A 28- Day Oral Toxicity Study of Pseudocedrela kotschyi Methanol Extract in Sprague-Dawley Rats

Abstract

Aims: To evaluate the safety profile of Pseudocedela kotschyi which is used in traditional medicine for the treatment of epilepsy, malaria, diarrhoea and pains, a 28 day sub chronic toxicity study was conducted was evaluated using the 28 day subchronic toxicity study. Place and Duration of Study: This study was conducted in the Departments of Pharmacology, Faculty of Pharmacy, University Sains Malaysia, during the period between January 2013 and February 2014. Methodology: The methanolic extract of P. kotschyi stem bark was evaluated for acute and sub chronic toxicity in female and male rats. In the acute oral toxicity study, a limit dose of 2000 mg/kg was administered to five non-pregnant female rats by oral gavage. They were observed for signs of toxicity/mortality for 14 days. In the sub chronic toxicity study 48 rats of both sexes were grouped into 4 groups of 12 animals (6 males, 6 females) and treated with P. kotschyi extract at a dose of 40, 200 and 1000 mg/kg respectively, the fourth group was considered as a control. Results: The 28 days acute oral toxicity study of P. kotschyi demonstrated a lack of toxicity of the methanol extract. Parameters such as general behavioural changes were observed to be normal; moreover no death was recorded at the end of the study period. Assessment for signs of chronic toxicity indicated no abnormalities in the test groups as compared to the controls. Haematological and biochemical values in treated groups were normal in comparison with the control group. Insignificant changes in body weight, internal organ weight and general behaviour were considered to be incidental. Conclusion: The stem bark methanol extract of P. kotschyi administered orally to female and male rats was relatively safe at the doses administered. We therefore conclude that toxic effects, if any occurred at doses higher than those used in our country.