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Bis ethylhexyl phthalate,
di(2 ethylhexyl)phthalate or DEHP
CAS Number: 117-81-7 Assessor A: Barry Mitcheson, Assessor B: Charlotte Clark, Final review: Panel/SF
Enviros
Hyder
Date 05/05/2009 Date 06/05/2009 Date 26/08/2009
Oral Dermal Inhalation Combine Oral and
Inhalation TDIs
Justification
Apply TDIoral to exposure routes
Yes Yes Yes
Apply IDoral to exposoure routes
Apply TDIinh to exposure routes
Apply IDinh to exposure routes
No No No
No No No
No No No
NR
Group 3 carcinogen (IARC), no strong evidence to be a
human carcinogen - TDIoral applied to oral, dermal
and inhalation routes.
TDI oral
Recommended TDI oral
Units
50 ug.kg-1.d-1
Justification
Value selected by COT, ECB, EFSA & SCF. Lower values used by WHO and RIVM based upon discredited studies. Most recent value (2005) and is compatible with
values referenced in several European sources. Other numbers are from American references
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
Confidence rating Basis Value Units UF UF description
Food Standards Agency (FSA) http://www.food.gov.uk/ 5 August 2005 (One site
date not given)
31/03/2009 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Health Protection Agency (HPA) http://www.hpa.org.uk/ 11-Sep-08 31/03/2009 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
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.
Committee noted
new evidence on
reproductive
effects published
after these TDIs
set.
Refers to SCF
temporary "group
restriction" of
0.05. COT notes
TDIs derived from
no effect dose in
animals.
100 SCF not details given
Expert Panel on Air Quality Standards http://www.defra.gov.uk/environment/airqu N/A 07/04/2009 No data found N/A N/A N/A N/A N/A N/A N/A N/A N/A
(EPAQS)
ality/panels/aqs/index.htm
European Chemicals Bureau (ECB) http://ecb.jrc.it/ Date of Last Literature 07/04/2009
0.145 mg/kgbw/day 145 Not given Moore (1996) with 14.5 NOAEL
adjustment for
50% absorption
mg/kgbw/day
Search : 2005 Review of
report by MS Technical
Experts finalised:
September 2005 Final
report: 2008
NOAEL for kidneys
(14.5mg/kgbw/day),
testicular
(4.8mg/kgbw/day,rep
roduction
(10mg/kgbw/day)
development
4.8mg/kgbw/day) and
added a MOS of 30 to
250 for adults to
babies and 100 for
children
0.048 mg/kgbw/day 48 Not given Wolfe et al. (2003)
Oral exposure
0.1 mg/kgbw/day 100 Not given Lamb et al. (1987)
with adjustment
for 50%
absorption
0.048 mg/kgbw/day 48 Not given Wolfe et al. (2003)
Oral exposure
4.8 NOAEL
mg/kgbw/day
10 NOAEL
mg/kgbw/day
4.8 NOAEL
mg/kgbw/day
100 UF of 10 for species differences. UFs of
3 and 10 for intraspecies differences
(worker and general population,
respectively). Giving Margin of Safety
of 30 (commercial) to 100 for children.
100 figure used. For infants of 3- 12
months a factor of 20, and for