TABLE 13.

Summary of tumour incidences in male mice in the NTP (2014) study.

	0 mg/kg bw a	250 mg/kg bw	500 mg/kg bw
Hepatocellular adenoma (including multiple)	32	33	38
Hepatocellular carcinoma (including multiple)	11	15	17
Hepatocellular adenoma or Hepatocellular carcinoma	39	39	43
Hepatoblastoma	2	11 b	8
Hepatocellular carcinoma or hepatoblastoma	12	24 b	20
Hepatocellular adenoma, hepatocellular carcinoma or hepatoblastoma	39	42	43
Caecum or colon: adenoma or carcinoma	0 c	0	3
Haemangiosarcoma (all organs)	1 c	5	8 b
Haemangioma or haemangiosarcoma	3 c	5	9

^a Groups of 50 mice were dosed by gavage 5 days per week for 2 years (averaged doses = 0, 179, 357 mg/kg bw per day). A higher dose group of 1000 mg/kg bw was not assessed for tumours due to early mortality.

^b Statistically significant at p ≤ 0.05 in pairwise comparisons with the control group.

^c Statistically significant trend at p ≤ 0.05.