Evaluation of Acute Oral Toxicity of Combined Aqueous Extracts of Nigella sativa Seeds and Hylocereus polyrhizus Fruit

Abstract

The safety profile of a combined aqueous extract of Nigella sativa (black cumin seed) and Hylocereus polyrhizus (dragon fruit) was evaluated through an acute oral toxicity study in female rats. A single dose of 5,000 mg/kg body weight was administered according to OECD guidelines, with observations conducted over a 14-day period. The study revealed no signs of mortality, adverse behavioral effects, or significant changes in body weight. Histopathological analyses of vital organs, including the liver, kidneys, and heart, showed no detectable abnormalities or cellular damage in the treated group compared to the control. These findings corroborate existing evidence regarding the safety of the individual components, which have been previously demonstrated to exhibit negligible toxicity at high doses. Behavioral assessments indicated normal skin, fur, eyes, mucosal membranes, and activity levels, with no symptoms such as tremors, lethargy, diarrhea, or coma observed. The absence of statistically significant body weight differences further suggested that the herbal combination does not interfere with metabolic or nutritional processes. Additionally, histopathological evaluations confirmed the absence of hepatotoxicity, nephrotoxicity, or cardiotoxicity, consistent with prior studies highlighting the antioxidant and protective properties of Nigella sativa and Hylocereus polyrhizus. The results of this study provide compelling evidence for the non-toxic nature of this herbal mixture, supporting its potential use as a safe therapeutic agent.