Toxicological evaluation of the red mold rice extract, ANKASCIN 568-R: 13-week chronic toxicity, and genotoxicity
Che-Wei Lin1, Hsiao-Lin Chen2, Yu-Hui Yang2
1SunWay Biotech Co., Taipei 112, Taiwan, ROC.
Abstract:
ANKASCIN 568-R is an extract derived from red mold rice (RMR) fermented using Monascus purpureus NTU 568. RMR fermented using M. purpureus NTU 568 prevents cardiovascular diseases and decreases blood lipid levels. This study 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. 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. The lowest reported concentrations for the low, middle, and high dose formulations were 34.7, 115.2, and 398.1 mg/mL, respectively. 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 study revealed the first toxicity evaluation data of ANKASICN 568-R, and the data demonstrated ANKASICN 568-R was safe and can be used in daily life.
Insights
ANKASCIN 568-R, a red mold rice extract, was evaluated for safety in rats. This study found no genotoxicity and established a no observed adverse effect level, confirming its safety for daily consumption.
Area of Science:
- Nutritional Science
- Toxicology
- Pharmacology
Background:
- Red mold rice (RMR) fermented by Monascus purpureus NTU 568 is known for cardiovascular benefits.
- ANKASCIN 568-R is an extract from this specific RMR strain.
- Previous safety data for ANKASCIN 568-R was lacking.
Purpose of the Study:
- To evaluate the safety and toxicity of ANKASCIN 568-R.
- To determine the genotoxicity potential of ANKASCIN 568-R.
- To establish the no observed adverse effect level (NOAEL) for ANKASCIN 568-R.
Main Methods:
- Subchronic oral toxicity study in Sprague-Dawley rats over 13 weeks.
- Dose formulation analysis of monascin and ankaflavin.
- Genotoxicity assessment.
- Determination of the no observed adverse effect level (NOAEL).
Main Results:
- The no observed adverse effect level (NOAEL) of ANKASCIN 568-R was determined to be 796.2 mg/kg/day.
- No genotoxicity was observed at any tested dose.
- Dose formulation analysis indicated variability in monascin and ankaflavin concentrations.
Conclusions:
- ANKASCIN 568-R demonstrated a favorable safety profile in a 13-week rat study.
- The extract showed no genotoxic potential.
- The established NOAEL supports the safety of ANKASCIN 568-R for daily use.
