Toxicological evaluation of the red mold rice extract, ANKASCIN 568-R: 13-week chronic toxicity, and genotoxicity studies

Che-Wei Lin; Hsiao-Lin Chen; Yu-Hui Yang; Ya-Yuan Chen; Ya-Wen Hsu; Tzu-Ming Pan

doi:10.1016/j.toxrep.2022.02.008

Toxicological evaluation of the red mold rice extract, ANKASCIN 568-R: 13-week chronic toxicity, and genotoxicity studies

Toxicol Rep. 2022 Feb 22:9:356-365. doi: 10.1016/j.toxrep.2022.02.008. eCollection 2022.

Authors

Che-Wei Lin¹, Hsiao-Lin Chen², Yu-Hui Yang², Ya-Yuan Chen², Ya-Wen Hsu¹, Tzu-Ming Pan^{1

3}

Affiliations

¹ SunWay Biotech Co., Taipei 112, Taiwan, ROC.
² Center of Toxicology and Preclinical Sciences QPS Taiwan, New Taipei City 221, Taiwan, ROC.
³ Department of Biochemical Science & Technology, College of Life Science, National Taiwan University, Taipei 106, 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.

Keywords: 13-week oral toxicity; AK, ankaflavin; ANKASCIN 568-R; Ankaflavin; CHO, Chinese hamster ovary; Genotoxicity; MS, monascin; Monascin; Monascus purpureus NTU 568; NOAEL, no observed adverse effect level; RMR, red mold rice; SD, Sprague Dawley.