Determination of Toxicological Evaluation of Red Mold Rice Extract (ANKASCIN 568-R): Study about Chronic Toxicity and Genotoxicity

Abstract

This chapter evaluates the safety of ANKASCIN 568-R, since it has not determined yet. After daily oral ANKASCIN 568-R for 13 consecutive weeks, we evaluated the toxicity tolerance of Sprague-Dawley rats and performed dose formulation analysis on monascin and ankaflavin. Red mould rice is the fermentation product of ordinary rice with certain mould species of the genus Monascus. An extract from red mould rice (RMR) fermented with Monascus purpureus NTU 568 is known as ANKASCIN 568-R. Blood lipid levels are reduced and cardiovascular diseases are prevented by RMR fermented with M. purpureus NTU 568. The dose formulation analysis showed that ANKASCIN 568-R concentrations were lower than the target concentration and out of range ( ± 15%) at week 8 and on the last dosing day for both monascin (all dose groups) and ankaflavin at the 100 mg/kg dose. ANKASCIN 568-R was administered once daily by gavage to rats for 13 consecutive weeks. No adverse effects were observed through clinical observations, ophthalmological examinations, body weight and food consumption analyses, or microscopic and clinical pathology examinations. The lowest reported concentrations for the low, middle, and high dose formulations were 34.7, 115.2, and 398.1 mg/mL, respec- tively. We also evaluated the genotoxicity of ANKASCIN 568-R and showed no genotoxicity potential at all ANKASCIN 568-R doses investigated. The no observed adverse effect level of ANKASCIN 568-R was determined to be 796.2 mg/kg/day.  This is an important safety assessment for clinical studies of ANKASICN 568-R. In addition, monascin and ankaflavin were the major active materials in ANKASICN 568-R. There is currently no separate toXicity test data, and it can be studied in the future.