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EC number: 915-730-3
CAS number: -
Foetal body weight reductions
(non-significant) seen only at maternally toxic doses.
A developmental toxicity study was performed in accordance with
the US FDA Guideline on detection of toxicity to reproduction for
medicinal products, which is equivalent to OECD414. The study was
performed under GLP conditions.
Groups of pregnant rats (25/dose group) were gavaged with 0
(control), 96, 240, or 480 mg/kg bw/day on gestation days 7-17 at dosage
volumes of 0.5, 0.1, 0.25, or 0.5 ml/kg bw, respectively. Viability,
abnormal clinical signs, body weights, abortions, premature deliveries,
and feed consumption were recorded. Mating performance was assessed. On
gestation day 21, surviving rats were euthanized by carbon dioxide
asphyxiation and Caesarean sections were performed to remove the
foetuses. Rats underwent gross necropsy. Foetuses were assessed for
litter parameters and gross external, soft tissue, or skeletal
Maternal animals showed reduced body weights and persistent
clinical signs (e.g., increased salivation and urine-stained abdominal
fur) at the highest dose. There were no treatment-related effects on
developmental parameters at any dose, although reduction (not
statistically significant) in foetal body weight was noted at the
highest dose. Based on these results, the maternal NOAEL was 240 mg/kg
bw/day and the developmental NOAEL was 480 mg/kg bw/day.
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