File No: NA/503Date:April 1997

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME

FULLPUBLICREPORT

2,6-Naphthalenedicarboxylicacid

ThisAssessmenthasbeencompiledinaccordancewiththeprovisions oftheIndustrialChemicals(NotificationandAssessment)Act1989(theAct),andRegulations.ThislegislationisanActoftheCommonwealthofAustralia.TheNationalIndustrialChemicalsNotificationandAssessmentScheme(NICNAS)isadministeredbyWorksafeAustraliawhichalsoconductstheoccupationalhealthsafetyassessment.TheassessmentofenvironmentalhazardisconductedbytheDepartmentoftheEnvironment,Sport,andTerritoriesandtheassessmentofpublichealthisconductedbytheDepartmentofHealthandFamilyServices.

Forthepurposesofsubsection78(1)oftheAct,copiesofthisfullpublicreportmaybeinspectedbythepublicattheLibrary,WorksafeAustralia,92-94ParramattaRoad,Camperdown NSW2050,betweenthefollowinghours:

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ForEnquiriespleasecontacttheAdministrationCoordinatorat:

StreetAddress: 92Parramatta RdCamperdown, NSW 2050,AUSTRALIA

PostalAddress:GPOBox58,Sydney2001,AUSTRALIA

Telephone:(61)(02)9577-9466 FAX (61)(02) 9577-9465

Director

ChemicalsNotificationandAssessment

NA/503

2,6-Naphthalenedicarboxylicacid

1.APPLICANT

AmocoChemicals PtyLtd of28-34 OrangeGrove RoadLIVERPOOLNSW 2170hassubmittedastandardnotificationstatementinsupportoftheirapplicationforanassessmentcertificatefor2,6-naphthalenedicarboxylicacid. Noapplicationforexemptinformationwasmade,hencetheFullPublicReportispublishedinitsentirety.

2.IDENTITYOFTHECHEMICAL

ChemicalName:2,6-naphthalenedicarboxylicacid

ChemicalAbstracts Service

(CAS)RegistryNo.:1141-38-4

OtherNames:2,6-napthalicacid

Trade Name:AmocoPNDA

MolecularFormula:C12H8O4

StructuralFormula:

MolecularWeight:216.2

MethodofDetectionandDetermination:

infrared(IR),nuclearmagneticresonance(NMR)spectroscopies

Spectral Data:IRspectrumcharacteristicpeaks 478,585,755,

778,831,915,951,1104,1144,1180cm-1

3.PHYSICALANDCHEMICALPROPERTIES

Appearanceat 20°Cand101.3kPa:

whitecrystallineorflakesolid,nocharacteristicodour

MeltingPoint:decomposesbeforemeltingpointisreached;onsetofdecompositionat300°C

Density:1.5g.mL-1

VapourPressure:notdetermined

WaterSolubility:1.03mg.L-1@20oC(seecommentsbelow)

PartitionCo-efficient

(n-octanol/water):logPow=-1.77@pH7(seecommentsbelow)

HydrolysisasaFunction

ofpH:notdetermined

Adsorption/Desorption:notdetermined

DissociationConstant:pKa1= 3.8,pKa2=4.7(estimated,seebelow)

FlashPoint:200°C

Particle size:90%offlakes0.6mm

FlammabilityLimits:notflammableAutoignitionTemperature:notavailableExplosiveProperties: stable

Reactivity/Stability:consideredinertunderatmosphericconditions;

noincompatibilitiesdetermined;stable;notpronetospontaneousdecomposition;ifinvolvedinfire,unpredictabledecompositionproductsmaybegenerated

CommentsonPhysico-ChemicalProperties

Thewatersolubilityofthenotifiedchemicalwasdeterminedbyextrapolatingalinearregressionofhightemperaturedata(320-150°C). Theregressionlinehadan r2valueof0.999.ThechemicalcontainscarboxylicacidfunctionalitiesandthewatersolubilityofthechemicalisexpectedtodependonthepHofthemedium.AtlowpHvalues,atwhichthechemicalexistspredominantlyinthefreecarboxylicacid form,thesolubility inwateris expectedtobe verylow. However,athigherpHthecarboxylicacidgroupswillbedeprotonatedandtheresultingwatersolubilityof

thecarboxylateformofthechemicalwillbehigher.

Nodataonthehydrolyticbehaviourofthechemicalwasprovidedbythe notifier.Thechemicalcontainsnofunctionalgroupswhichwouldbeexpectedtohydrolyseunderenvironmentalconditions.

ThepartitioncoefficientofthenotifiedchemicalwasdeterminedatpH7.AtthispHthechemicalwillbecompletelyionised,consequentlythepartitioncoefficientmeasuredisthatofthecarboxylateformratherthantheacidform.AnestimatedlogKOW=2.93wasestimatedfortheacidformusingtheatom/fragmentcontributionmethoddevelopedbySyracuseResearchCorporation{SyracuseResearchCorporation,1997#39}.

BasedonthemeasuredpartitioncoefficientthechemicalwouldnotbeexpectedtostronglyadsorbtosoilorsedimentatpH7(i.e.inthecarboxylateform). However,adsorptivityalsohasastrongnegativecorrelationwithsolubilityandthelowsolubilityofthecarboxylicacidformofthechemicalsuggeststhatitwilladsorbmorestrongly.ThenotifierhasprovidedanestimateoflogKOC=2.67basedonthemethodofLymanet al.{Lyman,1982#40}. ItappearsthisestimateisbasedestimatedonanestimatedlogKOWfortheacidformratherthanthemeasuredvalueof-1.77forthecarboxylateform.

ThepKavaluesforthechemicalwereestimatedbyreferencetotheliteratureandhavean uncertaintyof ± 0.2pKaunits.

4.PURITYOFTHECHEMICALDegreeofPurity:
Impurities: / 99.5%
0.5%
ChemicalName / CASNo. / Weight%
dicarboxy tetralin / - / 0.08
formylnaphthoicacid / - / 0.015
trimelliticacid / 528-44-9 / 0.001
naphthoicacid+methyl (NA) / - / 0.005
allothers / - / 0.02

noneoftheabovearelistedashavingtoxicorhazardouspropertiesinToxline

{ToxlineSilverPlatter,1996#27}.

Additives/Adjuvants:none

5.USE,VOLUMEANDFORMULATION

ThenotifiedchemicalwillnotbemanufacturedinAustralia. Itwillonlybeimportedinlimitedquantitiesfortrialdevelopmentstudies. Thenotifiedchemicalisamonomerusedtomanufacturepolyethylenenaphthalate(PEN)andpolyethylenephthalate(PET)polymersandcopolymers. PENandPET polymersareusedforpackagingofpharmaceuticalandcosmeticproducts,beverageandfoodcontainers,filmsforvariouspurposessuchassailing,photographicandelectricalapplications. Themaximumproportionofthenotifiedmonomerusedinthepolymersandcopolymerswillbelessthan8%. Thelevelofresidualmonomersincludingthenotifiedchemicalislow;theaverageislessthan210ppm.

Theestimatedimportvolumewillbenilforthefirstthreeyears,followedby0.4tonneforthefourthyear and1.3tonnesforthefifthyear.

6.OCCUPATIONALEXPOSURE

Thenotifiedchemicalwillbeimportedin22.7kgpolyethylenelinedfibredrums,tobesuppliedtoplasticmanufacturersfortrialproductruns.Waterside,warehouseandtransportworkerswillnotcomeintocontactwiththenotifiedmonomer,exceptintheeventofaccidentorleakingpackaging.

Dermalexposuremayoccurwhenworkerstransferthenotifiedchemicaltoaprocessvessel. Accidentaleyecontactmayalsooccuratthisstage.

Thenotifierstatesthatinhalational,dermalandocularexposuretothenotifiedchemicalwillbeminimisedduringpolymermanufacturesincetheseprocessesessentiallyoccurincontinuous,enclosedautomatedplants. Inaddition,theseprocesseswillbecarriedoutunderlocalexhaustandgeneralventilation.

Workersmayalsocomeintocontactwithplasticproductscontainingthenotifiedchemicalaftermanufacture. Dermalcontactwouldbeexpectedtobethemainrouteofexposure,forexamplewhentransferringrawpolymerforfurtherprocessingorloadingpolymerproductsintopackagesfordelivery. Sincethemonomerwillalmostentirelybeinthepolymerform,exposuretothenotifiedchemicalatthistimewouldbenegligible.

7.PUBLICEXPOSURE

Nopublicexposuretothenotifiedchemicalisexpectedtooccurduringitsdistributionorstorageatmanufacturingsites.

Disposalofanywastenotifiedchemicalbyincinerationortolandfillisnotexpectedtoresultinsignificantpublicexposure. Ifspillageofthenotifiedchemicalweretooccuritwouldbesweptupandplacedinsealedcontainersforre-useordisposal.

Thepublicisexpectedtohaveextensivecontactwithsomepolymerproductscontainingthenotifiedchemicalsuchasfoodandbeveragecontainers,andthe

packingmaterialusedforpharmaceuticalsandcosmetics. Howeverthepublicisunlikelytohavesignificantcontactwithotherproductscontainingthenotifiedchemical.

MigrationofthenotifiedchemicalfromPENplastictofourfoodsimulatingsolventshasbeenshowntooccur(completereferencetobeprovidedbynotifier).Water,oliveoiland15%and3%w/vaqueoussolutionsofethanolandaceticacid,respectivelywereusedassolventsundertestconditionsoftendaysat40oC (allsimulants)andtwohoursat70oC(aqueoussimulantsonly). Onlylowlevelsofthenotifiedchemicalweredetectedineachofthefoodsimulantstested(<0.05mgofthenotifiedchemicalperlitreofeachfoodsimulant1). Themeanlevelof notifiedchemicalinthePENplasticwasdeterminedtobe0.21mg.g-1.Giventhatmigrationofthenotifiedchemicalisnotsignificant,publicexposure,ifitweretooccur,wouldbeextremelylow. AlthoughnoinformationwasprovidedontheresiduallevelofthenotifiedchemicalinPEN/PETpolymersoritspotentialtomigratefromsuchpolymers,thenotifiedchemicalwillbeusedatalowerconcentrationandtherefore,thelevelofresidualnotifiedchemicalanditspotentialtomigratefromsuchplasticsisexpectedtobelower.

8.ENVIRONMENTALEXPOSURERelease

Nomanufacturingofthepolymerfromthenotifiedchemicalisenvisagedintheforeseeablefuture.Hence,itisanticipatedthatreleaseofthenotifiedchemicalwillbeminimal.Toprovideaworstcaseestimate,thefollowingreleasesofthenotifiedchemicalweregeneratedassumingallthenotifiedchemicalwaspolymerisedandusedintheproductionofarticlesfromthepolymer.

Residuesremaininginthedrumswillbedisposedofwithdrumstolandfill.Thenotifierhasestimatedthattheresidueremainingineachdrumwillbelessthan227g(<1%).Atthemaximumrateofimport,thiscorrespondstoamaximumof13kgperannumofchemical,whichwillbedisposedoftolandfillwithpackaging.

Releasetotheenvironmentofthepolymercontainingthenotifiedchemicalasaresultofmanufacturingintoarticlesisexpectedtobeminimal.Manufacturingtakesplaceinaclosedsystem.Thepolymerwillbefedautomaticallyintoextrusionandmouldingmachineryfromahopper.Scrapwillberegroundandreused.

Contaminatedpolymerscrapswillbedepositedintomunicipallandfillsorincinerated.Overall,suchwastestreamswouldaccountforatmost0.5%oftheannualimportofthechemical(i.e.amaximumof6.5kgofpolymerisedwastechemicalmaybedepositedinlandfillatthemaximumrateofimport).

Usedarticlescontainingthepolymerwillalsoeventuallybedepositedinlandfillsorrecycled.Theseaspectshavebeenaddressedinotherseparatenotifications(PLC/52andPLC/54).

Fate

Nodatafromstandardreadybiodegradationtestshavebeenprovidedbythenotifier.Thenotifierhasprovidedstudieswhichindicatethatthechemicalundergoesbiodegradationinwastewatertreatment.Measurementofthetotalorganiccarbon(TOC)oftheeffluentfromareactorsystemwhichwasdosedatratesupto500ppmperday,indicatedthatvirtuallyallthenotifiedchemicalwasremovedfromtheeffluent. Thetrialwasconductedoveratleasta3monthperiod.Thenotifierhaspresentedresultsofa"Neely100-DayPartitionPattern"whichpredictsthat94%wouldpartitiontowater,withsmallfractionstogroundandhydrosoil(~3%each),andvirtuallynonepresentinair.Thiswascalculatedfromchemicalpropertieswhichwereestimatedusingquantitativestructureactivityrelationship (QSAR)calculations {Montana StateUniversityInstitute for ProgramAnalysis, #41}includingawatersolubilityof1.3g.L-1whichisgreaterthan1000-foldthewatersolubilityestimatedfrommeasurement(~1.03mg.L-1at 20°C likelytobethefullyionisedform).

Shouldthepolymerisationofthenotifiedchemicaloccur,themajorityofthechemicalwouldnotbeexpectedtobereleasedtotheenvironmentuntilithasbeenpolymerisedandmouldedintofilms,sheetingorcontainers.Theenduse productswilleitherbedepositedinlandfillorrecycledattheendoftheirusefullife.Biodegradationofthepolymerscontainingthenotifiedchemicalisunlikely.

PolymerisationofthenotifiedchemicalwouldproducepolymerswhichareanalogoustoPET,andtherefore,wouldbeexpectedtoreplacePETin someapplications.Assuch,itisanticipatedthatitwillbecomepartofthePETwastestreamwhichaccountsforapproximately0.6%ofthedomesticwastestream

{PlanetArk,1997#42}. ThecompanyhasestimatedthatthecurrentrateofrecyclingofPETis30%Australiawidereaching50%incapitalcities.ThisisinaccordwithfigurespublishedbyPlanetArk.In199530%ofthePETwastestreamwasrecycledAustraliawide(~15000tonnesofPET).ThefigurewashigherinSydney whereit reached 53% {Planet Ark,1997 #42}. Itisanticipated that therecyclingratesofthepolymerscontainingthenotifiedchemicalwillbesimilartothatofPET.

9.EVALUATIONOFTOXICOLOGICALDATA

9.1AcuteToxicity

Summaryoftheacutetoxicityof2,6-naphthalenedicarboxylicacid

TestSpeciesOutcomeReference

acute oral toxicityratLD505000mg.kg-1{Johnson,

1991#67}

acutedermaltoxicity

rabbitLD502000mg.kg-1{Johnson,

1991#69}

inhalation toxicityrat4h LC50 1.23 mg.L-1{Ledbetter,

1988#46}

skinirritationrabbitslightirritant*{Johnson,

1991#68}

eye irritationrabbitslightirritant{Johnson,

1991#70}

skinsensitisationguineapignotasensitiser{Edgar,1997

#78}

*summaryonly

9.1.1OralToxicity{Johnson,1991#67}Species/strain:rat/unknownNumber/sexofanimals: 5 per sexObservationperiod: unknown

Methodofadministration:gavage,doseof5g.kg-1,preparedasa33%

(w/v)aqueoussuspension

Clinicalobservations:none

Mortality:nil

Morphologicalfindings:none

Testmethod:inaccordancewithUSFoodandDrugAdministration(FDA)Good LaboratoryPractice (GLP),protocol not identified

LD50:5000mg.kg-1`

Result:thenotifiedchemicalwasoflowacuteoraltoxicitytoratsinalimittest

9.1.2DermalToxicity{Johnson,1991#69}

Species/strain:rabbit/NewZealandWhite

Number/sexofanimals:5male/sex

Observationperiod:14 days

Methodofadministration:2g.kg-1appliedtomoistenedshavedbacks

for24hours(occluded)thenremovedandsitewashedwith0.9%salinesolution

Clinicalobservations:mildtransientdermalirritation(erythema)in

tworabbitsfollowingunwrapping

Mortality:nil

Morphologicalfindings:onefemalerabbithadredareasonlungsat

necropsy,allothersnormal

Testmethod:inaccordancewithUSFoodandDrugAdministration(FDA)Good LaboratoryPractice (GLP),protocol not identified

LD50:2000mg.kg-1

Result:thenotifiedchemicalwasoflowacutedermaltoxicityinrabbits

9.1.3InhalationToxicity{Ledbetter,1988#46}Species/strain:rat/Sprague-DawleyNumber/sexofanimals: 5males/sexObservationperiod: 14 days

Methodofadministration:ratsexposedtoaparticulateaerosolfor4

hourswithnoseonlyexposure;timeweightedaverage(TWA)was2.25mg.L-1with54.6%ofparticles10m,thereforeactualrespirableconcentrationwas1.23mg.L-1

Clinicalobservations:inguinalareawassoiled,animalswerecold

tothe touch for approximately2 hours afterexposure,rednessaroundnose;meanbodyweightsincreasedduringstudy

Mortality:nil

Morphologicalfindings:atnecropsy2malesandonefemalerathad

focionlungsandonemalehadredfocionthethymus

Testmethod:notstated

LC50:1.23mg.L-1

Result:thenotifiedchemicalwasoflowacuteinhalationaltoxicityin rats

9.1.4SkinIrritation{Johnson,1991#68}

Species/strain:rabbit/NewZealandWhiteNumber/sexofanimals: 3/sexnotspecifiedObservationperiod: 72hours

Methodofadministration:0.5 g.kg-1appliedtomoistenedshavedbacks

for24hours(occluded)thenremovedandsitewashedwithsalinesolution

Draizescores{Draize,1959

#4}:

rangedfrom0-8.0at48hours,primarydermalirritationscorewas0.2

Testmethod:notspecified

Result:slightskinirritantinrabbits

9.1.5EyeIrritation{Johnson,1991#70}

Species/strain:rabbitstrainnotspecifiedNumber/sexofanimals: 3/sexnotspecifiedObservationperiod: 72hours

Methodofadministration:0.1gintotherightconjunctivalsacofone eyeofeachanimal

Draizescores{Draize,1959#4}ofunirrigatedeyes:

TimeafterinstillationAnimal1day2 days3 days

Conjunctiva

rccdderccdderccdde

1 / 1 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0
2 / 2 / 3 / 1 / 1 / 1 / 0 / 0 / 0 / 0
3 / 1 / 1 / 0 / 1 / 0 / 0 / 1 / 0 / 0
1seeAttachment1forDraizescales

c rednessd chemosise discharge

alliridalandcornealscoreswerezero

Testmethod:notspecified

Result:slighteyeirritantinrabbits

9.1.6SkinSensitisation{Edgar,1997#78}

Species/strain:guineapig/Dunkin-Hartley

Numberofanimals:10controls/20testanimals

Inductionprocedure:day1-eachanimalwastreatedwith0.5mL

of75%(topicalapplicationtotheleftflank) ofthenotifiedchemicalinsteriledistilledwater;patchesweresecuredunderanocclusivewrapforsixhours,andthenremovedandcleanedwithsteriliseddistilledwater;

theprocedurewasrepeatedonceeachweekforthreeconsecutiveweeks.

Challengeprocedure:thirteendaysafterthefinal induction

application,0.5mLofa75%solutionofthenotifiedchemicalwasappliedtotherightflank,andheldwithocclusivewrap. Patcheswereremovedaftersixhoursandcleanedwithsteriliseddistilledwater.

Challengeoutcome:

Challengeconcentration

TestanimalsControlanimals

24hours*48hours*24hours48hours

75%0/200/200/100/10

* timeafterpatchremoval

** numberofanimalsexhibitingpositiveresponse

Testmethod:similartoOECDguidelines{OrganisationforEconomicCo-operationandDevelopment,1995-1996#15}

Result:thenotifiedchemicalwasnotaskinsensitiseringuineapigs

9.2RepeatedDoseToxicity{Johnson,1994#51}Species/strain:rat/Sprague-DawleyNumber/sexofanimals: 20/sex/group

Methodofadministration:administeredorally,admixedtothediet

Dose/Studyduration::2000,10000and50000ppmfor90days

Clinicalobservations:transientdiarrhoeainhighdoseanimals;

increasedfoodconsumptioninmiddleandhighdosemales

Clinicalchemistry/Haematology

no toxicologically significant effectswereobservedonclinicalchemistryorhaematologyparameters.

Histopathology:meanliverweightsweredecreasedinhighdosemaleshowevernomicroscopicchangeswereobserved;dilationofcaecumand/orcoloninmanyhighdoseanimals,insignificantdilationofthelumenofthecoloninsomeoftheseanimals

Testmethod:inaccordancewithUSFoodandDrugAdministration(FDA),GoodLaboratoryPractice (GLP),protocol not identified

Result:notarget organidentified;lowtoxicityfollowingrepeatdoses

9.3Genotoxicity

9.3.1SalmonellatyphimuriumReverseMutationAssay{San,1991#53}Strains: TA98,TA100,TA1535,TA1537,TA1538Concentrationrange: 667-10000g/platewithorwithoutratliver

S9fraction,dosepreparedinsolutionof

dimethylsulphoxide(DMSO)

Testmethod:similartoOECDguidelines{OrganisationforEconomicCo-operationandDevelopment,1995-1996#15}

Result:thenotifiedchemicalwasnotmutagenicinthissystemwithorwithoutmetabolicactivation

9.3.2.1Hypoxanthine-GuaninePhosphoribosylTransferase(HGPRT)MutationAssaywithChineseHamsterOvary(CHO)Cells{Jacobson-Kram,1991

#77}

Cellline:CHO-K1-BH4

Doses:685,342.5,171.3,85.7,42.9g/ml withorwithoutratliverS9fraction;positivecontrols-ethylmethanesulphonateinnon-activatedtests andbenzo(a)pyreneinactivated tests

Testmethod:inaccordancewithOECDguidelines

{OrganisationforEconomicCo-operationandDevelopment,1995-1996#15}

Result:thenotifiedchemicalwasnotmutagenicinthistestsystem;untreatedandpositivecontrolsgaveappropriateresponses

9.3.2.2CHOChromosomalAberrationAssayinvitro{Leddy, 1995#55}

Cellline:ChineseHamster Ovary

Doses:2000,1000,500,250,125g/mlwithorwithout ratliverS9fraction; vehicle controls,positivecontrols-cyclophosphamideandmethylmethanesulphonate

Testmethod:inaccordancewithOECDguidelines

{OrganisationforEconomicCo-operationandDevelopment,1995-1996#15}

Result:slightprecipitationwasobservedat1000and2000g.mL-1;somecytotoxicity at thesedoses;moderateincreaseinpolyploidyat

2 000g.mL-1withmetabolicactivation,someindicationthatthiswasdoserelated;the

1 000g/mL-1sampleindicatedalevelofclastogenesisthatishigherthancontrolsbutnotatthelevelofsignificancedemonstratedinthe2000g.mL-1test;thereforethechemicalisweaklyclastogenicinthissystem;“weakly”indicating5-10%aberrantcellsexcludinggaps;positivecontrolsgaveappropriateresponse;vehiclecontrolshadlevelsofaberrationswithinthe95%confidencelimitsofthehistoricalnegativecontroldata

9.3.2.3CHOChromosomalAberrationAssayinvitro{Putman,1991 #57}

Cellline:ChineseHamster Ovary

Doses:714,357,179,89.5g.mL-1with orwithout ratliverS9fraction;doseselectiondictatedbysolventsolubility;solventDMSO; positivecontrols-cyclophosphamideandmethylmethanesulphonate

Testmethod:inaccordancewithOECDguidelines

{OrganisationforEconomicCo-operationandDevelopment,1995-1996#15}

Result:statisticallysignificantincrease(p<0.05)inchromosomalstructuralaberrationsat714and89.5g.mL-1in thenon-activatedtestsystem;noapparentdose-responserelationship(usingCochran-Armitagetest);positiveandnegativecontrolresultsacceptable;someevidenceofclastogenesis,howeverresultsinconclusive

9.4OverallAssessmentofToxicologicalData

ThenotifiedchemicalwasoflowacuteoraltoxicityintheratwithanLD50inexcessof5000mg.kg-1. A dermaltoxicity study in rabbits alsoindicatedlowtoxicity withanLD50inexcessof2000mg.kg-1.Arat inhalational toxicitystudy didnot result inanymortalityatdosesofupto1.23mg.L-1. Onautopsy,30%ofanimalsshowedlungfoci. Inarepeatdosestudyfeedingof90daysdurationtherewasno

significant evidenceofadverseeffectsatdosesupto50000ppm;the only effectswereminorandincludeddilationofthecaecumandcolon,andareductioninmeanliverweight.

Thenotifiedchemicalhassomepotentialforbothskinandeyeirritation. Studiesusingrabbitsgaveslighterythemainaskinstudyandslightconjunctivalrednessinaneyeirritationstudy. Inbothstudiesthelevelofirritationwasbelow thatrequiringahazardousclassificationaccordingtotheNationalOccupationalHealthandSafetyCommission’sCriteriaforClassifyingHazardousSubstances{NationalOccupationalHealthandSafetyCommission,1994#9}. Thenotifiedchemicalproducednoresponseinanon-adjuvantskinsensitisationstudyinguineapigsatchallengeconcentrationsupto75%..

AmutagenicitystudyusingSalmonellatyphimuriumwasnegativebothwithorwithoutmetabolicactivationusingDMSOasasolvent. AChineseHamsterovary(CHO)assay(HGPRTlocus)wasnegative,withorwithoutmetabolicactivation. ACHOcellstudytoassessclastogenicpotentialindicatedthatclastogenesiswasdosedependent;however,therewereproblemsevidentwithprecipitationofthetestchemical. Asecondstudygavesignificantlevelsofchromosomalaberrationswithoutmetabolicactivation,howeverthelevelofaberrationswerenotclearlydosedependent. Insummary,thenotifiedchemicalintwotestsystemsinvitrowasnotmutagenic,however,itwasweaklyclastogenicinonein vitrostudyandpossiblyclastogenicinanother.

10.ASSESSMENTOFENVIRONMENTALEFFECTS

Thenotifierhasprovidedestimatesofthe96hourLC50foraquaticspeciesbasedontheprimarymodeofaction(nonpolarnarcosis)andstructure-toxicityrelationshipswhicharebasedonquantitativestructure-activityrelationship(QSAR)calculationsdeveloped by Montana State University {Montana State UniversityInstituteforProgramAnalysis, #41}.Theseresultsaresummarisedbelow:

Test / Species / LC50(mg.L-1)
acutetoxicity / bluegillsunfish / 55
acutetoxicity / fatheadminnow / 61
acutetoxicity / catfish / 52
acutetoxicity / rainbowtrout / 53
acutetoxicity / mosquitofish / 64
acutetoxicity / goldfish / 73
acutetoxicity / Daphniamagna / 52

Thesevaluesarestatedtohaveonlyafactor-of-tworeliabilityandwerecalculatedbasedonanestimatedwatersolubilityof1.3g.L-1.Additionally, according tothesuppliedoutputfromtheQSARSystem,thenotifiedchemicaldoesnotcontainstructuralfeatureswhicharecurrentlyregardedashighlytoxictoalgae.

ECOSAR {USEPA ECOSAR,1994 #43} estimatesthe fishacute 96 hourtoxicityas19mg.L-1anddaphnia48hourtoxicityas67mg.L-1. Italsopredictsachronicvalueforalgaeof1.5mg.L-1. Resultswerecalculatedonestimatedwatersolubilitiesof2.9g.L-1andusingstructureactivityrelationshipsdevelopedforesters.

Theabovedatasuggeststhatthenotifiedchemicalhasslighttoxicitytofishanddaphnia andmayhavemoderatetoxicityto algae.

11.ASSESSMENTOFENVIRONMENTALHAZARD

Disposalofthenotifiedchemicaltolandfillisunlikelytopresentahazardtotheenvironmentduetothelimitedrelease.Thenotifierhaspresentedaworstcaselandfillleachingconcentrationofthechemicalintheleachateof0.5mg.L-1(basedonthedissolutionof13kgwastechemicalinaleachatevolumeof2.529x107L inoneyear{Miller,1980#44}.Theestimatedconcentrationofthechemicalintheleachateisbelowtheestimatedwatersolubilityofthechemical.Incinerationofthenotifiedchemicalwillresultinitsdestruction,producingoxidesofcarbonandwater.

Shouldlocalpolymerisationofthenotifiedchemicaloccur,thechemicalwillbetrappedinthepolymermatrixoftheendusearticlesandcontaminatedpolymerscrapswhichwillultimatelybedisposedoftolandfill.Biodegradationofthearticlesisalsoconsideredunlikely.

Thelowenvironmentalexposureofthechemicalasaresultoftheproposeduse,togetherwithitsexpectednegligibleenvironmentaltoxicityoncepolymerised,indicatethattheoverallenvironmentalhazardshouldbenegligible.

12.ASSESSMENTOFPUBLICANDOCCUPATIONALHEALTHANDSAFETYEFFECTS

Thenotifiedchemicalisastable,non-volatile,whitecrystallinesolidwhichisoflowsolubilityinwater. Ithasamolecularweightof216.2whichindicatesthattransmissionacrossbiologicalmembranesispossible.Theoctanol-waterpartitioncoefficientdoesnotprecludebioaccumulation.

ThenotifiedchemicalwillnotbemanufacturedinAustraliabutwillbeimportedforplasticpolymerformulation. Transportworkerswouldonlybeexposedtothenotifiedchemicalintheunlikelyeventofanaccidentwhichcouldleadtoacutedermal,eyeandinhalationexposure. Workerexposureduringplasticproductionismostlikelytotakeplaceviainhalation.Basedonapossibilityofrelationshiptonaphthalene(showntohavesomelong-termlungtoxicityinanimals),chronicinhalationofthenotifiedchemicalmayhaveeffectsonthelungsofworkers.Thenotifierexpectsplasticmanufacturetoinvolveanautomatedplantwithlittleornodirectcontactofworkerswiththenotifiedchemical. Hencetheriskistoworkersislow.

ThenotifiedchemicalwillbepresentatlowlevelsinPENandPEN/PETpolymersandnosignificantmigrationofthenotifiedchemicalfromsuchpolymersisexpectedtooccur. TheuseofPENandPEN/PETplasticsinproductssuchasfoodandbeveragecontainersandaspackagingmaterialforpharmaceuticalsandcosmeticsisthereforenotexpectedtoresultinsignificantpublicexposuretothenotifiedchemical. Thereforetheproposeduseofthenotifiedchemicalpresentsnegligiblerisktopublicsafety.

Basedonthedescribedusepatternforthenotifiedchemical,andtheavailabletoxicologicalandphysico-chemicaldata,itisnotconsideredthatthenotifiedchemicalwillposeasignificantrisktoworkersexposedtothechemicalandisnotclassifiedashazardousaccordingtoWorksafeAustraliacriteria{NationalOccupationalHealthandSafetyCommission,1994#9}.

13.RECOMMENDATIONS

Tominimiseoccupationalexposureto2,6-naphthalenedicarboxylicacidthefollowingguidelinesandprecautionsshouldbeobserved:

  • ItisgoodpracticetowearindustrialclothingwhichconformstothespecificationsdetailedinAustralianStandard(AS)2919{StandardsAustralia,1987#18}andoccupationalfootwearwhichconformstoAustralian andNewZealandStandard(AS/NZS)2210{StandardsAustralia/StandardsNewZealand,1994#24};
  • Spillageofthenotifiedchemicalshouldbeavoided,spillagesshouldbecleaneduppromptlywithabsorbentswhichshouldthenbeputintocontainersfordisposal;
  • Goodpersonalhygieneshouldbepractisedtominimisethepotentialforingestion;
  • AcopyoftheMSDSshouldbeeasilyaccessibletoemployees.
  • theoccupationalatmosphericlevelfordimethyl2,6-naphthalenedicarboxylicacidwouldbeadvisedtobemaintainedbelowthetimeweightedaverage(TWA)atmosphericexposurestandardassetfornaphthaleneof10ppm

{NationalOccupationalHealthandSafetyCommission,1995#14}

  • Althoughthechemicalisnotclassifiedasflammable,andisnotnormallydust-generating,careshouldalsobetakentolimitatmosphericlevelsandpossiblestaticelectricitydischargesourcesintheworkenvironment. Allcarbonbasedpowderedsubstanceshavethepotentialforcombustionandexplosionandattentiontothispossibilityisadvisableintheworkenvironment.

Giventhattheproductscontainingthenotifiedpolymerwillbeusedaspackingmaterialforfoodandbeverages,thenotifiermayneedtocontacttheindividual

AustralianStatejurisdictions,asStatefoodlawsrequirethatmanufacturersmustensurethatmaterilasusedinfoodpackagingarefitforthatpurpose. Inaddition,giventhatthenotifiedpolymerwillalsobeusedtomanufacturepackagingmaterialforpharmaceuticals,thenotifiershouldsubmitanappropriateapplicationtotheMedicalDevicesSectionoftheConformityAssessmentBranchoftheTherapeuticGoodsAdministration.

14.MATERIALSAFETYDATASHEET

TheMSDSforthenotifiedchemicalwasprovidedinaccordancewiththeNationalCode of Practice for the Preparationof Material Safety Data Sheets{NationalOccupationalHealthandSafetyCommission,1994#13}.

ThisMSDSwasprovidedbytheapplicantaspartofthenotificationstatement. It isreproducedhereasamatterofpublicrecord. Theaccuracyofthis informationremainstheresponsibilityoftheapplicant.

15.REQUIREMENTSFORSECONDARYNOTIFICATION

SecondarynotificationunderSection64oftheActwillberequiredifthemethodofusechangesinsuchawayastogreatlyincreasetheenvironmentalexposureofthenotifiedchemical,orifadditionalinformationbecomesavailableonadverseenvironmentaleffectsofthechemical. Ecotoxicityresultsforfish,daphnia andalgaewouldberequiredtoconfirmtheQSARestimatesshouldmoresignificantexposureoftheaquaticcompartmentbe expected. Alternatively, QSAR estimatesusingthecorrectwatersolubilityfortheacidshouldbeprovided.

16.REFERENCES

1.SyracuseResearchCorporation1997,LogKowProgram,Internetaddress;

2.Lyman, W., Potts, RG, Magil,GC 1982, User's Guide Chemest- A ProgramforChemical PropertyEstimation, ,Arthur D.Little Inc,Aciorn ParkCambridgeMA.

3.ToxlineSilverPlatter 1996,ToxlineSilverPlatterCD-ROMdatabase:January1994-June1996,SilverPlatterInternational,N.V.

4.MontanaStateUniversityInstituteforProgramAnalysis,QSARSystem;AStructure-ActivityBasedChemicalModellingandInformationSystem,TDSNumericaTM, TechnicalDatabaseServicesIncorporated, New York.

5.PlanetArk 1997,TheplanetArkRecyclingReport,

6.Johnson,W.1991, Acuteoraltoxicitystudyof2,6-napthalenedicarboxylicacid(2,6-NDA)inrats, Projectno.,1659,Amoco Corporation,Chicago, Il,USA.

7.Johnson,W.1991, Acutedermaltoxicitystudyof2,6-napthalenedicarboxylicacid(2,6-NDA)inrabbits,Project no.,1660, IITResearchInstitute,Chicago,Il,USA.

8.Ledbetter, A. 1988,Acuteinhalationtoxicitystudyof 2,6-naphthalenedicarboxylicacidinrats,Projectno., 1227,IITResearch Institute,Chicago,Il,USA.

9.Johnson,W.1991, Abbreviatedacutedermalirritancy/corrosivitystudyof2,6-naphthalenedicarboxylicacid(2,6-NDA)inrabbits,Projectno.,1658,IITResearchInstitute,Chicago,Il,USA.

10.Johnson,W.1991, Abbreviatedprimaryeyeirritationstudyof2,6-naphthalenedicarboxylicacid(2,6-NDA)inrabbits,Projectno.,1657,IITResearchInstitute,Chicago,Il,USA.

11.Edgar,F. 1997,2,6-NapthaleneDicarboxylicAcidBuehlerSensitisationTest in Guinea Pigs,Project no., 15070, Inveresk Research, Tranet.

12.Draize,J.H.1959,'AppraisaloftheSafetyofChemicalsinFoods,DrugsandCosmetics',AssociationofFoodandDrugOfficials oftheUS,vol.49,pp.2-56.

13.OrganisationforEconomicCo-operationandDevelopment1995-1996,

OECDGuidelinesfortheTestingofChemicalsonCD-Rom,OECD,Paris.

14.Johnson,W.1994,90-dayoral(diet)toxicitystudyof2,6-naphthalenedicarboxylicacid(2,6-NDA)inrats,Projectno.,ProjectNo. L08518,IITResearchInstitute,Chicago,Il,USA.

15.San,R.H.C.,Wagner,V.O.1991,Salmonella/mammalianmicrosomeplateincorporationmutagenicityassay(Amestest)withaconfirmatoryassay,Project no., T9571.501014,Microbiological Associates, Inc., Rockville, USA.

16.Jacobson-Kram,D.1991, CHO/HGPRTmutationassaywithconfirmation,Projectno.,T9571.332001, MicrobiologicalAssociatesInc.,Rockville,MD,USA.

17.Leddy,I.A.,Innes,D.C.1995,2,6-napthalenedicarboxylicacidchromosommalaberrationassaywithChinesehamsterovarycellsinvitro.,Projectno.,10934,InvereskResearchInternational,Tranent, Scotland.

18.Putman,D.L.,Morris,M.J.1991,ChromosomeaberrationsinChineseHamsterOvary(CHO)cells, Projectno.,T9571.337,MicrobiologicalAssociates,Inc.,Rockville,USA.

19.NationalOccupationalHealthandSafetyCommission1994,ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008(1994)],AustralianGovernmentPublishingService,Canberra.

20.USEPAECOSAR1994,AComputerProgramfoEstimatingtheEcotoxicityofIndustrialChemicalsBasedonStructureActivityRelationships,United States Environment Protection Agency. EPA/748/R93/002, Washington DC.

21.Miller,D.W.1980,WasteDisposalEffectsonGroundwater:AComprehensiveSurveyoftheOccurrence andControlofGroundwaterContaminationResultingfromWasteDisposalPractices,PremierPressBerkleyCalifornia.

22.StandardsAustralia1987,AustralianStandard2919-1987,IndustrialClothing,StandardsAssociationofAustralia, Sydney.

23.StandardsAustralia/StandardsNewZealand1994,Australian/NewZealandStandard2210-1994,OccupationalProtectiveFootwear,StandardsAssociationofAustralia/StandardsAssociationofNewZealand,Sydney/Wellington.

24.NationalOccupationalHealthandSafetyCommission1995,'AdoptedNationalExposureStandardsforAtmosphericContaminantsintheOccupationalEnvironment,[NOHSC:1003(1995)]',inExposureStandardsforAtmosphericContaminantsintheOccupationalEnvironment:GuidanceNoteandNationalExposureStandards,AustralianGovernmentPublishingService, Canberra.

25.NationalOccupationalHealthandSafetyCommission1994,NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets[NOHSC:2011(1994)],AustralianGovernmentPublishingService,Canberra.

Attachment 1

TheDraizeScaleforevaluationofskinreactionsisasfollows:

ErythemaFormationRatingOedemaFormationRating

No erythema0Nooedema0

Veryslighterythema(barelyperceptible)

1Veryslightoedema(barely1

perceptible)

Well-definederythema2Slightoedema(edgesofareawell-2

definedbydefiniteraising

Moderatetosevereerythema3Moderateoedema(raisedapprox.13

mm)

Severeerythema(beetredness)4Severeoedema(raisedmorethan14

mmand extendingbeyondareaofexposure)

TheDraizescaleforevaluationofeyereactionsisasfollows:

CORNEA

OpacityRatingArea of CorneainvolvedRating

Noopacity0 none25%orless(notzero)1

Diffusearea,detailsof irisclearlyvisible

Easilyvisibletranslucentareas,detailsofirisslightlyobscure

1slight25%to50%2

2mild50%to75%3

Opalescentareas,nodetailsofirisvisible,sizeofpupilbarelydiscernible

3

moderate

Greaterthan75%4

Opaque,irisinvisible4severe

CONJUNCTIVAE
Redness / Rating / Chemosis / Rating / Discharge / Rating
Vesselsnormal / 0 none / No swelling / 0 none / No discharge / 0 none
Vesselsdefinitely / 1 / Anyswellingabove / 1slight / Anyamountdifferent / 1slight
injectedabovenormal / slight / normal / fromnormal
Morediffuse,deeper / 2mod. / Obviousswelling / 2mild / Discharge with / 2mod.
crimsonredwith / withpartialeversion / moisteningoflids
individualvesselsnot / oflids / andadjacenthairs
easilydiscernible / Swellingwithlids / 3mod. / Discharge with / 3
Diffusebeefyred / 3 / half-closed / moisteningoflids / severe
severe / Swellingwithlids / 4 / andhairsandconsiderablearea
half-closedto
completelyclosed / severe / around eye

IRIS

ValuesRating

Normal0 none

Foldsabovenormal,congestion,swelling,circumcornealinjection,irisreactstolight1slightNoreactiontolight,haemorrhage,grossdestruction 2severe