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Di n butyl phthalate, Di butyl phthalate or
DBP
Scientific Committee on Food (SCF) pre 2002 http://ec.europa.eu/food/fs/sc/scf/index_en
.html
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
1999 07/04/2009 TDI 0.05 mg/kgbw/day 50
European Centre for Ecotoxicology and
Toxicology of Chemicals (ECETOC)
http://www.ecetoc.org/ 1998 14/04/2009 TDI 100 ug/kg bw/day 100 LOAEL 52 mg/kg bw/day 500 10 inter, 10 intra and 5 as LOAEL
2001 21/04/2009 LOAEL 52 mg/kg (bw/day) 52 LOAEL 52 mg/kg bw/day 1000 10 inter, 10 intra and 10 as LOAEL
(SR2)
ICPS Environmental Health Criteria (EHC)
Monographs
http://inchem.org/pages/ehc.html 07/04/2009 ADI 0.066 mg/kgbw/day 66 Approximate LOAEL for
developmental and
reproductive effects in
rats observed in the
most sensitive studies
to date
66 mg/kgbw/day 1000 10 for interspecies, 10 for
interindividual variation, 10 for lack of
data on a NOAEL. Factor for lack of a
NOAEL considered adequate as
effects observed at lowest doses
moderate and probably reversible.
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 52 ug/kg bw/day 52 LOAEL based on Reevaluation
of humantoxicological
Maximum
Permissible Levels.
52 mg/kg bw/day 1000 10 for LOAEL to NOAEL and 100 for
intra and inter species variation
Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 17/12/2007 08/04/2009 TDI 0.0625 mg/kg bw/day 62.5 The NOEL for study in
mice for teratogenic
and fetotoxic effects.
62.5 mg/kgbw/day 1000 10 for intraspecies, 10 for
interspecies and 10 for severity of the
effect at the LOAEL in the critical
study -(teratogenicity) and for
database inadequacies (inadequate
chronic toxicity and
carcinogenicity);factor considered
conservative given large variation in
doses in the critical study i.e., the
LOAEL is 10 times NOEL.
US Agency for Toxic Substances and Disease
Registry (ATDSR) Toxicological Profiles and
Minimal Risk levels
http://www.atsdr.cdc.gov/
14/01/2009 for MRL
page (And report 30
June 2001)
39911 Acute-duration oral MRL 0.5 mg/kgbw/day 500 NOAEL from acute
study on rats.
50 mg/kgbw/day 100 10 for use of a LOAEL, 10 for
extrapolation from animals to
humans, 10 for human variability
USEPA Health Advisors
USEPA Integrated Risk Information System
(IRIS)
Entrez PubMed
http://www.epa.gov/waterscience/criteria/d
rinking
Last updated on Thur
http://epa.gov/iris/
http://www.ncbi.nlm.nih.gov/entrez/query.f
cgi
01/08/1990 (dtatabse
Date of paper 2007
(abstract only
viewed)
08/04/2009 Reference to IRIS
08/04/2009 Reference dose 1E-1
mg/kg/day
20/04/2009 TDI 10 ug/kg bw/day 10
mg/kgbw/day 100 Low NOAEL from Increased
mortality
Rat Subchronic to
Chronic, Oral in
Bioassay by Smith,
1953
125 mg/kgbw/day 1000 10 for interspecies variation, 10
sensitive human subpopulations, 10
for both the not chronic study and
study deficiencies e.g. only male
animals.
Date of paper 2007
(abstract only
viewed)
20/04/2009 TDI 10 ug/kg bw/day 10
TDI inhal
Recommended
TDIinhal
CLEA Units
ug.kg-1.d-1
10
Organisation Last Updated Health criteria type Value Initial Units CLEA units ug.kg- Confidence
1.d-1
rating
Drinking Water Inspectorate (DWI) http://www.dwi.gov.uk/ 31-Mar-09 31-Mar-09
Justification
Based on ECB study reporting including both local and systemic effects. (Note: value selected is higher than systemic effects based on oral exposure).
Basis Value Units UF UF description
Page 3 of 8
EIC proforma Di n butyl phthalate.xls26/08/2009