52-Week Oral Gavage Chronic Toxicity Study with Ubiquinone in Rats with a 4-Week Recovery

Potential ubiquinone (CoQ10; a natural fermentation product) toxicity was assessed in rats administered CoQ10 by oral gavage for 1 year at 100, 300, 600, and 1200 mg/(kg day). No adverse changes in mortality, clinical signs, body weight, food consumption, or clinical pathology results occurred. CoQ10 had elimination half-lives ranging from 10.7 to 15.2 h. At 1200 mg/(kg day), a high incidence of orange, granular, lumenal exudate in nasal turbinates occurred; microscopically, findings similar to those in the turbinates were occasionally observed in small granulomas within lung alveoli. A dose-related increased incidence of vacuolated macrophages (mesenteric lymph nodes) and vacuolated hepatic periportal cells was noted. Neither were associated with tissue damage or organ dysfunction, so they were not considered to be adverse. The nasal turbinate and lung findings were probably secondary to incidental exposure to crystallized test material. Overall, CoQ10 was well tolerated by male and female rats at dose levels up to 1200 mg/(kg day). Keywords: Ubiquinone; coenzyme Q10; toxicity; rats; pharmacokinetics