Evaluation of the acute and sub-acute toxicity of Azanza garckeana aqueous leaves extract in Wistar rats.

Abstract

This study evaluated the safety profile of Azanza garckeana aqueous leaves extract (AGALE) in rats through single and 28-day oral administrations. Twenty-eight (28) adult male Wistar rats (weighing 120-160 g) were used for acute and sub-acute studies. Acute study was carried out in 2 phases using Lorke’s method, AGALE was administered at single doses of 10, 100 and 1,000 mg/kg (n = 3) and observed for 14 days for mortality or toxicity signs. For the sub-acute study, AGALE was administered once daily for 28 days at 50, 100 and 150 mg/kg while the vehicle was administered to control (n = 4). The results revealed that mortality was recorded at 1000 mg/kg in phase I of the acute toxicity study. In phase II, mortality was recorded at 600 and 800 mg/kg doses. The LD50 of AGALE in rats was determined to be 490 mg/kg b.w. The oral administration of AGALE for 28 days showed significant decrease in the levels of the electrolytes in the 50 mg/kg treated group. Histological examination of the kidneys showed mild toxicity related abnormalities. There was no significant alteration in the liver function indices. Histopathology of the liver showed significant amount of immunological cells. Haematological parameters evaluated showed that there was significant difference (P < 0.05) in white blood cells, monocytes and lymphocytes. This study demonstrates that the LD50 of AGALE in Wistar rats is 490 mg/kg. It also demonstrated that if used pharmaceutically, AGALE extracts may not exert toxic effects at doses less than 150 mg/kg.