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
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Di n butyl phthalate, Di butyl phthalate or<br />
DBP<br />
TDI oral<br />
Food Standards Agency (FSA)<br />
Reference to Endocrine disruptors. States that EFSA Not stated.<br />
reviews all the scientific data to set a TDI.<br />
http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf - notes<br />
provisional TDI of 50ug/kgbw/day <strong>for</strong> all phthalte<br />
esters in contact with food (excluding diethylphthalate<br />
= 500ug/kgbw/day SCF (1996)).<br />
Phthalates in infant <strong>for</strong>mulae (Opinion expressed on 7 June 1996). Reports of<br />
the Scientific Committee on Food, 36th Series. Available at:<br />
http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html<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 />
Committee on the Toxicity of Chemicals in<br />
Food, Consumer Products and the<br />
Environment (COT)<br />
NOAEL<br />
Reference to a group restriction of 0.05mg/kg bw/day.<br />
Dibutylphthalate assessed further. References noted<br />
other effects but did not provide effect doses -<br />
synergistic /antagonistic effects with TCE and<br />
haptachlor, exposure of rats to high levels during<br />
pregnancy inducing a disorders in offspring similar to<br />
human Testicular Dysgenesis Syndrome, and in fetal<br />
life a substantial reduction in anogenital distances.<br />
Not stated.<br />
Variability and Uncertainty in Toxicology of Chemicals in Food, Consumer<br />
Products and the Environment March 2007 TOX/2003/09 COMMITTEE ON<br />
TOXICITY OF CHEMICALS IN FOOD, CONSUMER PRODUCTS AND THE<br />
ENVIRONMENT ADVERSE TRENDS IN DEVELOPMENT OF THE MALE<br />
REPRODUCTIVE SYSTEM - POTENTIAL CHEMICAL CAUSES 2003 and annual<br />
report 2006)<br />
http://cot.food.gov.uk/pdfs/cotstatementphthalates96.pdf also in<br />
http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf referring to SCF (1996).<br />
Phthalates in infant <strong>for</strong>mulae (Opinion expressed on 7 June 1996). Reports<br />
of the Scientific Committee on Food, 36th Series. Available at:<br />
http://europa.eu.int/comm/food/fs/sc/scf/reports_en.html<br />
(Other sites with no dose data<br />
http://cot.food.gov.uk/pdfs/vutreportmarch2007.pdf ,<br />
http://cot.food.gov.uk/pdfs/2003-09endocrine.PDF,<br />
http://cot.food.gov.uk/pdfs/cotsection06.pdf )<br />
There are also recent DBP data from US NTP dietary<br />
rat study using a range of doses. Males were exposed<br />
to DBP via their mothers throughout pregnancy and<br />
lactation and subsequently directly via the diet until<br />
adult. Effects on adult testis weight and<br />
histopathological lesions shown at doses of 570 mg/kg<br />
bw/day and above, with a no-effect level of 250 mg/kg<br />
bodyweight/day<br />
testes<br />
Jul 1996 STATEMENT ON PHTHALATES IN INFANT<br />
FORMULAE<br />
http://cot.food.gov.uk/pdfs/cotstatementphthalates96.pdf<br />
European Chemicals Bureau (ECB)<br />
Rat, 2 geenration<br />
reproductivity<br />
study<br />
LOAEL based on embryotoxic effects in rats. Absence Embryonic development and endocrine<br />
of maternal toxicity in a two-generation reproduction activity<br />
study with a continuous breeding protocol including<br />
improved sensitive endpoints and exposure of both<br />
sexes. Protocol intended to identify compounds with<br />
endocrine activity. 52 mg/kg bw chosen to be<br />
consistent with the EU SCTEE; in an assessment of PVC<br />
toys and child-care articles, the SCTEE identified the<br />
LOAEL of 0.1% in the diet as critical LOAEL <strong>for</strong> DBP and<br />
set it at 52 mg/kg bw (CSTEE, 1998). However, as<br />
observed effects more likely from maternal than<br />
paternal dosing, 0.1% of diet equates better to 80<br />
mg/kg bw than to 52 mg/kg bw. Lowest NOAEL <strong>for</strong> this<br />
peroxysomal proliferation in rats was 19.9 mg DBP/kg<br />
bw, however this effect not considered important in<br />
humans (ECETOC, 1992).<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 />
European Food Safety Authority (EFSA)<br />
Rat,<br />
Recent rat developmental study, with dietary DBP Germ cell development and mammary<br />
developmentaand exposure from late gestation (day 15) to end of glands.<br />
reproductive<br />
studies..<br />
lactation (postnatal day 21), showed effects on the<br />
development of male and female offspring at relatively<br />
low doses. Germ cell development and mammary<br />
gland change at 20 mg/kg in the diet (lowest tested<br />
dose), NOAEL could not be established.<br />
The EFSA Journal (2005) 242, 1-17<br />
Opinion of the Scientific Panel on Food Additives,<br />
Flavourings, Processing Aids and Material in Contact with Food (AFC)<br />
on a request from the Commission related to<br />
Di-Butylphthalate (DBP) <strong>for</strong> use in food contact materials<br />
Question N° EFSA-Q-2003-192<br />
Adopted on 23 June 2005 by written procedure<br />
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej242<br />
_dbp_en2.pdfssbinary=true<br />
Page 2 of 8<br />
EIC pro<strong>for</strong>ma Di n butyl phthalate.xls26/08/2009