Soil Generic Assessment Criteria for Human Health Risk ... - ESdat

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Bis ethylhexyl phthalate,
di(2 ethylhexyl)phthalate or DEHP
Scientific Committee on Food (SCF) pre 2002
http://ec.europa.eu/food/fs/sc/scf/index_en.
html
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
16 December 1994
report
07/04/2009 TDI 0.05 mg/kgbw/day 50 Not given( but
note the basis of
peroxisomal
proliferation now
not regarded as
significant in
humans)
NOEL of
perxoysomal
proliferation
5 NOEL
mg/kg/bw/d
100 Not given but less than 100 considered
International Agency for Research on Cancer
(IARC)
http://inchem.org/pages/iarc.html 07/04/2009 No data on noncarcinogenicity
- see
description
N/A N/A N/A N/A N/A N/A N/A N/A N/A
Joint Expert Committee on Food Additives
(JECFA)
WHO Guidelines for drinking water Quality
http://who.int/ipcs/food/jecfa/en/ 07/04/2009 DEHP use lowest
Level attainable
(1988)
http://www.who.int/water_sanitation_health
/dwq/guidelines/en
2006 08/04/2009 WHO for Drinking
Water standard of
8ug/l
N/A N/A N/A N/A N/A N/A N/A N/A N/A
25 ug/kg of body
weight for DEHP,
25 Low Based on a NOAEL 2.5 NOAEL
for peroxisomal
proliferation in the
liver in rats.
mg/kg/bw/d
100 Inter- and Intraspecies variation
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 TDI 4 ug/kg bw/day 4 Very low
superseded by
EFSA. Low
confidence in
study also
expressed by
others.
Testicular effects 3.7 mg/kg bw /day 1000 10 for extrapolation to life time, 10 for
intra-species and 10 for inter-species
variation
Other values detailed in study 1993 20/04/2009 TDI 20 ug/kg bw/day 20 Very low. NOAEL 19 mg/kg bw/day 1000 Not stated
1997 20/04/2009 TDI 50 ug/kg bw/day 50 Very low. Not stated. Not stated. Not stated. N/A N/A
Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 19/04/2007 08/04/2009 44ug/kgbw/day
based on
developmental
studies by Wolkowski-
Tyl et al.
0.044 mg/kgbw/day 44 No t given NOEL for nonhepatic
peroxisome
proliferation
effects.
44 mg/kg/day 1000 10 for inter-species variation, 10 for
intra-species variation and 10 for
potential teratogenicity
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/
14/01/2009 for MRL
page (And report June
2002)
08/04/2009 TDI Oral 0.1 mg/kg/day/ 0.06
mg/kg/day
Int. / Chromic 100 / 100 Repro. / Repro. Final Both values = 10 for animals to
humans, 10 for human variability.
USEPA Health Advisors
USEPA Integrated Risk Information System
(IRIS)
http://www.epa.gov/waterscience/criteria/dr Last updated on Thursday08/04/2009
Reference to IRIS
inking
http://epa.gov/iris/ 05/01/1991 last note in 08/04/2009 Reference Dose 0.02 mg/kg bw/day 20 Medium Increased relative
liver weight
LOAEL: 0.04% of
diet
(19 mg/kg
bw/day)
19 mg/kg bw /day 1000 10 for inter-species variation and 10
for sensitive humans. Additional factor
of 10 as guinea pig exposure longer
than subchronic but less than lifetime,
LOAEL effect was considered minimally
adverse.
Entrez PubMed
http://www.ncbi.nlm.nih.gov/entrez/query.fc
gi
Date of paper 2005
(abstract only)
Date of paper 2003
(abstract only)
Date of paper 2006
(abstract only)
20/04/2009 TDI 37 ug/kg bw/day 37
20/04/2009 TDI 37 ug/kg bw/day 37
20/04/2009 RfD 20 ug/kg/day 20
Date of paper 2006
(abstract only)
20/04/2009 TDI 20-48 ug/kg bw/day range 20-48
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