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A unique medicinal mushroom Antrodia cinnamomea has been used for centuries to treat various human diseases. Recent studies revealed its potent pharmacological effects including anticancer, anti-inflammation, anti-oxidant, anti-diabetic, neuroprotection and hepatoprotection. The present study was aimed to investigate the toxicological effects of A. cinnamomea health food product “Leader Antrodia cinnamomea Capsule (LACC)” by measuring its genotoxic, oral toxic and teratotoxic effects in vitro and in vivo. Result of Ames test with 5 strains of Salmonella typhimurium shows no sign of increase in the numbers of revertant colonies upon exposure to LACC. Treatment of Chinese Hamster Ovary cells (CHO-K1) with LACC did not affect increase in the frequency of chromosomal aberration in vitro. In addition, treatment with LACC did not affect the proportions of immature to total erythrocytes and the number of micronuclei in the immature erythrocytes of ICR mice. Moreover, acute oral toxicity (14-days single-dose) or prolonged oral toxicity (28and 90-days repeated oral dose) tests with rats showed that there were no observable adverse effects were found. Furthermore, teratological studies with LACC (500-2500 mg/kg/day) for 20 days, shows no observable segment II reproductive and developmental toxic evidences in pregnant SD rats and their fetus. These toxicological assessments strongly support the safety efficacy of LACC for human consumption.

fundamental toxicological sciences

&lt;i&gt;In vitro &lt;/i&gt;and &lt;i&gt;in vivo&lt;/i&gt; toxicological assessments of &lt;i&gt;Antrodia cinnamomea&lt;/i&gt; health food product (Leader &lt;i&gt;Antrodia cinnamomea&lt;/i&gt; Capsule)