title: Bioassay of aroclor for possible carcinogenicity.
abstract: A bioassay of Aroclor 1254 for possible carcinogenicity was conducted by administering the test chemical in feed to Fischer 344 rats. Groups of 24 rats of each sex were administered Aroclor 1254 at one of three doses, either 25, 50, or 100 ppm, for 104-105 weeks. Matched controls consisted of groups of 24 untreated rats of each sex. All surviving rats were killed at 104-105 weeks. Mean body weights of males and females receiving mid and high doses and females receiving low doses of the chemical were consistently below those of the corresponding controls, beginning at about week 10 of the study. The decrease in survival among males, but not among females, showed a significant dose-related trend. Adequate numbers of animals of both sexes survived for meaningful statistical analyses of the incidences of tumors. The combined incidences of lymphomas and leukemias showed a significant dose-related trend in males (controls 3/24, low-dose 2/24, mid-dose 5/24, high-dose 9/24, P=0.009). However, the direct comparisons of each dosed group with those of the matched controls were not statistically significant, and the tumors cannot clearly be related to administration of with Aroclor 1254. Hepatocellular adenomas and carcinomas were found in the dosed groups, but not in the controls (males: mid-dose 1/24, high-dose 3/24; females: mid-dose 1/24, high-dose 2/24).Additionally, a high incidence of nonneoplastic hyperplastic nodules was noted in the dosed animals (males: controls 0/24, low-dose 5/24, mid-dose 8/24, high-dose 12/24; females: controls 0/23, low-dose 6/24, mid-dose 9/22, high-dose 17/24). Although the incidences of tumors were not significant, the occurrence of the hyperplastic nodules appeared to be related to administration of the chemical. In the stomach, jejunum, or cecum, adenocarcinomas were observed in two dosed males and in two dosed females as well as a carcinoma in one dosed male. None of these lesions was found in control animals in this study. Historical incidences of these tumors at this laboratory (6/600 males [1%], 2/600 females [0.3%] suggest that the lesions, although not statistically significant, may be related to the administration of Aroclor 1254. It is concluded that under the conditions of this bioassay, Aroclor(R) 1254 was not carcinogenic in Fischer 344 rats; however, a high incidence of hepatocellular proliferative lesions in both male and female rats was related to administration of the chemical. In addition, the carcinomas of the gastrointestinal tract may be associated with administration of Aroclor 1254 in both males and females.