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Evaluation of the Mutagenic and Genotoxic Potential of Ubiquinol

Life Science Research Laboratories, Kaneka Corporation, Hyogo, Japan

Fukutaro Mizuhashi

Second Experimental Toxicology Department, Biosafety Research Center, Foods, Drugs and Pesticides, Shizuoka, Japan

Hiroshi Kubo
Hideyuki Kishida

Life Science Research Laboratories, Kaneka Corporation, Hyogo, Japan

Kenji Fujii
Mikio Kitahara

Functional Food Ingredients Division, Kaneka Corporation, Osaka, Japan

Kazunori Hosoe

Life Science Research Laboratories, Kaneka Corporation, Hyogo, Japan

Correspondence: Address correspondence to Mitsuaki Kitano, Life Science Research Laboratories, Kaneka Corporation, 1-8 Miyamae-machi, Takasago-cho, Takasago-shi, Hyogo 676-8688, Japan. E-mail:Mitsuaki.Kitano{at}kn.kaneka.co.jp

Ubiquinol (the reduced form of coenzyme Q₁₀) is the two-electron reduction product of ubiquinone (the oxidized form of coenzyme Q₁₀), and has been shown to be an integral part of living cells, where it functions as an antioxidant in both mitochondria and lipid membranes. To provide information to enable a Generally Regarded as Safe (GRAS) evaluation for the use of ubiquinol in selected foods, a series of Organisation of Economic Cooperation and Development (OECD) and good laboratory practice (GLP) toxicological studies was conducted to evaluate the mutagenic and genotoxic potential of Kaneka QH brand of ubiquinol. Ubiquinol did not induce reverse mutations in Salmonella typhimurium strains TA100, TA1535, TA98, and TA1537 and Escherichia coli WP2uvrA at concentrations up to 5000 µg/plate, in either the absence and presence of exogenous metabolic activation by rat liver S9. Likewise, ubiquinol did not induce chromosome aberrations in Chinese hamster lung fibroblast (CHL/IU) cells in short-term (6-h) tests with or without rat liver S9 at concentrations up to 5000 µg/ml or in a continuous (24-h) treatment test at concentrations up to 1201 µg/ml. Finally, no mortalities, no abnormal clinical signs, and no significant increase in chromosome damage were observed in an in vivo micronucleus test when administered orally at doses up to 2000 mg/kg/day. Thus, ubiquinol was evaluated as negative in the bacterial reverse mutation, chromosomal aberration, and rat bone marrow micronucleus tests under the conditions of these assays.

Key Words: Clastogenicity • Coenzyme Q₁₀ • Genotoxicity • Mutagenicity • Ubiquinol • Ubiquinone

International Journal of Toxicology, Vol. 26, No. 6, 533-544 (2007)
DOI: 10.1080/10915810701707460


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