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 methyl phthalate TDI oral Organisation Description Target organ/Critical Effect Reference Web link Food Standards Agency (FSA) Refence to Endocrine disruptors on infromaiton page. The site states that the European Food Safety Authority reviews all the scientific data in order to set a tolerable daily intake. This is an estimate of the amount of a substance in food or drinking water that can be consumed daily by people over a lifetime without any appreciable risk to health. 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 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 Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) Scientific Committee on Food (SCF) pre 2002 Reference made in Jul 1996 STATEMENT ON PHTHALATES IN INFANT FORMULAE to Tolerable Daily Intakes (TDIs) set by the EC Scientific Committee for Food for a group restriction of 0.05mg/kg bw/day. Phthalates in infant formulae (Opinion expressed on 7 June 1996). Reports of the Scientific Committee on Food, 36th Series. These exceed by 2-3 fold the temporary "group restriction" of 0.05 mg/kg bodyweight/day set by the 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 Available limited oral rat chronic toxicity/carcinogenicity, oral teratogenicity studies in rats and mice, Ames test. . Needed : gene mutation and chromosome aberration in mammalian cells in vitro and migration data in the first instance Jul 1996 STATEMENT ON PHTHALATES IN INFANT FORMULAE Variability and Uncertainty in Toxicology of Chemicals in Food, Consumer Products and the Environment March 2007 looks at phthalate esters as endocrine modulators affecting testes and exposure of rats during pregnancy to high levels of certain phthalate esters is able to induce in the male offspring a collection of disorders that is remarkably similar to Testicular Dysgenesis Syndrome in humans and in foetal life a substantial reduction in anogenital distances. also in TOX/2003/09 COMMITTEE ON TOXICITY OF CHEMICALS IN FOOD, CONSUMER PRODUCTS AND THE ENVIRONMENT ADVERSE TRENDS IN DEVELOPMENT OF THE MALE REPRODUCTIVE SYSTEM - POTENTIAL CHEMICAL CAUSES 2003 and annual report 2006) 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 (Other sites with no dose data http://cot.food.gov.uk/pdfs/vutreportmarch2007.pdf , http://cot.food.gov.uk/pdfs/2003-09endocrine.PDF, http://cot.food.gov.uk/pdfs/cotsection06.pdf ) Compilation of the Evaluations of the scientific committee on food on certain http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_42.pdf monomers and additives used in the manufacture of plastics materials intended to come into contact with food Stuffs Until 21 March 1997 SCF 1999 WHO Guidelines for drinking water Quality mg of toxicant per kg bw required to kill 50% of large population of test animals. Used in repellant. In table 5 which is for active ingrediantes unlikely to present active hazard in normal use The WHO recommended classification of pesticides by hazard and guidelines to classification : 2004. http://www.who.int/ipcs/publications/pesticides_hazard_rev_3.pdf Page 2 of 6 EIC proforma dimethyl phthalate.xls08/09/2009

www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di methyl phthalate CAS Number: 131-11-3 Assessor A: Barry Mitcheson, Assessor B: Alison Pugh, Final review: Panel/SF Enviros Hyder Date 05/05/2009 Date 06/05/2009 Date 08/09/2009 Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels http://www.rivm.nl/en/ 2001 (replaced 2008) 08/04/2009 Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 1989 20/04/2009 NOAEL 1% DMP = 0.8 g/kg/day rats 1989 20/04/2009 NOAEL 5% DMP = 3.6 g/kg/day rats TDI inhal Recommended TDI inhal n/a CLEA Units ug.kg-1.d-1 Justification No suitable study identified. Consideration given to use of DEP as surrogate set out by RIVM in report on dust exposure but toxic mechanism of DMP not known, consideration also given to group restriction on all phthalates. Careful consideration should be given to potential additive effects of different phthalates when setting HCVs. Organisation Last Updated Health criteria type Value Units Confidence rating Basis Value Units UF UF description Study type Drinking Water Inspectorate (DWI) http://www.dwi.gov.uk/ 31-Mar-09 31-Mar-09 Food Standards Agency (FSA) http://www.food.gov.uk/ Friday 5 August 2005 (One site date not given) 31/03/2009 Health and Safety Executive (HSE) http://www.hse.gov.uk/ 06/04/2009 HSC/04/06 Annex C . WEL 5mg/m3 and STEL 10mg/m3. Risk Phrases refer to R60 and R61 (harm fertility and harm the unborn child) and R50 toxic to aquatic organisms IPCS INCHEM http://inchem.org/ 07/04/2009 Occupational health limits 5mg/m3 Joint FAO/WHO Meeting on Pesticide Residues (JMPR) http://www.who.int/ipcs/food/jmpr/en/ 08/04/2009 JMPR 2 http://inchem.org/pages/jmpr.html 08/04/2009 Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels http://www.rivm.nl/en/ 2001 (replaced 2008) 08/04/2009 Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 1980 (abstract only) 20/04/2009 Maximum Allowable concentration (MAC) 0.3 mg/m3 2008 20/04/2009 OSHA standards - permissible exposure 5mg/m3 limit 2005 20/04/2009 NIOSH - recommended exposure limit 5 mg/m3 2005 20/04/2009 NIOSH - immediately dangerous to Life or Health 200 mg/m3 Page 3 of 6 EIC proforma dimethyl phthalate.xls08/09/2009

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