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EC number: 201-553-2
CAS number: 84-69-5
Only limited information is available on
uptake and fate of diisobutyl phthalate (DIBP) in vivo, however
supporting information is available for the homologues dibutyl phthalate
(DBP) and diethylhexyl phthalate (DEHP).
DIBP is absorbed by rat skin (Elsisi et al.,
1989) with around 50-60% of the applied dose excreted over 7 days,
primarily in urine. No information is available on uptake following oral
or inhalation exposure.
Information summarized in the EU risk
assessment report for DPB (EU, 2003) indicates rapid uptake and
excretion after oral administration, with greater than 90% excreted in
urine within 24-48 hr by rats and hamsters; faecal excretion is low.
After dermal exposure, rats excreted around 60% of an applied dose of
DBP within 7 days with around 12% of the dose found in faeces.
DEHP is similarly well absorbed from the gut
(EU, 2008) with recovery of around 50% of the dose from rats, non-human
primates and humans given up to about 200 mg/kg bw; at higher doses,
absorption in non-human primates is dose-limited in contrast to rodents.
Limited data on toxicokinetics following inhalation or dermal exposure
indicate that DEHP can be absorbed through the lungs whereas absorption
through the skin appears to be limited, with route-dependent uptake of
75% and 50%, respectively (EU, 2008). In vitro data (Scott et al., 1989)
indicate that rat skin is approx. 2-fold more permeable than is human
skin to topically applied DEHP.
The metabolism of phthalate esters is
typified by rapid hydrolysis to the mono ester and the corresponding
alcohol within the gut (EU 2003; 2008), although further hydrolysis is
reported in the liver and kidneys for DBP. In vitro studies with DIBP
demonstrate hydrolysis to monoisobutyl phthalates by carboxyesterases
(Mentelin and Butte, 1989).
Information on DBP shows that it is
initially excreted in the bile and subsequently enters the enterohepatic
with subsequent metabolism. Monobutyl phthalate forms MBP-glucuronide,
and undergoes subsequent omega- and omega-1 oxidation.
Phthalate esters are not associated with
accumulation in body tissues.
For the purposes of risk characterisation of
DIBP, it is proposed to assume 100% absorption for human oral and
inhalation exposures. For dermal absorption, information indicating
excretion of approximately 60% of an applied dose by rats together with
other findings suggesting that human skin is less permeable to phthalate
diesters than is rat skin leads to a conservative estimate of 50% uptake
by human skin.
EU (2003) European Union Risk Assessment
Report: dibutyl phthalate, volume 29. Office for Official Publications
of the European Communities, Luxembourg.
EU (2008) European Union Risk Assessment
Report: bis(2-ethylhexyl) phthalate, volume 80. Office for Official
Publications of the European Communities, Luxembourg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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