Bioassay of 2-nitro-p-phenylenediamine for possible carcinogenicity.

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Abstract

A bioassay for the possible carcinogenicity of 2-nitro-p-phenylenediamine was conducted using Fischer 344 rats and B6C3F1 mice. 2-Nitro-p-phenylenediamine was administered in the feed, at either of two concentrations, to groups of 50 male and 50 female animals of each species. Twenty animals of each sex and species were placed on test as controls. The high and low dietary concentrations of 2-nitro-p-phenylenediamine were, respectively, 1,100 and 550 ppm for male rats, 2,200 and 1,100 ppm for female rats, and 4,400 and 2,200 ppm for mice of both sexes. The compound was administered in the diet for 78 weeks, followed by an observation period of 27 weeks for rats and 12 to 13 weeks for mice. There were no significant positive associations between the dietary concentrations of 2-nitro-p-phenylenediamine administered and mortality in rats and mice of either sex. Adequate numbers of animals in all groups survived sufficiently long to be at risk from late-developing tumors. Mean body weight depression, relative to controls, was observed in dosed rats and mice of both sexes, indicating that the concentrations administered to these animals may have approximated the maximum tolerated dosages. When the female mice in each group, having hepatocellular carcinoma or hepatocellular adenoma, were combined and the resulting incidences statistically analyzed, there was a significant positive association between concentration administered and the incidence of these tumors. This finding was supported by a significant high dose to control Fisher exact comparison. No tumors occurred in statistically significant increased incidences when dosed male or female rats or male mice were compared to their respective controls. Under the conditions of this bioassay, dietary administration of 2-nitro-p-phenylenediamine was carcinogenic to female B6C3F1 mice, causing an increased incidence of hepatocellular neoplasms, primarily hepatocellular adenomas. There was no convincing evidence for the carcinogenicity of the compound in Fischer 344 rats or in male B6C3F1 mice.

2-硝基对苯二胺可能致癌性的生物测定。
用Fischer 344大鼠和B6C3F1小鼠进行了2-硝基对苯二胺可能致癌性的生物测定。将2-硝基对苯二胺以两种浓度中的任意一种添加到饲料中,每组50只雄性和50只雌性动物。各性别、各物种各20只作为对照进行试验。雄性大鼠饮食中2-硝基对苯二胺的高、低浓度分别为1100 ppm和550 ppm,雌性大鼠为2200 ppm和1100 ppm,雌雄小鼠分别为4400 ppm和2200 ppm。该化合物在饮食中给予78周,随后对大鼠和小鼠进行了27周和12至13周的观察期。饮食中2-硝基对苯二胺的浓度与大鼠和小鼠的死亡率之间没有显著的正相关。所有组中都有足够数量的动物存活了足够长的时间,从而有患晚期肿瘤的风险。在给药的大鼠和小鼠中观察到相对于对照组的平均体重下降,这表明给这些动物施用的浓度可能接近最大耐受剂量。当将每组中患有肝细胞癌或肝细胞腺瘤的雌性小鼠合并并对其发病率进行统计分析时,给药浓度与这些肿瘤的发病率之间存在显著的正相关关系。这一发现得到了高剂量控制费雪精确比较的支持。当给药的雄性或雌性大鼠或雄性小鼠与各自的对照组相比,没有统计学上显著增加的肿瘤发生率。在这种生物试验条件下,饮食中给予2-硝基-对苯二胺对雌性B6C3F1小鼠具有致癌性,导致肝细胞肿瘤,主要是肝细胞腺瘤的发病率增加。没有令人信服的证据表明该化合物在Fischer 344大鼠或雄性B6C3F1小鼠中具有致癌性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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