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 Di-n-octyl phthalate CAS Number: 117-84-0 Assessor A: B Mitcheson, Enviros Assessor B: S Cole, URS Final review: Panel/SF Date 05/05/2009 Date 10/08/2009 Date 09/09/2009 Oral Dermal Inhalation Combine Oral and Inhalation TDIs Justification Apply TDIoral to exposure routes Apply IDoral to exposure routes Yes Yes Yes No No No No information relating to potential carcinogenicity. TDIoral applied to oral, dermal and inhalation routes Apply TDIinh to exposure routes Apply IDinh to exposure routes No No No No No No NR No information relating to potential carcinogenicity. Insufficient information to derive TDIinhal, route-toroute from TDIoral used. TDI oral Recommended TDI oral Units 50 ug.kg-1.d-1 Justification Two values available: (1) 50 ug/kg/d is the temporary group restriction for phthalates with no specific TDI set by the SCF. This is based on dose-response data for DEHP (2) approx 400 ug/kg/d based on a sub chronic study by Poon. The sub chronic study is not considered of sufficient duration for derivation of a TDIoral and therefore preference is given to the SCF group restriction of 50 ug/kg/d as the TDIoral for di-n-octylphthalate. This assumes that the threshold toxicity of this compound is equivalent to that of DEHP. Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- 1.d-1 Drinking Water Inspectorate (DWI) http://www.dwi.gov.uk/ 31-Mar-09 No dose data identified - searched for plasticiser, phthalate, dicarboxylic. Note that tests for plastic pipes must comply with BS 6920 which includes a flavour and odour test Confidence rating Basis Value Units UF UF description Study type Food Standards Agency (FSA) http://www.food.gov.uk/ 31-Mar-09 31/03/2009 Provisional TDI for all phthalate esters in contact with food 50 μg/kg/day 50 Unknown Unknown Unknown Unknown Unknown Unknown Unknown Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) http://cot.food.gov.uk/ Friday 5 August 2005 (On 29/04/08 (uploaded infant milk formula file from July 2006) 06/04/2009 Provisional TDI for all phthalate esters in contact with food 0.05 mg/kg.bw/day 50 The Committee was aware that new evidence on the reproductive effects of phthalates has been published since these TDIs were set. NOAEL Unknown Unknown 100 Unknown Unknown Scientific Committee on Food (SCF) pre 2002 http://ec.europa.eu/food/fs/sc/scf/index_en.html 16 December 1994 report EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) http://ec.europa.eu/health/ph_risk/committees/sc t/sct_en.htm 07/04/2009 Provisional TDI for all phthalate esters in contact with food 0.05 mg/kg.bw/day 50 Unknown Based on extrapolated NOAEL for DEHP No info No info No info No info No info 24-Apr-98 16/05/2009 TDI 0.37 mg/kg.bw/day 370 Unknown NOAEL 36.8 mg/kg.bw/day 100 Assumed margin of safety required for calculating TDI from NOAEL in context of exposure to phthalates from children sucking plastic toys Subchronic 13week oral study in rats Joint FAO/WHO Meeting on Pesticide Residues (JMPR) http://www.who.int/ipcs/food/jmpr/en/ 08/04/2009 Reference to phthalates only relate to DMP as solvent for dermal test and DEHP and an interference JMPR 2 http://inchem.org/pages/jmpr.html 08/04/2009 Reference to phthalates only relate to DMP as solvent for dermal test and DEHP and an interference Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 1993 16/05/2009 Report identified with reference to tox studies but no TDI derived Page 1 of 6 EIC proforma di-n-octylphthalate 09/09/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di-n-octyl phthalate TDI oral Organisation Description Target organ/Critical Effect Reference Web link Drinking Water Inspectorate (DWI) Food Standards Agency (FSA) Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) Refers to a provisional TDI of 50ug/kgbw/day for all phthalate esters in contact with food. Also Plastic Materials and Articles In Contact With Food (England) Regulation 2008 look at specific limits on phthalate transfer into food. These e temporary "group restriction" of 0.05 mg/kg Unknown bodyweight/day set by the (Scientific Committee on Food (SCF) for those phthalates for which further toxicity testing is required. The Committee notes that TDIs are derived from doses which produce no effect in animal studies Unknown Unknown http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates; http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lang=en; http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf Jul 2006 STATEMENT ON PHTHALATES IN INFANT FORMULAE. Based on the Reports of the Scientific Committee on Food, 36th Series. Available at: http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html (Other sites Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment Risk Assessment of Mixtures of Pesticides and Similar Substances synergistic effects) http://cot.food.gov.uk/pdfs/reportindexed.pdf) http://cot.food.gov.uk/pdfs/cotstatementphthalates96.pdf also in http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf referring to SCF (1996). Phthalates in infant formulae (Opinion expressed on 7 June 1996). Reports of the Scientific Committee on Food, 36th Series. Available at: http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html Scientific Committee on Food (SCF) pre 2002 EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) Group restriction peroxisome proliferation, reproductive study, inadequate 90day oral study and Ames test available DNOP was shown to cause mild microscopic changes in the liver (endothelial nuclear prominence, nuclear hyperchromicity, anisokaryosis) and thyroid (reduced follicle size, reduced colloid density) at 5000 ppm in diet. NOAEL = 500 ppm which is equivalent to 36.8 mg/kg bw/day for male rats (Poon et al., 1997). Unknown Liver and thyroid EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE. Phthalate migration from soft PVC toys and child-care articles Opinion expressed at the CSTEE third plenary meeting Brussels, 24 April 1998 which cites Poon R, Lecavalier, P, Mueller, R, Valli, VE, Procter BG, Chu I (1997). Subchronic Oral toxicity of di-n-octyl phthalate and di(2-ethylhexyl) phthalate in the rat. Fd Chem Toxicol 35, 225-239. http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_42.pdf http://ec.europa.eu/health/ph_risk/committees/sct/documents/out12_en.pdf Joint FAO/WHO Meeting on Pesticide Residues (JMPR) JMPR 2 Health Canada Toxicological Values http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1- lsp1/dinoctylphthalate_phtalatedioctyle/dinoctylphthalate_phtalatedioctyle_2-eng.php Page 2 of 6 EIC proforma di-n-octylphthalate 09/09/2009
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