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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di n butyl phthalate, Di butyl phthalate or DBP USEPA Integrated Risk Information System (IRIS) http://epa.gov/iris/ CAS Number: 84-74-2 Assessor A: Barry Mitcheson, Assessor B: Alison Pugh, Final review: Panel/SF Envirso Hyder Date 05/05/2009 Date 05/05/2009 Date 26/08/2009 01/02/1990 (database last commented in 1998) 08/04/2009 Classification — D; not classifiable. Basis — Pertinent data regarding carcinogenicity was not located in the available literature. ID inhal Recommended Id inhal Units Justification n/a Weight of evidence indicates not carcinogenic Organisation Last Updated Non threshold effects Basis Health criteria type Health and Safety Executive (HSE) http://www.hse.gov.uk/ 06/04/2009 HSC/04/06 Annex C All three listed. WEL 5mg/m3 and STEL 10mg/m3. Risk Phrases refer to R60 and R61 (harm fertility and harm the unborn child) and R50 Very toxic to aquatic organisms European Chemicals Bureau (ECB) http://ecb.jrc.it/ Date of Last 07/04/2009 No adequate long-term toxicity Literature Search: and/or carcinogenicity studies in 1994 animals as well as humans are Review of report by available MS Technical Experts finalised: 1999 Final report: 2003 Value Units Confidence rating Basis Scientific Committee on Food (SCF) pre 2002 http://ec.europa.eu/food/fs/sc/scf/index_en .html 07/04/2009 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 "No TDI given no long term studies for carcinogenic effects of DBP, in human or in laboratory animals". Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 17/12/2007 08/04/2009 Group VI ("Unclassifiable with Respect to its Carcinogenicity to Humans") USEPA Integrated Risk Information System (IRIS) http://epa.gov/iris/ 01/02/1990 (database last commented in 1998) 08/04/2009 Classification — D; not classifiable. Page 7 of 8 EIC proforma Di n butyl phthalate.xls26/08/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di n butyl phthalate, Di butyl phthalate or DBP USEPA Integrated Risk Information System (IRIS) http://www.epa.gov/ncea/iris/subst/0038.htm ID inhal Organisation Health and Safety Executive (HSE) Study type Description Response Reference Web link http://www.hse.gov.uk/aboutus/meetings/hscarchive/2004/091104/c06c.p df European Chemicals Bureau (ECB) European Union Risk Assessment Report Volume 29 , 2003 with addendum 2004 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf Scientific Committee on Food (SCF) pre 2002 Available limited 90-day and 1 year oral rat studies oral reproduction and tetratogenicity studies, limited mutagenicity studies (RIVM May 1998). Needed : tests for gene mutation and if migration exceeds 0.05mg/kg 28 oral study and peroxisome proliferation study too. Compilation of the Evaluations of the scientific committee on food on certain monomers and additives used in the manufacture of plastics materials intended to come into contact with food Stuffs Until 21 March 1997 SCF 1999 http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_42.pdf Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Baars et al states that inhalation not considered relevant due to low volatility. The dust paper uses the oral EFSA value given above re-evaluation of maximum permissible levels By Baars et al RIVM 711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W. Noorlander http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf & http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al) Health Canada Toxicological Values Inhalation not specifically addressed. The weight of available data in in vitro assays indicates that dibutyl phthalate is not genotoxic. Carcinogenicity is potentially the most sensitive endpoint. No human epidemiological studies to assess carcinogenicity and available data considered inadequate to assess the carcinogenicity animals. Dibutyl Phthalate - PSL1 http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1- lsp1/phthalate_dibutyl_phtalate/phthalate_dibutyl_phtalate_3-eng.php USEPA Integrated Risk Information System (IRIS) Basis — Pertinent data regarding carcinogenicity was not located in the available literature. http://www.epa.gov/ncea/iris/subst/0038.htm Page 8 of 8 EIC proforma Di n butyl phthalate.xls26/08/2009
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