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EC number: 203-742-5
CAS number: 110-16-7
A two-generation study similar to OECD 416
was performed with maleic anhydride in Sprague-Dawley rats. The test
substance was administered orally at doses of 0, 20, 55 and 150 mg/kg
body weight and day, on 7 days/week, at a dose volume of 10 mL/kg body
F0 clinical observations: with the
exception of a few cases of respiratory rales, the clinical appearance
andbehaviorwere not remarkably different from the controls. Significant
mortality occurred in adults of both sexes from the 150 mg/kg group.
F1 clinical observations: Respiratory
rates were also observed and the incidence and severity appeared to
increase with dose. These rats often vigorously resisted handling at the
time of dosing. Due to 100% mortality among the high-dose females by
study week 42, the remaining high-dose males were terminated by study
weights in the F0 high-dose group were significantly reduced by Week 11
and this reduction persisted for the remainder of the test. The
mid-dose group means were low but not statistically significantly
different from the controls. F1
generation showed a similar pattern of depressed weight gain; however,
only the F1 males in the high-dose group had significantly significant
body weight depression at 30 weeks. No
fertility or offspring data are available from the high-dose animals.
and microscopic examination of tissues from F0 adults revealed
compound-related changes in the kidneys and bladder of rats from all
dose groups. However,
renal cortical necrosis, present in 60% of the males and in 15% of the
females from this group, was observed in the high-dose group only. In
the F1 generation, the absolute kidney weights of adult females in the
low- and mid-dose groups were significantly increased to 108 to 111%,
respectively, of the control value. There
were no microscopic changes in these kidneys.
was significantly reduced in the treatment groups at several timepoints;
however, neither a dose-related reduction nor a pattern within a
generation suggested a treatment-related effect.
adverse effects on litter size and on pup survival were observed at
doses up to 150 mg/kg/day in the F1 litters, or at 55 mg/kg/day in the
F2 litters. Microscopic
examination of tissues from pups in the F2 liters revealed no
treatment-related changes. Therefore,
treatment up to 55 mg/kg/day for two generations had no adverse effect
there was no significant reduction in the percentage of pregnant females
or the percentage of fertile males, it is concluded that no adverse
effects on fertility were observed with maleic anhydride at doses up to
55 mg/kg/day administered over two generations. Maleic
anhydride was toxic to parental animals at all dose levels.
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