A study was done to assess the toxicological profile of SierraSil® when rats are exposed daily to the test article over a period of 90 days, by oral gavage.
Groups of 10 male and 10 female Sprague Dawley rats were administered SierraSil® by oral gavage daily at the doses of 100 mg, 550 mg or 1000 mg per kg body weight for 90 days and were sacrificed on day 91 to evaluate its toxicity. Concurrent control group receiving vehicle at 10 ml/kg was also maintained. Additionally, groups of 5 rats per sex receiving vehicle at 10 ml/kg and the test article at 1000 mg/kg levels were further observed for a period of 28 days following 90 day exposure, for assessment of reversibility, persistence or delayed occurrence of toxicity.
The results showed that there was no treatment related mortality among rats exposed to SierraSil® at all three doses. No findings indicative of neurotoxic potential of the treatment were reported. Body weight gain by treatment group was found to be comparable to that by the control group. Food consumption was also comparable between treatment group and control group. Haematology, clinical chemistry, urinalysis, organ weights, gross pathology, histopathology all revealed no significant difference between treatment group and placebo group.
Based on the findings of this study, the no-observed-adverse-effect-level (NOAEL) of SierraSil® in Sprague Dawley rats, following oral administration for 90 days was found to be more than 1000 mg/kg body weight (Equivalent to greater than 35 times the recommended dosage/serving).
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