Hagiwara A, Miyata E, Tamano S, Shibata M A, Sugiura S, Inoue M, Hirose M
Daiyu-kai Institute of Medical Science, Ichinomiya, Japan.
Food Chem Toxicol. 1996 Jun;34(6):537-46. doi: 10.1016/0278-6915(96)00010-5.
2,2'-[(4-aminophenyl)imino]bisethanol sulfate (4APE) was administered at dietary levels of 0 (control), 300, 1000 and 3000 ppm to groups of 50 male and 50 female Fischer 344/DuCrj rats for 104 wk. As slight body weight retardation was observed in the male 3000 ppm group in the preliminary 13-wk feeding study, this dose was selected for the highest exposure level. Mean body weights of both sexes in the 3000 ppm group were lower than those of the controls from wk 2 to termination. However, there were no treatment-related clinical signs or adverse effects on survival rate, food consumption or haematology data. Very slight but statistically significant increases in relative thyroid weights were found in males of the 3000 ppm group, but there was no significant treatment-related increase in the incidence of any non-neoplastic or neoplastic lesions. Thus, under the experimental conditions used, 4APE was not carcinogenic in Fischer 344 rats of either sex.
将2,2'-[(4-氨基苯基)亚氨基]双乙醇硫酸盐(4APE)以0(对照)、300、1000和3000 ppm的膳食水平给予每组50只雄性和50只雌性Fischer 344/DuCrj大鼠,持续104周。在初步的13周喂养研究中,在雄性3000 ppm组中观察到轻微的体重增长迟缓,因此选择该剂量作为最高暴露水平。从第2周直至实验结束,3000 ppm组两性的平均体重均低于对照组。然而,未观察到与处理相关的临床体征,且对存活率、食物消耗量或血液学数据均无不良影响。在3000 ppm组的雄性大鼠中发现相对甲状腺重量有非常轻微但具有统计学意义的增加,但在任何非肿瘤性或肿瘤性病变的发生率方面,均未发现与处理相关的显著增加。因此,在所使用的实验条件下,4APE对Fischer 344大鼠两性均无致癌性。