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EC number: 202-607-8
CAS number: 97-77-8
Maternal toxic effects:
Clinical signs: The only treatment-related finding
was a dose-related incidence in the number of dams.
Mortality: No deaths occurred.
7.5 mg/kg/d: Body weight gain was marginally
reduced during treatment period (up to day 8 of gestation), but was
unaffected thereafter. This effect was of no biological relevance for
the progress and outcome of pregnancy.
15 mg /kg/d: Significant reduced body weight during
treatment period only.
30 mg/kg/d: Marked transient body weight loss
Necropsy: No gross treatment-related macroscopic
Teratogenic/embryo toxic effects (see table below):
effects were noted on the implantations, resorptions, number of live
foetuses, pre- and post-implantation losses.
Placental weight was slightly lower than concurrent control values, but
remained within the historical control range. Foetal weight was
unaffected and there was no evidence of foetal toxicity.
foetal weight was slightly below that of the concurrent control group (p
= 0.0507) and the incidence of small foetuses was slightly elevated, but
both values were within the historical control range. Placental weights
were slightly lower as compared to controls, but remained within the
historical control range. There was an increased incidence of foetuses
with reduced 13th
Mean foetal and placenta weights were significantly reduced (p 0.001),
and there was a high incidence of small foetuses with weights of less
than 2.7 g. There was an associated retardation of foetal development
and slightly increased incidences of subcutaneous oedema and reduced 13th
Teratogenic/embryo toxic effects
* significantly different from control: p<0.05 (nested analysis of
variance and weighed t-test)
hernia was noted in two foetuses (of different litters) of the low-dose
group, and in one foetus of the high-dose group. The occurrence of three
affected foetuses from three different litters in the treated groups was
higher than might be expected for this strain of rat. However, there was
no indication of any dose-related response and group mean values were
within historical control ranges. Thus, the possibility that this
abnormality is test substance-related was considered equivocal.
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