Background:
A standardized polyherbal preparation (POL-6) containing six plant extracts
Hypericum perforatum, Bacopa monnieri, Centella asiatica, Withania somnifera, Ocimum
sanctum and Camellia sinesis have good antioxidant, anti-inflammatory, and immunomodulatory
activities. The present study was carried out to evaluate the safety profile of POL-6 through acute
and subacute oral toxicity models in Wistar rats.
Methods:
In acute safety evaluation, a single dose of 2000mg/kg of POL-6 was given orally to five
rats and was observed for 14 days. In subacute safety evaluation POL-6 at the doses of 250, 500 and
1000 mg/kg was given orally to the rats once a day for 28 days. The animals were observed for the
signs of toxicity and mortality during the study period.
Results:
In acute toxicity evaluation, POL-6 treatment did not show any toxic signs and mortality in
animals during the observation period. In subacute toxicity studies, no changes were seen in any of
the dose levels of POL-6 treatment during the total body weights, organ weights and hematobiochemical
parameters examination of the rats. No lesions were seen during the
gross/histopathological examination.
Conclusion:
The study revealed that administration of POL-6 for 28 days showed no significant
treatment generated toxic effects in the animals, hence it can be considered as non-toxic if it is ingested
in a time not greater than a month.
Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part VI: When Salt and Sugar and Vegetables Are Positive, How Can Genotoxicity Data Serve to Inform Risk Assessment?
