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Di n butyl phthalate, Di butyl phthalate or
DBP
Scientific Committee on Food (SCF) pre 2002
Rat, 90 day and 1
year oral,
reproduction and
teratogenicity.
Limited 90-day and 1 year oral rat studies oral
reproduction and tetratogenicity studies, limited
mutagenicity studies (RIVM May 1998). Needed : tests
for gene mutation and if migration exceeds 0.05mg/kg
28 oral study and peroxisome proliferation study too.
Compilation of the Evaluations of the scientific committee on food on certain
monomers and additives used in the manufacture of plastics materials
intended to come into contact with food Stuffs Until 21 March 1997 SCF
1999
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_42.pdf
European Centre for Ecotoxicology and
Toxicology of Chemicals (ECETOC)
Rat, 2 generation
reproductive
Reduced pup weights observed in a 2 generation
reproductive study with rats
Reduced pup weights
EU Scientific Committee on Toxicity, Ecotoxicity and the Environment http://ec.europa.eu/health/ph_risk/committees/sct/documents/out12_en.
(CSTEE). Phthalate migration from soft PVC toys and child care articles pdf
Opinion expressed at the CSTEE third plenary meeting Brussels 24 April 1998
ICPS Environmental Health Criteria (EHC)
Monographs
Rat, 2 generation
reproductive
Rat, reproductive,
fertility,
developmental
2 generation rat study in evaluation of risk of
reproductive toxicity. - male reproductive system
considered to be main target. Also details a NOAEL
(50mg/kg bw/day) and LOAEL (100mg/kg bw/day) for 1
generation study.
NB. The severe, possibly irreversible, teratogenic,
testicular and epididymal effects were only observed
at the highest dose levels, which also produced other
signs of toxicity. Because DBP is rapidly metabolized
and eliminated, with no evidence of accumulation, no
additional factor was incorporated for lack of data on
chronic effects.
Reproductive system
Reproductive fertility
EU Scientific Committee on Toxicity, Ecotoxicity and the Environment
(CSTEE). Opinion of the results of the Risk Assessment Report of
Dibutylphthalate. 23rd penary meeting Brussels, 24 April 2001
INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
ENVIRONMENTAL HEALTH CRITERIA 189
Di-n-butyl Phthalate
http://ec.europa.eu/health/ph_risk/committees/sct/documents/out96_en.
pdf
http://www.inchem.org/documents/ehc/ehc/ehc189.htm
Dutch National Institute for Public Health
and the Environment (RIVM) Maximum
Permissible Risk (MPR) levels
Health Canada Toxicological Values
Rat, two
generation
Based on embryotoxic effects in rats in the absence of
maternal toxicity in a two-generation reproduction
study.
Embryonic development.
Mice,
62.5 mg/kg bw/d is the lowest reported NOEL in an Fetotoxic and teratogenic effects in mice
development and adequate study (for fetotoxic and teratogenic effects in observed at the next highest dose
teratogenic study mice observed at the next highest dose) (Hamano et
al., 1977). The number of live offspring was decreased,
incidence of external defects (spina bifida,
exencephaly, cleft palate, non-closing eyelid) and
skeletal anomalies (insignificantly) were increased in
the offspring of mice administered 625 mg/kg bw/d
throughout gestation. At this highest dose, an increase
in kidney weight in the mothers was reported.
Re-evaluation of human toxicological maximum permissible levels (Baars
2001) Report no. 711701025, available at http://www.rivm.nl/en/, National
Institute for Public Health
and the Environment, Bilthoven, The Netherlands. (Also used in Dust
evaluation report
Dibutyl Phthalate - PSL1
http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf &
http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al)
http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-
lsp1/phthalate_dibutyl_phtalate/phthalate_dibutyl_phtalate_3-eng.php
US Agency for Toxic Substances and Disease
Registry (ATDSR) Toxicological Profiles and
Minimal Risk levels
Acute study on
rats
Dose-dependent alterations in androgen-regulated Development of male offspring
male reproductive development in rats exposed during
late gestation. Developmental: Increased incidence
of retained areolas and nipple in the male offspring of
rats exposed to 100 mg/kg/day; no effects observed at
50 mg/kg/day. The systemic toxicity of di-n-butyl
phthalate has not been adequately assessed.
TOXICOLOGICAL PROFILE FOR
DI-n-BUTYL PHTHALATE (refers to Mylchreest E, Wallace DG, Cattley RC, et
al. 2000).
http://www.atsdr.cdc.gov/toxprofiles/tp135.pdf
USEPA Health Advisors
USEPA Integrated Risk Information System
(IRIS)
Rat, subchronic,
oral
NOAEL: 0.25% of diet
(125 mg/kg/day)
LOAEL: 1.25% of diet
(600 mg/kg bw/day)
Increased mortality
Rat Subchronic to
Chronic, Oral
Refers to BioassaySmith, 1953
http://www.epa.gov/ncea/iris/subst/0038.htm
Entrez PubMed
TDI defined by the European Union - paper not seen.
value from European Food Saefty Authority (EFSA) -
different to the one found on EFSA website above
Di-n-butylphthalate and butylbenzylphthalate - urinary metabolite levels and http://www.ncbi.nlm.nih.gov/pubmed/17006438ordinalpos=2&itool=Entre
estimated daily intakes: pilot study for the German Environmental Survey on zSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportP
children.J Expo Sci Environ Epidemiol 2007 Jul: 17(4): 378-87 Epub 2006 sep anel.Pubmed_RVDocSum
27
Internal phthalate exposure over the last 2 decades - a retrospective human
biomonitoring study. Int J Hyg environ Health 2007 May 210 (3-4): 319-33
http://www.ncbi.nlm.nih.gov/pubmed/17400024ordinalpos=1&itool=Entre
zSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportP
anel.Pubmed_RVDocSum
TDI inhal
Organisation
Study type Description Response Reference Web link
Drinking Water Inspectorate (DWI)
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EIC proforma Di n butyl phthalate.xls26/08/2009