Preclinical Safety Assessment of Standardized Extract of Centella asiatica (L.) Urban Leaves

CONTEXT: Centella asiatica (CA) leaves extract has been shown therapeutic potential. However, safety information is lacking. AIMS: To evaluate acute oral toxicity (AOT), sub-chronic toxicity, and mutagenic potential of standardized extract of CA (L.) Urban leaves (INDCA). MATERIALS AND METHODS: For the acute toxicity study, INDCA was orally administered to Sprague-Dawley rats at a dose range of 0–2000 mg/kg. For the repeated dose toxicity study, the rats of either sex were orally administered with INDCA at the doses of 250, 500, and 1000 mg/kg/day for a period of 90 days. The effects on body weight, food and water consumption, organ weight, hematology, clinical chemistry as well as histology were studied. The mutagenic potential of INDCA was tested using reverse mutation assay (Ames test). STATISTICAL ANALYSIS USED: Data of each parameter were analyzed by one-way ANOVA followed by Dunnett's test to compare the difference between treated groups. RESULTS: The administration of INDCA did not produce mortality or significant changes in the clinical signs included but not limited to changes in the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavior pattern. The appearance, progress, and disappearance of these signs were recorded. The lethal dose and no observable adverse effect level of INDCA were 2000 mg/kg and 1000 mg/kg, respectively. There were no significant differences in the organ weights, hematological parameters, clinical chemistry values, or gross and microscopic appearance of the organs from the treatment groups as compared to the control group. It was found to be nonmutagenic in reverse mutation assay. CONCLUSIONS: INDCA was found safe in AOT, sub-chronic toxicity, and mutagenicity studies when tested in rats.