Sub-chronic (Ninety Days) Toxicity Study of Hydroethanolic Leaf Extract of Datura stramonium L. in Rodents

Background: Phyto-medicine represents a vast pool of novel drug development, but understanding their safety requires elaborate, multifaceted approaches, including toxicity studies.

Objective: This study investigated the effects of 90 days of oral administration of Datura stramonium (DSE) leaf extract in Rats.

Methods: In the oral acute toxicity study, mice were treated with a single oral gavage of DSE at 500, 1000, and 2000 mg·kg-1/d, po and observed for signs of acute toxicity for 14 days. In the sub-chronic study, rats were randomized into four Groups (A–D). Group A received distilled water (10 mL·kg-1, po) while groups B–D received DSE (10, 50 and 250 mg·kg-1/d, po, respectively) orally for 90 days uninterrupted. Animals were weighed weekly, with food and water measured daily and relevant parameters assayed at the end of the 90days administration.

Results: In acute toxicity studies, oral administration of up to 2 g·kg-1/d, po of DSE did not elicit any semblance of toxicity or mortality within 24 h to 14 days. In the 90days studies, DSE (250 mg·kg-1/d, po) decreased the body weight, brain weight, and food intake in female rats. DSE (10–250 mg·kg-1/d, po) increased the red blood cell (RBC), packed cell volume (PCV) and hemoglobin (Hb) in both sexes. DSE (10–250 mg·kg-1/d, po) increased the triglycerides (TG), cholesterol and low-density lipoprotein (LDL); and decreased HDL in both sexes. DSE (10– 250 mg·kg-1/d, po) increased the white blood cells (WBC) and platelets in female rats. DSE (10–250 mg·kg-1/d, po) decreased the alkaline phosphatase (ALP) and alanine transaminase (ALT) in both studies. Serum urea level was decreased in both sexes. DSE (250 mg·kg-1/d, po) decreased male rats’ serum sodium ion levels. Liver, brain, testes and kidney showed severe lesions at 250 mg·kg-1/d, po of the extract.

Conclusion: D. stramonium is safe on acute exposure and relatively safe on sub-chronic oral administration. However, prolonged use, especially at high doses, could cause Liver, brain and kidney toxicities; and abnormal lipid metabolism.