Genotoxic, teratotoxic and oral toxic assessments of Antrodia cinnamomea health food product (Leader Deluxe Antrodia cinnamomea(®))

Antrodia cinnamomea is a rare and endemic medicinal mushroom native to Taiwan. The pharmacological effects of A. cinnamomea have been extensively studied. The aim of the present study was to assess the genotoxic, oral toxic and teratotoxic effects of A. cinnamomea health food product ⿿Leader Deluxe Antrodia cinnamomea (LDAC)⿿⿿ using in vitro and in vivo tests. The Ames test with 5 strains of Salmonella typhimurium showed no signs of increased reverse mutation upon exposure to LDAC up to concentration of 5 mg/plate. Exposure of Chinese Hamster Ovary cells (CHO-K1) to LDAC did not produce an increase in the frequency of chromosomal aberration in vitro. In addition, LDAC treatment did not affect the proportions of immature to total erythrocytes and the number of micronuclei in the immature erythrocytes of ICR mice. Moreover, 14-days single-dose acute toxicity and 90-days repeated oral dose toxicity tests with rats showed that no observable adverse effects were found. Furthermore, after treatment with LDAC (700⿿2800 mg/kg/day) there was no evidence of observable segment II reproductive and developmental toxic effects in pregnant SD rats and their fetuses. These toxicological assessments support the safety of LDAC for human consumption.