ABSTRACT
Aim: Many medicinal plants have been used traditionally in treating ailments in humans and animals. However, for most of herbal remedies, no scientific toxicity profiles exist in literature. In this study, the safety profile of an herbal extract mixture containing Entada leptostachya (EL) and Prosopis juliflora (PJ) was determined using acute oral toxicity tests using adult female Wistar albino rats. Place and Duration of Study: Laboratories in the departments of Chemistry, Zoology, Botany and Biochemistry of Jomo Kenyatta University of Agriculture and Technology (J.K.U.A.T.) between March 2012 and April 2012. Methodology: The OECD 425 guidelines (Up-and-Down procedure) were followed. Different dosages (control, 175, 550, 1750 and 5000 mg/kg body weight) were used in the experiment. Selective observations and analysis were made and recorded on mortality, signs of pain or distress and moribund animals, biochemical and macroscopic (pathological, organ and live body weights) analyses. Results: During the entire period of the study, no signs of pain or enduring distress were observed neither was there any mortality. Alanine aminotransferase (ALT) values were within range (for experimental rats) apart from the rat in control while Aspartate aminotransferase (AST) values were within range (for experimental rat) apart from two rats in the upper limit. Macroscopic organ observations did not show colour or texture consistent with drug-induced inflammation or lesions. The toxicity studies of the extract mixture showed that the median lethal dose (LD50) was above the upper limit of 5000mg/kg body weight. Conclusion: In conclusion, the LD50 of the extract mixture was found to be greater than 5000 mg/kg body weight and was, therefore, considered safe and has potential as a novel herbal preparation.