File No: NA/208 Date:19June1995
NATIONALINDUSTRIALCHEMICALSNOTIFICATIONANDASSESSMENTSCHEME
FULL PUBLIC REPORTALBRITECIX(N)ACTIVECOMPONENT
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/208
FULL PUBLIC REPORTALBRITECIX(N)ACTIVECOMPONENT
1.APPLICANT
Solvay Interox Pty Ltd of 20-22 McPherson St, Banksmeadow, NSW 2019
2.IDENTITY OF THE CHEMICAL
ALBRITECIX(N)ActiveComponentisnotconsideredtobehazardousbasedonthenatureofthechemicalandthedataprovided. Thereforethechemicalname,CASnumber,molecularandstructuralformulaeandexactusehavebeenexemptedfrompublicationintheFullPublicReportandtheSummaryReport
Trade name:ALBRITECIX(N)isa35-40%(w/w)aqueoussolutionofthenotifiedchemical
Molecularweight:490(acidform)
Methodofdetectionanddetermination:
Titrationwithcoppersulphatesolution. Ionexchangecolumnchromatographyusingnitricacidelutionanddetectionofferricioncomplexesat335nm.
Spectral data:
A31PNMRspectrumprovidedwasconsistentwithstructure.
3.PHYSICAL AND CHEMICAL PROPERTIES
Thephysico-chemicalpropertieslistedbelowarethoseoftheformulationtobeimportedexceptwhereindicated
Appearance at 20°C and 101.3 kPa:strawcolouredliquid
Odour:none
BoilingPoint:105°C
Density:1290kg/m3(chemicalitself,saltform)
Vapour Pressure:characteristicofwatervapour
WaterSolubility:freelysoluble
HydrolysisasafunctionofpH:hydrolyticstabilityisindicatedbytheconditions
usedinmanufacture,ie,severalhoursattemperaturesabove100°C
DissociationConstant
pKa:duetoahighlevelofimpuritiesanaccuratemeasurementwasnotpossiblebutcanbepredictedfromthechemicalstructure
FlashPoint:notapplicable
FlammabilityLimits:notapplicable
DecompositionTemperature:above200°Cthenotifiedchemicalinthe
formulationdecomposes(oftenviolently)formingphosphine
Reactivity/Stability:thenotifiedchemicalreactswithstrongoxidisingagentsandintheacidformreactswithalkalisandaluminium(liberatinghydrogengas)
Commentsonphysico-chemicalproperties
Characteristicsofchemicalsofthisnaturearetheirhighstabilityasaresultoftheirresistancetoabioticandbioticdegradationmechanisms. Bacteriawhichcandegradexenobioticmoleculesofthistypehavebeenfoundtoberelativelyscarceintheenvironment. Astheyarerecognisedbymicroorganismsmainlyasphosphorus sources,highphosphorusconcentrationscanbeinhibitorytowardsdegradation. Insuch casesabioticdegradationprocessesmaybecomeessentialforremoval.
4.PURITY OF THE CHEMICAL
Degreeofpurity:42%
Impurities:
Twoimpuritiesrelatedtothenotifiedchemicalmakeup47%(w/w)ofthecommercialformtogetherwithphosphorusacid8%(w/w)andphosphoricacid3%
(w/w).
Additives/Adjuvants: none
5.INDUSTRIAL USE
Thenotifiedchemical,tobeusedasanadditiveforthestabilisationofabiocide,willbeimportedatarateofless1tonneperyearforthefirstfiveyears.
6.OCCUPATIONAL EXPOSURE
Thenotifiedchemicalistobeimportedasa31%aqueoussolutioninsealed200Ldrums.Twoworkersareinvolvedintransferringsmallamountsoftheformulationfromthedrumstobiocideblendingtanks. Withthedruminadrumcradle,liquidtransferisaccomplishedbyreplacingthebungofthedrumwithaclosedvalvefollowingwhichthedrumistiltedandanamountoftheformulationisrunintoasmallcontainer(usually5L
capacity). Thissmallamountisthencarriedtoabiocideblendingtankandpouredthroughthemanwayopeningintothebiocidesolution. Thetankcontentsareallowedtomix,testedandpumpedintobulkstorage. Thefinalconcentrationofthenotifiedchemicalinthebiocidesolutionislessthan0.1%.
Initiallythestabilisedbiocideisexpectedtobeusedinasepticpackagingandjanitorialapplications. Fortheasepticpackagingthebiocideisconnectedtotheprocessoraddedtoasmallholdingtanktoservicetheprocess. Thepackagingistreatedbyusingeitherdippingorsprayingtechniquesonacontinuousprocessline.
Janitorialapplicationsincludedilutionofthebiocidesolution1:20inwaterpriortoapplicationwithamoporusingtheneatsolutionon,say,toiletbowlsandapplyingitwithascrubbingbrush.
7.PUBLIC EXPOSURE
Thepublicisunlikelytobeexposedtothenotifiedchemicalduringitsimportation,mixingwithbiocide,industrialuseanddisposal.
8.ENVIRONMENTAL EXPOSURE
.Release
Thenotifiedchemicalisusedasastabiliserforbiocidesolutionstypicallyatlevelslessthan1%. Whenbiocidecontainingthenotifiedchemicalisformulated,therecouldbeareleasetotheenvironmentofthenotifiedchemicalfromthebiocidesolutionintothesewagesystem. Itislikelythat,sincethebiocideisclassedasadangerousgood,itshouldbekeptinabundedcompoundandthereforeanyspillagewouldbecontained.
Itislikelythatspillsofaqueousthenotifiedchemicalwouldbeabsorbedontoaninertmediumsuchassandorvermiculiteandthenbedisposedofasanon-toxicwaste.
Spillsofthebiocidecontainingthenotifiedchemicalshouldbedealtwithaccordingtotherequirementsforthebiocideandassuchshouldbedilutedwithwatertolessthan1%andthenflushedtodrainwithwater.
Whenusedasajanitorialapplicationthenotifiedchemicalislikelytobereleasedintothesewersatconcentrationsupto200ppm(nodilution).
.Fate
Thenotifiedchemicalwillpredominatelyentertheenvironmentfromthedisposalofwashwaterfromthecleaningprocessandalsoviaeffluentatthenotifier'ssitewhereitisformulatedintocleaningproductsandfromasepticpackagingprocesssites.
NobiodegradationdataisrequiredforthelimitednotificationofchemicalsaccordingtotheAct.TheMSDSstatesthatchemicalsofthisclassarenotreadilybiodegradable,buttheyareinherentlybiodegradableundergoingphotolysis.
Whenthenotifiedchemicalentersthesewerstreamitmayadsorbtosuspendedmatter.Biodegradationatseweragetreatmentplantsisunlikelytobeextensive. Thenotifiedchemicalisunlikelytobereadilybiodegradedintheenvironmentduetotheenzymesrequiredfortheuptakeanddegradationofthisclassofchemicalbeingrelativelyscarceintheenvironment. Photodegradation,hydrolysisandfreeradicalmediatedbreakdownarelikelytocontributetothedegradationintheenvironment. Itispredictedthatunder
favourableenvironmentalconditions(15-25oC,aerobicconditions)chemicalsofthis
classinsolutionwillhydrolyse,withhalf-livesintheorderof50-200days.
9.EVALUATION OF TOXICOLOGICAL DATA
Toxicologicaldataarenotrequiredforchemicalsproposedtobeimportedatlessthan1tonneperyearaccordingtotheIndustrialChemicals(NotificationandAssessment)Act,1989. However,somedatawereavailable,weresuppliedandareevaluatedbelow. Thestudieswereperformedusingthecommerciallyavailableformofthenotifiedchemical,abrownliquidwithaspecificgravityof1.71.
9.1AcuteToxicity
Table 1SummaryoftheacutetoxicityofALBRITECIX(N)ActiveComponent
Test / Species / Outcome / ReferenceAcuteoraltoxicity / Rat / LD50 2000mg/kg / (1)
Skin Irritation / Rabbit / slightirritant / (2)
Skinsensitisation / Guinea-pig / non-sensitiser / (3)
9.1.1OralToxicity(1)
LD50:2000mg/kgSpecies/strain:Rat,Sprague-DawleyNumber/sexofanimals:5M,5F Observationperiod: 14 daysMethodofadministration(vehicle): gavage (none)
Clinicalobservations:nosignsofsystemictoxicity
Mortality:nodeaths
Morphologicalfindings:noabnormalitiesobserved
TestMethod:OECDGuidelinesfortheTestingofChemicals(4)No.401
9.1.2SkinIrritation(2)
Result:slightirritantSpecies/strain: NewZealandWhiterabbits(1M,5F)
Methodofadministration:semi-occludedpatch,fourhourduration
TestMethod:OECDGuidelinesfortheTestingofChemicals(4)No.404
SkinReactions:Veryslighterythemain2animalsat1hourand2animalsat1hour,1and2daysafterdecontamination. Veryslightoedemain2animals1hourafterdecontamination.
9.1.3SkinSensitisation(3)
Result:non-sensitiser
Species/strain:AlbinoDunkin-HartleyNumberofanimals:20test,10controlguinea-pigs
Induction:1%(w/v)indistilledwaterand1%inFCAplusdistilledwater(intradermal);undiluted(topical)
Results:
Challenge Concentration / 24hrstestcontrol / 48hrs
test / control
75% / 0/20 / 0/10 / 0/20 / 0/10
100% / 0/20 / 0/10 / 0/20 / 0/10
TestMethod:OECDGuidelinesfortheTestingofChemicals(4)No.406andCommissionDirective84/449/EEC(5)Test
9.4OverallAssessmentofToxicologicalData
Thenotifiedchemicalisofloworaltoxicityinrats,isaslightskinirritantinrabbitsandisnotaskinsensitiseringuinea-pigs. ItwouldnotbeclassifiedashazardousaccordingtoWorksafeAustralia’sApprovedCriteriaforClassifyingHazardousSubstances(6) inrelationtoAcutelethaleffects(oral);Irritanteffects(skin)orSensitisingeffects(skin).
10.ASSESSMENT OF ENVIRONMENTAL EFFECTS
NoecotoxicologicaldataisrequiredforthelimitednotificationofchemicalsaccordingtotheAct.However, the notifier has provided a study report on the acute toxicity of theproductCIX(contains35-40%ofthenotifiedchemical)torainbowtrout. ThestudywasconductedaccordingtoOECDTG203. Resultswerebasedonnominalconcentrationsastheproductwasshowntobestableover24hoursunderalight/darkregime. Attheendofthestudymeasuredconcentrationswere91-96%ofthenominalconcentrations.Theresultwasa96hLC50100mg/LandaNOEC100mg/L. Therefore,theproductcontainingthenotifiedchemicalispracticallynon-toxictothefishspeciestested.
Also,aresultofanactivatedsludgerespirationinhibitionstudyof3hEC50=880mg/LintheMSDSindicatesthenotifiedchemicalispracticallynon-toxictomicroorganismspresentinwastewatertreatmentplants.
11.ASSESSMENT OF ENVIRONMENTAL HAZARD
Approximately1000kgofthenotifiedchemicalperannumwouldbeformulatedintojanitorialcleaningproductsandusedintheasepticpackagingprocess. Assuming300kgmaybeusedinametropolitanarea(egMelbourne)peryear,aworstcasesituationmayoccurwhere1kgentersthesewerperdayfromtheuseofcleaningproductsandwastefromtheformulation/asepticpackagingprocesses. Theresultantconcentrationofthenotifiedchemicalataseweragetreatmentplant(500MLflowperday)wouldbe~2ppb. Furtherdilutionintheorderof1:5to1:25islikelytooccurinthereceivingwaters.
Thereforetheexpectedenvironmentalconcentrationofthenotifiedchemicalislikelytobeintheorderofsub-ppb.
Thesecalculationsarebasedonaworstcasescenarioandassumenoadsorptiontosuspendedmatterordegradationintheenvironment. Thenotifiedchemical'shazardtotheenvironmentfromtheproposeduseislikelytobelowasitisnotexpectedtoexistatconcentrationsthatwouldprovetoxictoaquaticorganisms.
12.ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETYEFFECTS
Fromtheavailabletoxicologicaldatathenotifiedchemicalisnotexpectedtoexhibitacutetoxiceffects,isnotlikelytocauseskinsensitisationbutmaycauseslightirritationoftheskin.
Exposuretothenotifiedchemicalismostlikelytooccurwhensmallamounts(lessthan5Loftheformulationtobeimported)areruninto5Lcontainerspriortoadditiontolargetankscontainingbiocide.Astheseoperationswilloccurnomorethanonceperweekfor15minutesduration,exposureislikelytobelow.
Oncethechemicalismixedwithbiocideitsconcentrationwillbelessthan0.1%.Consequently,exposuretothenotifiedchemicalwillbelowinallsubsequentoperationsincludingenduseforasepticpackagingandjanitorialapplications. Thesamewillbetrueforendusesnotimmediatelyenvisagedsuchaspulp,paperandtextilebleaching,hydrometallurgy,waterandeffluenttreatmentandchemicalsynthesis.
Inconclusiontheriskofadverseoccupationalorpublichealtheffectsoccurringasaresultoftransport,storage,dilutioninbiocideorenduseofthenotifiedchemicalisexpected to be low.
13.RECOMMENDATIONS
TominimiseoccupationalexposuretoALBRITECIX(N)ActiveComponentthefollowingguidelinesandprecautionsshouldbeobserved:
.ifengineeringcontrolsandworkpracticesareinsufficienttoreduceexposuretoasafelevel,thenpersonalprotectivedeviceswhichconformtoandareusedinaccordancewithAustralianStandards(AS)foreyeprotection(AS1336,AS1337) (7,8),impermeablegloves(AS2161)(9),protectiveclothing(AS2919)(10)andfootwear(AS2210)(11)shouldbeworn;
.acopyoftheMaterialSafetyDataSheet(MSDS)shouldbeeasilyaccessibletoemployees.
14.MATERIAL SAFETY DATA SHEET
The attached Material Safety Data Sheet for ALBRITE CIX(N) Active Component was providedinWorksafeAustraliaformat(12).
This MSDS was provided by Solvay Interox Pty Ltd as part of their notification statement andisreproducedhereasamatterofpublicrecord. TheaccuracyofthisinformationremainstheresponsibilityofSolvayInteroxPtyLtd.
15.REQUIREMENTS FOR SECONDARY NOTIFICATION
Under theIndustrialChemicals(NotificationandAssessment)Act1989, secondarynotificationofALBRITECIX(N)ActiveComponentshallberequiredifanyofthe circumstancesstipulatedundersubsection64(2)oftheActarise. Nootherspecificconditionsareprescribed.
16.REFERENCES
1.SafepharmLaboratoriesLimited,1992,'ProductCIX:AcuteOralToxicity(LimitTest) in the Rat',ProjectNo.71/86,dataonfile,AlbrightandWilsonLtd,Warley,WestMidlands,UK.
2.SafepharmLaboratoriesLimited,1992,'Product CIX: Acute Dermal Irritation TestintheRabbit',ProjectNo.71/87,dataonfile,AlbrightandWilsonLtd,Warley,WestMidlands, U K.
3.SafepharmLaboratoriesLimited,1992,'ProductCIX:MagnussonandKligmanMaximisationStudyintheGuinea-Pig',ProjectNo.71/89,dataonfile,AlbrightandWilsonLtd,Warley,WestMidlands,UK.
4.OrganisationforEconomicCo-operationandDevelopment,OECDGuidelinesforTestingofChemicals, OECD, Paris, France1.
1 The Guidelines relevant to the current notification are as follows:
.No. 401 Acute Oral Toxicity
.No. 404 Acute Dermal Irritation/Corrosion
5.EECCouncilDirective84/449ontheapproximationofthelaws,regulationsandadministrativeprovisionsrelatingtotheclassification,packagingandlabellingofdangerouspreparations,OfficialJournaloftheEuropeanCommunities,No.L251
(19September1984)2.
6.NationalOccupationalHealthandSafetyCommission,1994,ApprovedCriteriaforClassifyingHazardousSubstances[NOHSC:1008],AustralianGovernmentPublishingService.
7.StandardsAustralia,1994,AustralianStandard1336-1994,RecommendedPracticesforEyeProtectionintheIndustrialEnvironment,StandardsAssociationof Australia Publ., Sydney, Australia.
8.StandardsAustralia,1992,AustralianStandard1337-1992,Eye Protectors forIndustrialApplications, StandardsAssociationofAustraliaPubl.,Sydney,Australia.
9.StandardsAustralia,1978,AustralianStandard2161-1978,IndustrialSafetyGlovesandMittens(excludingElectricalandMedicalGloves),StandardsAssociationofAustraliaPubl.,Sydney,Australia.
10.StandardsAustralia,1987,AustralianStandard2919-1987IndustrialClothing,StandardsAssociationofAustraliaPubl.,Sydney,Australia.
11.StandardsAustralia,1994,AustralianStandard2210-1994OccupationalProtective Footwear, Part 1: Guide to Selection, Care and Use. Part 2: Specifications,StandardsAssociationofAustraliaPubl.,Sydney,Australia.
12.NationalOccupationalHealthandSafetyCommission,1990.,GuidanceNotefortheCompletionofaMaterialSafetyDataSheet, 2nd. edition, AGPS, Canberra,Australia.3
.No.406DermalSensitisation
2 The tests specified in this directive relevant to the current notification are as follows:
.TestB6SkinSensitisation
3ThisGuidanceNote,towhichanMSDSmustconforminaccordancewiththeAct,hasbeensupersededbyWorksafeAustralia’s National Code of Practice for the Preparation of Material Safety Data Sheets (March 1994) published by the Australian Government Publishing Service.