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EC number: 224-809-5
CAS number: 4500-29-2
The test item was orally administered in graduated doses of 0, 12, 30
and 75 mg/kg body weight per day to 3 groups of male and female Wistar
rats by oral gavage. One group receiving the vehicle sterile water
served as control. The volume of application was 5 mL/kg body weight and
the animals were dosed 7 days per week for a period of 28 days. No
mortality and no clinical signs were recorded in any of the dose groups
during the treatment period of this study. Additionally, no effects with
clinical relevance were observed in any of the parameters of the
functional battery testing and no ophthalmoscopic findings were noted.
Body weight development and food intake were not affected. No relevant
differences were found for haematological and blood coagulation
parameters. Slight deviations in the clinical biochemistry parameters
glucose, total protein, cholesterol and sodium in male or female
treatment groups were within the range of historical controls.
Additionally, deviation observed for relative weight (to terminal body
weight) of kidney in female high dose group animals were not associated
with histopathological findings and hence, were unlikely to be related
to treatment. Based on the data generated the no observed adverse effect
level (NOAEL) of Genamin CH 020 is considered to be equal or greater 75
mg/kg body weight per day.
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