Tetrakis(Methoxymethyl)Glycoluril

File No: NA/449

Date: November1997

NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME

FULLPUBLICREPORT

Tetrakis(methoxymethyl)glycoluril

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

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Director

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NA/449

FULLPUBLICREPORT

Tetrakis(methoxymethyl)glycoluril

1.APPLICANT

Cytec AustraliaLtdofSuite1,1st Floor,7-11RailwayStreetBAULKHAMHILLSNSW2153andH.B.FullerPowderCoatings(Australia)PtyLtdof6Marigold PlaceMILPERRANSW2214havejointlysubmittedastandardnotificationstatementinsupportoftheirapplicationforanassessmentcertificatefortetrakis(methoxymethyl) glycoluril.

2.IDENTITYOFTHECHEMICAL

ChemicalName:Imidazo[4,5-d]imidazole-2,5(1H,3H)-dione,tetrahydro-1,3,4,6-tetrakis(methoxymethyl)-

ChemicalAbstracts Service

(CAS)RegistryNo.:17464-88-9

OtherNames:Glycoluril,1,3,4,6-tetrakis(methoxymethyl)-Glycoluril, tetrakis(methoxymethyl)-

Trade Name:Powderlink1174Resin(contains85%notifiedsubstance)

WEPolyesterPowderCoating(containslessthan10%notifiedsubstance)

MolecularFormula:C12H22N4O6

StructuralFormula:

MolecularWeight:318

MethodofDetection

andDetermination:infrared(IR)andnuclearmagneticresonance

(NMR)spectroscopy

Spectral Data:infraredspectrum;majorcharacteristicpeakswereobservedat:3000,2950,2850,1730,1

480,1400,1340,1260,1230,1180,1090,1

040,1000,910and800cm-1

3.PHYSICALANDCHEMICALPROPERTIESAppearanceat 20°C

and101.3kPa:whitetopaleyellowgranulatedflakes

MeltingPoint:90-110°C

Density:1324kg/m3at25°C

VapourPressure:notapplicable

WaterSolubility:145g/Lat25°C

PartitionCo-efficient

(n-octanol/water):logPow= 0.516

HydrolysisasaFunctionofpH:

notdetermined

Adsorption/Desorption:notdetermined

DissociationConstant:notdetermined

FlashPoint:notdetermined

FlammabilityLimits:notapplicable

AutoignitionTemperature:notdetermined

ExplosiveProperties:thenotifiersstatethatthenotifiedchemicalisnot

explosiveundernormalconditionsofusebutexcessivequantitiesofdustmayformanexplosivemixturewithairinthepresenceofanignitionsource

Reactivity/Stability:stable

CommentsonPhysico-ChemicalProperties

TestswereperformedaccordingtoEEC/OECDtestguidelinesatfacilitiescomplyingwithOECDPrinciplesofGoodLaboratoryPractice.

ThenotifiersstatethattheimidazoloneringsmayundergohydrolysisunderhighlyacidicconditionsbutthesubstanceisexpectedtobestableintheenvironmentalpHrange.

Noinformationwasprovidedontheadsorption/desorptionpropertiesofthechemical. Giventhechemical'shighwatersolubilityandlowpartitioncoefficientitisanticipatedthatitwillnotstronglyadsorbtosoils.

Thenotifiedchemicalcontainsnodissociablehydrogensorbasicfunctionalities.

4.PURITYOFTHECHEMICALDegreeofPurity:85%ToxicorHazardous

Impurities:

Chemicalname:formaldehyde

CASNo.:50-00-0

Weightpercentage:~0.05%

Toxicproperties:confirmedcarcinogenwithexperimental

carcinogenic,tumorigenicandteratogenicdata;humanpoisonbyingestion;experimentalpoisonbyingestion,skincontact, intravenous,intraperitonealandsubcutaneousroutes;humansystemiceffectsbyinhalation:lacrimation,olfactorychangesandpulmonarychanges;humanmutationdatareported;humanskinandeyeirritant;frequentorprolongedexposurecancausehypersensitivityleadingtocontactdermatitis;anairconcentrationof20ppmisquickly irritatingtoeyes(1)

Non-hazardousImpurities

(>1%byweight):unidentifiedimpuritiesconsistingof5-15%ofthe

notifiedchemicalconsistofdimers,trimersandoligomers

Additives/Adjuvants:none

5.USE,VOLUMEANDFORMULATION

Thenotifiedchemicalisusedasacross-linkingagentinpowdercoatingsforvariousindoorandoutdoorapplications,forexample,computerhousings,appliances,outdoorfurnitureandlawnmowers. ThenotifiedchemicalwillbeimportedineitherPowderlink1174Resin(containing85%ofthenotifiedchemical)ata rateof 4.25to 8.5tonnesperyear for thefirst five years orinformulatedpowdercoatings(containinglessthan10%ofthenotifiedchemical)atarateof 1to 1.5tonnes peryearforthefirstfiveyears.

6.OCCUPATIONALEXPOSURE

Thenotifiedchemicalwillbeimportedin18kgfibrepacks,136kgfibredrumsor208Lsteeldrums. Itisanticipatedthatworkersinvolvedintransportorstorageofthesecontainerswillbeexposedonlyintherareeventofaccidentorleakingpackaging.

Thenotifiedchemicalwillbeincorporatedintopowdercoatingsatonesite. Theprocessformanufacturingpowdercoatingsinvolvesmanuallyscoopingtheflakesofthenotifiedchemicalintoamixingbowl(lessthan20kgperbatch)towhichothercomponentsareaddedpriortoblending. Themixingbowlisspeciallydesignedtofunctionasahopperandtheblendedmaterialsarefeddirectlyfromthehoppertoanextrusionprocess. Followingextrusion,thematerialintheformofasheetisrolled,cooledandkibbledintochips(approximately2cm2inarea)whicharefeddirectlyintoabin. Thebinisthentransportedtothemillwherethechipsaregrounddowntoproducethefinalpowdercoatingproductwhichisthenpackagedinairandmoisturetightplasticbagsinsertedinsidecardboardboxes.

Exposuretothenotifiedchemicalduringadditiontothehopperisexpectedtobelowgiventhatitisintheformoflarge,non-dustingflakes,theareaiswellventilated,theamountofchemicalusedperbatchislowandtheoperationisofshortduration.

Qualitycontrolsamplesofchipsarecollectedfromthebinfortestinginthelaboratory. Thechipsaregroundinagrinderandsievedbeforebeingsprayedontopanels. Mostofthisworkisconductedinaventilatedspraybooth.

Thenotifiershaveprovidedinformationoninspirabledustlevelsattheformulator’ssiteandtheserangefrom0.3to5.0mg/m3. Datafromoneofthejointapplicant’sNewZealandoperationssuggeststhatlevelsofinspirabledustinthegrindingarearangefrom1to9mg/m3.

Intheindustrialapplicators’workplacesthepowdercoatingismanuallyloadedintoahopperwhichfeedsautomaticallyintoaspraygun. Thenotifiershaveassumedthatinspirabledustlevelsinapplicators’workplacesarelessthan10mg/m3,inlinewiththelevelsintheformulator’sworkplace. However,thereisevidenceofgreatvariabilityintheselevelsdependingonwhetherpropersprayboothswithadequateairflowareemployed. Levelsofuptoapproximately130

mg/m3havebeenrecorded(2).

7.PUBLICEXPOSURE

Thenotifiedchemicalorreformulatedproductsareforindustrialuseonlyandwillnotbeavailabletothepublic.

Thepubicmaycomeincontactwithproductscoatedwithpowderscontainingthenotifiedchemical. However,thenotifiedchemicalactsasacross-linkingagentandbindswithpolyesterresin. Itsadhesiontothesubstrateandphysico-chemicalpropertiesofthedrycoatingwillprecludepublicexposure.

Wastescollectedfromreformulationandcoatingprocesseswillbedisposedoftodesignatedlandfill. AccidentalspillswillresultinminimalpublicexposureifthespillsarecollectedanddisposedofasoutlinedintheMaterialSafetyDataSheet(MSDS).

8.ENVIRONMENTALEXPOSURERelease

Itisestimatedbythenotifierthatresiduesremaininginpackagingwillbelessthan100kgperyear(~80kgfromtheimportedrawmaterialand~20kgfrom formulatedpowdercoatings)atthemaximumrateofimport. TheemptypackagingwillbedisposedoftolandfillinaccordancewithLocal,StateandFederalregulations.

Theblending,extrusionandgrindingprocessesinthereformulationarecarriedoutindustcontrolledenvironments. Dustsarecollectedbyabaghousefilteringsystem.Thedustcollectedfromthebaghouseisgenerallyreconstitutedintopelletswhicharerecycledinlaterbatches. FineswhicharenotrecycledaredisposedoftolandfillinaccordancewithLocalandStateregulations. Thenotifierestimatesthatthewastagewouldbeapproximately5%ofthebatch(~500kgof thenotifiedchemicalannually).

Thenotifierestimatesthatlossesfromsprayapplicationofthepowdercoatingswillbelessthan25%. Sprayingwilltakeplaceinasprayboothandtheoverspraywillbecollectedandeithersievedandreusedordisposedoftolandfill. Taking25%asaworstcase,amaximumof6100kgofthenotifiedchemicalwillbedisposedoftolandfillperannumaswastepowdercoating.

Fate

NearlyallofthePowderlink1174tobeusedwillbecomeimmobilisedthroughcross-linkingintheinsolublepolyestermatrixofthepowdercoating,whichisboundtothearticlesthatthecoatinghasbeenapplied. Thus,thefateofthemajorityofthenotifiedchemicalwillsharethefateofthesearticles,whichisexpectedtobelandfillattheend oftheusefullifeofthe article.

Amaximumof6700kgofPowderlink1174willbedisposedoftolandfillannually,aswastefromformulationandapplicationofthepowdercoatings. Themajorityofthiswillbeencapsulated(andpossiblyfurthercrosslinked)intheinsolublepolymer;leachingpotentialislow.

ThechemicalwasfoundtobenotreadilybiodegradableintheOECD301DTest(ClosedBottleTest),with46.8%biodegradationobservedattheendofthe28-dayexposureperiod. Thisresultindicatesthesubstancetobeinherentlybiodegradable.

Althoughthechemicalisnotreadilybiodegradable,thepotentialforbioaccumulationislowduetothelowpartitioncoefficient(logPow=0.516)andveryhighwatersolubilityofthesubstance.

9.EVALUATIONOFTOXICOLOGICALDATA

AllofthetoxicitystudieswereconductedwithPowderlink1174Resincontaininggreaterthan85%ofthenotifiedchemical.

9.1AcuteToxicity

SummaryoftheacutetoxicityofPowderlink1174Resin

TestSpeciesOutcomeReference

acute oral toxicityratLD502000mg/kgLD50=7.07 g/kg

(3,4)

acute dermal toxicityrabbitLD50 10.0 g/kg(4)

acute inhalation toxicityratLC500.291mg/L(5)skinirritation rabbit non-irritant (6,7)eye irritation rabbit moderateirritant (4,8)skinsensitisation guineapig non-sensitiser (9)

9.1.1OralToxicity(3,4)

9.1.1.1LimitTest(3)

Species/strain:rat/Sprague-Dawley

Number/sexofanimals:5/sex

Observationperiod:14 days

Methodofadministration:gavage;suspensionarachisoil

Clinicalobservations:lethargy(onefemale);hunchedposture(six

animals)

Mortality:nodeaths

Morphologicalfindings:none

Testmethod:accordingtoOECDGuidelines(10)

LD50:2000mg/kg

Result:thenotifiedchemicalwasofloworaltoxicityin rats

9.1.1.2StandardTest(4)

Species/strain:rat/Hilltop-Wistar

Number/sexof

animals/doses:5malesperdose;dosesof2.5,5.0and

10.0 g/kg

Observationperiod:14 days

Methodofadministration:gavage;suspensionin0.25%agarplus

0.1%Tween80

Clinicalobservations:sluggish,unsteadygait5to30minutespost-

intubation

Mortality:no deathsat2.5g/kg,1deathat 5.0g/kg and4deathsat10.0g/kg

Morphologicalfindings:nothingremarkableinsurvivors;in

decedents,stomachsdistended,liquidfilledwithglandularportionsinjected;intestinesinjected

Testmethod:notstated

LD50:7.07g/kg(confidencelimits:4.02to12.4g/kg)

Result:thenotifiedchemicalwasofloworaltoxicityin rats

9.1.2 / DermalToxicity(4)Species/strain:Number/sexofanimals:Observationperiod:
Methodofadministration: / rabbit/NewZealandWhite8/unknown
notstated
chemicalmoistenedwithwatertoforma
paste;thepastewascoveredwith
polyethylenesheetingfor24hours
Clinicalobservations: / none;noirritationobserved
Mortality: / none
Morphologicalfindings: / none
Testmethod: / notstated
LD50: / 10.0 g/kg
Result: / thenotifiedchemicalwasoflowdermal
toxicity in rabbits
9.1.3 / InhalationToxicity(5)
Species/strain: / rat/Sprague-Dawley
Number/sexofanimals: / 5/sex
Observationperiod: / 14 days
Methodofadministration: / thesolidtestmaterialwasgroundwitha
mortarandpestleandsievedthroughasize
20and60meshscreen;thematerialwas
packedinthedustcontainerofaWrightDust
Feederusingahydraulicpress;dry
compressedairwassuppliedtothedust
feederatapproximately8-12psi
backpressure,causingadustaerosoltobe
expelledintoaglassdiffuser;thediffuser
servedtoremovelargerparticlesandmixthe
dustaerosolwithadditionalroomairbefore
enteringtheexposurechamber;exposure
wasforfourhours;themassmedian
equivalentaerodynamicdiameterwas3.7
mandthetotalrespirableconcentration
was0.137mg/L

Clinicalobservations:uponremovalfromthechamber3rats

appearednormaland7ratsexhibitedminorabnormalities:slightlacrimation(2rats),clearordriedrednasaldischarge(3rats),whiteorredmaterialonthefacialarea(3rats),brownano-genitalstaining(1rat);onthedayfollowing exposure,8ofthe10ratsappearednormal,1displayedslightdriednasaldischargeand1displayedslightredmaterialaroundthefacialarea;allanimalsappearednormalfromdays2totermination

Mortality:none

Morphologicalfindings:5malesand3femalesexhibitedmottled

appearanceorfocionthelungs;1maleand1femaleexhibitedurinarybladdersvascularisedanddistendedwithathinyellowfluid;thefemalealsoexhibiteddarkredrenallymphnodeslargerthannormal;onemaledisplayedlargerthannormalmandibularlymphnodes;onefemaleexhibitedaspleenthatwaslargerthannormal,thickenedandmottledred;onefemalewasfreeofmacroscopicabnormalities

Testmethod:accordingtoOECDGuidelines(10)

LC50:0.291mg/L

Result:thenotifiedchemicalwasnotacutelytoxic byinhalationinratsexposedforfourhourstoaconcentrationof0.291mg/L(0.137mg/Lrespirableconcentration)inair

9.1.4 SkinIrritation(6,7)

9.1.4.1Study#1(6)

Species/strain:rabbit/NewZealandWhite

Number/sexofanimals:3/unknown

Observationperiod:3 days

Methodofadministration:0.5gofPowderlink1174Resinplacedunder

occlusivedressingfor4hours

Testmethod:unspecified

Result:noerythemaoroedemawasobservedinanyanimalatanytimepoint;thenotifiedchemicalwasnotaskinirritantinrabbits

9.1.4.1Study#2(7)

Species/strain:rabbit/NewZealandWhite

Number/sexofanimals:3/male

Observationperiod:3 days

Methodofadministration:0.5gofPowderlink1174Resinwas

moistenedwithdistilledwaterandplacedunderasemi-occlusivedressingfor4hours

Testmethod:accordingtoOECDGuidelines(10)

Result:oneanimalexhibitedslighterythemaat1hourpost-treatment;noothererythemaoroedemawasobservedinanyotheranimal;thenotifiedchemicalwasnotaskinirritantinrabbits

9.1.5EyeIrritation(4,8)

9.1.5.1Rangefindingstudy(4)

Species/strain:rabbit/unspecifiedNumber/sexofanimals:6/unspecifiedObservationperiod: 72hours

Methodofadministration:100mgofPowderlink1174Resinintoone

eye

Primaryirritationscores1ofunirrigatedeyes:

Mean Values1:

Timeafterinstillation

1day / 2days / 3days
Cornea / 12.5 / 8.3 / 2.5
Iris / 3.3 / 0.8 / 0.0
Conjunctivae / 10.0 / 8.0 / 3.3

1 primaryirritationscoreswerecalculatedastwicethesumofthevaluesforconjunctivaleffects(redness,chemosisanddischarge),maximumvalueof20;fivetimesthevalueforiridaleffects,maximumvalue10;fivetimestheproductofthevaluesforcornealeffects(opacityandarea),maximumvalue80;thevaluesusedareDraize(11)scores(seeAttachment1forDraizescales)

Testmethod:notspecified

Result:thenotifiedchemicalwasamoderateirritanttorabbiteyes

9.1.5.2MainStudy(8)

Species/strain:rabbit/NewZealandWhiteNumber/sexofanimals: 6/unspecifiedObservationperiod: 7 days

Methodofadministration:97mgofPowderlink1174Resinintothe

conjuntival sacoftheright eye ofeachrabbit

Draizescores1(11)ofunirrigatedeyes:

Timeafter instillation

Animal1 hour1 day2 days3 days7 days

Corneaoa
1d2
2d
3d / ab
3 / oa
1 / ab
2 / oa
1 / ab
1 / oa
1 / ab
1 / oa
0 / ab
0
1 / 1 / 1 / 1 / 1 / 0 / 0 / 0 / 0
2 / 1 / 2 / 1 / 1 / 0 / 0 / 0 / 0
Iris
1 / 1 / 1 / 0 / 0 / 0
2 / 0 / 1 / 1 / 0 / 0
3 / 1 / 1 / 0 / 0 / 0
Conjunctivrc
a / cd / de / rc / cd / de / rc / cd / de / rc / cd / de / rc / cd / de
1 / 2 / 2 / 2 / 2 / 2 / 1 / 1 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0
2 / 2 / 2 / 3 / 2 / 2 / 2 / 2 / 1 / 1 / 1 / 1 / 1 / 0 / 0 / 0
3 / 2 / 2 / 2 / 2 / 2 / 1 / 2 / 1 / 0 / 1 / 1 / 0 / 0 / 0 / 0
1seeAttachment1forDraizescales 2d=dullingofthenormallustreofthecornea

a opacityb areac rednessd chemosise discharge

Testmethod:accordingtoOECDGuidelines(10)

Result:thenotifiedchemicalwasamoderateirritanttorabbiteyes

9.1.6SkinSensitisation(9)

Species/strain:guineapig/DunkinHartley

Numberofanimals:20test;10control(sexunknown)

Inductionprocedure:injections(0.1mL)intheshoulderregionof:

i.Freund’s CompleteAdjuvant(FCA)plusdistilledwater(1:1);

ii.25%w/vsolutionofPowderlink1174Resininwater;

iii.25%w/vemulsionofPowderlink1174Resinina1:1preparationofFCApluswater

onday7thesameregionwastopicallytreatedwitha75%w/vaqueoussolutionof

Powderlink1174Resinunderocclusivedressingfor48hours

Challengeprocedure:onday21therightflankofeachanimalwas

treatedwitha75%aqueoussolutionofPowderlink1174Resinunderocclusivedressingfor24hours

Challengeoutcome:

TestanimalsControlanimals

Challenge
concentratio / 24hours* / 48hours* / 24hours / 48hours
n
50% / 0/20** / 0/20 / 0/10 / 0/10
75% / 0/20 / 0/20 / 0/10 / 0/10

* timeafterpatchremoval

** numberofanimalsexhibitingpositiveresponse

Testmethod:accordingtoOECDGuidelines(10)

Result:thenotifiedchemicalwasnotaskinsensitiseringuineapigs

9.2RepeatedDoseToxicity

Nodatasupplied.

9.3Genotoxicity

9.3.1SalmonellatyphimuriumReverseMutationAssay(12)

Strains:TA1535,TA1537,TA1538,TA98and

TA100

Concentrationrange:667-10000g/plate

Testmethod:accordingtoOECDGuidelines(10)

Result:thenotifiedchemicalwasnotmutagenicinanyofthestrainstestedineitherthepresenceorabsenceofmetabolicactivationprovided by rat liverS9fraction

9.3.2ChromosomalAberrationAssays(13,14)

9.3.2.1BoneMarrowCellsoftheMouse(13)Species/strain:mouse/ICRNumberandsexofanimals: 5/sex/group

Doses:0,1250,2500and5000mg/kg

Methodofadministration:bygavageincornoilon5consecutive days;

approximately1.5-2.5hourspriortoeuthanasiatheanimalswereinjectedintraperitoneallywith2mg/kgofcolchicineafterwhichbonemarrowwascollected

Testmethod:Internalprotocolno.451

Result:thenotifiedchemicaldidnotinducechromosomalaberrationsinbonemarrowcellsofthemouse

9.3.2.2ChineseHamsterOvaryCells (14)

Doses:withoutmetabolicactivation:rat liverS9fraction:

- 500and1250g/mL (10hourharvest

-500 to5 010g/mL (20hourharvest)

-2 500 to 5 010g/mL (30hourharvest

withmetabolicactivation:

-1 250 to5 010g/mL (10and20hourharvests)

Testmethod:internalprotocolno.437B

Result:withoutS9:

-significantincreasesininducedchromosomalaberrationsat2500

and3750g/mL atthe20hourharvestandaweaklysignificantincreaseat3750g/mLatthe30hourharvest(dosesabove3750g/mLwerenotanalysedforchromosomalaberrations)

withS9:

-significantincreasesininducedchromosomalaberrationsat

3 750g/mL and5010g/mL at the

20hourharvest

releaseofformaldehydeintotheculturemediumwasnotedatlevelswhichmayhavebeenresponsibleforinducingchromosomalaberrations(15)

9.4OverallAssessmentofToxicologicalData

Thenotifiedchemicalwasoflowacuteoraltoxicityinrats(LD502000mg/kginalimittestandLD50=7.07g/kginmalesinastandardtest). Itwasoflowdermaltoxicityinrabbits(LD502000mg/kg)andwasnotacutelytoxicviatheinhalationrouteataconcentrationof0.291mg/Ladministeredtoratsfor4hours. Nodataonrepeateddosetoxicityweresupplied.

Thenotifiedchemicalwasnotaskinirritantbutwasamoderateeyeirritantinrabbitsandwasnotaskinsensitiseringuineapigs. ItwasnotmutagenicinSalmonellatyphimuriumanddidnotinducechromosomalaberrationsinbonemarrowcellsofmicein vivo. However,chromosomalaberrationsinchinesehamsterovarycellsin vitrowereobservedbutwereattributedtoreleaseofformaldehydeintotheculturemedium.

ThenotifiedchemicalwouldnotbeclassifiedashazardousinaccordancewithWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(ApprovedCriteria)(16)inrelationtothetoxicological dataprovided. Despitethefactthatthenotifiedchemicalwouldnotbeclassifiedashazardousinrelationtoeyeirritancy,itwasconsideredtobeamoderateeyeirritantinrabbitsonthebasisofmoderateconjunctivaleffectspersistingfor24hours. ClassificationashazardousaccordingtotheApproved Criteriarequirespersistenceoftheeffectsfor72hours.

10.ASSESSMENTOFENVIRONMENTALEFFECTS

Thefollowingecotoxicitystudieshavebeensuppliedbythenotifier.Thetestswerecarriedout to OECD Test Methods.

TestSpeciesResults

AcuteToxicitybluegillsunfish(Lepomis

macrochirus)

LC501000mg/L

Theecotoxicitydataforthenotifiedchemicalindicatethatthechemicalispracticallynon-toxictobluegillsunfish.Duringthetestitwasnotedthatthetestmaterialwasslowtodissolveanditisunclearwhetherallthetestmaterialwasinsolution

duringthetest.Thisisincontrasttotheclaimedhighwatersolubilityforthechemical.

ThenotifierstatesthatnodatawereavailableforDaphniamagnaacuteimmobilisationoralgalgrowthinhibitionandthatconsiderationbegivenfortheomissionofthesedataonthegroundsoflimitedenvironmentalexposure.Thisisacceptablegiven thevery low toxicitiestofish and the likely very low level ofexposuretotheaquaticcompartment.

11.ASSESSMENTOFENVIRONMENTALHAZARD

Thelowenvironmentalexposureofthechemicalasaresultofnormaluseindicatesthattheoverallenvironmentalhazardshouldbenegligible. Onceincorporatedintopowdercoatingsthechemicalwillbeinertandboundtothearticleto which it coats.

Amaximumof6700kgofPowderlink1174willbedisposedoftolandfillannually,aswastefromformulationandapplicationofthepowdercoatings. Themajorityofthiswillbeencapsulated(andpossiblyfurthercrosslinked)intheinsolublepolymer,theleachingpotentialislow.

Theoverallenvironmentalhazardfromtheuseofthechemicalisratedaslow.

12.ASSESSMENTOFPUBLICANDOCCUPATIONALHEALTHANDSAFETYEFFECTS

Thetoxicologicaldatasuppliedindicatethatthenotifiedchemicalmaybeamoderateeyeirritantbutshouldnotexhibitacutetoxicityviatheoralanddermalroutes. Itshouldnotbeskinirritantorsensitiserandisunlikelytobegenotoxic.Anacuteinhalationtoxicitystudywasconductedinrats. Themaximumconcentrationusedinthestudy(0.291mg/L)wouldnotruleoutclassificationastoxicaccordingtotheApprovedCriteriasincethiswouldrequireanLC50between

0.25and1mg/L. Norepeatdosedatawereprovided. Thenotifiersarguedthat

themoleculeishighlypolarasindicatedbytherelativelyhighwatersolubility(145g/L)andlowlogPow(0.516)andthatthisindicatesrelativelyrapidclearanceand,therefore,limitedpotentialforbioaccumulation. Thelackofrepeatdosedatawasacceptedonthisbasisfollowingtheprovisionofquantitativeexposuredata.

Exposureofworkersinvolvedintransportandstorageisunlikelyexceptintheeventof anaccident.

Duringformulationofpowdercoatings,exposuretothenotifiedchemicalinitspurestformisonlypossibleatthestageofscoopingtheflakesintothehopperformixingwithotheringredientssuchasresinsandpigments. Theflakeswerestatedtobenon-dusting,theworkplaceiswellventilatedandthetimetakenisshort. Therefore,exposureatthispointisexpectedtobelow. Nevertheless,glovesandeyeprotectionasdescribedbelowshouldbeworn.

Atthesinglesitewherereformulationofthenotifiedchemicalintopowdercoatingsistooccur,measurementsofinspirabledustintheatmosphererangeupto5.0mg/m3andareconductedeverythreemonths. Intheabsenceofotherinformation,itisassumedthattheconcentrationofthenotifiedchemicalintheairbornedustwillbethesameasisaddedtotheformulation,thatis,amaximumof7%. Ifthenotifiedchemicalisataconcentrationof85to95%inthetechnicalgradematerial,theconcentrationofnotifiedchemicalinairmaybeamaximumof0.67mg/m3(0.95X 0.07 X 10 mg/m3). Inshopswherepowdercoatingsareappliedthisfigurewouldbeapplicableinmostcases. However,insomeshopspowdercoatingmaybeconductedin‘walk-in’sprayboothsandthedustconcentrationcanbeoftheorderof100mg/m3(2)inwhichcasetheconcentrationofnotifiedchemicalinairwouldbeabout10-foldhigher.

Thenotifiershavecalculatedintakefactors(anintakefactorisameasureofthequantityofthechemicalinthedustaworkerislikelytoinhale)of

9.39X10-3m3/kg/day forworkersinvolvedinpowdercoatingreformulationand

0.15m3/kg/dayforapplicators. Theaverageparticlesizeoftheformulated powdercoatingswasmeasuredat40-43mwitharespirablefraction(particlesizelessthan7m)of4%. Usingthefigureof4%,andassumingthatthisfractionwasthemajorcontributor,theabsorbeddosewascalculatedat2.5X10-4mg/kg/dayforreformulatorsand4.0X10-3mg/kg/dayforapplicators. Ifexposuretoapplicatorsinsomeshopsisabout10-foldhigherasnotedabove,theabsorbeddosecouldbeabout0.04mg/kg/day. Thesefiguresassume100%bioavailabilityofthenotifiedchemicalbutthisisunlikelygivenitsuseasacross-linkingagent. Therefore,giventhelikelypotentiallylowacutetoxicityofthenotifiedchemical,itslikelylimitedpotentialforbioaccumulationandlikelylowchronicdoselevel,theriskofadversehealtheffectstoworkersinvolvedinreformulationorapplicationofpowdercoatingsisexpectedtobelow. Nevertheless,inshopswhere‘walk-in’sprayboothsareused,particulaterespiratorsasdescribedbelowshouldbeemployed.

Theriskofadversepublichealtheffectsresultingfromcontactwiththenotifiedchemicalisexpectedtobenegligible,assuchcontactisonlylikelywhenthenotifiedchemicalisincorporatedintothecuredcoatingwhichisadheredtothesubstrate.

13.RECOMMENDATIONS

Tominimiseoccupationalexposuretothenotifiedchemicalthefollowingguidelinesandprecautionsshouldbeobserved:

• SafetygogglesshouldbeselectedandfittedinaccordancewithAustralianStandard(AS)1336(17)tocomplywithAustralian/NewZealandStandard(AS/NZS)1337(18);

• IndustrialclothingshouldconformtothespecificationsdetailedinAS2919(19);

• ImpermeableglovesormittensshouldconformtoAS2161(20);

• AlloccupationalfootwearshouldconformtoAS/NZS2210(21);

• DustlevelsshouldbemaintainedbelowWorksafeAustralia’sexposurestandardfornuisancedustsof10mg/m3(22);however,ifdust levelsabove10mg/m3areunavoidable,aparticulaterespiratorwhichprovidesafullheadcoveringshouldbewornandshouldcomplywithAS/NZS1715(23)andAS/NZS1716(24);

• Spillageofthenotifiedchemicalshouldbeavoided,spillagesshouldbecleaneduppromptlyandshouldthenbeputintocontainersfordisposalinaccordancewithLocal,StateorFederalgovernmentregulations;

• Goodpersonalhygieneshouldbepractisedtominimisethepotentialforingestion;

• AcopyoftheMSDSshouldbeeasilyaccessibletoemployees.

Foramoredetaileddescriptionofengineeringcontrolsandworkpracticeswhichwillservetominimiseexposurechemicalsinpowdercoatingsthestudyontriglycidylisocyanurate(2)undertakenbyNICNASshouldbeconsulted.

14.MATERIALSAFETYDATASHEET

TheMSDSforthenotifiedchemicalandforapowdercoatingcontainingitwereprovidedinaccordancewiththeNationalCodeofPractice forthePreparation ofMaterialSafetyDataSheets(25).

TheseMSDSwereprovidedbytheapplicantsaspartofthenotificationstatement.Theyarereproducedhereasamatterofpublicrecord. Theaccuracyofthisinformationremainstheresponsibilityoftheapplicants.

15.REQUIREMENTSFORSECONDARYNOTIFICATION

Undersubsection64(1)oftheAct,secondarynotificationofthenotifiedchemicalshallberequiredifsignificantexposureoftheaquaticcompartmentisexpectedinwhichcaseecotoxicityresultsdaphniaandalgaewillberequired. Secondarynotificationwillberequiredshouldanyofthecircumstancesstipulatedundersubsection64(2)oftheAct arise.

16.REFERENCES

1.Sax,N.I.Lewis,R.J.1996,DangerousProperties ofIndustrial Materials,9thedn,VanNostrandReinhold,NewYork.

2.NationalIndustrialChemicalsNotificationandAssessmentScheme1994,PriorityExistingChemicalNo.1Triglycidylisocyanurate (TGIC),AustralianGovernment PublishingService, Sydney.

3.Sanders,A. 1996, Powderlink1174Resin:AcuteOralToxicity(LimitTest) intheRat,Projectno.,971/016,SafepharmLaboratoriesLimited,NJ,USA.

4.Shaffer,C.B. 1980,RangeFindingToxicity Tests:SingleOralDose,SingleDermalDose,EyeIrritation, Project no.,43-508,Carnegie-MellonInstitute ofResearch,PA,USA.

5.Whitman,B.A.Phillips,R.D.1991, AcuteInhalationTestinRats,Projectno.,190216,Exxon BiomedicalSciencesInc, NJ,USA.

6.Moreno,O.M.,Cerven,D.R.,Cerven,B.W.Salyer,E.J.1991,PrimaryDermal/OcularIrritationinAlbinoRabbits,Projectno.,MB90-204C,PA,USA.

7.Sanders,A. 1996, Powderlink1174Resin:AcuteDermalIrritationTestintheRabbit,Projectno.,971/016,SafepharmLaboratoriesLimited,NJ,USA.

8.Sanders,A. 1996, Powderlink1174Resin:AcuteEyeIrritationTestintheRabbit,Projectno.,971/008,SafepharmLaboratoriesLimited,NJ,USA.

9.Sanders,A. 1996, Powderlink1174Resin:MagnussonKligmanMaximisationStudyintheGuineaPig,Projectno.,971/009,SafepharmLaboratoriesLimited,NJ,USA.

10.OrganisationforEconomicCo-operationandDevelopment1995-1996,

OECDGuidelinesfortheTestingofChemicalsonCD-Rom,OECD,Paris.

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

12.San,R.H.C.Wagner,V.O.1990,Salmonella/MammalianMicrosomePlateIncorporationMutagenicityAssay(AmesTest), Project no., T9568.501015,AmericanCyanamidCo.,NJ,USA.

13.Murli,H. 1993,MutagenicityTestonCT-459-90MeasuringChromosomalAberrationsinvivoinMouseBoneMarrowCells,Projectno.,15377-0-451,HazeltonWashingtonInc.,VA,USA.

14.Murli,H. 1993,MutagenicityTestonCT-459-90MeasuringChromosomalAberrationsinChineseHamsterOvary(CHO)CellswithMultipleHarvests,Projectno.,14889-0-437B,HazeltonWashingtonInc.,VA,USA.

15.Natarajan,A.T.,Darroudi,F.,Bussman,C.J.M.Leeuwen,v.K.-v.1983,'Evaluation oftheMutagenicityofFormaldehydeinMammalianCytogeneticAssaysinvivoandin vitro',Mutat.Res.,vol.122, pp.355-360.

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

17.StandardsAustralia1994,AustralianStandard1336-1994,EyeprotectionintheIndustrialEnvironment, StandardsAssociationofAustralia, Sydney.

18.StandardsAustralia/StandardsNewZealand1992,Australian/NewZealandStandard1337-1992,EyeProtectorsforIndustrialApplications,StandardsAssociationofAustralia/StandardsAssociationofNewZealand,Sydney/Wellington.

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

20.StandardsAustralia1978,AustralianStandard2161-1978,IndustrialSafetyGlovesandMittens(excludingelectricalandmedicalgloves),StandardsAssociation ofAustralia, Sydney.

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

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

23.StandardsAustralia/StandardsNewZealand1994,Australian/NewZealandStandard1715-1994,Selection,UseandMaintenanceofRespiratoryProtectiveDevices,StandardsAssociationofAustralia/StandardsAssociationofNewZealand,Sydney/Wellington.

24.StandardsAustralia/StandardsNewZealand1994,Australian/NewZealandStandard1716-1994,RespiratoryProtectiveDevices,StandardsAssociationofAustralia/StandardsAssociationofNewZealand,Sydney/Wellington.

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