Sodium Ascorbyl Phosphate
1.APPLICANT
BASFAustraliaLtdof500PrincesHighwayNOBLEPARKVICTORIA3174hassubmittedalimitednotificationstatementinsupportoftheirapplicationfor an assessment certificate forsodium ascorbylphosphate.
2.IDENTITY OFTHE CHEMICAL
ChemicalName:L-ascorbic acid, 2-(dihydrogen phosphate), trisodiumsalt
ChemicalAbstracts Service(CAS) RegistryNo.:
66170-10-3
Other Names:sodium ascorbylmonophosphatetrisodium ascorbate-2-phosphate
L-ascorbic acid, 2-monophosphate, trisodium salt
Trade Name:None
Molecular Formula:C6H6O9P. 3NaStructuralFormula:
Molecular Weight:322
Method of Detectionand Determination:
ultraviolet-visible(UV/Vis),NuclearMagneticResonance (NMR) and infrared (IR) spectroscopy
SpectralData:majorcharacteristicIRpeaksidentifiedatthefollowingwavelengths:3512,3 397, 3 168, 1 722, 1 597, 1 414, 1
162,1149,1118,1085,1062,1036,1024,991,844,
790, 712, 666 and 563 cm-1
UV/Visspectrum;absorbancemaximainwater261.3nm, in 1 molar sodium hydroxide 262.8 nm and in
1 molar hydrochloric acid 236.7 nm
3.PHYSICALAND CHEMICALPROPERTIES
Appearance at20oCand 101.3 kPa:
white to slightlybeige powder, almost odourless
MeltingPoint:notdetermined;thenotifiedchemicalturnsbrownatapproximately245oCandremainssolidupto260oC(end point temperature of the measurement)
Relative Density:1.94 at 20oC
BulkDensity:290 kg/m3
Vapour Pressure: 10-8KPa at20oC
10-7KPa at 130oC
Water Solubility:789 g/Lat 20oC, approximate pH 8.3PartitionCo-efficient
(n-octanol/water):logPow -4 at 25oC
Hydrolysis as aFunctionof pH:
stable at pH 5-8; stability decreases at pH 3 (seecommentsbelow)
Adsorption/Desorption:not determined (see comments below)Dissociation Constant: not determined (see comments below)Flash Point: not applicable
FlammabilityLimits:not determined
AutoignitionTemperature:238 oC
Explosive Properties:notdetermined(notifierstatesbasedonthemolecular
structure the notified chemical will not be hazardous)
Particle Size:not determined
Reactivity/Stability:Surface Tension:
thenotifiedchemicalisstableatambienttemperatureandisnotconsideredtobereactive;itisnon-flammableandnon-explosive;thenotifiedchemicallikemanyother organic powders can cause dust explosions
69.5 mN/m at 20oC
Comments on Physico-ChemicalProperties
TestswereperformedaccordingtoEEC/OECDtestguidelinesatfacilitiescomplyingwithOECD Principles of Good LaboratoryPractice.
Themeltingpointcouldnotbedetermined.Thenotifiedchemicalturnsbrownfromapproximately245oC,butremainssolidupto260oC(endpointtemperatureofthemeasurement).Theboilingpointcannotbedeterminedasthevapourpressureof thechemicalislowerthanthedetectionlimitofthetest[92/69/EECtestA4,effusionmethod(byloss of weight)].
NotestunderOECDguidelineswasundertakenforhydrolysis,butdataonstabilitywassuppliedbythenotifier.AtlowpHtherecoveryrateofthenotifiedchemicalover185 daysdecreasedwithincreasingtemperature.Athighertemperatures,therecoveryratedecreasedoverthepHrange3.05to8.08.Seebelowforanextractoftheresultstable.Samplesatlow pHandhightemperatureexhibitedadistinctdiscolourationandCO2releaseafter20and35 days,respectively. Ascorbic acid was determined (byHPLC) to be partiallyproduced.
Temperature / pH Range / % Recovered (after 185 days)5-8oC / 3 / 88
5-8 / 104-106
Ambient / 3 / 41
5-8 / 95-102
40oC / 3 / 0.3
5-8 / 74-87
NB:Varyingor excessive values were due to errors in HPLCdetermination.
Theadsorption/desorptioncoefficientanddissociationconstanthavenotbeendetermined.Giventhechemical’shighwatersolubilityandlowpartitioncoefficientitisanticipatedthatitwillnotstronglyadsorb.Thenotifiedchemicalisahighlywatersolublesaltandisexpectedto remain ionic in water in the environmental pH range of 4-9.
Thenotifiedchemicalisnotexpectedtobesurfaceactive.Bydefinition,achemicalhassurfaceactivitywhenthesurfacetensionislessthan60 mN/m(EuropeanEconomicCommunity(EEC), 1992).
4.PURITY OF THE CHEMICALDegree of Purity:83-90%
Toxic or HazardousImpurities:
none
Non-hazardous Impurities(> 1% byweight):
Chemical name:water
Weight percentage:2-11%
CAS No.:7732-18-5
Chemical name:ascorbic acid-2, 6-diphosphate pentasodium salt
Weight percentage:3-5%
CAS No.:-
Additives/Adjuvants:none
5.USE, VOLUME AND FORMULATION
Thenotifiedchemicalwillbemanufacturedasapowderoverseas.SodiumascorbylphosphatewhichisasodiumsaltofastablevitaminCderivativewillbeusedinsunscreenpreparations, skin-care products and vitamin creams.
InAustraliathenotifiedchemicalwillbeimportedinpowderformandreformulated,andpredominantlyforuseinsunscreenpreparations,andtoalesserextentinotherapplications.Thefinalconcentrationofsodiumascorbylphosphateinend-useproductscouldbeupto5%dependingon the application, but is typically0.01 to 0.1% in sunscreen preparations.
Importvolumesforthenotifiedchemicalarelessthan400kgperyearforeachofthefirstfive years.
6.OCCUPATIONALEXPOSURE
Thenotifiedchemicalisimportedin5kgor30kgmetaldrumswithantistaticinnerlining.Thetotalimportedvolume(shippingcontainerwithdrums)willbetransportedbyroadtothenotifier’swarehouse.Atthewarehousemetaldrumscontainingthenotifiedchemicalwillbeunloadedfromthecontainerandtransportedtoacustomersite.Oneto2driversand2storepersons are expected to be involved in this process.
Transport and Storage
Transportworkersandstoremenare unlikelyto be exposed to the notified chemicalunless thecontainers are accidentlybreached.
Reformulation
Atthecustomersite,oneto2storepersonnelwillreceivethedrumscontainingthenotifiedchemical.Drumswillbecarriedonpalletsorindividuallyonforkliftstoquarantineandsamplingareas,andthentothemanufacturingsite.Thetotaldelivery timecouldbeupto10minuteswithanexpected2deliveriesperyear.Onequalitycontrolpersonwillopen,sampleandcloseeachdrumcontainingthenotifiedchemical.Samplingmayinvolvemaximumof5minutestwiceperyear.Thenotifierhasnotprovided details of the samplingprocedure or themethodologyof testing.
Oneto2plantoperatorsareinvolvedinthereformulationproductionprocessforamaximumperiodof30minutes.Thenumberoftimesperweekwilldependonthenumberofbatches.Manufacturingof sunscreen is normallycarried out over an eight week period.
Anoperatorwillopenthedrumcontainingthenotifiedchemicalandmanually(orautomatically)weighandtransferthechemicaltotheblendingvesselwithotheringredients.Blendingiscarriedoutwithinanenclosedsystem.Theblendedproductcontainingthenotifiedchemicalisthenpumpedwithintheclosedsystemtocontainers,whichcouldbe50gmsticks,125gmtubes,250gmbottlesor1Lpumppacks.Theconcentrationofthenotifiedchemicalin the final product could be up to 5%, but will typicallybe 0.01 to 0.1% forsunscreenpreparations.Followingbatchproduction,thevesselsarecleaned.Spillagecouldoccurduringnormaloperatingprocedures,andwillbecontainedandcoveredwithsand,soiloradustbindingmaterial.Thenotifierstatesthespillwillbemixedthoroughly,butnotvigorously,toavoiddustgeneration.Itwillthenbesweptandcollectedfordisposalinappropriatelylabelledcontainers.Itisestimatedthatlessthan0.8kgofthenotifiedchemicalwillbedisposedofannually.Theprimarysourceofexposuretothenotifiedchemicalduringreformulationwillbewhenopeningandclosingofdrumsandwhenweighingandchargingtheblendingvessel.Inhalation,ocularanddermalexposuremayoccurduringtheseprocesses.Localexhaustventilationwillbeinplaceovertheweighing,mixingandfillingareastocaptureanyairbornedustparticlesorvapours.Thenotifierstatesthatthelocalexhaustventilationwillbeinstalledinareaswherenaturalventilationisconsideredtobeinadequate.
Thetotalnumberofworkersthatmaybepotentiallyexposedtothenotifiedchemicalattheformulationfacilityis normallylessthan 15.
Thenotifierstatesthatduringreformulationoperations,workerswillbeattiredwithsuitableindustrialclothing,safetyglasses/goggles,faceshieldsandprotectivegloves.Inareaswherethereisexposuretodustsapprovedairpurifying(dust)respiratorswillbeused,exceptwherelocal exhaust ventilation is adequate to preventexposure.
7.PUBLIC EXPOSURE
Thenotifiedchemicalwillbeusedasacomponentofcosmeticformulationsforuseonmostareasofthebody.Thenumberofpeopleexposedtotheproductisnotdeterminablefromtheinformationprovidedandislikelytobelimitedonlybythecommercialsuccessoftheproducts containingit.
Transportoffinishedcosmeticproductscontainingthenotifiedchemicalorofthenotifiedchemicalitselfisunlikelytoresultinsignificantpublicexposure.Intheeventofatransportaccidenttheproducts,whicharesmallvolumepacks,arelikelytobewidelydispersedandwillbereadilyrecoverablethroughadsorptiononsand,vermiculiteorsimilarmaterials.Spillageofthenotifiedchemicalpowdercouldbecontainedbysweepingorvacuuming.Wind dispersion maylead to wider exposure.
8.ENVIRONMENTAL EXPOSURE
8.1Release
The notified chemical will be reformulated into sunscreen and skin care products. Potential
environmental exposure may occur during the weighing of ingredients, although automatic weighing is employed where possible. After mix preparation, mixing occurs in an essentially closed system. Release of the notified chemical to the environment during reformulation is expected to be very low. Batch residues will be retained and sent to a licensed waste disposal facility. Empty product containers will be disposed of according to appropriate guidelines,
i.e. either to an approved drum recycler or to approved landfill. The expected total wastage from unused residues, equipment washings and batch residues is estimated by the notifier to be approximately 0.2%, or 0.8 kg per annum at maximum import quantities.
Releaseofthechemicaltotheenvironmentthroughitsproposeduseasaconsumerproductisexpectedtobewidespread.Forexample,thenotifierestimatesthatforeach10-20 gwipeofsunscreen onto the skin, typically0.005 to 0.1 gof the notified chemical will be released.
Theproductcontainersusedbyconsumersofthenotifiedchemicalareexpectedtobedisposed of with normal household garbage to landfill.
Fate
Thereformulationofproductscontainingthenotifiedchemicalislikelytooccuratasmallnumberofformulatingplants.Spillageswillbecontainedandcollectedfordisposal.Wasteswillberetainedandsenttoanapprovedwastedisposalfacility,presumablyeithertoatradewastesewerorlandfill.Thenotifiedchemicalisnotexpectedtopartitiontosediment/sludgeof the waste water treatment plant, but is likelyto undergodegradation (see below).
The notified chemical is intended for use in sunscreens and skin care products and, as such, would be expected to be released to the environment, via consumer use through washing the residual chemical off the skin, into either natural waterways or the sewerage system. It is unclear what proportion will be absorbed into the skin before being washed off, but the notifier has indicated that the chemical is readily absorbed and hydrolysed to ascorbic acid by enzymes in the skin.
Residuesinemptyconsumerpackagingsenttolandfillarelikelytoremainwithinthecontainers,andwillslowlydegrade(seebelow).Incinerationofthenotifiedchemicalwillproduce predominantlyoxides of carbon and water.
ThenotifiedchemicalhasbeendeterminedtobenotreadilybiodegradableaccordingtoOECDcriteriaintheManometricRespirometryTest(OECDTG301F),displayingonlypartialbiodegradabilityafter28 days(20-30%oftheoreticaloxygendemandThOD)(Beimborn,1997).However,theseresultsindicatethatthenotifiedchemicalcanbeexpectedto undergo some degree of degradation in the environment with time.
Nobioaccumulationofthechemicalisexpectedbecauseofitsveryhighwatersolubilityandlow octanol/water partition coefficient (Connell, 1989).
9.EVALUATION OF TOXICOLOGICALDATA
9.1Acute Toxicity
Summaryof the acute toxicityof Sodium AscorbylPhosphate
TestSpeciesOutcomeReference
acute oral toxicityratLD505 000 mg/kg(Kuehlem,
1997a)
skin irritationrabbitslight irritant(Kuehlem,
1997b)
eye irritationrabbitslight to moderateirritant
(Kuehlem,1997c)
skin sensitisationguinea pigmild sensitiser(Kuehlem,
1997d)
9.1.1 / Oral Toxicity(Kuehlem, 1997a)Species/strain: / rat/Wistar(SPF)
Number/sex of animals: / 5/sex
Observation period: / 14 days
Method of administration: / oral (gavage),5 000 mg/kgin water
Clinical observations: / allanimalsshowedimpairedgeneralstate;dyspnoea,apathy;staggering;piloerection;anddiarrhea
Mortality:none
Morphological findings:none
Test method:limit test, OECD TG 401
LD50:5 000 mg/kg
Result:thenotifiedchemicalwasofverylowacuteoraltoxicityin rats
9.1.2Skin Irritation (Kuehlem, 1997b)
Species/strain:rabbit/New Zealand White
Number/sex of animals:6 animals;3/sex
Observation period:72 hours
Method of administration:dermalapplicationof0.5gofthenotifiedchemical
moistened with water to flanks under semi-
occlusive dressingfor 4 hours
Test method:OECD TG 404
Result:tworabbitsexhibitedwelldefinederythemaatonehourafterapplication,thisdisappearedby48hoursinoneanimalandby72hoursintheother;theother4rabbitsexhibitedveryslighterythemaatonehourafterapplicationwhichpersistedupto48hours in one animal
the notified chemical was a slight to moderateirritant to theskin of rabbits
9.1.3EyeIrritation (Kuehlem, 1997c)
Species/strain:rabbit/New Zealand White
Number/sex of animals:6 animals;3/sex
Observation period:72 hours
Method of administration:58 mg (0.1 mL)of the notified chemical was
applied intotheconjunctivalsacoftherighteyeofeach animal
Irrigated eyes (24 hours afterapplication):
slightconjunctivalredness(scores1and2)observedin5animalspersistedupto48hours;slightchemosisobservedinoneanimalpersistedup to 48 hours; all eyes were normal after 72 hours
Test method:OECDTG405(OrganisationforEconomicCo-operation and Development, 1987)
Result:thenotifiedchemicalwasaslighteyeirritantinrabbits
9.1.4Skin Sensitisation (Kuhlem, 1997d)
Species/strain:guinea pigs/Pirbright White Strain(Tif:DHP)
Number of animals:30 females (test), 20females(10foreachof2control groups)
Induction procedure:day1:3pairsofinjections(0.1mL)weremadeon
shaved shoulder of each animal:
- frontrow:Freund’sCompleteAdjuvant(FCA)withoutnotifiedchemicalemulsifiedwith0.9%aqueous NaCl-solution (1:1) (v/v)
- middlerow:5%notifiedchemicalin0.9%aqueous NaCl solution
- backrow;5%notifiedchemicalinFCA/0.9%aqueous NaCl-solution (1:1) (w/v)
Controlgroupsweretreatedsimilarlywithoutthenotifiedchemical
day8-topicalinduction:occludedapplicationtotheshoulder,50%notifiedchemicalindistilledwaterfor48hours;notreatmentwascarriedoutonthecontrolgroupssincetheaqueousformulationwasnot expected to influence the results of the study
Challenge procedure:day 22-challenge: occluded application of 50%
notifiedchemicalindistilledwaterfor24hours;controlgroup1wastreatedinasimilarwaytothetest group and control group2 remained untreatedday28-rechallenge:similartothefirstchallengebutthetreatmentwascarriedoutonthetestgroupand both control groups
controlgroup1wasusedforchallengeandcontrolgroup2 for rechallenge
Challenge outcome:
Test animalsControl animals
Concentration / 24 hoursa / 48 hoursa / 24 hours / 48 hoursof notified
chemical
Challenge / b4/23 / 4/23 / 0/10d / 0/10d
50%c
0/10e
0/10e
Re-challenge50%c
0/230/230/10d
0/10e
0/10d
0/10e
atimeafterpatchremoval
bnumberofanimalsexhibitingpositiveresponsec50% notifiedchemical in distilledwaterd control group 1
e control group2
afterthefirstchallengewith50%ofthenotifiedchemical2testanimalsdevelopedveryslightspottederythemaand2othertestanimalshadwelldefinedspottederythema;at48hours3animalsexhibitedveryslightspottederythema(2ofthesewithscaling)andoneanimal exhibited well-definedspottederythema andscaling
Test method:MagnussonandKligmanMaximisationTest,similar to OECD TG 406
Comments:rationaleinusingtwocontrolgroupsisthatintheeventofborderlineresultsafterthefirstchallengethefirstcontrolgroupcannotbere-used;thesecondcontrolgroupwasusedexclusivelyforthesecond challenge
7testgroupanimalsdiedatdays8,9or10;amacroscopicexaminationrevealedthedeathswereduetopneumoniaandwerenotrelatedtotreatmentdueto the notifiedchemical
Result:thenotifiedchemicalwasamildskinsensitiseringuinea pigs
9.2Genotoxicity
9.2.1SalmonellatyphimuriumandEscherichiacoliReverseMutationAssay(Engelhardt,1997)
Strains:S.typhimuriumTA98,TA100,TA1535, TA1537 and E.coliWP2uvrA
Concentration range:StandardPlateTest:0,24,120,600,3000and6
000g/plateinthepresenceorabsenceofmetabolicactivationprovidedbyAroclorinducedratliver S9 fraction
PreincubationTestsimilartoabovedosageandconditions
Test method:OECD TG 471 and 472
Comment:noincrease in the mutation freguencywas observedforthenotifiedchemicalincomparisonwithnegativecontrol(water);mutagenicitywasobserved with thepositive control
Result:thenotifiedchemicaldidnotinducegenemutationsinthestrainsofbacteriatestedinthestudywith or without metabolic activation
9.3 Overall Assessment of Toxicological Data
Thenotifiedchemicalwasofverylowacuteoraltoxicity(LD505000mg/kg)inrats. Itwasaslighttomoderateskinirritantandaslighteyeirritantinrabbits. Itwasamild skin sensitiser in guinea pigs.
The notifiedchemicalwas not mutagenic in a reverse mutationassay.
AccordingtotheNOHSCApprovedCriteriaforClassifyingHazardousSubstances(NationalOccupationalHealthandSafetyCommission,1994a),thenotifiedchemicalis not determined to be a hazardous substance based on the above studies.
10.ASSESSMENT OF ENVIRONMENTALEFFECTS
Althoughnoecotoxicologicaldataarerequiredforchemicalswithimportvolumes1 tonneperannumaccordingtotheAct,thenotifierhasprovidedanaquaticinvertebratetoxicitytestresult and report.
TestSpeciesResults(Actual)References
Acute ImmobilisationStatic
48 hour
Dir 79/831/EEC C2
Water Flea(Daphniamagna)
EC50 100 mg/L(Nikolaitschik, 1997)
Thenotified chemical was tested on daphnids in the range of concentrations between 12.5 and100 mg/L.Nostatisticallysignificantimmobilisationwasobservedoverthe48 hoursatanyof the test concentrations.
Thedataforthenotifiedchemicalindicatedthatitispracticallynon-toxictoaquaticinvertebrates.
11.ASSESSMENT OF ENVIRONMENTALHAZARD
Themajorityofnotifiedchemicalwillbeincorporatedintosunscreenandskincareproductsatconcentrationsupto5%.UseoftheseproductsisexpectedtobewidespreadacrossAustraliawithreleaseofaportionofthechemicaldirectlytotheaquaticcompartmentsoftheenvironmentoccurringthroughuse.Releaseofthechemicalfromsunscreensismorelikelytonaturalwaterways,e.g.oceans,lakesandrivers.However,thisreleaseisexpectedtobeverydiffuseandatconcentrationsunlikelytobetoxictoaquaticlife.Thenotifiedchemicalwas shown to be practicallynon-toxic to aquatic invertebrates.
Otherproducts,suchasskincarecreams,maybedischargeddirectlyintothesewerthroughwashing.Acalculationbasedonaworstcasescenario,predictsanenvironmentalconcentrationof0.4x10-3mg/Lifalltheimportedchemicalremainsdissolvedinsewagewaters(assuming:400 kgmaximumannualuse,anAustralianpopulationof18millionandadailypercapitawastewaterdischargeof150L).Thisisbelowlevelsthathavebeenshownto be non-toxic to aquatic invertebrates (bygreater than five orders of magnitude).
Wastesgeneratedthroughproductreformulationareestimatedtobeminimal,andwillbedisposedoftoapproveddisposalfacilities.Smallamountsofresiduesinproductcontainerswill be disposed of with normal household garbage in a verydiffuse manner to landfill.
The environmental hazard from the notified chemical is expected to be verylow.
12.ASSESSMENT OF PUBLIC AND OCCUPATIONALHEALTH AND SAFETYEFFECTS
Thenotifiedchemicalexhibitedverylowacuteoraltoxicity(LD505000mg/kg)inrats.Thenotifiedchemicalwasaslighttomoderateskinirritantandaslighteyeirritantinrabbitsandamildsensitiseringuineapigsandmaycausetheseeffectsinsomeindividuals.Thenotifiedchemicalwasnotmutagenicinvitro.BasedonthedatasubmittedthenotifiedchemicalisnotdeterminedtobeahazardoussubstanceinaccordancewithNOHSCApprovedCriteriaforClassifyingHazardousSubstances(NationalOccupationalHealthandSafetyCommission, 1994a).
Occupational Health and Safety
Duringtransportationofthenotifiedchemical,thereisunlikelytobeanyworkerexposure,exceptintheeventofanaccidentalspill.ExposureafteraspillmaybecontrolledbyuseoftherecommendedpracticesforcleaningupofspillsgivenintheMaterialSafetyDataSheet(MSDS) supplied bythe notifier.
Thereispotentialforocularcontactandinhalationexposuretothedustformofthenotifiedchemicalduringopeningorclosingofdrums,weighingandchargingtheblendingvessel.However,exposuretothenotifiedchemicalwillbeminimalduetolocalexhaustventilationoverweighing,mixingandfillingareasandgeneralventilationinrestoftheworkarea.Exposuremayalsooccurduringcleaningofmixervessels.Shoulddermal,ocularcontactorinhalationexposureoccur,itisunlikelythatthenotifiedchemicalwillcause systemictoxicitybasedontoxicitystudiespresented.Ofparticularconcernwouldberespiratoryirritation,astheparticlesizeofthenotifiedchemicalwasnotprovided,somaybewithintherespirablerange(thatisanaerodynamicdiameterlessthan7m).Ifnecessary,respiratoryandocularexposureshouldbecontrolledandworkersmustbeattiredwithsafetyglasses/goggles,faceshieldsorheadcovering,protectivegloves,respiratoryprotectionandoverallsasstipulatedunder Recommendations.
Thenotifierstatesthattheworkerswillreceiveeducationandtrainingonsafeuseofdustproductsandpreventivecontrols.This,incombinationwithengineeringcontrolsandpersonalprotectiveequipment,willcontrolexposuretothenotifiedchemical andconsequentlyanyadverse health effects.
Toavoidadversehealtheffectsofhighconcentrationofdustintheworkplace,goodhygienepracticesshouldbeadoptedtominimiseairbornedustlevels.ExposuretothedustintheworkplaceshouldbecontrolledbelowtheNOHSCexposurestandardforDusts,nototherwiseclassified,10mg/m3TWA(measuredasinspirablefraction)(NationalOccupationalHealthandSafetyCommission1995). Employersareresponsibleforensuring
theexposurestandardisnotexceeded.Itisrecommendedthatlabelsfor the notifiedchemical carrythe safetyphrase – avoid breathingdust.
Thepotentialfordustexplosionexistswhenhandlingthenotifiedchemicalinthepowderedform.The notifiers MSDS provides advice on safe storage and handling.
Public Health
Asthenotifiedchemicalistobeusedincosmeticformulationsintendedforapplicationdirectlytotheskin,substantialpublicexposureislikely.However,giventhenatureofthecompound,itsuseinthismannerisunlikelyto result in systemic toxicityand the skin and eyeirritancypotentialatconcentrationsbelow5%islikelytobelow.Atconcentrationsatorbelow 5%the notifiedchemical is unlikelyto present askin sensitisationhazard.
13.RECOMMENDATIONS
Tominimiseoccupationalexposuretosodiumascorbylphosphatethefollowingguidelinesand precautions should be observed:
- Safetyglasses/gogglesshouldbeselectedandfittedinaccordancewithAustralianStandard(AS)1336(StandardsAustralia,1994)tocomplywithAustralian/NewZealandStandard(AS/NZS)1337(StandardsAustralia/StandardsNewZraland,1992);
- Air-purifying(dust)respiratorsshouldbeselectedandfittedinaccordancewithAustralian/NewZealandStandard(AS/NZS)1715(StandardsAustralia/StandardsNew Zealand, 1994a);
- Industrial clothing should conform to the specifications detailed in AS 2919(Standards Australia, 1987);
- ImpermeableglovesormittensshouldconformtoAS2161.2(StandardsAustralia/Standards New Zealand, 1998);
- AlloccupationalfootwearshouldconformtoAS/NZS2210(StandardsAustralia/Standards New Zealand, 1994b);
- Spillageofthenotifiedchemicalshouldbeavoided.Spillageshouldbecleaneduppromptlywith absorbents which should then be put into containers for disposal;
- Good personal hygiene should be practised to minimise the potential for ingestion;
- NOHSCexposurestandardfordustshouldbeobservedandMSDSandlabelshouldcarrythe safetyphrase – avoid breathingdust; and
- A copyof the MSDSshould be easilyaccessible to employees.
Ittheconditionsofusearevaried,andinparticularifthenotifiedchemicalistobeusedatgreaterthan5%ofacosmeticproductformulation,greaterexposureofthepublictothenotifiedchemicalmayoccurandfurtherinformationmayberequiredinordertoassesstherisks to public health.
Assodiumascorbylphosphateisapharmacologicallyactivesubstanceitsuseatconcentrationslikelytoleadtophysiologicalactionssuchasskinwhiteningmayconstituteatherapeuticuse,regardlessofwhethertherapeuticclaimsaremadeforproducts containingthecompound, for which TGA approval maybe required.
14.MATERIALSAFETY DATA SHEET
TheMSDSforthenotifiedchemicalwasprovidedinaccordancewiththeNationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets(NationalOccupationalHealthand SafetyCommission, 1994b).
ThisMSDSwasprovidedbytheapplicantaspartofthenotificationstatement.Itisreproducedhereasamatterofpublicrecord.Theaccuracyofthisinformationremainstheresponsibilityof the applicant.
15.REQUIREMENTS FOR SECONDARY NOTIFICATION
UndertheAct,secondarynotificationofthenotifiedchemicalshallberequiredifanyofthecircumstancesstipulatedunder subsection 64(2) of the Act arise.No other specific conditionsare prescribed.
16.REFERENCES
Beimborn, 1997.Determination of the Biodegradabilityof Sodium ascorbylphosphate in theManometric RespirometryTestBASFAktiengesellschaft,Ludwigshafen,Germany.
Unpublished.
Connell DW, 1989.General characteristics of organic compounds which exhibitbioaccumulationInConnell DW, (Ed)Bioaccumulation of Xenobiotic Compounds.CRCPress, Boca Raton, USA.
DraizeJH(1959)AppraisaloftheSafetyofChemicalsinFoods,DrugsandCosmetics.Association of Food and DrugOfficials of the US, 49 : 2-56.
EngelhardtG(1997)BacterialReverseMutationTestofP-#620,ProjectNo.40M0170/974073,DepartmentofToxicologyofBASFAktiengesellschaftD-67056Ludwigshafen/Rhein, FRG.
EEC (European Economic Community), 1992.EEC Directive 92/69, AnnexV, Part A,Methods for the determination of physico-chemical properties, A.5Surface Tension EECPublication No. L383.December 1992.
KuehlemMV(1997a)P-#97/170:AcuteOralToxicityinRats,ProjectNo.10A0170/971040, BASF Aktiengesellschaft Department of Toxicology, Rhein, Germany.
KuehlemMV(1997b)P-#97/170:SkinIrritationtotheRabbit,ProjectNo.14H0170/972068, BASF Aktiengesellschaft Department of Toxicology, Rhein, Germany.
KuehlemMV(1997c) P-#97/170:EyeIrritationtotheRabbit,ProjectNo.13H0170/972069,BASF Aktiengesellschaft Department of Toxicology, Rhein, Germany.
Kuehlem MV (1997d) P-#97/170: Skin Sensitisation in the Guinea Pig, Project No.30H0170/972070, BASF Aktiengesellschaft Department of Toxicology, Rhein, Germany.National Occupational Health and Safety Commission (1994a) Approved Criteria forClassifyingHazardousSubstances[NOHSC:1008(1994)].AustralianGovernmentPublishingService, Canberra.
NationalOccupationalHealthandSafetyCommission(1994b)NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets[NOHSC:2011(1994)].AustralianGovernment PublishingService, Canberra.
NationalOccupationalHealthandSafetyCommission(1995)NationalExposureStandards[NOHSC:1003(1995)].Australian Government PublishingService, Canberra.
Nikolaitschik, 1997. Determination of the acute effect of Sodium ascorbylphosphate on theswimmingabilityofthe water flea Daphnia magnaSTRAUS, BASFAktiengesellschaft,Ludwigshafen,Germany. Unpublished.
Organisation for Economic Co-operation and Development 1992-1997, OECD Guidelines forthe Testingof Chemicals on CD-Rom,OECD, Paris.
StandardsAustralia(1987)AustralianStandard2919-1987,IndustrialClothing.StandardsAssociation of Australia, Sydney.
StandardsAustralia(1994)AustralianStandard1336-1994,EyeprotectionintheIndustrialEnvironment. Standards Association of Australia, Sydney.
Standards Australia (1998) Australian Standard 2161.2:1998, Occupational ProtectiveGloves, Part 2: General Requirements. Standards Association of Australia, Sydney.
StandardsAustralia/StandardsNewZealand(1992)Australian/NewZealandStandard1337-1992,EyeProtectorsforIndustrialApplications.StandardsAssociationofAustralia/Standards Association of New Zealand,Sydney/Wellington.
StandardsAustralia/StandardsNewZealand(1994)Australian/NewZealandStandard2210-1994,OccupationalProtectiveFootwear.StandardsAssociationofAustralia/StandardsAssociation of New Zealand,Sydney/Wellington.
Attachment 1
TheDraizeScaleforevaluationofskinreactionsisasfollows:
ErythemaFormationRatingOedemaFormationRating
Noerythema0Nooedema0
Veryslighterythema(barelyperceptible)
1Veryslight oedema(barely1
perceptible)
Well-definederythema2Slight oedema (edgesofarea well-2
definedbydefiniteraising
Moderatetosevereerythema3Moderateoedema (raisedapprox. 13
mm)
Severeerythema(beetredness)4Severeoedema(raisedmorethan14
mmandextendingbeyondareaofexposure)
TheDraizescaleforevaluationofeyereactionsisasfollows:
CORNEA
OpacityRatingAreaofCorneainvolvedRating
Noopacity0none25%orless(notzero)1
Diffusearea,detailsofirisclearlyvisible
Easilyvisibletranslucentareas,detailsofirisslightlyobscure
1slight25% to 50%2
2mild50% to75%3
Opalescentareas,nodetailsofirisvisible,sizeofpupilbarelydiscernible
3
moderate
Greater than 75%4
Opaque,irisinvisible4severe
CONJUNCTIVAERedness / Rating / Chemosis / Rating / Discharge / Rating
Vesselsnormal / 0none / Noswelling / 0none / Nodischarge / 0none
Vesselsdefinitelyinjectedabovenormal / 1
slight / Anyswellingabovenormal / 1slight / Anyamountdifferentfromnormal / 1slight
Morediffuse,deepercrimsonredwithindividualvesselsnoteasilydiscernible
Diffusebeefyred / 2mod.
3severe / Obviousswellingwithpartialeversionoflids
Swellingwithlidshalf-closed
Swellingwithlidshalf-closedtocompletelyclosed / 2mild
3mod.
4severe / Dischargewithmoisteningoflidsandadjacenthairs
Dischargewithmoisteningoflidsandhairsandconsiderableareaaround eye / 2mod.
3severe
IRIS
ValuesRating
Normal0none
Foldsabovenormal,congestion,swelling,circumcornealinjection,irisreactstolight1slightNoreactiontolight,haemorrhage,grossdestruction 2severe