Abstract

Herbal medicines, like all other drugs, are liable to induce a risk of severe adverse effects resulting from inappropriate and uncontrolled use. The present study aimed to assess the preclinical safety of a phytomedicine named “ANOL”, developed for high blood pressure management in Burkina Faso. Acute and sub-chronic toxicity studies were carried in accordance with the Organization for Economic Cooperation and Development (OECD) test guidelines. For the acute toxicity test, a single oral dose of 5000 mg/kg bw of the phytomedicine was administered to Naval Medical Research Institute (NMRI) mice and Wistar rats. The sub-chronic toxicity of "ANOL" was assessed by observing abnormal changes in biochemical parameters and macroscopic antemortem changes in rats receiving 100, 500, and 1000 mg/kg bw/day of the phytomedicine. The results show that the single oral dose of 5000 mg/kg bw did not cause mortality in the test animals nor alter their physical parameters. The LD50 of “ANOL” is greater than 5000 mg/kg bw in mice and rats. The subchronic toxicity study showed that the test substance significantly reduced serum urea in all treated rats and blood glucose levels in all treated males. Weight gain decreased significantly in all treated males from the tenth week to the end of the test period. Statistically significant changes were noted in serum glucose levels in male rats at 100, 500, and 1000 mg/kg bw/day, serum urea levels at 500 and 1000 mg/kg bw/day in both sex, and serum calcium levels at 100, 500 and 1000 mg/kg bw/day in female rats. The phytomedicine also induced a statistically significant decrease in serum chlorine at 1000 mg/kg bw/day. Findings show that "ANOL" is relatively safe in acute and sub-chronic administration to rats. However, the alteration of specific parameters observed recommends caution when using this phytomedicine. Further investigations, such as hematological and anatomopathological analyses, could improve our knowledge of the phytomedicinal's toxic potential.

Key words: Anogeissus leiocarpus; phytomedicine; wistar rat; biochemical parameters; toxicological profile; ANOL; Burkina Faso.