Fundamental Toxicological Sciences

Paper Details

Fundamental Toxicological Sciences
Vol. 8 No. 1 March 09, 2021 p.7-16
Original Article
Genotoxicity of Monascus Color Y-001
  • Toyohiko Aoki (DIMS Institute of Medical Science, Inc. /
Ryosuke Sato 1) , Michihito Takabe 1) , Takahiro Ishii 2) , Norio Imai 3) , Yuko Doi 3) , Toyohiko Aoki 3)
1) Tokyo Laboratory, BoZo Research Center Inc. , 2) Gotemba Laboratory, BoZo Research Center Inc. , 3) DIMS Institute of Medical Science, Inc.
Keywords: Monascus Color Y-001, Genotoxicity, Ames test, Chromosomal aberration test, Micronucleus test

The genotoxic potential of Monascus Color Y-001 was assessed using the standard battery of assays including the in vitro reverse mutation test in bacteria (Ames test), the in vitro chromosomal aberration test in mammalian cells and the in vivo micronucleus test in rats. The results of the Ames test, the chromosomal aberration test in CHL/IU cells with and without S9 mix (metabolic activation) and the in vivo bone marrow micronucleus test in rats were all negative. Therefore, it is concluded that Monascus Color Y-001 does not possess any genotoxic risk in humans.