Subchronic toxicity test of songaria cynomorium herb aqueous extract in rat

OBJECTIVE: To observe the sub-chronic toxicity of songaria cynomorium herb aqueous extract in rat at different oral dose levels. METHODS: The study was conducted according to the protocol of sub-chronic toxicity study in rat in Procedures and Method for Toxicolohical Assessment on Food Safety(GB 15193. 13-2015). Total 80 SPF grade Wistar rats, weighing 60-80 g, were randomized into 4 groups of 10/sex/group based on their body weight. The animals from groups 1 to 4 were orally dosed once daily with songaria cynomorium herb aqueous-soluble extract at 0, 2. 83, 5. 66 and 8. 49 g/kg BW respectively for continuous 90 days. And the dose volume was 13 mL/kg. The clinical signs, body weight, food consumption, food utilization rate, hematology, serum chemistry and histopathology were monitored or tested. RESULTS: No obvious toxic signs were observed and no animals were found dead during the whole study. There were no significant differences between the control and test article groups in the body weight, food consumption, food utilization rate. Although some hematology and serum chemistry parameters in a single dose group changed significantly, their values were still in the normal ranges of our laboratory. Therefore, all the above changes were not considered as adverse effects. However, the prothrombin time(PT) at male middle and high dose group prolonged significantly(P<0. 05). In addition, Compared with that of control, significantly increased testes index was observed in the mid-dose group, while increased spleen index, testes index, epididymis index were observed in high-dose group. no obvious histopathology changes were detected in all test article groups. CONCLUSION: Under the condition of this experiment, the No-observed-adverse-effect-level(NOAEL) was 2. 83 g/kg BW and the lowest-observed-adverse-effect-level(LOAEL) was 5. 66 g/kg BW for songaria cynomorium herb aqueous-soluble extract in the rat sub-chronic toxicity study.