Fujikawa K, Sakaguchi Y, Harada S, Holtz E, Smith J A, Svendsen O
Drug Safety Research Center, Developmental Research Laboratories, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
J Toxicol Sci. 1995 Oct;20 Suppl 1:107-15. doi: 10.2131/jts.20.supplementi_107.
The reproductive toxicity of iodixanol, a non-ionic isotonic contrast medium, was investigated in rats and rabbits. Iodixanol was administered intravenously to male rats at doses of 0.3, 1.0 or 2.0 gI/kg/day for 80 days or more until successful copulation. Female rats were treated with iodixanol at the same dose levels for at least 14 days prior to and in the early stage of pregnancy. No remarkable adverse effects on fertility were noted at any dose level. Increased water consumption and swollen paws/face were observed among male rats receiving > 1.0 gI/kg/day. In addition, decreased food consumption was observed in males of the 2.0 gI/kg/day group. In female rats, no remarkable adverse effects were noted at any dose level. Iodixanol elicited no evidence of teratogenicity when administered during the fetal organogenesis period to pregnant rats and rabbits at doses of 0.3, 1.0 or 2.0 gI/kg/day. No remarkable changes were observed in rat or rabbit fetuses, nor in dams of any dose group. In a perinatal and postnatal dosing study in rats using doses of 0.3, 1.0 or 2.0 gI/kg/day, iodixanol did not adversely affect the reproductive performance of the treated parent animals and pre- and postnatal development of their offspring.
研究了非离子等渗造影剂碘克沙醇对大鼠和家兔的生殖毒性。以0.3、1.0或2.0 gI/kg/天的剂量对雄性大鼠静脉注射碘克沙醇，持续80天或更长时间直至成功交配。雌性大鼠在怀孕前至少14天及怀孕早期用相同剂量水平的碘克沙醇进行治疗。在任何剂量水平下均未观察到对生育力的显著不良影响。接受>1.0 gI/kg/天的雄性大鼠出现饮水量增加和爪子/面部肿胀。此外，2.0 gI/kg/天组的雄性大鼠出现食物摄入量减少。在雌性大鼠中，任何剂量水平下均未观察到显著不良影响。在胎儿器官形成期，以0.3、1.0或2.0 gI/kg/天的剂量对怀孕大鼠和家兔给药时，碘克沙醇未显示出致畸性证据。在大鼠或家兔胎儿以及任何剂量组的母鼠中均未观察到显著变化。在一项使用0.3、1.0或2.0 gI/kg/天剂量的大鼠围产期和产后给药研究中，碘克沙醇对接受治疗的亲代动物的生殖性能及其后代的产前和产后发育没有不利影响。
