Safety profile of Irvingia gabonensis (Aubry-Lecomte ex O’Rorke) Baill. root bark extract: Acute and sub-acute toxicity studies in Wistar rats

Abstract
Background: Irvingia gabonensis (Aubry-Lecomte ex O’Rorke) Baill. has been widely prescribed in African traditional medicine system for the management of hernia, yellow fever, gastrointestinal, liver conditions and sterility, as well as for some other ethno-medicinal uses. Aim: The study was to investigate the safety margins of ethanol extract of I. gabonensis root barks (EEIGRB) in Wistar rats. Setting: This research is a toxicology investigation. Methods: The acute and sub-acute toxicity studies conducted on the EEIGRB, according to the Organization for Economic Cooperation and Development (OECD) methods. Results: The acute toxicity studies revealed that LD50 was > 5000 mg/kg. In the sub-acute study, significant increase in body weights (p < 0.05) was observed at 200 mg/kg and 400 mg/kg in the weeks 2, 3 and 4 compared with week 0. There were no statistically significant (p > 0.05) changes in the haematological, hepatic and renal indices except for significant reduction (p < 0.05) in serum concentrations of sodium and creatinine at 400 mg/kg of EEIGRB compared with control group. Histopathological examination of the liver and kidney revealed that at 200 mg/kg, there was a slight hepatic necrosis in the liver and a slight tubular necrosis in the kidney, whereas at 400 mg/kg, there was a moderate foci necrosis in the liver and a slight glomerular distortion occurred in the kidney. Conclusion: The results indicate that EEIGRB was found to be practically safe after acute administration, and there were histomorphological alterations in the liver and kidney after prolonged administration in the sub-acute dosages.