Finzelberg GmbH & Co. KG, Andernach 56626, Germany.
Consulting HMP, Weinheim 69469, Germany.
Toxins (Basel). 2018 Jun 24;10(7):258. doi: 10.3390/toxins10070258.
Griseb. has a long history of collection from the wild as a traditional remedy for respiratory and gastrointestinal complaints. It has also been investigated for its promising pharmacological activities in the central nervous system. However, its toxicological data is entirely missing. This study investigated the acute and repeated-dose oral toxicity of a 20% (/) ethanol extract in Sprague Dawley rats, and mutagenicity using the Ames test. No gross pathological abnormalities and no toxicity signs or mortality were detected in animals treated with the dose of 2000 mg/kg bw during 14 days of observation. The tested extract was assigned to category 5 of the GHS. To evaluate a repeated-dose toxicity, an extract has been tested over a 28-day period followed by a 14-day recovery period. No mortality and no changes in body/organ weight or food consumption have been observed. The no-observed-adverse-effect-level of the extract was determined at 1000 mg/kg bw. The results of Ames tests conducted on extracts of different polarity (water; 20% (/) ethanol; 50% (/) ethanol; n-heptane), were unequivocally negative. The study reveals no toxicity of and no concerns for its mutagenic effects, supports its positive safety profile, and confirms the acknowledged traditional medicinal use in human.
格里塞布。作为一种传统的治疗呼吸道和胃肠道疾病的药物，它有着悠久的野生采集历史。它在中枢神经系统方面也具有有前景的药理学活性，因此也受到了研究。然而，它的毒理学数据完全缺失。本研究在 Sprague Dawley 大鼠中评估了 20%（/）乙醇提取物的急性和重复剂量口服毒性，并使用 Ames 试验评估其致突变性。在 14 天的观察期内，用 2000mg/kg bw 的剂量处理动物未发现明显的大体病理异常、毒性迹象或死亡。该受试提取物被归为 GHS 的第 5 类。为了评估重复剂量毒性，已在 28 天的试验期后进行了为期 14 天的恢复期试验。未观察到死亡，也未观察到体重/器官重量或食物消耗的变化。提取物的无明显不良作用水平确定为 1000mg/kg bw。在不同极性（水；20%（/）乙醇；50%（/）乙醇；正庚烷）提取物的 Ames 试验结果均为阴性。该研究表明无毒性，也无致突变作用的担忧，支持其积极的安全性特征，并确认其在人类中的传统药用用途。
