Subchronic oral toxicity study of Monascus Color in beagle dogs

Monascus Color Y-001, a natural food pigment produced from 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) observed males females in 25, but not 1 bw/day group relatively high frequency. addition, loose stools were this on single occasion. These signs considered be effects test article digestive tract. No treatment-related noted detailed observations symptoms, body weights, consumptions, ophthalmology, hematology, chemistry, urinalysis, gross pathology, organ weights histopathology. Thus, no-observed-adverse-effect level (NOAEL) judged both sexes dogs.