Repeated dose 90-day oral toxicity study of an Antrodia cinnamomea product via a novel process in sprague dawley rats

Antrodia cinnamomea as a medicinal mushroom exhibited neuroprotective, hepatoprotective, anti-inflammatory, antioxidant, or even antineoplastic activities. However, wood-cultured A. cinnamomea products cost too high to afford, and some people in Taiwan still had a concern for the safety of A. cinnamomea. Hence, the purpose of the study was conducted to evaluate repeated dose 90-day oral toxicity of a high-quality and low-price A. cinnamomea product via a novel process, spraying solid-state-cultivated A. cinnamomea extracts on wood-cultivated A. cinnamomea powder, in Sprague Dawley rats. Three dose levels were conducted in the study, namely 1000, 2000, and 4000 mg/kg BW. Results showed that no clinical abnormality of the rats was observed, and all rats gained weights normally without any significant difference. No treatment-related histopathological changes were observed, but significantly different and dose-independent responses were revealed for leukocyte esterase in male urine, chloride in male serum, and female liver weight. The significant changes of chloride in male serum, hemoglobin and mean corpuscular hemoglobin in male blood, and relative weight of adrenal glands were within normal ranges. In conclusion, the repeated dose 90-day oral toxicity study showed no treatment-related adverse effect in the Sprague Dawley rats after administration of the A. cinnamomea product via the novel process.