FileNo:NA/598May1998
NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME
FULLPUBLICREPORT
“Eastman AQ” 1350 Copolyester
ThisAssessmenthasbeencompiledinaccordancewiththeprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989(theAct)andRegulations.ThislegislationisanActoftheCommonwealthofAustralia.TheNationalIndustrialChemicalsNotificationandAssessmentScheme(NICNAS)isadministeredbytheNationalOccupationalHealthandSafetyCommissionwhichalsoconductstheoccupationalhealthsafetyassessment.TheassessmentofenvironmentalhazardisconductedbytheDepartmentoftheEnvironmentandtheassessmentofpublichealthisconductedbytheDepartmentofHealthandAgedCare.
Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybeinspectedbythepublicattheLibrary,NationalOccupationalHealthandSafetyCommission,92-94ParramattaRoad,CamperdownNSW2050,betweenthefollowing hours:
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Director
ChemicalsNotificationandAssessment
ASSESSMENTREPORT:COMMERCIALIN CONFIDENCE2 November,2000
NA/598
NA/598
Eastman AQCopolyester
1.APPLICANT
EastmanChemicalLimitedofLevel 8,15TalaveraRoadNORTH RYDENSW2113hassubmittedalimitednotificationstatementinsupportoftheir applicationforanassessmentcertificatefor ”EastmanAQ” Copolyester.
2.IDENTITYOF THE CHEMICAL
EastmanAQCopolyester isconsiderednottobehazardousbasedonthenatureofthechemical andthedataprovided. Thereforethechemical name,CASnumber,molecular andstructural formulaehavebeenexemptedfrompublicationintheFullPublicReportandtheSummaryReport.
Trade Names:
EastmanAQ1950CopolyesterEastmanAQ14000CopolyesterEastmanAQ1045CopolyesterEastmanAQ1350CopolyesterPM18009
Number-Average
MolecularWeight(NAMW):Upto10000
Maximum Percentage of Low MolecularWeightSpecies
MolecularWeight500:MolecularWeight1000:
0.6%
2.6%
Polydispersity:4.01
MethodofDetection
and Determination:Sizeexclusionchromatography(SEC) wasusedto
determinetheNAMWandlowmolecular weightspecies;infrared(IR) spectroscopy
SpectralData:major characteristic peakswerefoundintheinfraredspectrumat:625,760,1400,1450,
1050,1130,1175,1250,1310,1725and
2950cm-1
Comments on ChemicalIdentity
Thenotifiedpolymer products,EASTMANAQCopolyesters1045,1350,14000and1950,areallchemicallyidentical,highmolecular weightpolymers(NAMW5000g.mol-1),withonlysomevariationinthemolecular weighttoprovidedifferentmeltviscosityvalues,ie.theyvaryinthelengthofthepolymer chain. Itisthenotifier’sintentiontoimportanygradesthatarechemicallyidentical.
AnIR spectrometrictracewassubmittedfortheidentificationofthenotifiedsubstance. Combustionanalysis ofasampleindicatedthefollowing elementalcontent: 58.98%Carbon,8.39%Hydrogen,30.75%Oxygen,1.09%Sulphur and
0.79%Sodium.
ASEC testreport,including trace,wassuppliedtodeterminetheNAMWandpercentageoflowmolecular species(1). Thepolydispersityofthepolymer is 4.01whichindicatesawidemolecular weightdistribution.
Thenotifier claimsthatresidualmonomersandstarting materialsarebelow0.6%asthepolymer containsthis amountbelow500g.mol-1.
3.PHYSICALANDCHEMICALPROPERTIESAppearanceat20°C
and101.3kPa:yellowsolidwithasweetodour
MeltingPoint:thepolymerdoesnothaveacrystallinemeltingpoint;softensandbeginstoflowatapproximately90°C
Density:1000kg.m-3
Vapour Pressure:notdetermined;expectedtohaveanegligible
vapour pressure
WaterSolubility:notdetermined; polymer isdispersibleinwaterbutnotsoluble
PartitionCo-efficient
(n-octanol/water):notdetermined
Hydrolysis as a Function
ofpH:notdeterminableusing OECDTG 111(2)
Adsorption/Desorption:notdeterminedDissociation Constant:notdeterminedFlash Point: notdetermined
FlammabilityLimits:notdetermined;polymer iscombustible
Autoignition Temperature:notdetermined
ExplosiveProperties:notknown
Reactivity/Stability:hazardouspolymerisationwill not occur; stable
under normalconditionsbutreactswithstrongoxidising agents
ParticleSize:2.5cm
Comments on Physico-Chemical Properties
Tests wereperformedaccordingtoEEC/OECDtestguidelines atfacilitiescomplyingwithOECDPrinciplesofGoodLaboratoryPractice.
Thenotifiedpolymerdoesnothaveacrystallinemeltingpoint. Thenotifierexpectsthepolymer tohaveanegligiblevapour pressureasitis asolidwitharelativelyhighsoftening/flowpoint.
Hydrolysistesting indicatedthatthepolymer wasnotsolubleinthebuffer solutions(detectionlimitsofthepolymer inwater bytheUV-visiblespectrophotometer wereapproximately100mg.L-1). However,thenotifier claimsthatitiswater dispersible,ie.thepolymer isbrokenintoparticlessmallenoughtoremaininsuspensioninwater anddonotgointosolution,mixing onamolecular level. This allowsarticlesmanufacturedwiththispolymer asanadhesivecomponenttobe“repulped” withwater whichcanbebeneficial for recycling operations. However,thepresenceof7%of1,3-benzenedicarboxylicacid,5-sulfo-bis(2-(2-hydroxyethoxy(ethyl) ester,sodiumsalttogether with26%2,2’-oxybisethanolis noted. Bothoftheseconstituentscouldbeexpectedtoconfersomedegreeofaffinityfor water ontheresultantpolymer.
Thenotifiedpolymer wasnotsolubleinthepH4,7and9buffers atahighenoughconcentrationfortheestimatedhalf-lifetobecalculated,using theanalyticaltechniqueemployed. Addition oforganicsolvents to enhance water solubilitywasunsuccessful, withthesolubilitynotmodifiedtoalevel thatcouldbeaccuratelydetermined. Hydrolysis oftheester linkagesintheenvironmental pH range,althoughtheoreticallypossible,shouldbeprecluded(or beveryslow) duetothepolymer’slowwatersolubility.
Thenotifier didnotsupplyanydatafor partitioncoefficient,adsorption/desorptionanddissociationconstant. The“sulfonicsalt” functionalitiesarelikelytoremainintheionicformunder normalenvironmentalconditions. However,duetothelowsolubility,thenotifiedpolymer is expectedtopartitiontotheorganic phaseandtoadsorbto,orbeassociatedwith,soil andsediment.
4.PURITYOFTHECHEMICALDegree of Purity:99%
Non-hazardous Impurities
(> 1%byweight):none
Toxic or Hazardous
Impurities:None
MaximumContent
of Residual Monomers:0.1%
Additives/Adjuvants:Theimportedpolymer normallydoesnotcontain
additives; stabilisers such as Irganox1010 (CASNo.6683-19-8) and/orDSTDP(CASNo.693-36-
7)maybeaddedduring themanufactureofthepolymer atalevelbelow0.5%
5.USE,VOLUMEANDFORMULATION
The notified polymer is a thermoplastic and will be used as an adhesive, primarilyforpaper and plastic articles. The notified polymer normallywill not make up 100% oftheadhesiveproduct,butwillbemeltedandmixedwithavarietyoftackifiers,waxesandplasticisers toresultinafinal formulatedhotmeltadhesive. Formulationsmaycontainupto50to70%ofthenotifiedpolymer. Theuseofthenotifiedpolymer asanadhesivewilleliminatetheuseofsolvents.
Thenotifiedpolymer will beimportedinthepureformas solidpellets.
It is estimated that 4.5 tonnes ofthe notified polymerwill be imported in the first yearrising to18.5tonnesperannumbythefifthyear.
6.OCCUPATIONALEXPOSURE
The notified polymerwill be imported in 20 kgor 136 kg polyethylene lined drums.Thenotifiedpolymer will betransportedfromthewharftothenotifier’swarehouse.
Itwillthenbedistributedbyroadtocustomersites. Amaximumof4peoplewouldinvolved. Exposureduring transportandhandling wouldonlybelikelyintheeventofanaccident.
Formulationofthenotifiedpolymer mayoccuratuptotencustomer sites. Nodetailsregarding formulationprocessesateachsitewereavailabletothenotifier.Thepolymer isweighedandchargedtoahopperofatumbleblender whereitismeltedandmixedwithother additivesandwater toformahotmeltadhesive.
Weighingandintroductiontotheblender iscarriedoutunder localexhaustventilation,tocaptureanyfugitivedust. Afterformulationwithothercomponentstheproductcontaining thenotifiedpolymer isdriedandappliedasamelt,typicallyasamoltenbeador spraydepending ontheadhesiveofthemanufacturedarticleegpackaging,bookbinding,labelsoncontainersetc. Theseoperationsarecarriedoutunderlocalexhaustventilation. Ateachsite20to80workerswillbeexposedtothe
notifiedpolymer.
Dermal andinhalationalexposuretodustsandfumesofthenotifiedpolymer mayoccur whenworkersareweighing andintroducing thenotifiedchemical totheblender andduring meltextrusionfor substratebonding. Themajorityoftheparticlesaregreater than200minsize,whichexceedsthecut-offlimitconsideredtobeinspirable. Thereisstillthepossibilitythattheworkersmightinhalefumesfromthemoltenpolymer productduring bonding. Asdescribedabove,theseoperationswillbeconductedunderlocalexhaustventilation,thusminimisingthepotential for inhalationalexposure.
7.PUBLICEXPOSUREConsumerArticles
Theextentofpublic contactwitharticlescontaining thenotifiedpolymer isindeterminatebutmaybehighdepending onthenatureoftheapplicationsfor whichthenotifiedpolymer is used. Exposureinmostcircumstanceshowever islikelytobenegligibleduetothesolidnatureofthepolymer anditspositionbetweenlayers ofmaterialwhichithasbeenusedtogluetogether.
Industrial Use
Thenotifiedpolymerwillbeprocessedatapproximately10sites. Althoughtheprocessmayresultinthegenerationofdustsandfumesthequantityproducedisunlikelytobesubstantialgiventhenatureofthematerial anddustsshouldbeconstrainedbynormalindustrialventilationandfiltrationsystems. Publicexposurefromtheindustrialprocessing ofthispolymer isexpectedtobenegligible.
Transport
Intheeventofatransportaccident,thenotifiedpolymer being asolidpelletdispersion will be minimal and recoveryand disposal bylandfill or incinerationaccording tolocalgovernmentregulationsshouldbereadilyachievable. Publicexposurefollowing atransportaccidentislikelytobenegligible.
8.ENVIRONMENTALEXPOSURERelease
Becausethepolymer isshippedassolidpellets,thereshouldbelittlecontamination
ofthecontainers,whichcanberecycled.
Thepolymer ismeltedandmixedwithother additivestoformthehot-meltadhesive.Lossesofthepolymer arenotexpectedtobesignificantasthepolymer canbemeltedandreused. For example,shouldaformulationnotbewithinspecification,thebatchwillbere-workedbyblending withsubsequentbatches. Thenotifieranticipates anoverallmateriallossrateofbelow1%, whichwill becollectedand
disposed ofbyincineration or to landfill.
Thepolymer productis thenappliedasamelt,typicallyasamoltenbeador spraydepending ontheadhesiveneedforthemanufacturedarticle,eg.Packaging,bookbinding andlabelsoncontainers. Applicationofthehot-meltadhesiveisclaimedasagenerallyefficientprocess. Itisexpectedthatlessthan0.5%oftheimportedpolymer volumewill berequiredtobedisposedof.
Thenotifier claimsthatthenotifiedpolymer iswater dispersible,allowing bondedarticlestoberecycledby“repulping”. Articlesaresoakedinwater,dispersing andremoving theadhesive. Thesubstratecanthenbedriedandrecoveredfor reuse.Theadhesivecanberemovedfromthewater dispersionbyadjusting theionicstrengthofthedispersion,eg.additionofdivalentcalciumsalts.
Fate
The vast majorityofnotified polymerwill be used in manufacturing adhesives. Thefateofthepolymer adhesiveistiedtothefateofthearticletowhichitisapplied.
Environmental exposureofarticlescontaining thepolymer productthroughleachingin landfill is not expected due to its insolubility. Once the adhesive is dried, thenotifiedpolymer shouldbecomeinertbythehardening process.
Should treated articles be recycled, the polymeradhesivewill becomedispersed inthewatercolumn. Thepolymeradhesivewilltheneitherberemoved,asindicatedabove,or disposedoftosewer withthewastewater. Shouldthepolymer productbedisposedoftosewer,itshouldpartitiontothesludgeandbetrappedinthesolidsatthe sewagetreatment works. The solids are disposed ofbylandfill or incineration.
Incineration products will include water,oxides ofcarbon and sulphur, with a smallamountofsodiumsaltsintheash.
Thenotifiedpolymer wasfoundtobenotreadilybiodegradableintheOECD 301BTest for ReadyBiodegradability“CO2Evolution/ModifiedSturmTest” (3). A28-daytest for readybiodegradabilityusingunacclimated micro-organisms as the inoculumshowed5%and7%degradationofthenotifiedpolymer at20mg DOC.L-1(theoretical),basedoncarbondioxideevolution. However,duetothestringencyofthe test, lowCO2evolutiondoesnotnecessarilymeanthatthetestsubstanceis notdegradableunder environmentalconditions,orafter wastewater treatment. Thepolymer’s inherent biodegradabilitywas not measured.
Biologicalmembranesarenotpermeabletopolymersofverylargemolecular sizeandthereforebioaccumulationofthenotifiedpolymer is notexpected(4,5).
9.EVALUATION OF TOXICOLOGICALDATA
Notoxicitydataarerequiredfor polymersofNAMWgreater than
1000,undertheAct. However,thedatasummarisedbelowwereprovidedbythenotifier.
9.1Acute Toxicity
Summaryof the acute toxicityof “Eastman AQ” 1350 Copolyester
TestSpeciesOutcomeReference
acuteoraltoxicityratLD505000mg.kg-
1
(6)
skinirritationrabbitslightirritant(7)
eyeirritationrabbitnon-irritant(8)
skinsensitisationguineapignon-sensitiser(9)
9.1.1 OralToxicity(6)
Species/strain:Number/sexofanimals: / rat/CD(SD)BR
5/sex
Observationperiod: / 14days
Methodofadministration: / oral gavageofasingledoseat
5000mg.kg-1;thenotifiedpolymer was
administeredasa25%solutionindeionised
water
Clinicalobservations: / discoloured(lightbrown) faeceswere
observedinallmalesand2femalesinthefirst
twentyfour hours
Mortality: / nil
Morphologicalfindings: / none
Testmethod: / similartoOECDguidelines(10)
LD50: / 5000mg.kg-1
Result: / thenotifiedchemicalwasoflowacuteoral
toxicityin rats
9.1.4 / Skin Irritation(7)
Species/strain: / rabbit/NewZealandWhite
Number/sexofanimals: / 3males
Observationperiod: / 72hours
Methodofadministration: / thenotifiedpolymer wasadministeredasa
paste(0.5g) inwater toabradedsitesunderasemi-occludeddressing for4hours
Testmethod:similartoOECDguidelines(19)
Result:veryslighterythemawasobservedatoneabradedsiteinoneanimal at24and48hoursandinanother animal at48and72hours
thenotifiedchemicalwasaslightskinirritantinrabbits
9.1.5EyeIrritation(8)
Species/strain:rabbit/NewZealandWhite
0
Number/sexofanimals:3/sex
Observationperiod:3days
Methodofadministration:0.1gofthenotifiedpolymer wasadministered
intotheconjunctival sacoftherighteyeofeachanimal,thelefteyeserving ascontrol
Testmethod:similartoOECDguidelines(10)
Result:nosignsofocular irritationwereobservedinanyanimal,throughoutthestudy
9.1.6SkinSensitisation
thenotifiedchemicalwasnotanirritant totherabbiteye
9.1.6.1SkinSensitisationstudyintheGuineaPig(9)
Species/strain:guineapig/Dunkin-Hartley
Number ofanimals:20test/10control
Inductionprocedure:forthetestgroup
day0:three pairs ofintradermalinjections(0.1mL) inthescapular region:
Freund’scompleteadjuvant(FCA),1:1withdeionisedwater
thenotifiedchemical,dilutedto5%withdeionisedwater
thenotifiedchemical at5%,emulsifiedina1:1mixtureofFCAanddeionisedwater
forthecontrolgroup
day0:threepairs ofintradermalinjections(0.1mL) inthescapular region:
FCA,1:1withdeionisedwaterdeionisedwater
FCAemulsion
day6after injections,thesameregionwastreatedwith0.5mLof10%sodiumlaurylsulphateinpetroleum(testandcontrolgroups)
day7,thesameregionwastreatedwith25%ofthenotifiedpolymer indeionisedwaterunder occlusivedressing for approximately48hours;thecontrolgroupreceivedonlydeionisedwater
Challengeprocedure:day21,theleftflankofeachanimal (bothtest
andcontrolgroups) wastreatedwith25%ofthenotifiedpolymer under occlusivedressing;therightflankwastreatedwithdeionisedwater only
Challengeoutcome:
TestanimalsControlanimals
Challengeconcentration / 24hours* / 48hours* / 24hours / 48hours
25% / **0/20 / 0/20 / 0/10 / 0/10
* timeafterpatchremoval
**numberofanimalsexhibitingpositiveresponse
Testmethod:similartoOECDguidelines(10)
Result:thenotifiedchemicalwasnotaskinsensitiseringuineapigs
9.1.6.2RepeatedInsult PatchTest forSkinSensitisation(11)
Species/strain:Homosapiens
Number ofpersons:119completedthestudy
Dose:thenotifiedchemical,dilutedto25%withdeionisedwater
Testmethod:ModifiedDraizeprocedure
allexposureswereby24+1hourcontactunder occlusiveconditions
129subjectsstartedthestudy;119completed;10subjectswithdrewfor reasonsunrelatedtouseofthetestsubstance
Result:mildtransienterythemawasobservedinonesubjectduring inductionandnoresponseswereobservedinanyofthesubjectsduringchallenge
noevidenceofclinicalsensitisationwasobservedinresulting fromuseofthenotifiedchemical
9.3Genotoxicity
9.3.1 Salmonella typhimurium ReverseMutationAssay(12)
Strains:TA98,TA100,TA1535,TA1537and
TA 1538andEscherichiacoli strainWP2uvrA(pKM101)
Concentrationrange:100-5000g.plate-1
Testmethod:similartoOECDguidelines(10)
Result:thenotifiedchemical notmutagenicinS.typhimuriumandEscherichiacoli inthepresenceorabsenceofmetabolicactivationprovidedbyratliver s9fraction
9.4OverallAssessment ofToxicologicalData
Thenotifiedpolymer wasoflowacuteoraltoxicityinrats(oral LD505000mg.kg-1).Itwasaslightskinirritant but notaneyeirritantinrabbits. Itwasnotaskinsensitiser whentestedinguineapigs. AHumanRepeatPatchTestperformedusingthenotifiedpolymer didnotshowanyevidenceofclinicalsensitisationpotential.
Thenotifiedpolymer wasnotfoundtobemutagenicinbacteria.
Inrelationtothetoxicitystudiessummarisedabove,thenotifiedpolymer wouldnotbeclassifiedashazardousaccording totheApprovedCriteriaforClassifyingHazardousSubstances (13).
10.ASSESSMENT OF ENVIRONMENTALEFFECTS
Noecotoxicologydataisrequiredfor polymersofNAMW1000according totheAct. However,thenotifierhassuppliedan“ActivatedSludgeRespirationInhibitionTest” report.
TestSpeciesResults
Respirationinhibition Aerobicwastewater
bacteria
*NOEC-noobservableeffectconcentration
3hEC50>1000mg.L-1(14)
NOEC=1000mg.L-1
A3-hour activatedsludgerespirationinhibitiontestwasperformedusing activatedsludgefromadomesticwastewater treatmentplant. Thesludgemicro-organismswereexposedtofive(theoretical) nominalconcentrationsofthetestsubstanceinthetestvessels,25,50,100,500and1000mg.L-1. Duetothelowsolubilityofthenotifiedpolymer,itwasaddeddirectlytothetestbeakers andwastestedasaparticulateinthetestmedium. Testresultsindicatethatthenotifiedpolymer isnot
expectedtoaffectsecondarywastetreatmentmicro-organisms.
11.ASSESSMENT OF ENVIRONMENTALHAZARD
Themainenvironmentalexposuretothenotifiedpolymer couldoccur whenthearticlescontaining theadhesiveareeither recycledor disposedof. Thefinaldestinationislikelytobeeitherlandfill,wherethepolymercanbeexpectedtopersistbutremainimmobileinthehardenedform,or sewer,wherethepolymer isexpectedtobecomeassociatedwiththesludgeandbeincinerated. Thepolymer wasfound tobenon-toxic towastetreatmentmicro-organisms uptothelimit ofits solubility.
Duringthe holt-melt adhesive formulation process, the notifier claims that losses willbelessthan1%(i.e.lessthan200kgperannumatmaximumimportrates). Thefinal destinationofthiswastewill beeither incinerationor landfill.
Losses duringapplication ofthe adhesive are difficult to determine and willvarydepending onthemethodofapplication. However,theselossesareexpectedtobelocalisedwithinthemanufacturingplant. Thenotifier expectsthatlosseswill belimitedto0.5%ofall ofthepolymer imported,approximately90kgperannumatthemaximumimport rate. Anyspillageswill be easilycleaned up as the notifiedpolymer isinasolidpellet form.
Thelowenvironmentalexposureofthenotifiedpolymer asaresultoftheproposeduseindicatesthattheoverallenvironmentalhazardshouldbelow.
12.ASSESSMENT OF PUBLIC ANDOCCUPATIONALHEALTHANDSAFETYEFFECTS
Basedonthetoxicological data,thenotifiedpolymer is notexpectedtoexhibitacuteor systemictoxicity. Itis notlikelytobeaneyeirritant,askinsensitiser or genotoxic.AHumanRepeatPatchTestshowednoevidenceofclinicalsensitisationpotentialinhumans. Itmaybeaslightskinirritant. Thepolymer wouldnotbeclassifiedhazardousaccording totheNOHSC ApprovedCriteriaforClassifyingHazardousSubstances (13).
Exposureoftransportandstorehouseworkerstothenotifiedpolymer islikelytooccur onlyintheeventofanaccident.
Exposuretoworkersinvolvedinreformulationofthenotifiedpolymer andsubstratebondingisexpectedtobelow. Formulationandsubstratebonding willbecarried outunder localexhaustventilation,whichwouldreduceanyexposuretofugitivedustandmoltenpolymer productrespectively.
Intheeventofexposurethemainoccupationalhealthriskduring formulationandsubstratebonding ofthenotifiedpolymer wouldbeslightskinirritation. Theriskcanbeminimisedbytheuseofprotectiveglovesandclothing asoutlinedbelow.
Althoughpublicexposuremaybesignificantdepending ontheapplicationtowhichthenotifiedpolymer is put,theriskofadverseeffectsfollowing suchexposureis
likelyto be negligible due to its lowtoxicityprofile and highNAMW,whichwilllargelypreventdermal or gastrointestinalabsorption.
13.RECOMMENDATIONS
To minimiseoccupationalexposuretothenotifiedpolymer thefollowing guidelinesandprecautionsshouldbeobserved:
- Ifengineering controlsareinsufficienttoreduceexposuretothemoltenproductofthenotifiedpolymer toasafelevel safetygogglesshouldbeselectedandfittedinaccordancewithAustralianStandard(AS) 1336(15) tocomplywithAustralian/NewZealandStandard(AS/NZS) 1337(16);
- Industrialclothing shouldconformtothespecificationsdetailedinAS2919(17);
- Impermeableglovesor mittensshouldconformtoAS2161(18);
- Alloccupationalfootwear shouldconformtoAS/NZS2210(19);
- Spillageofthenotifiedchemicalshouldbeavoided. Spillagesshouldbecleaneduppromptlywithabsorbentswhichshouldthenbeputintocontainersfor disposal;
- Goodpersonalhygieneshouldbepractisedtominimisethepotential foringestion;
- AcopyoftheMaterial SafetyDataSheets(MSDS) shouldbeeasilyaccessibletoemployees.
14.MATERIALSAFETY DATASHEET
TheMSDSforthenotifiedpolymer wasprovidedinaccordancewiththeNationalCodeofPracticeforthePreparationofMaterial SafetyDataSheets(20).
This MSDSwasprovidedbytheapplicantaspartofthenotificationstatement. Itisreproducedhereasamatterofpublicrecord. Theaccuracyofthis informationremains the responsibilityofthe applicant.
15.REQUIREMENTSFORSECONDARYNOTIFICATION
Under theAct,secondarynotificationofthenotifiedchemicalshall berequiredifanyofthecircumstancesstipulatedunder subsection64(2) oftheActarise. Nootherspecific conditionsareprescribed.
16.REFERENCES
1.IsaacsB,1996a.“Copolymer of DMCD-CX13-DEG-CHDM-TNP:MolecularWeightDistributionDetermination”,Analytical TechnologyDivision,EastmanKodakCompany,ReportNo.MWD-00314.
2.Isaacs B, 1996b. “Copolymer ofDMCD-CX13-DEG-CHDM-TNP: AbioticDegradation: Hydrolysis asaFunctionofpH”,ChemicalsQualityServicesDivision,EastmanKodakCompany,ReportNo.HYD-00406.
3.Beglinger JMandRuffing CJ,1996b. “Sodiosulfopolyester: ActivatedSludgeRespirationInhibitionTest”,HealthandEnvironmentLaboratories,EastmanKodakCompany,StudyNo.EN-620-165245-A
4.Anliker R, Moser PPoppinger D (1988). "Bioaccumulationofdyestuffs andorganicpigmentsinfish. Relationshipstohydrophobicityandsteric factors".Chemosphere17(8): 1631-1644.
5.GobasFAPC,OpperhuizenAHutzinger O(1986). “Bioconcentrationofhydrophobicchemicalsinfish:relationshipwithmembranepermeation”.EnvironmentalToxicologyandChemistry5: 637-646.
6.K.P.,Shepard1995. Acuteoraltoxicitystudywith“EastmanAQ”1350Copolyester inrats.ReportNo.TX--0208,TheToxicologyScienceLaboratory,EastmanKodakCompany,Rochester,NewYork,USA.
7.K.P.,Shepard1995. PrimaryDermalIrritationstudywith“EastmanAQ”1350Copolyester inrabbits.ReportNo.TX-95-135,TheToxicologyScienceLaboratory,EastmanKodakCompany,Rochester,NewYork,USA.
8.K.P.,Shepard1996. AcuteEyeIrritation studywith“EastmanAQ”1350Copolyester inrabbits.ReportNo.TX-96-236,TheToxicologyScienceLaboratory,EastmanKodakCompany,Rochester,NewYork,USA.
9.K.P.,Shepard1995.SkinSensitisationstudywith“EastmanAQ”1350Copolyester inrabbits.ReportNo.TX-95-154,TheToxicologyScienceLaboratory,EastmanKodakCompany,Rochester,NewYork,USA.
10.Organisationfor EconomicCo-operationandDevelopment,OECDGuidelinesfor TestingofChemicals, OECD, Paris.
11.R.A.,Harper 1996. RepeatedInsultPatchTestwith“EastmanAQ”1350Copolyester inhumans. Report No. 95-1706-70, Hill Top Research Inc.,Miamiville,Ohio,USA.
12.Barber,E.D.,1997. Salmonella/mammalian-microsomemutagenicitytestwith“EastmanAQ”1350Copolyester. ReportNo.17906-0-409R,CorningHazleton Inc., Virginia, USA.
13.NationalOccupationalHealthandSafetyCommission1994,ApprovedCriteriafor ClassifyingHazardousSubstances [NOHSC:1008(1994)],AustralianGovernmentPublishing Service,Canberra.
14.Beglinger JMandRuffing CJ,1996a. “Copolymer ofDMCD-CX13-DEG-CHDM-TNP: Determination ofReadyBiodegradability(Biotic Degradation)using theCO2EvolutionTest(ModifiedSturm)”,HealthandEnvironmentLaboratories,EastmanKodakCompany,StudyNo.EN-113-165245-A.Unpublished.
15.AustralianStandard1336-1994,EyeprotectionintheIndustrialEnvironment,StandardsAssociationofAustraliaPubl.,Sydney.
16.StandardsAustralia/StandardsNewZealand1992,Australian/NewZealandStandard1337-1992,EyeProtectors for IndustrialApplications,StandardsAssociationofAustraliaPubl.,Sydney,StandardsAssociationofNewZealand Publ, Wellington.
17.StandardsAustralia,1987. AustralianStandard2919-1987,IndustrialClothing,StandardsAssociationofAustraliaPubl.,Sydney.
18.StandardsAustralia,1978.AustralianStandard2161-1978, IndustrialSafetyGlovesandMittens(excludingElectrical andMedicalGloves),StandardsAssociationofAustraliaPubl.,Sydney.
19.StandardsAustralia/StandardsNewZealand1994, Australian/NewZealandStandard2210-1994Occupational ProtectiveFootwear,Part1:GuidetoSelection,CareandUse. Part2:Specifications,StandardsAssociationofAustraliaPubl.,Sydney, StandardsAssociationofNewZealandPubl.Wellington.
20.NationalOccupationalHealthandSafetyCommission1994,NationalCodeofPracticeforthePreparationofMaterial SafetyDataSheets[NOHSC:2011(1994)],AustralianGovernmentPublishing Service,Canberra.
Attachment 1
TheDraizeScaleforevaluationofskinreactionsisasfollows:
ErythemaFormationRatingOedemaFormationRating
Noerythema0Nooedema0
Veryslight erythema (barelyperceptible)
1Veryslight oedema (barely1
perceptible)
Well-definederythema2Slightoedema(edgesofareawell-2
definedbydefiniteraising
Moderatetosevereerythema3Moderateoedema(raisedapprox.13
mm)
Severeerythema (beet redness)4Severe oedema(raised more than 14
mmand extendingbeyondareaofexposure)
TheDraizescaleforevaluationofeyereactionsisasfollows:
CORNEA
OpacityRatingAreaofCorneainvolvedRating
Noopacity0none25% or less(not zero)1
Diffusearea,detailsof irisclearlyvisible
Easily visibletranslucentareas,detailsofirisslightlyobscure
1slight25%to50%2
2mild50%to75%3
Opalescentareas,nodetailsofirisvisible,sizeofpupilbarelydiscernible
3
moderate
Greaterthan75%4
Opaque,irisinvisible4severe
CONJUNCTIVAERedness / Rating / Chemosis / Rating / Discharge / Rating
Vesselsnormal / 0none / No swelling / 0none / No discharge / 0none
Vesselsdefinitely / 1 / Any swellingabove / 1slight / Anyamount different / 1slight
injectedabovenormal / slight / normal / fromnormal
More diffuse, deeper / 2mod. / Obviousswelling / 2mild / Dischargewith / 2mod.
crimsonredwith / withpartialeversion / moisteningoflidsand
individualvesselsnot / oflids / adjacenthairs
easilydiscernible / Swellingwithlids / 3mod. / Dischargewith / 3
Diffuse beefyred / 3 / half-closed / moisteningoflidsand / severe
severe / Swellingwithlids / 4 / hairsand
considerablearea
half-closedto
completelyclosed / severe / aroundeye
IRIS
ValuesRating
Normal0none
Foldsabovenormal,congestion,swelling,circumcornealinjection,irisreactstolight1slightNoreaction to light, haemorrhage, gross destruction 2 severe