Table 20.
Males | Females | |||||
---|---|---|---|---|---|---|
Dose (mg/kg bw per day) | Control | 125 | 250 | Control | 125 | 250 |
Hepatocellular adenomas | 11/50 (22%) | 20/50 (40%)a , b |
29/50 |
0/50 (0%) |
18/50 |
22/50 |
Hepatocellular carcinomas | 11/50 (22%) | 15/50 (30%) |
17/50 (34%) |
3/50 (6%) |
4/50 (8%) |
9/50 (18%)a |
Hepatocellular adenomas or carcinomas | 20/50 (40%)c | 34/50 (68%)a , b |
38/50 |
3/50 (6%)d |
22/50 |
28/50 |
Thyroid follicular cell adenomas or carcinomas |
3/49 (6%) |
4/50 (8%) |
3/49 (6%) |
8/50 (16%)e |
12/49 (24%) |
15/49 |
Harderian gland adenomas | – | – | – |
1/50 (2%)f |
6/50 |
2/50 (4%) |
Alveolar/bronchiolar carcinomas |
0/50 (0%)g |
3/50 (6%) |
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): 109/298 (37% ± 12%); historical incidence in NTP studies: 357/1,091 (33% ± 10%).
Historical incidence at the study laboratory (mean ± SD): 18/300 (6% ± 3%); historical incidence in NTP studies: 74/1,092 (7% ± 4%).
Historical incidence at the study laboratory (mean ± SD): 19/291 (7% ± 3%); historical incidence in NTP studies: 40/1,009 (4% ± 3%).
Historical incidence at the study laboratory (mean ± SD): 5/300 (2% ± 2%); historical incidence in NTP studies: 21/1,096 (2% ± 3%).
No specific historical incidence data reported for alveolar/bronchiolar carcinomas. Historical incidence of the alveolar/bronchiolar tumours (adenomas and carcinomas) at the study laboratory (mean ± SD): 54/298 (18% ± 7%); historical incidence of the alveolar/bronchiolar tumours in NTP studies: 169/1,093 (15% ± 6%).