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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948<br />

Barry Mitcheson,<br />

Bis(2 ethylhexyl)phthalate CAS 117-81-7 Assessor A: Enviros Assessor B: Charlotte Clark, Hyder Final review: Panel/SF<br />

Date 06/05/2009 Date 06/05/2009 Date 26/08/2009<br />

MDI Recommended MDIoral Units Justification: High end exposure selected by FSA from diet study in 1993. Exposure may be greater <strong>for</strong> infants due to infant milk bottles, but will<br />

300 ug day-1 be <strong>for</strong> a relatively short period. High values selected instead of Mean to allow <strong>for</strong> potential exposure from toys.<br />

Organisation Date Media Value Units Description Reference Web link<br />

Food Standards Agency 1993 diet 300 ug day-1 Mean 0.15 mg/person/day and 0.3mg/person/day <strong>for</strong> high<br />

end<br />

Committee on Toxicity of Chemicals<br />

in Food, Consumer Products and the<br />

Environment (COT)<br />

82: MAFF UK - Phthalates in Food (March 1996) Table 2: Estimated mean and high level<br />

(97.5th percentile) intakes of individual phthalates from carcass meat, poultry, eggs<br />

and milk, based on the analysis of 1993 Total Diet Study samples.<br />

www.food.gov.uk<br />

http://archive.food.gov.uk/maff/archive/food/infsheet/19<br />

96/no82/table2.htm#Table2<br />

1998 Infant milk 77.28 ug day-1 At birth exposure is 13.8ug/kgbw/day, at six months Food Survweillance sheet Number 168 December 1998 MAFF UK - http://archive.food.gov.uk/maff/archive/food/infsheet/19<br />

7.7ug/kgbw/day. Conversion made using 5.6kg bodyweight PHTHALATES IN INFANT FORMULAE - FOLLOW-UP SURVEY<br />

fo 0-1 year old.<br />

Concentrations and Estimated Average. Exposure to Individual and Total<br />

98/no168/tables.htm<br />

Phthalates of Infants at Birth and Six Months of Age from Retail Infant Formulae<br />

Table 2:<br />

12/04/2009 No Data TOX/2004/25 COMMITTEE ON TOXICITY OF CHEMICALS IN FOOD, CONSUMER www.cot.food.gov.uk<br />

PRODUCTS AND THE ENVIRONMENT- TOXICOLOGICAL EVALUATION OF A PILOT STUDY<br />

FOR A BREAST- MILK ARCHIVE<br />

European Chemicals Bureau (ECB) 12/04/2009 Food, air and water 1036 ug day-1 14.8ug/kg bw/day <strong>for</strong> a 70kg adult based on modelling of a European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 80 , 2008.<br />

http://ecb.jrc.it/<br />

sewage treatment plant scenario<br />

http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />

Chemicals/RISK ASSESSMENT/REPORT/dehpreport042.pdf<br />

12/04/2009 Food, air and water 135.1 ug day-1 1.93ug/kg bw/day <strong>for</strong> a 70kg adult based on modelling European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 80 , 2008. http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />

Chemicals/RISK ASSESSMENT/REPORT/dehpreport042.pdf<br />

12/04/2009 Food, air and water 1190 ug day-1 17ug/kg bw/day <strong>for</strong> a 70kg adult based on biomonitoring<br />

near sewage treatment works.<br />

European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 80 , 2008.<br />

http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />

Chemicals/RISK ASSESSMENT/REPORT/dehpreport042.pdf<br />

12/04/2009 Food, air and water 664 ug day-1 83ug/kg bw/day <strong>for</strong> a 8kg child based on modelling of<br />

exposure at a sewage tretment plant<br />

European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 80 , 2008,<br />

http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />

Chemicals/RISK ASSESSMENT/REPORT/dehpreport042.pdf<br />

12/04/2009 Food, air and water 155.2 ug day-1 19.4ug/kg bw/day <strong>for</strong> a 8kg child based on regional European Union <strong>Risk</strong> <strong>Assessment</strong> Report Volume 80 , 2008.<br />

http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-<br />

European Food Safety Authority<br />

(EFSA)<br />

12/04/2009 Diet 0.15 (mean) 0.3 (97.5th)<br />

mg/person/day<br />

300/150ug/day<br />

modelling<br />

Limited available data on DEHP in foods and diets in UK Opinion of the Scientific Panel on Food Additives,<br />

and Denmark used to estimate dietary exposure. In the UK, Flavourings, Processing Aids and Materials in Contact with Food (AFC)<br />

mean and high (97.5th percentile) dietary intakes of DEHP on a request from the Commission related to<br />

estimated to be respectively 0.15 and 0.3 mg/person/day Bis(2-ethylhexyl)phthalate (DEHP) <strong>for</strong> use in food contact materials<br />

Question N° EFSA-Q-2003-191<br />

bw/day) <strong>for</strong> a 60 kg adult. Exposure of infants vai <strong>for</strong>mulae Adopted on 23 June 2005 by written procedure<br />

exposure calculated to be 23.5ug/kg be/day(Muller et al)<br />

Chemicals/RISK ASSESSMENT/REPORT/dehpreport042.pdf<br />

www.efsa.europa.eu/en.htm<br />

http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/a<br />

fc_op_ej243_dehp_en2.pdfssbinary=true<br />

12/04/2009 Diet 300 <strong>for</strong> adults,in first<br />

study and in second study<br />

315 <strong>for</strong> adults, 208 <strong>for</strong> 1-<br />

6 children and 11 *<br />

bodyweight of a 7-14<br />

year old child<br />

ug day-1<br />

A Danish study estimated mean DEHP exposure ranging<br />

<br />

70 kg adult). Based on the highest concentration of DEHP,<br />

high percentile exposure estimated as 1.1 mg/day (i.e. 15.7<br />

<br />

exposure as leaf crops (53%), root crops (13%), milk (12%)<br />

<br />

<br />

<br />

http://ec.europa.eu/fppd/fs/sc/scf/index_en.html<br />

European Centre <strong>for</strong> Ecotoixcology<br />

and Toxicology of Chemicals<br />

(ECETOC)<br />

12/04/2009 Infant milk <strong>for</strong>mula and<br />

breast milk<br />

56 <strong>for</strong>

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