This study evaluates the preclinical safety of glycosides from standardized fenugreek seed extract (SFSE-G) through acute toxicity, subchronic toxicity (90 days), and mutagenicity tests in Sprague-Dawley rats. The findings indicate that SFSE-G is safe, with no mortality or significant adverse effects observed at doses up to 2000 mg/kg. The no-observed-adverse-effect levels (NOAEL) were determined to be 1000 mg/kg for males and 500 mg/kg for females, with no mutagenic potential identified.

Highlights -📊

• Safety Profile: SFSE-G demonstrated no mortality at doses up to 2000 mg/kg. 🐭
• NOAEL Determined: 1000 mg/kg for male rats and 500 mg/kg for female rats. ⚖️
• No Adverse Effects: No significant clinical signs or weight changes in rats during the 90-day study. 📉
• Mutagenicity Testing: SFSE-G showed no mutagenic potential in vitro. 🚫
• Standardized Extract: The extract is standardized to contain 89.42% glycosides. 📋
• Compliant with Guidelines: Studies conducted following OECD guidelines. 📜
• Potential for Human Use: HED derived indicates safety for human consumption at higher doses. 👩‍⚕️

Key Insights -🔍

• Robust Safety Evidence: The absence of mortality or significant adverse effects after acute and subchronic administration supports the extract’s safety, crucial for future clinical trials. This indicates a favorable risk-to-benefit ratio for potential therapeutic applications. 🛡️
• Importance of NOAEL: Establishing NOAEL values is critical for risk assessment and regulatory approval, providing a benchmark for safe dosing in humans. This study’s findings aid in determining safe consumption levels for products containing SFSE-G. ⚖️
• Hematological and Biochemical Stability: Consistent hematological and biochemical parameters across treatment groups suggest that SFSE-G does not adversely affect blood profiles, reinforcing its safety for long-term use. This stability is crucial for herbal supplements aimed at health maintenance. 🩺
• Non-Mutagenic Nature: The lack of mutagenic effects implies that SFSE-G does not pose a genetic risk, making it a safer option for consumers wary of potential DNA damage from herbal products. This aspect enhances its appeal in the herbal supplement market. 🧬
• Regulatory Compliance: The adherence to established guidelines (OECD) during testing underscores the reliability of the findings and supports the extract’s use in compliance with regulatory standards. This compliance is essential for gaining consumer trust and regulatory acceptance. 📋
• Potential for Broader Applications: Given its safety profile, SFSE-G may have applications beyond traditional uses, including in functional foods and nutraceuticals, promoting health and wellness. This opens avenues for product development in the health sector. 🌱
• Human Equivalent Dose Calculations: The derived HED suggests that the extract is safe for consumption at levels significantly higher than those reported effective in clinical studies, indicating a broad margin of safety for users. This finding is pivotal for consumer reassurance and product marketing. 🧑‍⚕️