Monascus purpureus MTCC 410-fermented rice (red mould rice) is one of the food supplements to lower blood-lipid levels and monacolins have been proven to be the main active constituents in red mould rice (RMR). In this study, we have assessed the safety of RMR by conducting toxicological studies in albino rats. Acute and sub-chronic toxicity studies were conducted on both sexes of albino rats. Feeding acute doses of RMR at 0.5, 1.0, 2.5 and 5.0 g/kg body weight to rats did not cause any symptoms of toxicity or mortality. Similarly, dietary feeding of RMR at 2.0%, 4.0%, 8.0% and 12.0% level (w/w) for 14 weeks did not produce any significant changes in food intake or gain in body weight of the experimental rats compared to control rats. There were no significant differences in the relative weight of vital organs, hematological parameters, macroscopic and microscopic changes in vital organs and serum clinical enzyme levels between the experimental and control groups. Moreover, the rats fed with RMR showed a significant reduction in cholesterol and triglyceride levels in both serum and liver. The results showed that toxicity studies with RMR of M. purpureus did not cause any toxic effects in albino rats.
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