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EC number: 470-080-3
CAS number: -
In a 28 -day repeated dose toxicity study,
was administered to male and female Wistar rats by gavage at dose levels
of 0 (vehicle control), 100, 300 and 1000 mg/kg body weight per day over
a period of 4 weeks. Control and high dose groups consisted of each 10
animals per sex, whereas low and mid dose groups consisted of each 5
animals per sex. After 4 weeks of treatment 5 animals per sex of alt
dose groups were sacrificed (main groups). The remaining 5 animals per
sex of control and high dose groups were maintained for another 14 days
without administration of the test substance (recovery groups). The dose
volume was 5 ml/kg bw.
Food consumption and body weight were
determined weekly. The animals were examined for signs of toxicity or
mortality at least once a day. Detailed clinical examinations in an open
field were conducted prior to the start of the administration period and
weekly thereafter. Functional observational battery (FOB) as well as
measurement of motor activity (MA) was carried out at the end of the
treatment period. Clinicochemical, hematological examinations and
urinalyses were performed towards the end of the administration period.
At the end of the study all animals were assessed by gross pathology,
followed by histopathological examinations.
No substance related effects were observed
in any treatment group. Concerning Clinical Pathology no
treatment-related adverse findings were measured. Moreover, regarding
Pathology, there were no substance-related weight changes, gross lesions
or microscopic findings in male and female Wistar rats observed after 4
weeks of treatment. In addition, during the recovery period also no
effects were noted.
In conclusion, under the conditions of the
present study no substance-related adverse findings were obtained.
Therefore, the no-observed-adverse-effect level (NOAEL) was 1000 mg/kg
body weight per day in both sexes.
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