Evaluation of acute and 28-day repeated dose toxicity of <i>Tolypocladium sinense</i> soft capsule in Sprague-Dawley rats

<i>Tolypocladium sinense</i> is a new asexual strain isolated from natural <i>Cordyceps sinensis</i>. The mycelium produced by its fermentation culture has similar chemical components and pharmacological effects to <i>C. sinensis. T. sinense</i> soft capsule is primarily prepared from <i>T. sinense</i> mycelium, which is mainly used for the treatment of body damage induced by low-dose ionizing radiation. However, its potential toxicity remains unclear. This study was designed to assess the toxicological characteristics of <i>T. sinense</i> soft capsules through acute and 28-day repeated dose toxicity studies. In the acute toxicity study, no toxic symptoms or mortality were observed in rats following a single oral administration of 10 000 mg/kg of <i>T. sinense</i> soft capsules. The maximum tolerated dose for a single oral dose of <i>T. sinense</i> soft capsules in rats was over 10 000 mg/kg. During the repeated dose toxicity test, oral administration of 90, 360, and 1440 mg/kg/day of <i>T. sinense</i> soft capsules for 28 consecutive days did not lead to significant toxic effects in rats. The no observed adverse effect level in rats surpassed 1440 mg/kg/day. These results provide preliminary evidence that <i>T. sinense</i> soft capsules are relatively safe.