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EC number: 203-570-0
CAS number: 108-30-5
In a developmental toxicity study
(equivalent to OECD 414), CD rats (25 mated females/group) were treated
orally with 30, 90, or 140 mg/kg/day of maleic anhydride from Day 6
through Day 15 of gestation. Mated females in the control group were
treated in a similar manner with 14 mL/kg of corn oil. All females were
sacrificed with carbon dioxide on Day 20 of gestation, and the fetuses
were delivered by cesarean section. All fetuses were weighed and
examined for external abnormalities. Approximately one-third of the
fetuses were placed in Bouin’s fixative and examined for soft tissue
abnormalities . The remaining fetuses were fixed in alcohol, cleared
with potassium hydroxide, stained with Alizarin Red S and examined for
no changes in appearance or behavior attributable to treatment with
maleic Anhydride at dosage levels of 30, 90 and 140 mg/kg bw/day.
Respiratory involvement and red nasal discharge were observed in all
dosage groups. The incidence of these was higher in the treated groups,
though not in a dose-related pattern. One rat in each dosage group dl.dd
during the first part of treatment. The cause of death was not
determined. There were reduced mean maternal body weight gains during
the first three days of treatment in the 30 mg/kg bw/day dosage group
when compared to the control group. In the 90 and 140 mg/kg bw/day
dosage groups mean body weight losses were observed for the first 3 days
of treatment. These reductions in weight gains resulted in reduced mean
weight gains over the entire treatment period in all treatment groups
when compared to the control group. There were no biologically
meaningful differences in the mean number of viable fetuses,
implantations, post implantation losses, corpora lutea or in the male to
female sex ratio between any of the maleic anhydride treated groups and
the control group. Based on the results, the NOAEL for maternal toxicity
is considered to be 140mg/kg
no treatment-related effects in developmental parameters. Therefore,
based on the result the developmental NOAEL is also considered to be 140
developmental toxicity study in the rat is classified acceptable and
satisfies the guideline requirement for a developmental toxicity study
(OECD 414) in rats.
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