摘要:Abstract Natural products play a dominant role in the development of novel drug leads for the treatment and prevention of diseases. Toxicity is an expression of being poisonous, indicating the state of adverse effects led by the interaction between toxicants and cells. This interaction may vary depending on the chemical properties of the toxicants and the cell membrane. Hence, evaluation of toxic properties of a substance is crucial when considering for public health protection. Protease inhibitors (PIs) are low molecular mass proteins that are ubiquitous in nature. They are natural antagonists of protease, which are present in all life forms. The present study aims to determine the toxicity of purified PI from the fruits of Solanum aculeatissimum using an acute and subchronic oral toxicity test in animal models. No significant changes in the enzymes level were observed. No adverse changes were noticed in the experimental animal treated with purified PI.