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EC number: 252-558-1
CAS number: 35435-21-3
No clinical signs or observations were noted up to and
included dose level of 1000 mg/kg bw/day. Food consumption, body weight
and corrected body weight gain (corrected for the gravid uterus weight)
were not affected by treatment with the test item up to and included
dose level of 1000 mg/kg. No test item-related effects on the relevant
reproduction parameters were observed up to and included dose level of
1000 mg/kg bw/day. No test item-related effects on development of
embryos or fetuses were observed at the dose level of 100 mg/kg bw/day.
An increased incidence of supernumerary rudimentary ribs and long or
interrupted costal cartilages observed at the dose levels of 300 and
1000 mg/kg bw/day indicate a treatment-related minor disturbance in the
development of the axial skeleton at these dose levels. Both types of
variations belong to the most common seen in the control groups. They
are of minor nature and not likely to affect further development and
postnatal live of the animal. Therefore the increase of their incidence
was considered not to be adverse.
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