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EC number: 201-557-4
CAS number: 84-74-2
Conclusion on toxicokinetics, metabolism and distribution:
Dibutyl phthalate is rapidly absorbed and excreted after oral
administration as was demonstrated in studies in laboratory animals. Up
to more than 90% of oral doses given to rats or hamsters was excreted in
urine within 24-48h. Fecal excretion is low (1.0-8.2%). Also in human
oral absorption of DBP takes place. After dermal exposure of rats
absorption occurred; ca. 60% of the dose was excreted in urine within 7
days. In feces ca. 12% of the dose was found. An in vitro study revealed
slower absorption of DBP by the human skin (2.40 μg/cm2/hour) than by
the rat skin (93.35 μg/cm2/hour). Data on absorption after exposure by
inhalation are not available. A substantial fraction of DBP is initially
excreted in the bile and subsequently enters the enterohepatic
circulation. No significant accumulation in tissues was observed in
laboratory animals after oral as well as dermal exposure; limited
inhalation data revealed an indication for some accumulation in tissues.
The major part of DBP is hydrolysed to MBP and the corresponding alcohol
prior to absorption by the small intestines, but hydrolysis can also
occur in liver and kidneys. The metabolites that occur in urine are MBP,
MBP-glucuronide, various ω- and ω-1-oxidation products of MBP (more
polar ketones, carboxylates) and a small amount of free phthalic acid .
Species differences in the excretion of MBP and its glucuronide were
observed; rats excreted a larger proportion unconjugated MBP in urine
than hamsters. There are no data on biotransformation after dermal
exposure and exposure by inhalation. Transplacental transfer of DBP and
its metabolites was demonstrated in an oral study with 14C-labelled DBP
in rats. Levels of radioactivity in placenta and embryo were 1/3 of
those in maternal plasma; radioactivity in embryonic tissues accounted
for less than 0.12-0.15% of the administered dose. MBP accounted for
most of the radioactivity in maternal plasma, placenta and embryo.
Unchanged DBP was found only in small amounts. No accumulation of
radioactivity was seen in maternal or embryonic tissues.
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