Imoto S, Kamada S, Yahata A, Kosaka M, Takeuchi M, Shinpo K, Sudo J, Tanabe T
J Toxicol Sci. 1985 Aug;10 Suppl 1:83-103. doi: 10.2131/jts.10.supplementi_83.
A teratogenicity study of halopredone acetate (THS-201), a synthetic corticosteroid, was carried out using Jcl: Wistar rats. Pregnant rats were treated subcutaneously in doses of 0.1, 0.5, 2.5 and 12.5 mg/kg/day, from day 7 to day 17 of gestation. Two-thirds of pregnant rats were killed on day 20 of gestation to examine the development of fetuses, and remaining rats were allowed to litter naturally in order to investigate the postnatal development of offspring. The results obtained from the present study were as follows. During the gestation and lactation periods, there occurred a decrease in the maternal body weight gain in 2.5 and 12.5 mg/kg groups. No influences of THS-201 administration were observed on gestation, delivery and lactation of dams. No external, visceral and skeletal anomalies attributable to THS-201 were observed in the fetuses. THS-201 administration did not have any influences on viability and development, various functions such as reflex response, learning and reproductive performance of F1 generation, and further on development of F2 generation. Therefore, it was concluded that the non-effect dose of THS-201 for the reproduction of dams and development of F1 generation was 12.5 mg/kg/day.
使用Jcl: Wistar大鼠对合成皮质类固醇醋酸卤泼尼龙（THS - 201）进行了致畸性研究。妊娠大鼠在妊娠第7天至第17天接受皮下注射，剂量分别为0.1、0.5、2.5和12.5 mg/kg/天。三分之二的妊娠大鼠在妊娠第20天处死，以检查胎儿发育情况，其余大鼠自然产仔，以研究后代的产后发育情况。本研究获得的结果如下。在妊娠和哺乳期，2.5和12.5 mg/kg组的母鼠体重增加有所减少。未观察到给予THS - 201对母鼠的妊娠、分娩和哺乳有影响。在胎儿中未观察到归因于THS - 201的外部、内脏和骨骼异常。给予THS - 201对F1代的活力和发育、各种功能如反射反应、学习和生殖性能以及F2代的进一步发育均无影响。因此，得出结论，THS - 201对母鼠繁殖和F1代发育的无作用剂量为12.5 mg/kg/天。
