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
Data review
Based on peroxysomal proliferation. Also referes to NOEL of
35/mg/kg/bw/d for reproductive toxicity.
Peroxyisomal proliferation
Phthalates in infant formulae (Opinion expressed on 7 June
1996). Reports of the Scientific Committee on Food, 36th Series.
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_36.pdf
International Agency for Research on Cancer
(IARC)
Data review
Overall evaluation is not classifiable as to its carcinogenicity
to humans (Group3) - this updated the previous issue of
1982 - mechanism that increases the incidence of tumours in
rats and mice is not relevant to humans.
N/A N/A N/A
Joint Expert Committee on Food Additives
(JECFA)
N/A N/A N/A N/A N/A
WHO Guidelines for drinking water Quality
Rat
Hinton RH et al. Effects of phthalic acid esters on the liver
and thyroid.
Liver
DEHP in Drinking-Water Background document for development of WHO
Guidelines for Drinking-water Quality WHO 2003, & Guidelines for Drinkingwater
Quality FIRST ADDENDUM TO THIRD EDITION Volume 1
Recommendations WHO 2006.
http://www.who.int/water_sanitation_health/dwq/gdwq0506.pdf &
http://www.who.int/water_sanitation_health/dwq/chemicals/di2ethylhexyp
hthalate.pdf
Dutch National Institute for Public Health and
the Environment (RIVM) Maximum
Permissible Risk (MPR) levels
Mce
Baars et al study exposure in household dust value of
4ug/kgbw/day. Also references reproduction study and
teratogenicity studies. Oral NOAEL 35mg/kg bw/day for
reproductive effects noted. Most prominent effects in
repeated dose study are testicular - dietary NOEAL of 3.7
mg/kg bw/day for 13 weeks.
Testes
Re-evaluation of maximum permissible levels By Baars et al RIVM
711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to
chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W.
Noorlander
http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf &
http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al)
Health Canada Toxicological Values
Not stated Not stated Not stated Hassauer M et al, (1993) Basisdate Toxikologie fur umweltrelevante Stoffe zur
Gefahrenbeuteilung bei Altlasten, Germany
Not stated Not stated Not stated EC (1997) Food Sciences and Techniques, Report of the Scientific Committee
for Food, no.39, Office of Official Publicaions of the European Communities,
Luxembourg.
Reproduction
toxicity in mice
Wolkowski-Tyl et al . (1984a) mouse study found LOAEL for
mothers and offspring was 91 mg/kg bw/d (maternal toxicity,
increased resorptions and dead foetuses)NOEL for mothers
and offspring was 44 mg/kg bw/d - teratogenic effects at
higher doses and evidence of teratogenicity Shiota and Mima
study (1985). Data indicate humans may be less sensitive
than rodents but insufficient information to take this into
account when setting UF.
44 mg/[kg (b.w.)·d] is the NOEL for effects other than
those related to hepatic peroxisome proliferation2 [i.e.,
adverse developmental effects observed at the next
highest dose in the investigation by Wolkowski-Tyl et al.
(1984a); lower NOELs in other developmental studies are a
function predominantly of wider spacing of the
administered doses].
Bis(2-ethylhexyl) Phthalate - PLS1. Canadian Environmental Protection Act
Priority Substances List Assessment Report Bis(2-ethylhexyl)Phthalate 1994.
Study for NOEL is Wolkowski-Tyl R, C.Jones Price, MC Marr and CA Kinmel
Teratologic Evaluation of Diethylhexyl Phthalate in CD-1 Mice, Final Report,
National Center for Toxicological Research, Jefferson, AR, PB5-15674 (1984)
http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-
lsp1/bis_2_ethylhexyl/bis_2_ethylhexyl_3-eng.php
US Agency for Toxic Substances and Disease
Registry (ATSDR) Toxicological Profiles and
Minimal Risk levels
Rat
Male and female rats fed DEHP for 104 weeks. NOAEL for
females of 7.3mg/kg/day.
For Intermediate the lowest dose, 14 mg/kg/day, is a
NOAEL for reproductive toxicity in the male and female
mice. For Chronic the lowest dose, 5.8 mg/kg/day, is a
NOAEL for testicular toxicity in the male rats.
Toxicological Profile for Di (2 ethylhexyl) Phthalate, September 2002 Study
from David RM, Moore MR, Finney DC, et al. 2000a. Chronic toxicity of di(2-
ethylhexyl)phthalate in rats. Toxicol Sci 55:433-443.
http://www.atsdr.cdc.gov/toxprofiles/tp9.pdf (&
http://www.atsdr.cdc.gov/mrls/index.html for MRLs)
USEPA Health Advisors
USEPA Integrated Risk Information System
(IRIS)
See Description
Increased relative
liver weight
Guinea Pig Subchronic-to-Chronic
Oral Bioassay
Increased relative liver weight. Guinea Pig sub-chronic-tochronic
oral Bioassay. Carpenter et al., 1953
IRIS Database Carpenter CP, CS Weil and HF Smyth 1953 Chronic oral toxicity
of di(2 ethyl hexyl)phthalate for rats and guinea pigs. Arch. Indust. Hyg.
Occup. Med. 8: 219-226
http://www.epa.gov/ncea/iris/subst/0014.htm
Entrez PubMed
level established by the EU Scientific Committee for Toxicity,
Ecotoxicity and Environment (SCTEE)
level established by the EU Scientific Committee for Toxicity,
Ecotoxicity and Environment (SCTEE)
Human monitoring of phthalates and risk assessment. 1: J Toxicol Environ
Health A. 2005 Aug 27;68(16):1379-92.
An estimation of the daily intake of di(2-ethylhexyl)phthalate (DEHP) and
other phthalates in the general population. Int J Hyg Environ Health. 2003
Mar;206(2):77-83
no referece - likely to be USEPA Di(2-ethylhexyl)phthalate (DEHP): human metabolism and internal exposure--
an update and latest results Int J Androl. 2006 Feb;29(1):155-65; discussion
181-5
http://www.ncbi.nlm.nih.gov/pubmed/16009652ordinalpos=3&itool=Entrez
System2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPane
l.Pubmed_RVDocSum
http://www.ncbi.nlm.nih.gov/pubmed/12708228ordinalpos=2&itool=Entrez
System2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPane
l.Pubmed_RVDocSum
http://www.ncbi.nlm.nih.gov/pubmed/16466535ordinalpos=1&itool=Entrez
System2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pu
bmed_Discovery_RA&linkpos=5&log$=relatedreviews&logdbfrom=pubmed
no reference Di(2-ethylhexyl)phthalate (DEHP): human metabolism and internal exposure--
an update and latest results. Int J Androl. 2006 Feb;29(1):155-65; discussion
181-5
http://www.ncbi.nlm.nih.gov/pubmed/16466535ordinalpos=1&itool=Entrez
System2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pu
bmed_Discovery_RA&linkpos=5&log$=relatedreviews&logdbfrom=pubmed
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