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: European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en.html Report from 2005 07/04/2009 No comment on carcinogenicity B Mitcheson, Enviros Assessor B: S Cole, URS Final review: Panel/SF Date 05/05/2009 Date 10/08/2009 Date 09/09/2009 International Agency for Research on Cancer (IARC) http://inchem.org/pages/iarc.html 16/05/2009 No data US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ 2000 14/01/2009 for MRL page (And report June 2002) 16/05/2009 Di-n-octylphthalate has not been classified for carcinogenic effects by the Department of Health and Human Services, the International Agency for Research on Cancer, or the EPA. ID inhal Recommended ID inhal n/a Units Justification Weight of evidence indicates unlikely carcinogenic. Organisation Web Link Last Updated Date Web Checked Non threshold effects Basis Health criteria type Value Units Confidence rating Basis Study type Food Standards Agency (FSA) Health Protection Agency (HPA) http://www.food.gov.uk/ http://www.hpa.org.uk/ Friday 5 August 2005 (On 11-Sep-08 European Chemicals Bureau (ECB) http://ecb.jrc.it/ Date of Last Literature Search : 2005. Review of report by MS Technical Experts finalised: September 2005. Final report: 2008 31/03/2009 No data on inhalation doses identified. Site refers to endocrine disruptors not carcinogens. 31/03/2009 Page on exposure standards details no drinking water standard no soil standard or air standard 07/04/2009 No data European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en.html Report from 2005 07/04/2009 No data International Agency for Research on Cancer (IARC) http://inchem.org/pages/iarc.html 07/04/2009 No data US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ 2000 14/01/2009 for MRL page (And report June 2002) 08/04/2009 No studies were located regarding geotaxis effects in humans after inhalation, oral, or dermal exposure to DEHP. As discussed below, DEHP has been extensively tested in a variety of shortterm genotoxicity assays with predominantly negative or falsepositive results. The weight of evidence from these assays, as well as the tumour initiating/promoting activity studies summarized in Section 3.5.2 (Mechanisms of Toxicity), indicate that DEHP does not induce lesions in nuclear DNA, is not mutagenic/geotaxis, and is not a tumour initiator, but rather that it is a rodent liver mutagen and tumour promoter, and is best characterized as an epigenetic toxicant. Page 5 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 European Food Safety Authority (EFSA) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej243_dehp_en2 Materials in Contact with Food (AFC) on a request from the Commission related to Bis(2- .pdfssbinary=true ethylhexyl)phthalate (DEHP) for use in food contact materials Question N° EFSA-Q-200 International Agency for Research on Cancer (IARC) International Agency for Research on Cancer (IARC) - Summaries & Evaluations DI(2-ETHYLHEXYL) PHTHALATE (Group 3) VOL.: 77 (2000) (p. 41) http://www.inchem.org/documents/iarc/vol77/77-01.html US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels TOXICOLOGICAL PROFILE FOR DI-n-OCTYLPHTHALATE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry September 1997 http://www.atsdr.cdc.gov/toxprofiles/tp95.pdf (& http://www.atsdr.cdc.gov/mrls/index.html for MRLs) ID inhal Organisation Description Response Reference Web link Food Standards Agency (FSA) Health Protection Agency (HPA) Phthalates (Diisononylphthalate and Di(2-ethylhexyl)phthalate) Incident management, Health Protection Agency 2008 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 ( European Chemicals Bureau (ECB) European Union Risk Assessment Report Volume 80 , 2008 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947324949 European Food Safety Authority (EFSA) International Agency for Research on Cancer (IARC) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to Bis(2-ethylhexyl)phthalate (DEHP) for use in food contact materials Question N° EFSA-Q-200 International Agency for Research on Cancer (IARC) - Summaries & Evaluations DI(2-ETHYLHEXYL) PHTHALATE (Group 3) VOL.: 77 (2000) (p. 41) http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej243_dehp_en2 .pdfssbinary=true US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels Toxicological Profile for Di(2-ethylhexyl)phthalate (DEHP) September 2002 including Reference: David RM, Moore MR, Finney DC, et al. 2000a. Chronic toxicity of di(2-ethylhexyl)phthalate in rats. Toxicol Sci 55:433-443. http://www.inchem.org/documents/iarc/vol77/77-01.html http://www.atsdr.cdc.gov/toxprofiles/tp9.pdf (& http://www.atsdr.cdc.gov/mrls/index.html for MRLs) Page 6 of 6 EIC proforma di-n-octylphthalate 09/09/2009
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