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EC number: 811-683-7
CAS number: 1799707-26-8
In a reproductive and
developmental screening study the substance was
administered to 10 rats/sex/dose
by oral gavage at
dose levels of 0, 100, 300 and 1000 mg/kg bw/day for a duration of 28
days. Dosing of the females was continued during lactation. There were
no substance-related effects on parental mortality, clinical signs, body
weight, food consumption, haematology, clinical chemistry, organ
weights, or gross pathology. Histopathological examination revealed a
degenerative change in the heart (myofiber necrosis in the apex and/or
left papillary muscle) of males treated at 1000 mg/kg. The
parental NOAEL is 300 mg/kg bw/day based on the degenerative change in
the heart at the top dose in males. The reproduction and developmental
NOAEL is >1000 mg/kg bw/day based on no treatment-related effects being
observed in the reproductive and developmental parameters.This
study in the rat is acceptable and
satisfiesthe guideline requirement for
a subacute oral study OECD 422 in rats with screening for reproductive
and developmental effects.
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