Safety Assessment of a Standardized Polyherbal Formulation (Glubloc™): Acute Toxicity Study and 28-Day Repeated Dose Toxicological Studies

Abstract

The standardized extract of Morus alba and Malus domestica Peel is widely recognized as a dietary supplement with potential benefits for blood sugar management, cholesterol reduction, and weight management. This study aimed to evaluate the general toxicity of the extract. Toxicity studies were conducted by OECD guidelines 425 and 407 and Schedule Y of the Drugs and Cosmetics Act, which mandates the use of two species for such studies. A single dose of GlublocTM at a concentration of 2000 mg/kg body weight was administered to Sprague Dawley rats and Albino mice, and no fatalities were reported, indicating good tolerability. Additionally, repeated oral administration of GlublocTM to rats and rabbits for a maximum duration of 28 days, at doses up to 414.16 mg/kg body weight per day in rats and 207.08 mg/kg body weight per day in rabbits, did not result in significant changes in medical assessments, ocular evaluations, weight gains, feeding behavior, or pathological findings compared to the control group. Overall, this study suggests that GlublocTM is well-tolerated without inducing any toxicity. The extracts No-Observed-Adverse-Effect Level (NOAEL) is considered to be 414.16 mg/kg per day when administered repeatedly for 28 days in rats and 207.08 mg/kg in rabbits.