Toxicological safety assessment of AP-Bio®, a standardized extract of Andrographis paniculata in Sprague Dawley rats

Andrographis paniculata, commonly known as green chiretta, is a traditionally used plant in India, China, and Southeast Asian countries for its varied health benefits including immune health. The objective of the present study was to assess the safety of AP-Bio®, a standardized A. paniculata extract in Sprague Dawley rats by following the Organisation for Economic Cooperation and Development (OECD) test guidelines of acute and 90-day repeated dose sub-chronic toxicity studies. AP-Bio® did not show any treatment-related clinical signs of toxicity or mortality during the 14-day observation period in animals tested in the single-dose acute oral toxicity study up to a dose of 5000 mg/kg body weight. In the 90-day repeated dose sub-chronic oral toxicity study, no treatment-related adverse clinical signs were observed in any of the treated groups (300, 600, and 900 mg/kg). All treated animals showed usual weight gain and comparable feed intake. The ophthalmoscope examination did not reveal any abnormalities. Also, no toxicologically significant changes were observed in urinalysis, hematology, and blood chemistry parameters. Absolute organ weights and relative organ weights of vital organs did not differ significantly compared to control. Gross and histopathological findings did not show any remarkable and treatment-related changes. Results of the safety evaluation showed the median lethal dose (LD₅₀ ) of AP-Bio® was found to be more than 5000 mg/kg rat body weight and the no observed adverse effect level (NOAEL) of AP-Bio® was found to be 900 mg/kg rat body weight.