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EC number: 201-148-0
CAS number: 78-83-1
The only statistically significant differences between the groups are
the lower number of low and intermediate dose fetuses with soft tissue
variations and the lower number of high dose fetuses with skeletal
retardations which are, of course, without any biological relevance. The
external malformations (i.e. cleft palate and/or anasarca) noted for two
high dose fetuses (out of 250) and the rare soft tissue finding (i.e.
globular shaped heart) observed in one high dose fetus (out of 122) are
finally assessed as being of incidental nature and not related to the
test substance exposure, because they occurred with very low incidences
only and there were no indications of an increased malformation rate in
the high dose fetuses if all classified findings are summarized.
Moreover, the spontaneous occurrence of both external malformations is
documented in the historical control data. All other observations, which
are summarized in the relevant tables occurred in all test groups
including the control to about the same amount, without any clear,
dose-related differences between the groups and/or are present in the
same magnitude in the historical control data.
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