Soil Generic Assessment Criteria for Human Health Risk ... - ESdat

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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Antimony CASNumber: 7440360 AssessorA: AndreasNeymeyer, BuroHappold AssessorB: MikeRogers, OPUSJOYNES PIKELtd Finalreview: Panel/SF Date 16/04/2009 Date 16/04/2009 Date 26/08/2009 Oral Dermal Inhalation CombineOral andInhalation TDIs Justification ApplyTDIoraltoexposureroutes ApplyIDoraltoexposureroutes Yes Yes No No No No Nodatatoindicatecarcinogenicitybytheoralroute. TDIoralappledtooralanddermalexposures. ApplyTDIinhtoexposureroutes ApplyIDinhtoexposureroutes No No Yes No No No Yes Someevidenceforthecarcinogenicityofcertain antimonycompoundsbyinhalation;however,nodata toderiveahealthcriteriavalueforcancerrisk.TDIinh appliedtoinhalationexposures. TDIoral Recommended TDIoral Units Justification 6 ug.kg1.d1 TDIassuggestedbytheWHOandFSA.NotethatthelowerHealthCanadavalue(0.2ug.kg1.d1)isbasedonaNOAELof0.06mg/kgofbodyweightperdayproposedbyPoonetal.(1998).ThisNOAELwasquestionedbyLynchetal.(1999)whopreferredaNOAELof6.0mg/kgof bodyweightperday,whichhassubsequentlybeenusedbytheWHOandFSA. ggg Organisation WebLink LastUpdated DateWebChecked Healthcriteriatype Value InitialUnits CLEAunitsug.kg Confidencerating Basis Value Units UF UFdescription Studytype Description Targetorgan/CriticalEffect 1.d1 FoodStandardsAgency(FSA) http://www.food.gov.uk/ 2003 27/03/2009 TDI 6 g/kgbw/day 6 NOAEL 6 mg/kgbody weightperday Effectsofantimonyonratsfollowing90day exposureviadrinkingwater 1000 100forinterandintraspecies animal(rats) variation,10fortheshortdurationof thestudy Animalstudies:decreasedlongevityandaltered bloodlevelsofglucoseandcholesterol,reversible lossofbodyweightgain,subtlehistopathological changesinthyroids(increasedepithelialheight, decreasedfollicularsize) Humans:vomiting,nausea,abdominalcrampsand diarrhoea,opticnervedestruction,uveitidesand retinalbleeding,accompaniedbyheadache, coughing,anorexia,troubledsleepandvertigo Antimonycontainingcompoundsmayalsoproduce alterationsincardiacfunctionandautopsystudies haveshownthatcardiactoxicitywasthecauseof deathinpatientstreatedwithantimonialdrugs. Thereisnoinformationontheoralcarcinogenicityof antimonyandcompoundsinhumans.However basedoninhalationdatainratsandinvitrodata,the IARCconcludedthatantimonytrioxideispossibly carcinogenictohumans(Group2B),andantimony trisulfideisnotclassifiableastoitscarcinogenicityto humans(Group3) WHOGuidelinesfordrinkingwaterQuality http://www.who.int/water_sanitation_healt h/dwq/guidelines/en 2003 27/03/2009 TDI 6 g/kgbw/day 6 NOAEL 6 mg/kgbody weightperday 1000 100forinterandintraspecies animal(rats) variation,10fortheshortdurationof thestudy Effectsofantimonyonratsfollowing90day exposureviadrinkingwater HealthCanadaToxicologicalValues http://www.hcsc.gc.ca/index_e.html Aug1999 27/03/2009 TDI 0.0002 mg/kgbodyweight perday 0.2 3 NOAEL 0.06 mg/kgbody weightperday 300 ×10forintraspeciesvariation;×10for interspeciesvariation;and×3forthe useofashorttermstudy animal(rats) Effectsofantimonyonratsfollowing90day exposureviadrinkingwater TDIinhal Recommended TDIinhal Units Justification 0.057 ggg HealthcriteriacalculatedfromRfCassuggestedbyIRIS.CalculationperformedinlinewithSC050021/SR2 Organisation WebLink LastUpdated DateWebChecked Healthcriteriatype Value InitialUnits CLEAunitsug.kg Confidencerating Basis Value Units UF UFdescription Studytype Description Response 1.d1 USEPAIntegratedRiskInformationSystem (IRIS) http://epa.gov/iris/ 09/01/1995 12/08/2009 RfC 0.0002 mg/m 3 0.057 Medium Study&Database 0.07 mg/kgbody weightperday (0.0002mg/m 3 x 20m 3 /day/70kg(bw) =0.00007 mg/kgbw/day) 300 Anuncertaintyfactorof10isusedfor animal(rats) theprotectionofsensitivehuman subpopulations,3isusedfor interspeciesextrapolationbecausethe dosimetricadjustmentsaccountfor partofthisareaofuncertainty,3is appliedfordatabaseinadequacies.An additionalthreefolduncertaintyfactor toaccountforalessthanlifetime exposuredurationisapplied.Thisis lessthanthe10folduncertaintyfactor normallyappliedtoadjustfrom subchronic(90day)tochronicstudies becauseexposureslastedfor1full year. Chronicstudyinwhichgroupsofratswere exposedtotargetconcentrationsof0,0.05, 0.50,or5.00mg/m 3 antimonytrioxidefor6 hours/day,5days/weekfor1year. "Microscopiclesionsofthelungsrevealedinterstitial inflammationincontrolandexposuregroupsatthe endof6,12,18,and24months. Granulomatous inflammationandgranulomaswereobservedinall exposuregroupsat18and24months.Anincreasein thenumberofalveolarandintraalveolarparticle ladenmacrophageswasobserved(ateveryexposure duration)inallbutthecontrolgroups." WHOGuidelinesfordrinkingwaterQuality http://www.who.int/water_sanitation_healt h/dwq/guidelines/en "Althoughthereissomeevidenceforthecarcinogenicityofcertainantimonycompoundsbyinhalation,therearenodatatoindicatecarcinogenicitybytheoralroute."Therealsoappearstobenodataavailabletoderivea guidancevalueforinhalationexposure. IDoral Organisation WebLink LastUpdated DateWebChecked Nonthreshold effects IDinhal Organisation WebLink LastUpdated DateWebChecked Nonthreshold effects Recommended IDoral Units Justification Althoughthereissomeevidenceforthecarcinogenicityofcertainantimonycompoundsbyinhalation,thereisnodatatoindicatecarcinogenicitybytheoral n/a ggg route. Basis Healthcriteria Value Units Confidencerating Basis Studytype Description Response type Recommended IDinhal Units Justification n/a NodataforinhalationIndexDose ggg Basis Healthcriteria Value Units Confidencerating Basis Studytype Description Response type Page 1 of 4 EIC proforma antimony.xls 17/11/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Antimony TDIoral Organisation FoodStandardsAgency(FSA) Reference Poonetal.1998&Lynchetal.1999 Weblink http://cot.food.gov.uk/pdfs/TOX200339.PDF WHOGuidelinesfordrinkingwaterQuality Poonetal.1998&Lynchetal.1999 http://www.who.int/water_sanitation_health/dwq/chemicals/antimony.pdf HealthCanadaToxicologicalValues Poonetal.1998 http://www.hcsc.gc.ca/ewhsemt/pubs/watereau/antimonyantimoine/classification eng.php TDIinhal Organisation USEPAIntegratedRiskInformationSystem (IRIS) Reference Newtonetal.1994,Muhleetal.1990 Weblink http://www.epa.gov/ncea/iris/subst/0676.htm#inhalrfc WHOGuidelinesfordrinkingwaterQuality IARC.1989.Someorganicsolvents,resinmonomersandrelatedcompounds, pigmentsandoccupationalexposuresinpaintmanufactureandpainting. Lyon,InternationalAgencyforResearchonCancer,pp.291–305(IARC MonographsontheEvaluationofCarcinogenicRiskstoHumans,Vol.47in WHO.2003.AntimonyinDrinkingwaterBackgrounddocumentfor developmentofWHOGuidelinesforDrinkingwaterQuality http://www.who.int/water_sanitation_health/dwq/chemicals/antimony.pdf IDoral Organisation Reference Weblink IDinhal Organisation Reference Weblink Page 2 of 4 EIC proforma antimony.xls 17/11/2009
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