Borzelleca J F, Goldenthal E I, Wazeter F X, Schardein J L
Food Chem Toxicol. 1987 Jul;25(7):495-7. doi: 10.1016/0278-6915(87)90199-2.
Charles River CD rats (20 pregnant rats/group) received by gavage on days 6-15 of gestation 0.5% Methocel (controls, A, B and C), retinoic acid at 7.5 mg/kg/day or FD & C Blue No. 2 in doses of 25, 75 or 250 mg/kg/day. Pregnant Dutch belted rabbits (ten pregnant does/group) received by gavage on days 6-18 of gestation 0.5% Methocel (controls A, B and C), thalidomide at 150 mg/kg/day or FD & C Blue No. 2 in doses of 25, 75 or 250 mg/kg/day. All animals were observed twice daily during gestation for signs of toxicity. The animals were killed 1 day before term and appropriate maternal and foetal parameters were evaluated. There were no consistent, significant compound-related adverse effects on any of these parameters. Foetal malformations occurred in both positive control groups. Under the conditions of this study, FD & C Blue No. 2 did not exert any teratogenicity or other developmental toxicity in either rats or rabbits.
在妊娠第6至15天，给查尔斯河CD大鼠（每组20只孕鼠）经口灌胃给予0.5%甲基纤维素（对照组A、B和C）、7.5毫克/千克/天的视黄酸或25、75或250毫克/千克/天剂量的FD&C蓝色2号。在妊娠第6至18天，给怀孕的荷兰带兔（每组10只孕兔）经口灌胃给予0.5%甲基纤维素（对照组A、B和C）、150毫克/千克/天的沙利度胺或25、75或250毫克/千克/天剂量的FD&C蓝色2号。在妊娠期内，每天对所有动物观察两次，检查毒性迹象。在足月前1天处死动物，并评估适当的母体和胎儿参数。对于这些参数，未发现与化合物相关的一致、显著的不良反应。两个阳性对照组均出现胎儿畸形。在本研究条件下，FD&C蓝色2号在大鼠或兔中均未表现出任何致畸性或其他发育毒性。
