Subchronic oral toxicity study of Monascus Color in beagle dogs

Monascus Color Y-001, a natural food pigment produced from Monascus purpureus Y-001 fermentation, was administered orally by gavage to 4 Beagle dogs/sex/group for 90 days at doses of 0 (vehicle: 0.1% Tween 80, 10 mL/kg bw), 1, 5 and 25 mg/kg bw/day. In the clinical observations, vomiting/vomitus (dark red watery substance or undigested feed) was observed for males and females in the 25, but not 5 or 1 mg/kg bw/day group at a relatively high frequency. In addition, loose stools were observed for males in this group on a single occasion. These signs were considered to be effects of the test article on the digestive tract. No treatment-related effects were noted in the detailed observations for symptoms, body weights, food consumptions, ophthalmology, hematology, clinical chemistry, urinalysis, gross pathology, organ weights or histopathology. Thus, the no-observed-adverse-effect level (NOAEL) was judged to be 5 mg/kg bw/day in both sexes of the dogs.