PRECLINICAL SAFETY EVALUATION OF SWIETENIA MAHAGONI LEAF IN WISTAR RATS NAVEEN Y P, ASNA UROOJ* *DOS in Food Science and Nutrition, University of Mysore, Manasagangothri, Mysore 570006 Email: asnaurooj@foodsci.uni.mysore.ac.in Original Article Received: 08 Mar 2015 Revised and Accepted: 05 Apr 2015 ABSTRACT Objective: The study evaluates the acute toxicity of the Swietenia Mahagoni leaf in rats of Wistar strain. Methods: Whole leaf powder at a maximum allowable dose (as per OECD guidelines (2000 mg Kg -1 Keywords: Swietenia mahagoni, Acute toxicity, Hepatic enzymes, Histopathology. BW)) was orally administered for 14 d and the effect of administration on the mortality, behavioral and biochemical changes in rats was observed. Results: There was no mortality or any toxic reaction was recorded in the treated group in the duration of administration. The powder did not cause any behavioral or physical changes in experimental rats. There was no significant (p ≤ 0.05) difference in the serum biochemical parameters analyzed between the normal control and test groups. Hematological parameters in the test group were also similar to the normal control group. Conclusion: The study establishes the non-toxicity of the Swietenia mahagoni leaf powder in therapeutic uses. INTRODUCTION Traditional medicine is the most widely used treatment for a long time to treat various human ailments in many parts of the world. WHO reports that about 80% of the people living in the developing countries depend on traditional plant-based medicine for basic health care needs [1]. Medicinal plants are blessed with a wide array of phytochemicals with various physiological actions; most of them are beneficial to human health and well being [2]. But some of the bio-actives derived from plants may have physiological actions that are deleterious to human health [3]. To develop a medicinal plant or its derivative(s) as a pharmaceutical, require the results from animal tests that are used in combination with results on the pharmacological efficacy of a medicinal plant, to decide whether the beneficial effects of the treatment would outweigh the risks of adverse side effects, and to establish a safe dose for use in clinical trials. The toxicological studies also evaluate the potential side effects that must be monitored carefully while using as pharmaceutical. Swietenia mahagoni Jacq. Is a small leafy, medium sized tree native to the west indies. Around the world, the plant is commonly called as West Indies mahogany, caoba, caoba dominicana or acajou. It is one of the species of genus Swietenia which belongs to chinaberry family, meliacea [4-6]. The parts of the plant have been used to treat many human ailments such as malaria, diabetes, diarrhea, astringent, hypertension etc. locally. The fruit of the plant is used as the powerful anti-hyperglycemic drug. The seed oil is being used as an alternative body ointment therapy for a range of skin cuts, itches and wounds to ameliorate the healing process in African countries. Decoction of bark is used to increase appetite, as an energizer in case of tuberculosis, to treat anemia, diarrhea, dysentery, fever and toothache. The decoction of leaves is used to treat nerve disorders, the infusion of seed to relief from chest pain [7, 8]. There are no data regarding the toxic effects, dose and long term side effects of treatment in the animal system. The present study evaluates the effect of an acute dose of the leaf powder on normal physiology, biochemistry and behavior in rats. MATERIALS AND METHODS Chemicals and reagents Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Total protein, albumin, urea, creatinine, total bilirubin, tryglycerides, total cholesterol assay kits were purchased from Aggappe Diagnostics, Ernakulam, India. Reduced glutathione (GSH), 5, 5-dithio (bis) Nitro benzoic acid (DTNB) were purchased from Sigma-Aldrich, Bangalore, India. All the chemicals and reagents used in the study were of analytical grade. Collection and preparation of samples The leaf of Swietenia mahogani was collected from Mysore district of Karnataka, India and subsequently identified by Dr. G. R. Shivamurthy, Department of Studies in Botany, University of Mysore, Mysore, India. The collected sample was thoroughly washed under running water to remove adhering dirt and other foreign particles, dried overnight at 50 °C, powdered, passed through 60 mesh sieve and stored in air tight container at 4 °C till further use. Experimental animals Adult rats of Wistar strain weighing around 140-180 g were procured from the animal house of University of Mysore, Mysore. The obtained rats were kept in the polyacrylic cages in the room maintained by 25±2 °C, 45 to 60 % RH and 12 h photoperiod, and acclimatized for these standard conditions for 14 d. During the acclimatization period the animals were observed for general conditions every day. Pellet diet (procured from Amrut feeds, Pune, India) and water ad libitum were provided. The experimental protocols of toxicological study were reviewed and approved by the Institutional Animal Ethical Committee for the purpose of control and supervision of experiments on animals (UOM/IAEC/03/2013). Acute toxicity studies The animals were grouped into 2 groups Group I–Control; Group II– Mahagony leaf powder consisting of 6 animals each (3 male, 3 female) using Randomized Block design. According to OECD guidelines the Group-II was administered with leaf powder at a dose of 2000 mg kg -1 body weight [9]. The powder was given in the form of suspensions for 14 d. The animals were observed individually after the initiation of dose during the first 30 min and at every half an hour interval of 6 h and thereafter and once in 24 h for 14 d. Individual records for physical or behavioral changes such as skin and fur, eyes and mucous membrane, respiratory, circulatory, autonomic and central nervous systems (ANS & CNS respectively) and somato motor activity, behavior pattern and mortality. Observations were also made for the presence of tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma. At the end of the study period, animals were euthanized and decapitated. International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 7, Issue 5, 2015 Innovare Academic Sciences