Safety evaluation of the genotoxicity and subchronic toxicity of standardized Bacopa extract (Bacognize®) from Bacopa monnieri

Bacopa monnieri is an important medicinal plant widely used in various food systems and gaining interest these days for its health benefits such as boosting brain function and improving quality of life. The objective of the present study was to examine the safety of Bacognize®, a standardized botanical extract obtained from the whole herb Bacopa monnieri (L.) Wettst., in subchronic toxicity and genotoxicity studies conducted in compliance with Good Laboratory Practice (GLP) and test guidelines established by the Organization for Economic Cooperation and Development (OECD). In the subchronic toxicity study, treatment with Bacognize® did not result in any toxicologically significant treatment-related changes in clinical observations, and in the clinical pathology as studied by hematology, serum chemistry, urinalysis, and terminal necropsy. Treatment-related adverse effects were not observed in ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. The results of genotoxicity studies as assessed by gene mutations in Salmonella typhimurium, in vitro chromosome aberrations and in vivo micronucleus test did not reveal any genotoxicity of Bacognize ®. The no-observed-adverse-effect level (NOAEL) for Bacognize® was established based on the subchronic study and was determined as at least 1000 mg/kg bw/day. These results indicate that Bacognize® does not cause significant adverse effects and suggest its tolerability up to 1000 mg/kg (highest dose tested) for the daily administration of 90 days in rats.