A 91-d repeated dose oral toxicity study of PureSorb-Q(TM)40 in rats.
As part of a series of non-clinical studies to evaluate the safety of PureSorb-Q(TM)40 (Water-soluble type CoQ(10) powder, CoQ(10) content is 40 w/w%; hereinafter referred to as P40), male and female rats were treated orally by gavage with P40 once a day for 91 d, and its repeated dose toxicity was assessed. Control animals were treated with a 0.5 w/v% solution of methylcellulose, the vehicle for P40. Each test group consisted of 6 animals of each sex. No adverse effects of P40 were noted in general signs, body weight, food consumption, ophthalmological examination, urinalysis, hematological examination, blood chemical analysis, necropsy, organ weights, or histopathological examination in animals of either sex. From these results, the no observed adverse effect level of P40 was estimated at 2,000 mg/kg in both sexes of rats under the conditions of the present study, and P40 was confirmed to be a food material whose safety is high.
Nukui
Kazuki
K
Nisshin Pharma Inc., Tokyo 101-8441, Japan. nukuik@mail.ni-net.co.jp
Koike
Tsuneo
T
Yamagishi
Toshihiko
T
Ihota
Hiromi
H
Nagase
Takahiko
T
Kimura
Hitoshi
H
Sato
Kiyoshi
K
D000284:Administration, Oral; D000818:Animals; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D003067:Coenzymes / Q000633:toxicity*; D004435:Eating / Q000187:drug effects; D005260:Female; D005503:Food Additives / Q000633:toxicity*; D006403:Hematologic Tests; D006651:Histocytochemistry; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects / Q000502:physiology; D051381:Rats; D017207:Rats, Sprague-Dawley; D014451:Ubiquinone; D016482:Urinalysis
D003067:Coenzymes; D005503:Food Additives; C522292:PureSorb-Q40; D014451:Ubiquinone