Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
Soil Generic Assessment Criteria for Human Health Risk ... - ESdat Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di n butyl phthalate, Di butyl phthalate or DBP Food Standards Agency (FSA) http://www.food.gov.uk/ 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 31/03/2009 Friday 5 August 2005 (On Health and Safety Executive (HSE) http://www.hse.gov.uk/ 06/04/2009 WEL and STEL 8 hrs - 5, 15 mins - 10 mg.m-3 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 07/04/2009 NOAEC of 509mg/m3 for systemic effects and 1.18 LOAEC for local effects 0.012 for local effects ( 1.616 for systemic effects) mg/kg bw/day 12 and 1616 Note UF for workers not for children For local effect an effect was seen at lowest dose (11.18 mg/m3) which is a LOAEC . For systemic effects, no effects observed at highest dose (509 mg/m3) which is a NOAEC. 1.18 and 509 mg/m3 27 for local effects (and 90 for systemic effects) Interspecies x 3, Intraspecies x 3, experimental conditions vs worker's exposure pattern, Type of critical effect x 1, dose-response curve x 1, Confidence of the database x 3. Total UF = 27 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 USEPA Health Advisors USEPA Integrated Risk Information System (IRIS) http://www.epa.gov/waterscience/criteria/d rinking http://epa.gov/iris/ Last updated on Thursday, March 26th, 2009. 26/7/1990 (database last commented in 1998) 08/04/2009 Reference to IRIS 08/04/2009 ID oral Recommended ID oral Units n/a Justification Weight of evidence indicates not carcinogenic Organisation Last Updated Non threshold effects Basis Health criteria type Food Standards Agency (FSA) http://www.food.gov.uk/ Friday 5 August 2005 31/03/2009 Site refer to endocrine disruptors (One site date not given) not to carcinogenicity Value Units Confidence rating Basis 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 07/04/2009 No adequate long-term toxicity and/or carcinogenicity studies in animals as well as humans are available 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") Page 5 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 Food Standards Agency (FSA) Not data on inhalation dose. Reference make to endocrine disruptors. Site relates to contact with food 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 Health and Safety Executive (HSE) Risk Phrases refer to R60 and R61 (harm fertility and harm the unborn child) and R50 toxic to aquatic organisms HSC/04/06 Annex C http://www.hse.gov.uk/aboutus/meetings/hscarchive/2004/091104/c06c.p df European Chemicals Bureau (ECB) Rat, 28-day inhalation Study in line with current good practise. Further notes Upper respiratory tract (local effect) on UF: Because an inhalation study is used a factor for allometric scaling is not necessary, and a factor 3 is applicable. A factor for extrapolation of exposure duration is not considered necessary since it is assumed that exposure duration will only have influence on the severity of the effects and not on the level of toxicity c) A factor 3 is introduced for the extrapolation of a LOAEC to a NOAEC European Union Risk Assessment Report Volume 29 , 2003 with addendum 2004. Refers to Gamer et al., 2000. http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf Joint FAO/WHO Meeting on Pesticide Residues (JMPR) reference to phthalates only relate to DMP as solvent for dermal test and DEHP and an interference JMPR 2 reference to phthalates only relate to DMP as solvent for dermal test and DEHP and an interference Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels USEPA Health Advisors 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) USEPA Integrated Risk Information System (IRIS) ID oral The health effects data for dibutyl phthalate were reviewed by the U.S. EPA RfD/RfC Work Group and determined to be inadequate for derivation of an inhalation RfC. http://www.epa.gov/ncea/iris/subst/0038.htm Organisation Food Standards Agency (FSA) Study type Description Response Reference Web link 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 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 Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Health Canada Toxicological Values Carcinogenicity is potentially the most sensitive endpoint. The weight of available data in in vitro assays indicates that dibutyl phthalate is not genotoxic. No human epidemiological studies to assess carcinogenicity and available data considered inadequate to assess the carcinogenicity animals. re-evaluation of maximum permissible levels By Baars et al RIVM http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf & 711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al) chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W. Noorlander Dibutyl Phthalate - PSL1 http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1- lsp1/phthalate_dibutyl_phtalate/phthalate_dibutyl_phtalate_3-eng.php Page 6 of 8 EIC proforma Di n butyl phthalate.xls26/08/2009
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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948<br />
Di n butyl phthalate, Di butyl phthalate or<br />
DBP<br />
Food Standards Agency (FSA)<br />
Not data on inhalation dose. Reference make to<br />
endocrine disruptors. Site relates to contact with food<br />
http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates/ &<br />
http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lan<br />
g=en & http://cot.food.gov.uk/pdfs/TOX-<br />
2004-14.pdf SCF (1996). Phthalates in infant <strong>for</strong>mulae (Opinion expressed<br />
on 7 June<br />
1996). Reports of the Scientific Committee on Food, 36th Series. Available<br />
at: http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html<br />
<strong>Health</strong> and Safety Executive (HSE)<br />
<strong>Risk</strong> Phrases refer to R60 and R61 (harm<br />
fertility and harm the unborn child) and<br />
R50 toxic to aquatic organisms<br />
HSC/04/06 Annex C<br />
http://www.hse.gov.uk/aboutus/meetings/hscarchive/2004/091104/c06c.p<br />
df<br />
European Chemicals Bureau (ECB)<br />
Rat, 28-day<br />
inhalation<br />
Study in line with current good practise. Further notes Upper respiratory tract (local effect)<br />
on UF: Because an inhalation study is used a factor <strong>for</strong><br />
allometric scaling is not necessary, and a factor 3 is<br />
applicable. A factor <strong>for</strong> extrapolation of exposure<br />
duration is not considered necessary since it is<br />
assumed that exposure duration will only have<br />
influence on the severity of the effects and not on the<br />
level of toxicity c) A factor 3 is introduced <strong>for</strong> the<br />
extrapolation of a LOAEC to a NOAEC<br />
European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 29 , 2003 with addendum<br />
2004. Refers to Gamer et al., 2000.<br />
http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />
Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf<br />
Joint FAO/WHO Meeting on Pesticide<br />
Residues (JMPR)<br />
reference to phthalates only relate to DMP as solvent<br />
<strong>for</strong> dermal test and DEHP and an interference<br />
JMPR 2<br />
reference to phthalates only relate to DMP as solvent<br />
<strong>for</strong> dermal test and DEHP and an interference<br />
Dutch National Institute <strong>for</strong> Public <strong>Health</strong><br />
and the Environment (RIVM) Maximum<br />
Permissible <strong>Risk</strong> (MPR) levels<br />
USEPA <strong>Health</strong> Advisors<br />
Baars et al states that inhalation not considered<br />
relevant due to low volatility. The dust paper uses the<br />
oral EFSA value given above<br />
re-evaluation of maximum permissible levels By Baars et al RIVM<br />
711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to<br />
chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W.<br />
Noorlander<br />
http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf &<br />
http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al)<br />
USEPA Integrated <strong>Risk</strong> In<strong>for</strong>mation System<br />
(IRIS)<br />
ID oral<br />
The health effects data <strong>for</strong> dibutyl phthalate were<br />
reviewed by the U.S. EPA RfD/RfC Work Group and<br />
determined to be inadequate <strong>for</strong> derivation of an<br />
inhalation RfC.<br />
http://www.epa.gov/ncea/iris/subst/0038.htm<br />
Organisation<br />
Food Standards Agency (FSA)<br />
Study type Description Response Reference Web link<br />
http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates/ &<br />
http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lan<br />
g=en & http://cot.food.gov.uk/pdfs/TOX-<br />
2004-14.pdf SCF (1996). Phthalates in infant <strong>for</strong>mulae (Opinion expressed<br />
on 7 June<br />
1996). Reports of the Scientific Committee on Food, 36th Series. Available<br />
at: http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html<br />
European Chemicals Bureau (ECB)<br />
European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 29 , 2003 with addendum<br />
2004<br />
http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />
Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf<br />
Dutch National Institute <strong>for</strong> Public <strong>Health</strong><br />
and the Environment (RIVM) Maximum<br />
Permissible <strong>Risk</strong> (MPR) levels<br />
<strong>Health</strong> Canada Toxicological Values<br />
Carcinogenicity is potentially the most sensitive<br />
endpoint. The weight of available data in in vitro<br />
assays indicates that dibutyl phthalate is not genotoxic.<br />
No human epidemiological studies to assess<br />
carcinogenicity and available data considered<br />
inadequate to assess the carcinogenicity animals.<br />
re-evaluation of maximum permissible levels By Baars et al RIVM<br />
http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf &<br />
711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al)<br />
chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W.<br />
Noorlander<br />
Dibutyl Phthalate - PSL1<br />
http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-<br />
lsp1/phthalate_dibutyl_phtalate/phthalate_dibutyl_phtalate_3-eng.php<br />
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