Evaluation of a novel anti-oxidant Ubiquinol acetate (EnQ10) for its safety by in vitro methods.

BACKGROUND: As an active form of Coenzyme Q10 (CoQ10), Ubiquinol acetate (EnQ10) is a newly developed, chemically stable, and physiologically active novel antioxidant. In addition to its anti-oxidant properties, CoQ10 is a useful cosmetic agent for human skin. PURPOSE: This study goal was to examine the safety of EnQ10 using in vitro models instead of animal models. The models that were used for cosmetic and genotoxicity testing were approved by the OECD. METHODS: The study included testing for a number of toxicological endpoints, including skin irritation test (OECD TG 439), skin corrosion test (OECD TG 431), eye irritation test (OECD TG 492), phototoxicity test (OECD TG 432), and Mouse lymphoma assay for in vitro cell gene mutation test (OECD TG 490). Regulatory authorized EpiSkin(TM)-SM skin model (for skin irritation/corrosion); SkinEthic(TM)-HCE model (for eye irritation); BALB 3T3 NRU phototoxicity assay (for phototoxicity test); and mouse lymphoma assay (for TK gene mutation test) are among the series of chosen in vitro models that were conducted as per GLP standards. RESULTS: In terms of cosmetic toxicity and genotoxicity, none of the tests that were run produced positive results for EnQ10. CONCLUSION: As an alternatives to animal model procedures, we utilized extensive, well known in vitro methodologies to analyze the health effects of EnQ10, a new antioxidant used in cosmetic and nutraceutical products. These in vitro investigations showed that ubiquinol acetate (EnQ10) is safe for genotoxicity, phototoxicity, skin and ocular irritation/corrosion.