Table 5.

Summary of non‐neoplastic lesions in rats and mice taken from NTP (1993)

Lesion	Dosage (mg/kg bw per day)	Incidencea
Rats		Male	Female
Biliary tract cysts	0 2 4 8	0/50 44/50** 47/50** 49/50**	0/50 49/50** 50/50** 46/50**
Biliary tract fibrosis, multifocal	0 2 4 8	0/50 44/50** 48/50** 49/50**	0/50 49/50** 50/50** 49/50**
Biliary tract hyperplasia	0 2 4 8	0/50 44/50** 48/50** 49/50**	0/50 49/50** 48/50** 49/50**
Biliary tract inflammation chronic multifocal	0 2 4 8	0/50 44/50** 48/50** 49/50**	0/50 49/50** 50/50** 49/50**
Biliary tract metaplasia	0 2 4 8	0/50 44/50*** 48/50*** 49/50***	0/50 49/50*** 50/50*** 49/50***
Hepatocyte cytomegaly	0 2 4 8	0/50 35/50** 46/50** 49/50**	0/50 44/50** 50/50** 49/50**
Hepatocyte degeneration	0 2 4 8	0/50 33/50** 46/50** 49/50**	0/50 35/50** 49/50** 47/50**
Hepatocyte hyperplasia, multifocal	0 2 4 8	0/50 33/50 46/50** 49/50**	0/50 32/50 47/50** 46/50**
Hepatocyte necrosis, multifocal	0 2 4 8	0/50 32/50** 46/50** 49/50**	0/50 18/50** 46/50** 47/50**
Hepatocyte vacuolisation, cytoplasmic	0 2 4 8	0/50 39/50** 45/50** 49/50**	0/50 43/50** 49/50** 47/50**
Kupffer cell pigmentation, multifocal	0 2 4 8	0/50 44/50** 48/50** 49/50**	0/50 49/50** 50/50** 48/50**
Mice
Multifocal hyperplasia liver	0 8 15	1/50 44/50** 49/50**	0/50 7/50 11/50
Biliary tract fibrosis	0 8 15	0/50 45/50** 49/50**	0/50 47/50** 50/50**
Biliary tract hyperplasia	0 8 15	0/50 46/50** 49/50**	0/50 47/50** 50/50**
Biliary tract inflammation	0 8 15	0/50 44/50** 49/50**	2/50 48/50** 50/50**
Hepatocyte hepatomegaly	0 8 15	8/50 45/50** 50/50**	0/50 48/50** 50/50**
Hepatocyte degeneration	0 8 15	0/50 43/50** 43/50**	0/50 47/50** 48/50**
Hepatocyte necrosis	0 8 15	2/50 39/50** 41/50**	0/50 44/50** 47/50**
Kupffer cell pigmentation	0 8 15	2/50 43/50** 50/50**	5/50 48/50** 50/50**

bw: body weight.

^a**equals significant at > 0.01; ***equals significant at > 0.001.