Acute and Sub-acute (28-days) Oral Toxicity Studies of Ethanol Leaf Extract of Thaumatococcus daniellii (Benn.)

Abstract

Thaumatococcus daniellii (Benn.) is a medicinal plant widely employed in traditional medicine because of its sweetening activity and potential therapeutic activities, including anti-inflammatory and antibacterial activities. Toxicological data concerning its safety profile are scarce. This study examines the acute and sub-acute (28-day) oral toxicity of ethanol leaf extract of Thaumatococcus daniellii in Wistar rats. In acute toxicity test, the limit dose of 5000 mg/kg body weight was given, and the animals were examined for 14 days for symptoms of toxicity. Sub-acute toxicity comprises daily oral therapy with 250, 500, and 1000 mg/kg for 28 days and assessments of body weight, organ-to-body weight ratios, hematological, and biochemical parameters. The acute toxicity study confirmed that there was no mortality or serious symptoms of acute toxicity, and the calculated LD₅₀ was greater than 5000 mg/kg, which provided a good margin of safety. In the sub-acute study, there were no changes in the hematological or biochemical parameters of the experimental rats treated with the extract. Normal growth was seen as evidenced by weekly body weights taken for the two treatment groups, and organ-to-body weight ratios were similar to the control except for the marginal increase in liver weight at the 1000 mg/kg dose. Liver function tests revealed mild, dose-dependent elevations in ALT (23.33–40.33 µ/L), AST (38.67–89.67 µ/L), and urea (57.90–63.37 mg/dL) at higher doses, suggesting potential hepatotoxic effects. Kidney function tests showed no significant changes in creatinine levels (0.87–1.23 mg/dL), sodium, potassium, chloride, or bicarbonate concentrations, indicating no major renal toxicity. Hematological markers, including RBC, WBC, hemoglobin, and platelet counts, were unaltered by the treatment. Overall, oral administration of Thaumatococcus daniellii ethanol leaf extract is reportedly safe at low doses without any major side effects being reported. It can, however, cause hepatotoxic problems at higher doses with repeated exposure. Further pathophysiological studies and chronic toxicity studies are recommended to establish its long-term safety profile.