Background: Balanites aegyptiaca (BAE) is a thorny tree that grows in most arid and semi-arid areas of Africa, the Middle East and India. It is used in traditional medicine for its cardioprotective, deworming, antihelmintic, anti-infectious and antifungal properties. Excessive consumption of this plant's products can present risks of intoxication for consumers.

Objective: The aim of this study was to assess the acute and subchronic oral toxicity of the aqueous extract of Balanites aegyptiaca leaves and roots, to ensure the safety of its consumers.

Method: Acute toxicity assessment was carried out in accordance with the OECD experimental protocol. The plant extract was administered orally to female rats at a unique dose of 2000 mg/kg. Then the   animals were observed for 14 days. For the subchronic toxicity assessment, the aqueous extract was administered orally daily to male and female rats at different doses (250, 500 and 1000 mg/kg) for 30 days. After the treatment period, the animals were sacrificed for hematological, biochemical and histopathological analyses.

Results: The results of the acute oral toxicity test showed that the aqueous extract of Balanites aegyptiaca leaves and roots was non-toxic at a dose of 2000 mg/kg. More so sub-chronic test revealed no abnormalities of rat signs and behaviours, in the groups of animals treated with the extract compared to the controls. A significant variation in relative heart and liver weights was observed at 1000 mg/kg. In addition, there was a significant reduction in concentrations of aspartate aminotransferase, total cholesterol, triglycerides and low-density lipoproteins in these rats. compared to the control groups. There was also a significant decrease in hemoglobin and mean corpuscular hemoglobin, with an increase in lymphocytes and white blood cells at the same dose of 1000mg/kg.

Histological examinations of the kidneys and liver showed normal renal architecture, and the liver also showed normal hepatic architecture with slight degeneration at a dose of 1000mg/kg of the extract.

Conclusion: Single administration of the 2000 mg/kg dose did not induce signs of significant toxicity in rats. However, in long-term oral treatment, safety measures must be taken. Thus, sub-chronic oral exposure of BAE to lower doses is recommended, while higher doses, of the order of 1000 mg/kg, should be avoided.