Safety Assessment of Antrodia cinnamomea Cultured in Red Quinoa and Barley: Genotoxicity in Mice and 90-Day Feeding Toxicity in Rats.

Antrodia cinnamomea (AC) is a medicinal mushroom native to Taiwan. This study evaluated the genotoxicity and toxicity of red quinoa and barley-based solid-state fermented AC mycelium (RQBACM). The safety of RQBACM was evaluated via a 90-day repeated-dose oral toxicity study in rats and a battery of genotoxicity assays, including the Ames, CHO-K1 chromosomal aberration, and in vivo micronucleus tests. RQBACM exhibited no mutagenicity in the Ames test, regardless of S9 metabolic activation, nor did it induce chromosomal aberrations in CHO-K1 cells. In mice, no significant changes in reticulocyte or micronucleus frequency were observed at doses up to 5000 mg/kg. In the 90-day study, Sprague-Dawley rats receiving up to 3000 mg/kg/day showed no treatment-related adverse effects, except for a slight reduction in body weight in high-dose males. No significant changes were found in hematology, serum biochemistry, urinalysis, organ weights, or histopathology. The no-observed-adverse-effect level (NOAEL) was determined to be 3000 mg/kg/day, supporting the safety of RQBACM for potential human consumption.