Preclinical safety assessment of glycosides based standardized fenugreek seeds extract: Acute, subchronic toxicity and mutagenicity studies

Pallavi Deshpande,Prasad Thakurdesai,Vishwaraman Mohan

doi:10.7324/japs.2016.60927

Abstract

Objective: To evaluate acute oral toxicity (AOT), subchronic toxicity, and mutagenic potential of glycosides based standardized fenugreek (Trigonella foenum graecum L.) seeds extract (SFSE-G). Materials and Methods: The AOT, subchronic (90-day repeated dose) toxicity and mutagenicity (reverse mutation test) of oral administration of SFSE-G were evaluated using Sprague-Dawley (SD) rats as per OECD guideline no. 423, No. 408 and 471 respectively. Results: The SFSE-G did not show mortality or treatment-related adverse signs during acute (limit dose of 2000 mg/kg) and subchronic (90-days repeated dose of 250, 500 and 1000 mg/kg with 28 days of recovery period) administration. The SFSE-G showed oral median lethal dose (LD50) more than 2000 mg/kg during AOT study. The no-observed adverse effect level (NOAEL) of SFSE-G was 1000 mg/kg in male rats and 500 mg/kg in female rats during subchronic toxicity study. Furthermore, SFSE-G did not show mutagenic potential in vitro. Conclusions: SFSE-G was found safe for acute and subchronic (90 days repeated dose) administration in rats with no mutagenic potential.

Highlights

There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice (Upton et al, 2016) Most of the natural products or herbal medicines contain a diverse variety of phytoconstituents because of variation in growth pattern, geographical location, time of harvesting and storage (Yau et al, 2015)
Fenugreek seeds are certified as GRAS (Generally recognized as safe) item under clause §182.20 (Essential oils, oleoresins and natural extractives including distillates) by US Food and Drug Administration (US FDA)
Acute oral toxicity (AOT) None of the rats died during the observation period

Summary

Introduction

There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice (Upton et al, 2016) Most of the natural products or herbal medicines contain a diverse variety of phytoconstituents because of variation in growth pattern, geographical location, time of harvesting and storage (Yau et al, 2015). Correct identification of composition of herbal medicine is essential to ensure consistent quality, safety and efficacy (Upton et al, 2016). Past reports on fenugreek seeds highlighted a variety of medicinally active phytoconstituents namely alkaloids and polysaccharides (Petropoulos, 2003), flavonoids (Huang and Liang, 1999, Wagner et al, 1973), triterpenoids (Shang et al, 1998) and steroidal sapogenins (Sauvaire et al, 1991).Safety of fenugreek seeds in powder form in human has been established in many clinical trials and reviews (Basch et al, 2003). Fenugreek seeds are certified as GRAS (Generally recognized as safe) item under clause §182.20 (Essential oils, oleoresins and natural extractives including distillates) by US Food and Drug Administration (US FDA)

Methods

Results

Conclusion