DiNardo J C, Picciano J C, Schnetzinger R W, Morris W E, Wolf B A
Toxicol Appl Pharmacol. 1985 Mar 30;78(1):163-6. doi: 10.1016/0041-008x(85)90316-3.
The oxidative dyes, 4,4'-diaminodiphenylene sulfate, N'-(2-hydroxyethyl)-4-nitro-O-phenylenediamine, N,N-dimethyl-p-phenylenediamine, 2,3-dihydroxynaphthalene, and resorcinol, were evaluated for teratogenic potential. Dyes were administered by gavage to pregnant Sprague-Dawley rats on gestation Days 6 through 15 at doses ranging from 12.5 to 500 mg/kg. No overt signs of toxicity were observed during the treatment period. A significant reduction in mean maternal weight gain was noted during the treatment period at the high dose for 4,4'-diaminodiphenylene sulfate, N'-(2-hydroxyethyl)-4-nitro-O-phenylenediamine, and 2,3-dihydroxynaphthalene. The high dose for N,N-dimethyl-p-phenylenediamine and resorcinol, which exceeded a 100-fold exaggeration of human exposure, did not produce a significant reduction in maternal weight gain. An evaluation of fetal external, visceral, and skeletal anomalies revealed no statistically significant differences between dye-treated and vehicle control groups. Administration of 100,000 units of vitamin A, the positive control, on Day 9 of gestation resulted in a significant increase in abnormal fetuses.
对氧化染料4,4'-二氨基二苯醚硫酸盐、N'-(2-羟乙基)-4-硝基邻苯二胺、N,N-二甲基对苯二胺、2,3-二羟基萘和间苯二酚的致畸潜力进行了评估。在妊娠第6至15天，通过灌胃法给怀孕的斯普拉格-道利大鼠施用染料，剂量范围为12.5至500毫克/千克。在治疗期间未观察到明显的毒性迹象。在高剂量下，4,4'-二氨基二苯醚硫酸盐、N'-(2-羟乙基)-4-硝基邻苯二胺和2,3-二羟基萘在治疗期间母体平均体重增加显著减少。N,N-二甲基对苯二胺和间苯二酚的高剂量超过人类暴露量的100倍，并未导致母体体重增加显著减少。对胎儿外观、内脏和骨骼异常的评估显示，染料处理组与赋形剂对照组之间无统计学显著差异。在妊娠第9天给予100,000单位维生素A（阳性对照）导致异常胎儿显著增加。
