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EC number: 442-300-8
CAS number: -
The test article was administered orally by
gavage to groups of 10 male and 10 female Wistar rats at dose levels of
0 (test group 0), 100 (test group 1), 300 (test group 2) and 1000 mg/kg
body weight/day (mg/kg bw/d; test group 3) over a period of 3 months.
Polyethylene glycol 400 served as vehicle. Food consumption and body
weight were determined weekly. The animals were examined for signs of
toxicity or mortality at least once a day. In addition, the rats were
daily examined for any clinically abnormal signs before and within 2
hours as well as within 5 hours after treatment. Furthermore, detailed
clinical examinations in an open field were conducted prior to the start
of the administration period and weekly thereafter. Ophthalmological
examinations were performed before the beginning and at the end of the
administration period. In addition, a functional observational battery
(FOB) as well as measurement of motor activity (MA) were carried out at
the end of the administration period. Clinicochemical and hematological
examinations as well as urinalyses were performed towards the end of the
administration period. After the administration period all animals were
sacrificed and assessed by gross pathology. Organ weights were
determined followed by histopathological examinations. No
treatment-related, adverse effects were observed at any of the dose
levels in any of the parameters examined. In conclusion, the oral
administration of the test article by gavage to male and female Wistar
rats for 3 months caused no signs of systemic toxicity up to the highest
dose level tested (1000 mg/kg bw/d). Therefore, under the conditions of
the present study the no observed adverse effect level (NOAEL) was 1000
mg/kg bw/d for male and female Wistar rats.
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