Safety assessment of a proprietary fenugreek mucilage composition (FenuMat®): Acute and subchronic toxicity studies

Abstract

Fenugreek (Trigonella foenum-graecum) seeds and their extracts are popular culinary ingredients and nutraceuticals. The seed mucilage contains galactomannan, a soluble dietary fiber with prebiotic potential and divergent therapeutic effects. A proprietary fenugreek galactomannan preparation (F-GM), FenuMat®, functions as a natural self-emulsifying hydrogel, enhancing nutrient delivery and bioavailability. Although fenugreek seed safety is well documented, the safety evaluation of FenuMat® is warranted to ensure its compliance with regulatory standards. Hence, the present study evaluated the safety of FenuMat® in adult Wistar rats of both sexes, following OECD guidelines. In the acute oral toxicity study (14 days; OECD Guideline 423), no treatment related adversities were observed, indicating an LD₅₀ above 2000 mg/kg body weight. The subchronic toxicity study (OECD Guideline 408, repeated dose; 90 days) at doses of 250, 500 and 1000 mg/kg b.wt. revealed no significant alterations in hematological or biochemical parameters, or in food and water intake. However, significant reductions in serum glucose levels (at 500 mg/kg and 1000 mg/kg b.wt.) and LDL cholesterol levels (at 1000 mg/kg b.wt.) were observed. Histopathological evaluation revealed no morphological abnormalities in the major organs. Terminal autopsy revealed consistent relative organ weights and no treatment-related histopathological alterations. The high-dose recovery group (1000 mg/kg b.wt.) exhibited no mortality or adverse effects, with hematological and biochemical parameters comparable to controls, indicating a no-observed-adverse-effect level (NOAEL) of 1000 mg/kg b.wt. Further, the Ames test on four Salmonella triphimurium strains, with and without metabolic activation, demonstrated no mutagenic potential, indicating FenuMat®’s suitability for human use.