File No: NA/287
Date:February 1996
NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME
FULL PUBLIC REPORTDIUREA
ThisAssessmenthasbeencompiledinaccordancewiththeprovisionsoftheIndustrialChemicals(NotificationandAssessment)Act1989,andRegulations.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
NA/287
FULL PUBLIC REPORT
DIUREA
1.APPLICANT
DuluxAustraliaofMcNaughtonRoad,Clayton,VIC3168hassubmittedastandardnotificationstatementaccompanyingtheirapplicationforanassessmentcertificateforDiurea.
2.IDENTITY OF THE CHEMICAL
Thehazardousnatureofthenotifiedchemicalisunknownexceptforthefactthatitisunlikelytobeaskinirritant. Variationofschedulerequirementsfortheremainderofthetoxicologicaldatawassoughtandgrantedonthebasisthattheresinsolutiontobeimportedisatarelativelylowconcentrationofthenotifiedchemicalinsturdysteeldrums,isformulatedintoapaintatasinglesiteandthepaintcontainsthenotifiedchemicalataconcentrationwhichwouldnotleadtoitsclassificationasahazardoussubstanceaccordingtoWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(1)evenifitwerepositiveinoneormoreofthetoxicologicaltestsnormallyrequiredaspartofastandardnotificationundertheAct. However,inviewoftheunknownnatureofthehazarditisdeemedprudenttotreatthechemicalaspotentiallyhazardous.Thereforecertainconditionsareplacedonthegrantingofexemptstatusforthechemicalidentity. These are:
- Adescriptivegenericname,Aromaticaliphaticureaderivative,beusedtoidentifythesubstanceinpublicreportsandtheMSDS,
- TherelevantemployeeunionsshallbeinformedoftheconditionsofuseofDiurea,
- Thefullchemicalnameshallbeprovidedtoanyhealthprofessionalsinthecaseofalegitimateneedwhereexposuretothechemicalmayinvolveahealthrisk,
- Thefullchemicalnameshallbeprovidedtothoseonsitewhoareusingthechemicalandtothosewhoareinvolvedinplanningforsafeuse,etc.inthecaseofalegitimateneed,
- TheDirectorofNICNASwillreleasethefullchemicalnameetcinthecaseofarequestfromamedicalpractitioner,
- Confidentialitywillexpireaftera3yearperiod,
- ReferencetoassessmentofDiureabyNICNASbemadeontheMSDS,
- TheseconditionsshallbepublishedintheChemicalGazette.
Trade names:Diurea,4422/148RheologyControlAgent
Molecularweight:382
Methodofdetectionanddetermination:
FTIRspectroscopy
3.PHYSICAL AND CHEMICAL PROPERTIES
Asthenotifiedchemicalisdifficulttoisolateandonlyavailableinlimitedquantitiesasapuresubstanceonlythemeltingpointandwatersolubilityhavebeenmeasured.Otherpropertiesareestimates,mostlyobtainedfromtheUSEPA’sAssessmentToolsfortheAssessmentofRisk(ASTER)database.
MeltingPoint:218°C
SpecificGravity:1.1(estimated)
Vapour Pressure:3.210-13kPaat25°C(estimated)(ASTER)
WaterSolubility:0.05mg/Lat24°C(turbidimetricmethod).Estimatedvalue41.9mg/L(ASTER)
PartitionCo-efficient
(n-octanol/water)log Pow:log P = 3.86 (ASTER). An estimate
of3.2(HanschandLeo’smethod)hasbeenprovidedbytheCSIRODivisionofChemicalsandPolymers,onbehalfofthenotifier.
Hydrolyticstability:Notavailable. Diureawouldnotbeexpectedtohydrolyseat
significantratesunderenvironmentalconditionsbecauseoflowsolubility.
Adsorption/Desorption:Expectedtobeimmobileinsoilsby
virtueofitslowsolubility. The estimatedsoilorganiccarbonpartitioncofficientis2800(ASTER), indicativeofstrongbindingtosoils.
DissociationConstant:Thesubstancecontainsnoreadily
dissociablegroups.
4.PURITY OF THE CHEMICAL
Degreeofpurity:> 98%
Toxicorhazardousimpurities:Noneidentified
Non-hazardousimpurities:Noneidentified
Additives/Adjuvants:Nil
5.INDUSTRIAL USE
Diureawillbeimportedasacomponent(5-10%)ofaresinsolutionforuseasaflowcontrolagentinpaints. Theannualimportvolumeisexpectedtobe1-10tonnesperyearforthefirstfiveyears.
6.OCCUPATIONAL EXPOSURE
Aresinsolutioncontainingthenotifiedchemicalat5-10%istransportedbyroadin200Lsteeldrumstothenotifier’spremisesandtransferredfromthedrumtoapaintmixerbypumping. Fourtofivedrumsofsolutionareaddedtothemixerperbatchandexposureispossiblewhenremovingdrumbungsorwhentransferringadrumlancefromonedrumtoanother. Spillsofresinsolutionmayoccurasdripsfromthedrumlanceandareexpectedwithperhaps1in20drumshandled. Thevolumeinvolvedisexpectedtobesmall-100-200mLofresinsolutionwhichiscleanedupusingamopandbucketofsolvent.
Mixingiscarriedoutinanenclosedmixerfittedwithlocalexhaustventilationtocapturevolatilesatsource. Drummingoffofthepaint,containing0.25%ofthenotifiedchemicalisaccomplishedbygravityfeedfromthebaseofthepaintmixerinto200Lopenheadsteeldrums. Theflowofpaintiscontrolledthroughatapsystemwhichisswitchedoffasthedrumsfill. Exposuretothepaintmayoccurbyskincontactwhenclosingdrumsandcleaningupminorspills-atworstinvolving20-30kgofpaintcontaining100gDiurea.
Smallamountsofpaintwillbehandledduringlaboratorydevelopmentandqualitycontrol.
Threeworkerswillbeinvolvedon10daysperyear,8hoursperdayinlaboratorydevelopment,qualitycontroltestinganddrumfillingoperationsand3hoursperdayinpaintmake-up.
Thefinishedautomotivepaintistobeusedatasinglesiteandappliedautomaticallytovehiclesinasprayboothwithfumeextraction.
7.PUBLIC EXPOSURE
Thepublicisunlikelytocomeincontactwiththenotifiedchemicalduringimportation,formulation,useordisposalofthenotifiedchemical. Theonlypossiblecircumstanceswouldbeintheeventofanaccidentduringtransportofthenotifiedchemicalorthepaintintowhichitisformulatedandcontactwiththenotifiedchemicalorpaintdisposedtolandfill.
8.ENVIRONMENTAL EXPOSURE
.Release
Thenotifierestimatesthatupto100kgwastediureafromformulationmayrequiredisposal. Thisismostlikelytooccurtolandfill,aftertreatmentthroughthe‘Dusol”processtoreclaimsolventsandimmobilisetheresidueasaninertsolid. Incinerationisanotherdisposaloption.
Drumswillbesenttoadrumreconditioner forincineration,washingandrecycling.
Additionalwastes(upto60%ofimports,oramaximumof6tonnesperannum)willbegeneratedasoversprayduringuse. Solidwastesfromspraypaintingwillbedisposedoftolandfill.
.Fate
Diureawillmainlybedisposedoftolandfillasresiduesfromspraypaintingoperations.Diureahaslowintrinsicmobility,andwillbeeffectivelyimmobilisedinthesesolidresidues.
AMackaylevel1calculationindicatesthat47%ofdiureareleasedtotheenvironmentwouldpartitiontowateratequilibrium,with27%tosoiland25%tosediment(ASTER).
Notethatthismaybeanoverestimateoftheaqueousfractionasmeasuredsolubilityismuchlessthanthatcalculated.
Thereisnoevidencetosuggestthatdiureawillbiodegrade. TheASTERdatabase citesabiodegradationhalf-lifeinexcessof20days,notingthatthedegradationratecan notbeestimated.
Diureahasthepotentialtobioaccumulate,basedonitsoctanol-waterpartitioncoefficientandapparenthydrolyticstability. Theestimatedbioconcentration
factorinfatheadminnowis448(ASTER).
9.EVALUATION OF TOXICOLOGICAL DATA
Theonlytoxicologicaldataavailablewasfordermalirritation. Variationofschedulerequirementsfortheremainderofthetoxicologicaldatawassoughtandgrantedonthebasisthattheresinsolutiontobeimportedisatarelativelylowconcentrationofthenotifiedchemicalinsturdysteeldrums,isformulatedintoapaintatasinglesiteandthepaintcontainsthenotifiedchemicalataconcentrationwhichwouldnotleadtoitsclassificationasahazardoussubstanceaccordingtoWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(1)evenifitwerepositiveinoneormoreofthetoxicologicaltestsnormallyrequiredaspartofastandardnotificationundertheAct.
9.1SkinIrritation(2)
Result:non-irritanttorabbitskinSpecies/strain:NewZealandWhite
rabbits
Number/sexofanimals:3M
Methodofadministration:sampleasfinepowdermoistenedwithde-ionisedwater
andappliedundersemi-occlusivegauzedressingforfour hours.
Clinicalobservations:Noclinicalsignswereobserved
TestMethod:OECDGuidelinesfortheTestingofChemicals(3)no.404
10.ASSESSMENT OF ENVIRONMENTAL EFFECTS
Nomeasureddataareavailable. LC50sforfishandwaterfleasestimatedusingQSARtechniquesandassumingnonpolarnarcosistobethemodeofacutelytoxicactionareinthe range of 2-8 mg/L, indicative of moderate toxicity (ASTER).
DatahavebeenestimatedforDaphniamagna(48 h LC50=4.5mg/L),bluegillsunfish(96h LC50=6.0mg/L),fatheadminnow(96hLC50=7.4mg/L),channelcatfish(96hLC50=
3.2mg/L)andrainbowtrout(96hLC50= 2.8 mg/L).
Theestimatedmaximumacceptabletoxicantconcentrationunderconditionsofchronicexposuretofatheadminnowsis1.0mg/L,basedongrowtheffects(ASTER).
11.ASSESSMENT OF ENVIRONMENTAL HAZARD
Thepredictedhazardislowbecauseenvironmentalexposuretodiureaisexpectedtobelow.
ItisimportantthatdiureabeexcludedfromwaterinviewofitspotentialforbioaccumulationandtheMackaycalculationsindicatingasignificantfractionwouldpartitiontotheaquaticcompartment. Currenthandlinganddisposalpractices,asoutlinedabove,areexpectedtobeeffectiveinexcludingdiureafromwaterways. Thematerialsafetydatasheetsfortheresinsolutionandthetopcoatinstructthatspillsshouldbepreventedfromcontaminatingdrainsandwaterways.
12.ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETYEFFECTS
Littleisknownaboutthetoxicityofdiureaalthoughitisnotlikelytobeaskinirritantbasedonastudyinrabbits. Theconcentrationofdiureaintheimportedresinsolution-10%maximum-isexpectedreducethelikelihoodthattheimportedformulationwouldbehazardousasaresultofitsdiureacontent.
Theresinsolutioninwhichdiureaisimportedisexpectedtobehazardousasaresultofthe content of xylene (up to 30%) and aromatic hydrocarbon solvent (up to 30%). At the
singlesiteofreformulationoftheresinsolutionengineeringcontrolsareinplacetominimiseexposuretosolventsfrombothinhalationanddermalcontactduringpaintmakeup. Theefficiencyofthesecontrols-enclosedmixersandtheuseofpumpsforadditiontothemixtank-wouldbeindicatedbysolventvapourlevels,whicharestatedtoberoutinelymonitored,andshouldensurelowexposuretothenotifiedchemical. Dermalexposuretotheresinsolutionispossibleduringremovalofbungsfromdrumsandduringpumpingoperationswhenthedrumlanceistransferredfromonedrumtoanotheralthoughthenotifierestimatesthatspillsoccurinfrequently-onespillin20drumsprocessed.
Theriskofadversehealtheffectsoccurringduringpaintmakeupisnotpossibletoquantifybutmaybeexpectedtobelowasaresultofthelowconcentrationofthenotifiedchemicalintheresinsolutioncoupledwithlimitedopportunitiesfordermalcontact. Therisksofadversehealtheffectsfromconductinglaboratorytestsandqualitycontroloperationsareexpectedtobecorrespondinglylowergiventhelimitedquanititiesused.
Astheresinsolutionisflammable,thereisapotentialforcombustionintheworkplaceifitcomesincontactwithanignitionsource.
Thefinalconcentrationofdiureaintheautomotivepaintofwhichitisacomponentis0.25%sothatthepaintisunlikelytobehazardousaccordingtoWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(1). Asthepaintisappliedautomaticallytovehiclesinasprayboothwithfumeextraction,theriskofadversehealtheffectsfromthissourceisexpectedtobeminimal.
Theisexpectedtobelittleopportunityforpubliccontactwiththenotifiedchemicalsothatthereisalowriskofadversepublichealtheffects.
13.RECOMMENDATIONS
Tominimiseoccupationalexposuretodiureathefollowingguidelinesandprecautionsshouldbeobserved:
.duringremovalofdiureafromthedrumsinwhichitisimported,paintformulationanddrumcleaningpersonalprotectiveequipmentasdescribedinAustralian(AS)orAustralian/NewZealand(AS/NZS)Standardsasfollowsshouldbeworn:
-eyeprotectionshouldbeselectedandfittedinaccordancetoAS1336(4)andmeettherequirementsofAS/NZS1337(5);
-impermeableglovesshouldconformtoAS2161(6);
-protectiveclothingshouldconformtoAS2919(7)andthefabricshouldprovideatleastlimitedprotectionagainstcertainhazardouschemicalsinaccordancewithAS3765.2(8);
-protectivefootwearshouldconformtoAS/NZS2210(9).
.goodworkpracticesshouldbeimplementedtoavoidspillagesandsplashing;
.goodhousekeepingandmaintenanceshouldbepractised.SpillagesshouldbecleaneduppromptlywithabsorbentswhichshouldthenbeputintocontainersfordisposalinaccordancewithLocalorStategovernmentregulations;
.storageshouldbeinrobustsealedcontainersawayfromsourcesofignitionorhightemperatures;
.theworkplaceshouldbewellventilated;
.goodpersonalhygieneshouldbeobserved;and
.acopyoftherelevantMaterialSafetyDataSheet(s)(MSDS)shouldbeeasily accessibletoemployees.
14.MATERIAL SAFETY DATA SHEET
TheattachedMSDSfortheresinsolutionandpaintcontainingDiureawereprovidedinaccordancewithWorksafeAustralia'sNationalCodeofPracticeforthePreparationofMaterial Safety Data Sheets(10).
TheseMSDSwereprovidedbyDuluxAustraliaaspartoftheirnotificationstatement.Theyarereproducedhereasamatterofpublicrecord. TheaccuracyofthisinformationremainstheresponsibilityofDuluxAustralia.
15.REQUIREMENTS FOR SECONDARY NOTIFICATION
Under theIndustrialChemicals(NotificationandAssessment)Act1989, secondarynotificationofDiureashallberequiredifanyofthecircumstancesstipulatedundersubsection64(2)oftheActarise. Secondarynotificationundersubsection64(1)oftheActshallberequiredifthesiteofmanufactureofpaintscontainingDiureachangesandifexposureofworkersortheenvironmenttoDiureamaypotentiallyincreaseforanyreason.
16.REFERENCES
1.NationalOccupationalHealthandSafetyCommission1994,ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008(1994)], AustraliaGovernmentPublishingService,Canberra,Australia.
2.TechlinkAustralasiaPtyLtd,1994 Skinirritation/CorrosionTeston4422/148RheologyControlAgent, data on file, ICI Australia Operations Pty Ltd, Melbourne,Australia.
3.OrganisationforEconomicCo-operationandDevelopment,OECDGuidelinesforTestingofChemicals, OECD, Paris, France1.
1 The Guidelines relevant to the current notification are as follows:
.No. 404 Acute Dermal Irritation/Corrosion
4.StandardsAustralia,1994,AustralianStandard1336-1994,RecommendedPracticesforEyeProtectionintheIndustrialEnvironment,StandardsAssociationof Australia Publ., Sydney, Australia.
5.StandardsAustralia,StandardsNewZealand1992,Australian/NewZealandStandard1337-1992,EyeProtectorsforIndustrialApplications,StandardsAssociationofAustraliaPubl.,Sydney,Australia,StandardsAssociationofNewZealandPubl.Wellington,NewZealand.
6.StandardsAustralia1978,AustralianStandard2161-1978,IndustrialSafetyGlovesandMittens(excludingElectricalandMedicalGloves),StandardsAssociationofAustralia Publ., Sydney, Australia.
7.StandardsAustralia,1987,AustralianStandard2919-1987IndustrialClothing,
StandardsAssociationofAustraliaPubl.,Sydney,Australia.
8.StandardsAustralia1990,AustralianStandard3765.2-1990ClothingforProtectionagainstHazardousChemicals Part2Limitedprotectionagainstspecificchemicals. StandardsAssociationofAustraliaPubl.,Sydney,Australia.
9.StandardsAustralia,StandardsNewZealand1994,Australian/NewZealandStandard2210-1994OccupationalProtectiveFootwear,Part1:GuidetoSelection,CareandUse. Part2:Specifications,StandardsAssociationofAustraliaPubl.,Sydney,Australia,StandardsAssociationofNewZealandPubl.Wellington,NewZealand.
10.NationalOccupationalHealthandSafetyCommission1994,NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets[NOHSC:2011(1994)],AGPS, Canberra, Australia.