Genotoxicity and sub-chronic toxicity of MYOLUTION^® (branched chain keto acids)

MYOLUTION^®, which consists of a mixture of the branched chain keto acids, keto-leucine, keto-isoleucine and keto-valine, as their calcium salts, may potentially be used as a food ingredient based on the reported contributions of these compounds to muscle health and exercise performance. Tests on genotoxicity and sub-chronic toxicity were performed to evaluate the safety of branched chain keto acids. No genotoxic effects were observed in the bacterial mutation assay or the in vitro micronucleus assay in human lymphocytes. In the 28 day and 90 day repeated dose toxicity studies no test item related mortality or toxicological effects on clinical signs, body weight, food consumption, urine parameters, hematology, clinical biochemistry parameters, organ weight, gross pathological findings and histopathology were observed. Based on the studies described here, MYOLUTION^® does not exert a genotoxic effect, and a no-observed-adverse-effect-level of 3318.38 mg/kg bw/day in males and 3733.28 mg/kg bw/day in females was determined in the 90 day repeated dose toxicity study.