Bioanalytical characterization and subacute oral toxicity evaluation of Balanophora fungosa methanolic extract in Wistar albino rats.

Balanophora fungosa is a medicinal plant found in tropical and subtropical regions. Despite its traditional use, scientific validation on its bioactive compounds and safety profile are limited. This study evaluates the toxicity of its methanol extract in rats to assess its potential therapeutic safety. Acute toxicity was assessed for 14 days, followed by a 28-day subacute study at doses of 50, 100, and 200 mg/kg. Body weight, biochemical, liver/kidney function, hematological and glycolipid metabolism were analyzed. Chemical composition of the extract was elucidated by GC-MS and their ADMET properties were analyzed. The methanolic extract did not cause any mortality or adverse reactions in sub-acute toxicity analysis up to a dose of 2000 mg/kg, suggesting a high safety margin. In the subacute toxicity study, no adverse effects were observed across all dose groups. Histopathological examination revealed no notable changes in organs indicating no organ-specific toxicity and significant injuries. GCMS analysis revealed 35 phytocompounds and no significant toxicity emerged from ADMET analysis. Hence, it is affirmed that B. fungosa has potential applications in safe drug development as proved by its dose-response effects and can be ascertained safe for oral consumption.