title: Safety and mutagenicity evaluation of red mold dioscorea fermented from Monascus purpureus NTU 568.
abstract: Monascus-fermented products, including red mold rice and red mold dioscorea, have been developed as functional foods with many health benefits. We performed safety and mutagenic evaluations on red mold dioscorea powder (RMDP) fermented from Monascus purpureus NTU 568. The results of Ames test using Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535 showed that RMDP (⩽5 mg/plate) was not mutagenic. The mammalian chromosomal aberration test showed that the number of Chinese hamster ovary cells with abnormal chromosomes was <3% after RMDP treatment (maximum concentration: 5 mg/mL). Imprinting control region mice were used to estimate the genotoxicity of RMDP. Compared with the control, high-dose RMDP administration (2000 mg/kg) did not show significant differences in the number of reticulocytes or the occurrence of micronucleated reticulocytes. A 28-day oral toxicity assay in Sprague-Dawley rats was performed to investigate the no observed adverse effect level of RMDP. Compared with the control, high-dose RMDP administration (2000 mg/kg) caused no toxicological responses such as mortality, variation in body weight, or toxicopathologic lesions. Thus, RMDP from M. purpureus NTU 568 shows no significant mutagenic or toxic effects.
authors.affiliation: Department of Biochemical Science & Technology, College of Life Science, National Taiwan University, Taipei 106, Taiwan, ROC.
authors.forename: Li-Chuan
authors.initials: LC
authors.lastname: Hsu
authors.affiliation: SunWay Biotech Co., Taipei 112, Taiwan, ROC.
authors.forename: Ya-Wen
authors.initials: YW
authors.lastname: Hsu
authors.affiliation: MedGaea Life Science LTD., New Taipei City 251, Taiwan, ROC.
authors.forename: Chih-Chun
authors.initials: CC
authors.lastname: Hong
authors.affiliation: Department of Biochemical Science & Technology, College of Life Science, National Taiwan University, Taipei 106, Taiwan, ROC. Electronic address: tmpan@ntu.edu.tw.
authors.forename: Tzu-Ming
authors.initials: TM
authors.lastname: Pan
mesh_terms: D000818:Animals; D016466:CHO Cells; D002869:Chromosome Aberrations; D006224:Cricetinae; D003412:Cricetulus; D005285:Fermentation; D005658:Fungi / Q000378:metabolism*; D032741:Monascus / Q000737:chemistry*; D009152:Mutagenicity Tests; D051381:Rats; D017207:Rats, Sprague-Dawley
keywords: Monascus purpureus NTU 568; No observed adverse effect level (NOAEL); Red mold dioscorea powder (RMDP)