Safety assessment of the dried hydroethanolic extract of Pterocarpus erinaceus Poir. stem bark

Background: Medicinal plants are used to treat diseases but can be toxic in certain doses or due to the presence of certain compounds. Thus, the safety of medicinal plants must be scientifically established before their use. Pterocarpus erinaceus is one of medicinal plants used in traditional medicine to treat several diseases including diabetes and its complications.Purpose: This study aims to assess the safety of P. erinaceus in vitro in brine shrimp larvae Artemia salina and in vivo in Sprague Dawley rats in order to prove its use in the formulation of phytomedicine.Study design and methods: The fresh bark of P. erinaceus stem was dried and powdered. The dry extract was obtained by hydroethanolic extraction. The cytotoxicity of P. erinaceus was evaluated in vitro in brine shrimp larvae Artemia salina for 24 h. The acute and subchronic toxicity of P. erinaceus were assessed in vivo in rats by oral administration of extract at a single dose of 5 g/kg bw and repeated doses of 500 and 1000 mg/kg bw for 28 consecutive days.Results: The extract of the stem bark of P. erinaceus has a LC50 = 2.941 mg/mL in brine shrimp larvae Artemia salina and considered nontoxic on the Mousseux scale. In acute toxicity using ATC method, a single oral administration of extract did not result in any mortalities or signs of toxicity in gross necropsy during the 14 days of observation in rats. Therefore, P. erinaceus has a LD50 > 5 g/kg bw and considered nontoxic. Subchronic oral administration of P. erinaceus at doses of 500 and 1000 mg/kg bw, also did not cause any mortalities or significant changes in body weight, relative weight of organs, hematological and biochemical parameters. No abnormalities in liver, spleen and kidneys were observed in the histopathological study. However, a significant (p < 0.001) decrease in basal blood glucose levels in rats was observed during treatment, but was not correlated with organ damage.Conclusion: This study showed that P. erinaceus stem bark was safe and had no cyto-histopathological impact in animal health. Thus, it can be used in the formulation of phytomedicine; but further studies such as genotoxicity and chromosomal aberration are needed to prove its safety at the genomic level.