Twenty-Eight-Day Repeated-Dose Oral Toxicity Study of Water-Miscible Coenzyme Q10 Preparation (Q10EP40) in Rats

Q10EP40, a new water-miscible and emulsified floury preparation for dietary supplements, consists of coenzyme Q10 (CoQ10), fatty acid ester of glycerin, casein, dextrin and sodium carbonate. The safety of CoQ10 bulk substance itself has been evaluated by several subacute and chronic toxicity studies in animals. However, the safety of CoQ10 preparation produced with food ingredients has not yet been fully confirmed. The present study was conducted to evaluate the toxicity of Q10EP40 in Sprague-Dawley rats with gavage administration at concentrations of 500, 1000 or 2000 mg/kg for 28 days. No deaths were observed in any group, and there were no adverse effects on general condition, behavior, body weight or food consumption, results of urinalysis, hematology, blood chemistry, ophthalmological examination, gross pathological examination or histopathological examination, or organ weights. On the basis of these findings, the no-observed-adverse effect level (NOAEL) for Q10EP40 in Sprague-Dawley rats is considered to be 2000 mg/kg/day.