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EC number: 203-052-4
CAS number: 102-77-2
Appearance and behavior:
a slight increase in hair loss was observed in the treatment groups when
compared to the control group. A dose-related increase in the incidence
and duration of matting and/or yellow staining of the anogenital and
ventral haircoat regions was observed in the 300 mg/kg bw/d group (5/25)
and in the 1000 mg/kg bw/d group (16/25) when compared to the control
group (3/25). A dose-related increase in red staining of the anogenital
region was also noted in the 300 mg/kg bw/g group (2/25) and in the 1000
mg/kg bw/d group (5/25) when compared to control (0/25).
No test substance related death; one death occured in the 1000 mg/kg
bw/d group on gestation day 14 which attributed to a gavage
error.survival was 100 % in the 0, 100 and 300 mg/kg bw/d dose groups.
There was no biologically meaningful difference in mean maternal body
weight gain in the 100 mg/kg bw/d treatment group compared to control. A
slight decrease in mean maternal body weight gain was noted in the 300
mg/kg bw/d group during gestation day 6 to 9 interval which resulted in
a very slight decrease in weight gain over the treatment period when
compared to control (-15 %). A mean body weight loss was observed during
the first three days of treatment in the 1000 mg/kg bw/d group, which
resulted in a slight to moderate reduction in mean body weight gain
during the treatment period (-30 %).
Cesarean section observations:
No biologically meaningful or statistically significant differences were
observed in the mean numbers of corpora lutea, total implantations,
viable fetuses, early or late resorptions, postimplantation loss, mean
fetal body weights, or mean fetal sex distribution in the treated groups
when compared to the control group. Slight variations in the treatment
group means (in particular the corpora lutea and postimplantation loss
means) are found within the historical control ranges and are not
considered meaningful differences.
Fetal morphological observations:
There were no biologically meaningful or statistically significant
differences in the number of litters with malformations in the treated
groups when compared to the control group. The slight increase in
malformations in the 1000 mg/kg bw/d treatment group was due to a
genetic anomaly (two fetuses with dwarfish) observed in the strain used
in this laboratory. No biologically meaningful differences in the number
of fetuses or litters with developmental or genetic variations were
observed in the treated groups when compared to the control group.
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