Objective： Systematically evaluate the general toxicity and genetic toxicity of Cistanche formula tea， provide safety data for Cistanche formula tea， and offer a basis for further advancing the functional research of Cistanche formula tea. Methods： The general toxicity of Cistanche formula tea was evaluated using acute toxicity test in ICR mice and 30-day feeding test in SD rats. The genetic toxicity was assessed by bacterial Ames test， micronucleus test in polychromatic erythrocytes of bone marrow in Kunming mice， and sperm deformity test. Results： The maximum tolerated dose (MTD) of Cistanche formula tea concentrate in ICR mice was greater than 20.00 g·kg-1， classifying it as non-toxic. All genetic toxicity test results of Cistanche formula tea concentrate were negative. In the 30-day gavage experiment in SD rats with doses of 3.75， 7.50， and 15.00 g·kg-1of Cistanche formula tea concentrate， the rats showed good growth and development during the experiment. No statistically significant differences (P>0.05) were observed in body weight， food utilization rate， blood biochemical indicators， blood routine parameters， main organ weights， and organ/body weight ratios between the Cistanche formula tea concentrate groups and the control group. No abnormal lesions clearly attributable to the treatment with Cistanche formula tea concentrate were found through gross anatomical observation and histopathological examination. These results indicated that the concentrate did not produce obvious toxic effects on rats within the 30 d feeding period. Conclusion： Under the experimental conditions， both the general toxicological evaluation and genetic toxicological test results of Cistanche formula tea concentrate were negative， and its safety can provide a supporting basis for subsequent functional studies.
