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 Diethyl Phthalate CAS Number: 84-66-22 Assessor A: Mathew Rouge Assessor B: Gareth Wills Final Review: Panel/SF Date: March 09 Halcrow Date: April 09 PB Date: 26/08/2009 Apply TDIoral to exposure routes Apply IDoral to exposure routes Oral Dermal Inhalation Combine Oral and Inhalation TDIs Yes Yes Yes No No No Justification TDIoral applied to oral and dermal routes. Not classifiable as a human carcinogen Apply TDIinh to exposure routes Apply IDinh to exposure routes No No No No No No Yes Not classifiable as a human carcinogen. Insufficient data with sufficient detail on derivation to derive inhalation TDI. Use routeto-route extrapolation from oral route. TDI oral Recommended TDIoral 200 Units ug.kg-1.d-1 Justification Most conservative value chosen (RIVM and EC SCF), based on longest term study (Brown et al 1978). RfD from IRIS has low confidence, although is taken from same study (Brown et al, 1978). Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence Basis Value Units UF UF description 1.d-1 rating IPCS concise International Chemical Assessment Documents (CICADs) http://inchem.org/pages/cicads.html 2003 Mar-09 TDI 5000 ug/kg/bw/day 5000 Not provided NOAEL 1600 mg/kg bw/day 300 3 for incompleteness of database, 10 each for intra and interspecies variation Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.rivm.nl/en/ 2000 Mar-09 TDI (Provisional). It was adopted from the European Communities temporary limit value of 0.2 mg/kg/ day http://www.atsdr.cdc.gov/ 1995 Mar-09 Database not adequate for determination of a chronic MRL 200 ug/kg/bw/day 200 Not provided NOAEL 100 mg/kg bw/day 500 intra and interspecies extrapolation and a poor database n/a n/a n/a n/a n/a n/a n/a n/a n/a http://www.atsdr.cdc.gov/ 1995 Mar-09 acute oral MRL 7 mg/kg bw/d 7,000 Not provided LOAEL 2000 mg/kg bw/d 300 3 for conversion of minimal LOAEL to NOAEL, 10 for interspecies variability, 10 for protection of sensitive humans http://www.atsdr.cdc.gov/ 1995 Mar-09 intermediate duration oral MRL 6 mg/kg bw/d 6,000 Not provided LOAEL 1753 mg/kg bw/d 300 3 for conversion of minimal LOAEL to NOAEL, 10 for interspecies variability, 10 for inter individual variation USEPA Integrated Risk Information System (IRIS) EC Scientific Committee for Food http://epa.gov/iris/ 1993 Mar-09 RfD 8.00E-01 mg/kg/d 800 Study - Medium, Database - Low, RfD - Low http://archive.food.gov.uk/maff/archive/foo d/infsheet/1996/no82/82phthal.htm NOAEL:1% of diet (750 mg/kg bw/day) 800 mg/kg bw/day 1000 10 extrapolation from subchronic to chronic, 10 for interspecies variation and an additional 10-fold factor to protect sensitive human subpopulation 1996 Mar-09 Oral TDI 0.2 mg/kg bw/d 200 Not Provided Not Provided Not Provided Not Provided Not Provided Not Provided (Page 1 of 4) (EIC proforma diethyl phthalate.xls 26/08/2009)
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Diethyl Phthalate TDI oral Organisation Study type Description Target organ/Critical Effect Reference Web link IPCS concise International Chemical Assessment Documents (CICADs) Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Mice, dermal study Rat, Subchronic Oral Feeding Study. Brown et al, 1978 Diethylphthalate at 500, 1600 and 5600 mg/kg bw/day administered percutaneously to pregnant ICR mice from day 0 to day 17 of gestation Groups of CD rats (15/sex) were fed diets containing 0, 0.2, 1.0, or 5.0% DEP for 16 weeks Reproductive toxicity Tanaka C et al, (1987) A teratological evaluation following dermal application of diethylphthalate to pregnant mice liver and testes Brown, D., K.R. Butterworth, I.F. Gaunt, P. Grasso and S.D. Gangolli. 1978. Short-term oral toxicity study of diethyl phthalate in the rat. Food Cosmet. Toxicol. 16: 415-422 http://inchem.org/documents/cicads/cicads/cicad52.htm http://www.rivm.nl/en/ US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels n/a n/a n/a n/a http://www.atsdr.cdc.gov/toxprofiles/tp73.html acute rat study 2 day study, rats received 2,000 mg/kg bw/d DEP for 2 days by gavage Leydig cell ultra structural changes Jones et al 1993 http://www.atsdr.cdc.gov/toxprofiles/tp73.html male rat study peroxisomal proliferation, slightly elevated liver weight, changes in hepatic enzyme activities Moody and Reddy 1978 http://www.atsdr.cdc.gov/toxprofiles/tp73.html USEPA Integrated Risk Information System (IRIS) Rat, Subchronic Oral Feeding Study. Brown et al, 1978 Groups of CD rats (15/sex) were fed diets Decreased growth rate, food consumption Brown, D., K.R. Butterworth, I.F. Gaunt, P. Grasso and S.D. Gangolli. 1978. containing 0, 0.2, 1.0, or 5.0% DEP for 16 weeks and altered organ weights Short-term oral toxicity study of diethyl phthalate in the rat. Food Cosmet. Toxicol. 16: 415-422 http://epa.gov/iris/ EC Scientific Committee for Food Not Provided Not Provided Not Provided Not Provided http://archive.food.gov.uk/maff/archive/food/infsheet/1996/no82/82phth al.htm (Page 2 of 4) (EIC proforma diethyl phthalate.xls 26/08/2009)
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