsensitive(25),thegrowthinhibitioneffectofthedyeonalgaewasshowntobeafunctionofdecreasedlightintensityorchangeinlightqualityreachingthealgaeinthecolouredmedia. However,thehighwatersolubilityofFat45’165/Asuggeststhatoncereleasedintothewaterways,itwouldbequicklyreducedtoundetectableenvironmentallevels.

Thesubstanceisnotexpectedtoreachtheterrestialcompartmentinanysignificantamounts,norhaveanyimpactonterrestial(soil)organisms.

12.ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETYEFFECTS

FAT45’165/Aisstableatroomtemperature,isnotflammableandhasnegligiblevapourpressure. ItshighMWwouldtendtominimizetransmissionthroughbiologicalmembranes. TheFat45’165/Apowderhasaparticlesizedistributionwhere 3%is5

minsize.Thecommercialproductwillbeformulatedtocontainananti-dustingagenttominimizeinhalationalexposure. Asthenotifiedchemicalisnotasensitiserbaseduponthefindingsofthemaximizationtestontheskin,inhalationofthepowderisnotconsideredtobeamajorconcern.

Thefavourabletoxicologicalprofile: lowacuteoralanddermaltoxicitiesinrats(>2000mg/kg),negativeresultsintheskinandeyeirritationstudiesandskinsensitisationinthemaximizationtest,negativeresultsinbacterialreverse-mutationandthein vitrochromosomalaberrationstestonovarycellsofChinesehamsters,allindicatealowhazardpotential.

Thenotifiedchemicalisnotexpectedtobioaccumulateduetoalowpartitioncoefficientandalowfatsolubility.

Inviewofthephysico-chemicalproperties(dermalabsorptionnotexpectedtooccur),thetoxicologicalprofileandthelikelylowexposurethroughtheuseofenclosedsystems,FAT45’165/Aisnotexpectedtopresentasignificantoccupationalhealthrisk.

13.RECOMMENDATIONS

TominimiseoccupationalexposuretoFAT45’165/Athefollowingguidelinesandprecautionsshouldbeobserved:

.IfengineeringcontrolsandworkpracticesareinsufficienttoreduceexposuretodyesolutionscontainingFAT45’165/Atoasafelevel,thefollowingpersonalprotectiveequipmentshouldbeused:

-respiratoryprotectionconformingtoAustralianStandards(AS)1715(26)and1716(27),

-eye protection conforming to AS 1336 (28) and AS 1337 (29)

-impervioushandglovesconformingtoAS2161(30),and

-overalls (31)

.Goodworkpracticesshouldbeimplementedtoavoidgenerationofdust.

.Goodpersonalhygienepracticesshouldbeobserved.

.A copy of the Material Safety Data Sheet (MSDS) should be easily accessible to employees.

14.MATERIAL SAFETY DATA SHEET

TheattachedMSDSforFAT45’165/AwasprovidedinWorksafeAustraliaformat(32).

ThisMSDSwasprovidedbyCibaGeigyAustraliaLtd.aspartoftheirnotificationstatement. Itisreproducedhereasamatterofpublicrecord. TheaccuracyofthisinformationremainstheresponsibilityofCibaGeigyAustraliaLtd.

15.REQUIREMENTS FOR SECONDARY NOTIFICATION

Under theIndustrialChemicals(NotificationandAssessment)Act1989, secondarynotificationofFAT45’165/Ashallberequiredifanyofthecircumstancesstipulatedundersubsection64(2)oftheActarise. Nootherspecificconditionsareprescribed.

16.REFERENCES

1.Weber E J, Environmental Toxicology and Chemistry, 1991, 10,609-618.

2.Reference25inS.Hobbs, IndustryCategoryDocument:UKDyeProductionandUseintheTextileIndustry,UKDepartmentoftheEnvironment(CR36/38),July1988.

3.C-P Yen, T A Perenich and G L Baughman, Environmental Toxicology and Chemistry, 1991,10,1009-1017.

4.Anlikeretal., Chemosphere,1988,17,1631-1644.

5.Gobasetal.,EnvironmentalToxicologyandChemistry,1986,5,637-646.

6.RCC Project 358830.Acute Oral Toxicity with Fat 45’ 165/A in Rats. Research and ConsultingCompanyLtd.,CH-4452Itingen,Switzerland,1993.

7.RCCProject358841. AcuteDermalToxicitywithFat45’165/AinRats. Research andConsultingCompanyLtd.,CH-4452Itingen,Switzerland,1993.

8.RCCProject358852. PrimarySkinIrritationStudywithFat45’165/AinRabbits. ResearchandConsultingCompanyLtd.,CH-4452Itingen,Switzerland,1993.

9.RCCProject358863. PrimarySkinIrritationStudywithFat45’165/AinRabbits. ResearchandConsultingCompanyLtd.,CH-4452Itingen,Switzerland,1993.

10.RCCProject358874. ContactHypersensitivitytoFat45’165/AinAlbinoGuinea Pigs.MaximizationTest. ResearchandConsultingCompanyLtd.,CH-4452Itingen,Switzerland,1993.

11.OECDGuidelinesforTestingofChemicals-AcuteOralToxicityNo.401,1981.

12.OECDGuidelinesforTestingofChemicals-AcuteDermalToxicityNo.402,1981.

13.OECDGuidelinesforTestingofChemicals-AcuteDermalIrritation/CorrosionNo.404,1981.

14.OECDGuidelinesforTestingofChemicals-AcuteEyeIrritation/CorrosionNo.405,1981.

15.OECDGuidelinesforTestingofChemicals-AcuteSkinSensitizationNo.406,1981.

16.MagnussonB,KligmanA.M., TheIdentificationofContactAllergensbyAnimal Assay.The Guinea Pig Maximization Test.J. Invest. Dermatol., 1969.

17.RCC Project 358885.Subacute 28-Day Oral Toxicity (Gavage) Study in Rats. ResearchandConsultingCompanyLtd.,CH-4452,Itingen,Switzerland,1993.

18.OECDGuidelinesforTestingofChemicals-RepeatedDoseOralToxicityNo.407,1981.

19.CCRProject438715. SalmonellatyphimuriumandEscherichiacoliReverseMutationAssayforAzoDyeswithFAT45’165/A.CytotestCellResearchGMBHandCo.KG,D-64380,Rossdorf,FRG,1993.

20.OECDGuidelinesforTestingofChemicals-Salmonellatyphimurium, ReverseMutationAssayNo.471,1983.

21.OECDGuidelinesforTestingofChemicals-Escherichiacoli, ReverseMutationAssayNo.472,1983.

22.CCRProject438726. ChromosomeAberrationAssayinChineseHamsterV79Cells In Vitro with FAT 45’ 165/A. Cytotest Cell Research GMBH and Co. KG,

D-64380,Rossdorf,FRG,1994.

23.OECDGuidelinesforTestingofChemicals-InVitroMammalianCytogeneticTestNo.473,1983.

24.ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008],AustralianGovernmentPublishingService,1994.

25.USEPA, Environmental Effects Test Guidelines, Algal Acute Toxicity Test, EG-88, 1982.

26.AustralianStandard1715-1991, Selection,useandmaintenanceofrespiratoryprotective devices. Standards Association of Australia Publ., Sydney, 1991.

27.AustralianStandard1716-1991, Respiratoryprotectivedevices. StandardsAssociation of Australia Publ., Sydney, 1991.

28.AustralianStandard1336-1982, Eyeprotectionintheindustrialenvironment.Standards Association of Australia Publ., Sydney, 1982.

29.AustralianStandard1336-1982, Eyeprotectorsforindustrialapplications.Standards Association of Australia Publ., Sydney, 1982.

30.AustralianStandard2161-1978, Industrialsafetyglovesandmittens(excludingelectricalandmedicalgloves). StandardsAssociationofAustraliaPubl.,Sydney,1978.

31.AustralianStandard3765.2-1990, Clothingforprotectionagainsthazardouschemicals. Part2 Limitedprotectionagainstspecificchemicals.

Standards Association of Australia Publ., Sydney, 1990.

32.NationalOccupationalHealthandSafetyCommission, Guidancenoteforcompletionofamaterialsafetydatasheet, 3rdedition, AustralianGovernmentPublishingServicePubl.,Canberra,1991.