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 Tributyltin(oxide) CASNumber: 56359 AssessorA: AndreasNeymeyer, BuroHappold AssessorB: MikeRogers, OPUSJOYNES PIKELtd Finalreview: Panel/SF Date 16/04/2009 Date 16/04/2009 Date 28/08/2009 Oral Dermal Inhalation CombineOral andInhalation TDIs Justification ApplyTDIoraltoexposureroutes Yes Yes No ApplyIDoraltoexposoureroutes ApplyTDIinhtoexposureroutes No No No No No Yes Yes TheweightofevidenceshowsthatTBTOisnot genotoxic ApplyIDinhtoexposureroutes No No No TDIoral Recommended TDIoral Units 0.25 ug.kg1.d1 Justification ConsistentvaluefromIPCS,SCF,WHO&RIVM Organisation WebLink LastUpdated DateWebChecked Healthcriteriatype Value InitialUnits CLEAunitsug.kg Confidencerating Basis Value Units UF UFdescription 1.d1 ScientificCommitteeonFood(SCF)pre 2002 http://ec.europa.eu/food/fs/sc/scf/index_en .html 09/04/2009 27/03/2009 TDI 0.0003 mg/kgbody weightperday 0.3 NOAEL 0.025 mg/kgbody weightperday InternationalProgrammeonChemical http://www.who.int/ipcs/en/ 09/04/2009 27/03/2009 TDI 0.0003 mg/kgbody 0.3 NOAEL 0.025 mg/kgbody 100 Safety(IPCS) weightperday weightperday 09/04/2009 27/03/2009 TDI 0.0003 mg/kgbody weightperday 0.3 NOAEL 0.025 mg/kgbody weightperday 100 WHOGuidelinesfordrinkingwaterQuality http://www.who.int/water_sanitation_health/dwq/gu idelines/en 09/04/2009 27/03/2009 TDI 0.25 ug/kgbodyweight perday 0.25 NOAEL 0.025 mg/kgbody weightperday 100 forinterandintraspeciesvariation DutchNationalInstituteforPublicHealth andtheEnvironment(RIVM)Maximum http://www.rivm.nl/en/ //2009 28/08/2009 TDI 0.25 ug/kgbodyweight perday EntrezPubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi 27/03/2009 27/03/2009 TDI 0.25 ug/kgbodyweight perday 0.25 medium NOAEL 0.025 mg/kgbody weightperday 0.25 NOAEL 0.025 mg/kgbody weightperday 100 forinterandintraspeciesvariation TDIinhal Recommended TDIinhal Units Justification 0.0057 ug.kg1.d1 BasedonprovisionalTCAderivedbyRIVM(0.02ug/m3x20m3/d/70kg) Organisation WebLink DateWebChecked DateWebCheckedHealthcriteriatype Value InitialUnits CLEAunitsug.kg Confidencerating Basis Value Units UF UFdescription 1.d1 InternationalProgrammeonChemical http://www.who.int/ipcs/en/ Noadequatedataavailabletoderiveaguidancevalueforinhalationexposure. Safety(IPCS) DutchNationalInstituteforPublicHealth andtheEnvironment(RIVM)Maximum PermissibleRisk(MPR)levels http://www.rivm.nl/en/ //2009 28/08/2009 pTCA 0.02 ug/m3 0.0057 provisionalvalue NAOEL(adjusted) 20 ug/m3 1000 nodata IDoral Recommended IDoral Units n/a Organisation WebLink LastUpdated DateWebChecked Nonthreshold effects Basis Healthcriteria type InternationalProgrammeonChemical http://www.who.int/ipcs/en/ 09/04/2009 27/03/2009 TheweightofevidenceshowsthatTBTOisnotgenotoxic Safety(IPCS) Recommended IDinhal IDinhal Units n/a Organisation WebLink LastUpdated DateWebChecked Nonthreshold Basis Healthcriteria effects type InternationalProgrammeonChemical http://www.who.int/ipcs/en/ 09/04/2009 27/03/2009 TheweightofevidenceshowsthatTBTOisnotgenotoxic Safety(IPCS) Justification TheweightofevidenceshowsthatTBTOisnotgenotoxic Value Units Confidencerating Justification TheweightofevidenceshowsthatTBTOisnotgenotoxic Value Units Confidencerating Basis Basis Page 1 of 4 EIC proforma TBTO.xls 17/11/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Tributyltin(oxide) TDIoral Organisation Studytype Description Targetorgan/CriticalEffect Reference Weblink ScientificCommitteeonFood(SCF)pre 2002 InternationalProgrammeonChemical Safety(IPCS) WHOGuidelinesfordrinkingwaterQuality animal(rats) Longtermanimalstudywithrats Effectsonliverthehaematologicaland theendocrinesystem animal(rats) Numerousstudies,bothshorttermandlong term animal(rats) "Numerouswellconductedstudies,bothshort termandlongterm" Transientincreaseinadrenalweight shortlyafterexposureandatransient effectonthyroidfollicles.Inaddition, reversibleeffectsonthepituitaryandon levelsofadrenocorticotrophichormones, thyroidstimulatinghormone,thyroxine, andserumcortisol.Atthehighestdose mortality5/10inmalesand6/10in femalesinflammatoryreactions animal(rats) 17monthfeedingstudyinrats Themostsensitiveendpointappearsto beimmunotoxicityrelatedtosuppression ofresistancetothenematodeTrichinella spiralis IPCS,1990. e.g.,Funahashietal.,1980 Truhautetal.1979 Schweinfurth&Gunzel1987 http://ec.europa.eu/research/endocrine/pdf/drinking_water_en.pdf http://www.inchem.org/documents/cicads/cicads/cicad14.htm http://www.who.int/ipcs/publications/cicad/en/cicad14.pdf http://www.emro.who.int/ceha/pdf/Guidelines_DrinkingWater_Recommendations.pdf DutchNationalInstituteforPublicHealth andtheEnvironment(RIVM)Maximum EntrezPubMed animal(rats) 17monthfeedingstudyinrats Immunotoxiceffects Vosetal.,1990;Westeretal.,1988,1990;Tryphonasetal.,2004 http://www.rivm.nl/bibliotheek/rapporten/711701092.pdf http://www.ncbi.nlm.nih.gov/pubmed/18979060ordinalpos=1&itool=EntrezSystem2.PEntr ez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum TDIinhal Organisation Studytype Description Response Reference Weblink InternationalProgrammeonChemical Safety(IPCS) DutchNationalInstituteforPublicHealth andtheEnvironment(RIVM)Maximum PermissibleRisk(MPR)levels animal(rats) 4weekstudywithrats.Notetheprovisional Nodata TCAisunchangedsincefirstRIVMevaluationof TBTOin1995.RIVMnotethattherehasbeen noadditonalrelevanttoxicologicaldatainthe interveningperiod. JanssenPJCM,ApeldoornMEvan,KotenVermeulenJEMvan,MennesWC (1995).HumanToxicologicalCriteriaforSeriousSoilContamination: Compoundsevaluatedin1993&1994.RIVMreportno.715810009. EvaluationofTCAforTBTObasedontoxciologicalstudyreportedbyPrins andVanVelzen,1983andBUA,1988 http://www.who.int/ipcs/publications/cicad/en/cicad14.pdf http://www.rivm.nl/bibliotheek/rapporten/711701092.pdf IDoral Organisation InternationalProgrammeonChemical Safety(IPCS) Studytype Description Response Reference Weblink http://www.inchem.org/documents/cicads/cicads/cicad14.htm IDinhal Organisation InternationalProgrammeonChemical Safety(IPCS) Studytype Description Response Reference Weblink http://www.inchem.org/documents/cicads/cicads/cicad14.htm Page 2 of 4 EIC proforma TBTO.xls 17/11/2009
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