Key Laboratory of Veterinary Chemical Drugs and Pharmaceutics, Ministry of Agriculture and Rural Affairs, Shanghai Veterinary Research Institute, Chinese Academy of Agricultural Sciences, Shanghai, 200241, PR China.
Key Laboratory of Veterinary Chemical Drugs and Pharmaceutics, Ministry of Agriculture and Rural Affairs, Shanghai Veterinary Research Institute, Chinese Academy of Agricultural Sciences, Shanghai, 200241, PR China.
Regul Toxicol Pharmacol. 2020 Jun;113:104623. doi: 10.1016/j.yrtph.2020.104623. Epub 2020 Feb 20.
In the current study, to support the safety assessment of ethanamizuril as a new potent anticoccidial agent of triazine compounds, a reproductive toxicity and teratogenic potential assay of ethanamizuril was investigated. Groups of 30 males and 30 females were administered 0, 0.02, 0.1 or 0.2 mg/ml ethanamizuril by gastric incubation through a 10-week prebreed period as well as during mating, gestation, parturition and lactation in any generation. Compared to the control group, no test compound-related changes in copulation index, fertility index, gestation length, litter size, pup weight, pup sex ratio, pup viability, epididymal sperm counts or motility or other functional reproductive measures were noted in any generation, except few significant changes in high dose group in the number of sperm motility at III level in F0 males and the body weights of GD14 and GD21 in F1 rats. There were no compound-related necropsy findings or effects on organ weight. Histopathologic examinations revealed no evidence of compound-related changes in any organs including the reproductive organs of both sexes. In conclusion, long-term administrated 0.2, 1.0 and 2.0 mg/kg of ethanamizuril by means of oral gavage did not affect the reproduction of Sprague-Dawley rats and the development ability of their offspring under the experimental conditions.
在当前的研究中，为了支持乙酰胺嗪作为一种新型三嗪类抗球虫药的安全性评估，我们对乙酰胺嗪的生殖毒性和致畸潜力进行了研究。30 只雄性和 30 只雌性大鼠分别给予 0、0.02、0.1 或 0.2mg/ml 的乙酰胺嗪，通过胃内孵育的方式进行 10 周的预交配期以及交配、妊娠、分娩和哺乳期的任何阶段。与对照组相比，在任何一代中，除了 F0 雄性中 III 级精子活力和 F1 大鼠 GD14 和 GD21 体重的几个显著变化外，没有观察到与试验化合物相关的交配指数、生育指数、妊娠长度、窝产仔数、幼仔体重、幼仔性别比、幼仔活力、附睾精子计数或活力或其他功能生殖指标的变化。没有与化合物相关的尸检发现或对器官重量的影响。组织病理学检查未发现任何器官（包括雌雄两性的生殖器官）与化合物相关的变化的证据。总之，在实验条件下，经口灌胃给予 SD 大鼠长期 0.2、1.0 和 2.0mg/kg 的乙酰胺嗪，不会影响其繁殖能力及其后代的发育能力。
