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EC number: 609-066-0
CAS number: 35123-06-9
of all fetal external, soft tissue and skeletal observations
noted external, soft tissue and skeletal malformations in all groups.
When the different findings were combined, the following can be
dose fetuses from different litters were multiple-malformed. Female
fetus No. 82-05 had a gastroschisis, associated with a situs inversus,
while the findings in male fetus No. 94-11 consisted of agnathia
(comprising severely malformed skull bones), open eyes and astomia. No
ontogenetic pattern is recognizable for the individual malformations nor
was there any cluster of any of these individual malformations seen in
the other offspring of the high-dose group. Apart from gastroschisis all
of them are present in the historical control data of the rat strain.
Thus a relationship of these two cases of malformed fetuses to the
treatment is not assumed.
malformations, such as diaphragmatic hernia, abnormal lung lobation,
malpositioned and bipartite sternebrae, misshapen tuberositas deltoidea
and misshapen basisphenoid, observed in all groups including controls
are common for this rat strain and can be found in the historical
control data at a comparable or higher frequency. An association of
these findings to the treatment is also not assumed.
external variation, two soft tissue variations and a broad range of
skeletal variations occurred in all test groups including the controls.
None of the incidences showed a relation to dosing and all variations
can be found in the historical control data at a comparable or higher
spontaneous origin is also assumed for the unclassified skeletal
cartilage observations which were observed in several fetuses of test
groups 0, 1, 2 and 3 (0, 100, 200 and 500 mg/kg bw/day). The
distribution and type of these findings do not suggest any relation to
fetal examinations revealed that there is no effect of the compound on
the respective morphological structures up to the highest dose tested
(500 mg/kg bw/day).
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