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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 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 Apply TDIoral to exposure routes Apply IDoral to exposoure routes Apply TDIinh to exposure routes Apply IDinh to exposure routes Oral Inhalation Dermal Yes Yes No No No No No No Yes No No No Combine Oral and Inhalation TDIs No Justification No strong evidence to be a human carcinogen - TDIoral applied to oral and dermal routes No strong evidence to be a human carcinogen- TDIinh based on localised effects where additivity unlikely to be relevant. TDI oral Recommended TDI oral CLEA Units 10 ug.kg-1.d-1 Justification Value selected by EFSA for localised effects based on most recent rat study(2004), which was not considered by most other references. Food Standards Agency (FSA) http://www.food.gov.uk/ Friday 5 August 2005 (One site date not given) 31/03/2009 See Description for information Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) http://cot.food.gov.uk/ 29/4/8 (uploaded infant milk formula file from July 2006) 06/04/2009 TDI 0.05 mg/kgbw/day 50 Not given. COT noted The Committee notes that TDIs are derived new evidence from doses which on reproductive produce no effect in animal studies effects published after TDIs set. 100 SCF, no details given TDI Oral 2.5 mg/kg bw/day 2500 Low as study not designed for risk assessment Developmental study as part of US NTP 250 mg/kg bw/day 100 Margin of safety used by COT European Chemicals Bureau (ECB) http://ecb.jrc.it/ Date of Last Literature Search: 1994 Review of report by MS Technical Experts finalised: 1999 Final report: 2003 (The last full literature survey was carried out in 1994 - targeted searches were carried out subsequently). 07/04/2009 TDI 0.052-0.104 mg/kg bw/day 52 - 104 LOAEL of 52 mg/kg bw based on embryotoxic effects in rats is basis for risk assessment. 80mg/kg bw may be more appropriate - see description 52 mg/kg bw/day 500 - 1000 Includes factor of 5 for uncertainty of LOAEL European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en.html 2005 TDI 0.01 mg/kg bw/day 10 LOAEL from developmental study on rats. Not typo in report referring to 20mg/kg bw/day early on) 2 mg/kg bw/day 200 Effects reversible at all dose levels , especially lowest dose (1.5 to 3 mg/kg bw/day) and also findings of several reproductive studies with longer exposure showing 30 -fold higher NOAELs or LOAELs, uncertainty factor of 200 considered sufficent. Page 1 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 TDI oral Food Standards Agency (FSA) Reference to Endocrine disruptors. States that EFSA Not stated. reviews all the scientific data to set a TDI. http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf - notes provisional TDI of 50ug/kgbw/day for all phthalte esters in contact with food (excluding diethylphthalate = 500ug/kgbw/day 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 http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates/ & http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lan g=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) NOAEL Reference to a group restriction of 0.05mg/kg bw/day. Dibutylphthalate assessed further. References noted other effects but did not provide effect doses - synergistic /antagonistic effects with TCE and haptachlor, exposure of rats to high levels during pregnancy inducing a disorders in offspring similar to human Testicular Dysgenesis Syndrome, and in fetal life a substantial reduction in anogenital distances. Not stated. Variability and Uncertainty in Toxicology of Chemicals in Food, Consumer Products and the Environment March 2007 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 ) There are also recent DBP data from US NTP dietary rat study using a range of doses. Males were exposed to DBP via their mothers throughout pregnancy and lactation and subsequently directly via the diet until adult. Effects on adult testis weight and histopathological lesions shown at doses of 570 mg/kg bw/day and above, with a no-effect level of 250 mg/kg bodyweight/day testes Jul 1996 STATEMENT ON PHTHALATES IN INFANT FORMULAE http://cot.food.gov.uk/pdfs/cotstatementphthalates96.pdf European Chemicals Bureau (ECB) Rat, 2 geenration reproductivity study LOAEL based on embryotoxic effects in rats. Absence Embryonic development and endocrine of maternal toxicity in a two-generation reproduction activity study with a continuous breeding protocol including improved sensitive endpoints and exposure of both sexes. Protocol intended to identify compounds with endocrine activity. 52 mg/kg bw chosen to be consistent with the EU SCTEE; in an assessment of PVC toys and child-care articles, the SCTEE identified the LOAEL of 0.1% in the diet as critical LOAEL for DBP and set it at 52 mg/kg bw (CSTEE, 1998). However, as observed effects more likely from maternal than paternal dosing, 0.1% of diet equates better to 80 mg/kg bw than to 52 mg/kg bw. Lowest NOAEL for this peroxysomal proliferation in rats was 19.9 mg DBP/kg bw, however this effect not considered important in humans (ECETOC, 1992). 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 European Food Safety Authority (EFSA) Rat, Recent rat developmental study, with dietary DBP Germ cell development and mammary developmentaand exposure from late gestation (day 15) to end of glands. reproductive studies.. lactation (postnatal day 21), showed effects on the development of male and female offspring at relatively low doses. Germ cell development and mammary gland change at 20 mg/kg in the diet (lowest tested dose), NOAEL could not be established. The EFSA Journal (2005) 242, 1-17 Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food (AFC) on a request from the Commission related to Di-Butylphthalate (DBP) for use in food contact materials Question N° EFSA-Q-2003-192 Adopted on 23 June 2005 by written procedure http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej242 _dbp_en2.pdfssbinary=true Page 2 of 8 EIC proforma Di n butyl phthalate.xls26/08/2009
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