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EC number: 442-300-8
CAS number: -
In a GLP-compliant prenatal developmental
toxicity study following OECD guideline 414, groups of mated Wistar Han
(10 per group) rats were dosed by oral gavage from Day 6 to Day 19
post-coitum, inclusive, at target dose levels of 0, 300 and 1000 mg/kg
bw/day. The rats of the control group received the vehicle, polyethylene
glycol 400, alone. Females were checked daily for the presence of
clinical signs. Body weight and food consumption of females were
determined at periodic intervals. Formulations prepared on one day
during treatment were analyzed for accuracy and homogeneity, and
formulations prepared after completion of the in-life phase were
analyzed for stability. On Day 20 post-coitum, all animals were
subjected to an examination post-mortem and external, thoracic and
abdominal macroscopic findings were recorded. A laparohysterectomy was
performed on each surviving female of the groups. The uteri, placentae
and ovaries were examined, placenta weights were determined, and the
numbers of fetuses, early and late resorptions, total implantations and
corpora lutea were recorded. (Gravid) uterine weights were recorded, and
corrected body weights (changes) were calculated. The fetuses were
weighed, sexed, and examined for external malformations and
developmental variations. All live fetuses were euthanized. One half of
the fetuses were decapitated and the heads were fixed in Bouin’s
fixative. All fetuses were dissected and examined for visceral anomalies
and subsequently fixed in 96% aqueous ethanol and stained with Alizarin
Red S for skeletal examinations.
Accuracy, homogeneity and stability of
formulations were demonstrated by analyses. No maternal toxicity was
observed in the 100, 300 and 1000 mg/kg bw/day groups. No developmental
toxicity was noted in the 100, 300 and 1000 mg/kg bw/day groups. Based
on the results in this prenatal developmental toxicity study the
maternal and developmental No Observed Adverse Effect Level (NOAEL) for
the test substance was established as being at least 1000 mg/kg bw/day.
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