Table 19.
Males | Females | |||||
---|---|---|---|---|---|---|
Dose (mg/kg bw per day) | Control | 312 | 625 | Control | 312 | 625 |
Hepatocellular neoplastic nodules | 0/50 (0%) | 10/50 (20%)a , b | 16/48 (33%)a , b |
0/50 (0%) |
4/50 (8%)a |
7/50 |
Hepatocellular carcinomas | 0/50 (0%) |
3/50 |
2/48 (4%) |
0/50 (0%) |
1/50 (2%) |
1/50 (2%) |
Hepatocellular neoplastic nodules or carcinomas | 0/50 (0%)c | 13/50 (26%)a , b | 16/48 (33%)a , b |
0/50 (0%)d |
5/50 (10%)a |
7/50 |
Renal tubular‐cell adenomas or adenocarcinomas | 0/50 (0%)e | 9/50 (18%)a , b |
3/49 (6%) |
0/50 (0%) |
0/50 (0%) |
0/50 (0%) |
Mononuclear cell leukaemia | 7/50 (14%)f | 12/50 (24%)a | 14/50 (28%)a |
11/50 (22%)g |
22/50 (44%)a |
16/50 (32%) |
Thyroid follicular cell adenomas or carcinomas | 3/50 (6%) |
3/50 (6%) |
3/50 (6%) |
0/50 (0%)h |
6/50 (12%)a , b |
6/50 |
bw: body weight.
Life table analysis, p < 0.05, increase relative to control.
Incidental tumour test for trend, p < 0.05, increase relative to control.
Historical incidence at the study laboratory (mean ± SD): 8/299 (3% ± 3%); historical incidence in NTP studies: 43/1,098 (4% ± 4%).
Historical incidence at the study laboratory (mean ± SD): 2/300 (0.7% ± 1%); historical incidence in NTP studies: 21/1,098 (2% ± 3%).
Historical incidence at the study laboratory (mean): 1/300 (0.3%); historical incidence in NTP studies: 5/1,098 (0.5%).
Historical incidence at the study laboratory (mean ± SD): 19/300 (6% ± 6%); historical incidence in NTP studies: 152/1,100 (14% ± 8%).
Historical incidence at the study laboratory (mean ± SD): 36/300 (12% ± 6%); historical incidence in NTP studies: 196/1,100 (18% ± 9%).
Historical incidence at the study laboratory (mean ± SD): 3/297 (1% ± 1%); historical incidence in NTP studies: 15/1,076 (1% ± 2%).