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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di n butyl phthalate CAS 84-74-2 Assessor A: Barry Mitcheson, Enviros Assessor B: Alison Pugh, Hyder Final review: Panel/SF Date 05/05/2009 Date 05/05/2009 Date 26/08/2009 MDI Recommended MDIoral Units Justification: Large range of values for oral exposure. A mid range value (towards the upper end) which is referenced in Canada, and 2 of the recent German studies. 133 ug day-1 Exposure may be greater for infants due to infant milk, but will be for a relatively shor Organisation Date Media Value Units Description Reference Web link Food Standards Agency 1993 Diet 31 ug day-1 Mean 0.013mg/person/day High end 0.031mg/person per day) 82: MAFF UK - Phthalates in Food (March 1996) Table 2: Estimated mean and high level (97.5th percentile) intakes of individual phthalates from carcass meat, poultry, eggs and milk, based on the analysis of 1993 Total Diet Study samples Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) 1998 Infant milk 13.44 ug day-1 At birth 2.4ug/kgbw/day to 1.4ug/kgbw/day at six months, converts using 5.6kg bodyweight fo 0-1 year old Food Surveillance sheet Number 168 December 1998 MAFF UK - PHTHALATES IN INFANT FORMULAE - FOLLOW-UP SURVEY Table 2: Concentrations and Estimated Average. http://archive.food.gov.uk/maff/archive/food/infsheet/1998/no168/tables.htm Exposure to Individual and Total Phthalates of Infants at Birth and Six Months of Age from Retail Infant Formulae 12/04/2009 No Data TOX/2004/25 COMMITTEE ON TOXICITY OF CHEMICALS IN FOOD, CONSUMERPRODUCTS AND THE ENVIRONMENT- TOXICOLOGICAL EVALUATION OF A PILOT STUDY FOR A BREAST- MILK ARCHIVE European Chemicals Bureau (ECB) 12/04/2009 Food, air and water 25.13 ug day-1 3.59x10-4 mg/kgbw/day based on regional modelling using EUSES Calculation for adults using 70kg body weight European Union Risk Assessment Report Volume 29 , 2003 with addendum 2004 www.food.gov.uk http://archive.food.gov.uk/maff/archive/food/infsheet/1996/no82/table2.htm #Table2 www.cot.food.gov.uk http://ecb.jrc.it/ http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf European Food Safety Authority (EFSA) 12/04/2009 Food, air and water 2.872 ug day-1 3.59x10-4 mg/kgbw/day based on regional modelling using EUSES Calculation for children ujsing 8kg body weight 12/04/2009 Diet 31 ug day-1 The limited available data on DBP concentration in foods and diets in the UK and Denmark were used to provide an estimation of dietary exposure. In the UK, mean and high (97.5th percentile) intakes of DBP from dietary sources were estimated to be respectively 0.013 and 0.031 mg/person/day in the adult population (equivalent 12/04/2009 Diet 29 for adults,in first study and in second study 112 for adults, 64 for 1-6 children and 3.5 * bodyweight of a 7- 14 year old child ug day-1 European Union Risk Assessment Report Volume 29 , 2003 with addendum 2004 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 A Danish study estimated mean DBP exposure between 0.13 to 0.29 mg/day, i.e. The EFSA Journal (2005) 242, 1-17 Opinion of the Scientific Panel on Food Additives, concentrations, exposure at high percentiles estimated as 0.72 mg/day equivalent Flavourings, Processing Aids and Material in Contact with Food (AFC) on a request from the Commission related to root crops (83%) and leaf crops (13%). The oral daily intake for Denmark was Di-Butylphthalate (DBP) for use in food contact materials Question N° EFSA-Q-2003-192 Adopted on 23 June 2005 by written procedure http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf www.efsa.europa.eu/en.htm http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej242_d bp_en2.pdfssbinary=true http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej242_d bp_en2.pdfssbinary=true European Centre for Ecotoixcology and Toxicology of Chemicals (ECETOC) 12/04/2009 Infant milk formula and breast milk 91.84 for
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di n butyl phthalate CAS 84-74-2 Assessor A: Barry Mitcheson, Enviros Assessor B: Alison Pugh, Hyder Final review: Panel/SF Date 05/05/2009 Date 05/05/2009 Date 26/08/2009 US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk Levels Toxicological Data Network (TOXNET) 12/4/9 (report 2001) Cites canadian data Cites Canadian data above as US data out of date http://www.atsdr.cdc.gov/toxprofiles/tp135.pdf www.atsdr.cdc.gov/ 12/04/2009 Average Daily Water Intake 0.02 to 10ug/day ug day-1 HSDB database WATER INTAKE: (assume 0-2.5 ug/L(2)) 20 ng-10,000 ng; FOOD INTAKE: insufficient data(SRC). [(1) Kelly TJ et al; Environ Sci Technol 28: 378-87 (1994) (2) Davies K; Adv Environ Sci Technol 23: 525-40 (1990) ]**PEER REVIEWED** http://toxnet.nlm.nih.gov/ Entrez PubMed 20/04/2009 / Abstract of paper only (2007) 20/04/2009 / Abstract of paper only (2007) 20/04/2009 / Abstract of paper only (2007) 20/04/2009 / Abstract of paper only (2008) 20/04/2009 / Abstract of paper only (2003) Median Daily Intake 532.7 (assumes 70kg bw) ug/day 4.07 / 7.61 ug/kg bw/day. Calculated values (creatinine based / volume based model) - from analysed urine samples from pilot stidy for German Evironmental Survey Di-n-butylphthalate and butylbenzylphthalate - urinary metabolite levels and estimated daily intakes: pilot study for the German Environmental Survey on children.J Expo Sci Environ Epidemiol 2007 Jul: 17(4): 378-87 Epub 2006 sep 27 Estimated Daily Intake 133(assumes 70kg bw) ug/day 1.9ug/kg bw /day, 1996 -2003 value - analysed urine samples from German study Internal phthalate exposure over the last 2 decades - a retrospective human biomonitoring study. Int J Hyg environ Health 2007 May 210 (3-4): 319-33 Median Daily Intake / food 21, (assumes 70kg bw) ug/day 0.3ug/kg bw/day, duplicate diet samples to compare data with calculated data based on urinary levles - age group 14-60 years Median Daily Intake 147 (assumes 70kg bw) ug/day 2.1 ug/kg bw/day, based on urine analysis of 102 german subjects Intake of phthalates and di(2-ethylhexyl)adipate: results of the Integrated Exposure Assessment Survey based on duplicate diet samples and biomonitoring data. Environ Int. 2007 Nov;33(8):1012-20. Epub 2007 Jul 3 Phthalates: metabolism and exposure. Int J Androl. 2008 Apr;31(2):131-8. Epub 2007 Dec 7 95th intake value 1134 (assumes 70kg bw) ug/day 16.2ug/kg bw/day, analysed urine sample from general german population An estimation of the daily intake of di(2-ethylhexyl)phthalate (DEHP) and other phthalates in the general population. Int J Hyg Environ Health. 2003 Mar;206(2):77- 83 MDI Recommended MDIinh Units Justification: Value for adult selected by ECB in regional modelling. 0.12 ug day-1 Organisation Date Media Value Units Description Reference Web link European Chemicals Bureau (ECB) 12/04/2009 Air 0.12 ug day-1 0.006ug/m3 based on regional PEC modelling using EUSES Calculation for adults using 20m3/day European Centre for Ecotoixcology and Toxicology of Chemicals (ECETOC) 12/04/2009 Air 0.0564 ug day-1 0.006ug/m3based on regional PEC modelling using EUSES Calculation for adults using 9.4m3/day 22/04/2009 (2001) Air 40000 (assumes 20m3/day) ug day-1 2mg/m3 (could be as high as 10mg/m3 but this is most likely value). Air concentrations of DBP during use of DBP containing products causing aerosol formation. Non-aerosol forming activities inhalation exposure levels are negligible. 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 Union Risk Assessment Report Volume 29 , 2003 with addendum 2004, http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). Opinion of the results of the Risk Assessment Report of Dibutylphthalate. 23rd penary meeting Brussels, 24 April 2001 www.ncbi.nlm.nih.gov/entrez/query.fcgi http://www.ncbi.nlm.nih.gov/pubmed/17006438ordinalpos=2&itool=EntrezS ystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.P ubmed_RVDocSum http://www.ncbi.nlm.nih.gov/pubmed/17400024ordinalpos=1&itool=EntrezS ystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.P ubmed_RVDocSum http://www.ncbi.nlm.nih.gov/pubmed/17610953ordinalpos=7&itool=EntrezS ystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.P ubmed_RVDocSum http://www.ncbi.nlm.nih.gov/pubmed/18070048ordinalpos=1&itool=EntrezS ystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pub med_Discovery_RA&linkpos=5&log$=relatedreviews&logdbfrom=pubmed http://www.ncbi.nlm.nih.gov/pubmed/12708228ordinalpos=6&itool=EntrezS ystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.P ubmed_RVDocSum http://ecb.jrc.it/ www.ecetoc.org/ http://ec.europa.eu/health/ph_risk/committees/sct/documents/out96_en.pdf IPCS Environmental Health Criteria (EHC) Monographs Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissable Risk (MPR) Levels 12/04/2009 Air Ambient air 0.09 to 0.12ug/day Indoor air 0.06 to 8.4ug/day 12/04/2009 Dust report does not separate out the inhalation of indoor dust as it is small compared to ingestion ug day-1 Ambient air : Data extremely limited. The most extensive information is the range of 4.5 to 6.2 ng/m3 in air sampled along the Niagara River (1983). These values are similar to recent values from Barcelona. Based on adult inhalation of 22 m3, body weight of 64 kg, a 4hr/day outdoor exposure, mean intake estimated to be 0.26 to 0.36 ng/kg bw/d. Indoor air : Maximum concentration of DBP in indoor air in nine homes in Montreal, was 2.85 μg/m3. In a survey of 125 homes in California in 1990, median daytime concentration was 420 ng/m3 . Based on daily inhalation volume for adults of 22 m3, body weight of 64 kg, a 20hr daily exposure and DBP concentration indoor air concentration of 420ng/m3 the daily intake of DBP estimated at 120 ng/kg bw/d. ENVIRONMENTAL HEALTH CRITERIA 189 http://inchem.org/pages/ehc.html Di-n-butyl Phthalate (1997) http://www.inchem.org/documents/ehc/ehc/ehc189.htm#SubSectionNumber:5.2.4 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) www.rivm.nl/en/ Health Canada Toxicological Reference Values 12/04/2009 Ambinet and indoor air 0.8 ug/kg bw/day for adults equivalent to 6ug/day 0.9ug/kg bw/day equivalent to about 7-9ug/day ug/day Substrate/Mediuma Estimated Intake (μg/[kg(b.w.)·day]) 0 to 0.5 yrb 0.5 to 4 yr 5 to 11yrd 12 to 19 yre 20 to 70 yrf Ambient air 0.0002 to 0.0003 to 0.0003 to 0.0003 to 0.0002 to 0.0003 0.0004 0.0004 0.0004 0.0003 Indoor air 0.7 0.9 1.1 0.9 0.8 17/12/2007 Dibutyl Phthalate - PSL1 http://www.hc-sc.gc.ca/ewh- semt/pubs/contaminants/psl1- lsp1/phthalate_dibutyl_phtalate/phthalate_dibutyl_phtalate_3- eng.php www.hc-sc.ga.ca/index_e.html US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk Levels 12/04/2009 Ambient air 1-6ng/m3 equivalent to 0.02ug/day to 0.12ug/day ug day-1 Di-n-butyl phthalate is present in both urban and rural air (1–6 ng/m3), (Data noted to be old http://www.atsdr.cdc.gov/toxprofiles/tp135.pdf www.atsdr.cdc.gov/ Page 2 of 3 EIC proforma Di n butyl phthalate.xls26/08/2009
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