Table 5.

Incidence of Neoplasms exhibiting significant change in mice

	Effect	Vehicle Control	2.5 mg/kg	12.5 mg/kg	25 mg/kg
Male
Small Intestine, Carcinomaa	↑	0/50 (0%)$	1/50(2%)	2/50 (4%)	4/50 (8%)
Small Intestine, Adenoma or Carcinomab	↑	1/50 (2%)$	2/50 (4%)	4/50 (8%)	6/50 (12%)
Alveolar/bronchiolar Carcinoma (includes multiple)c	↑	1/50 (2%)$	4/50 (8%)	5/50 (10%)	7/50 (14%)*
Female
Alveolar/bronchiolar Carcinoma (includes multiple)	↓	5/50 (10%)	0/50 (0%)*	0/50 (0%)*	1/50 (2%)
Malignant lymphomad	↑	6/50(4%)$	2/50(8%)	9/50 (18%)	12/50 (24%)

^*Significantly different (P≤0.05) from vehicle control by the Poly−3 test

^**(P≤0.01)

^$Significant by Poly−3 trend test (P≤0.05)

^aHistorical incidence for 2−year studies, all routes, all vehicles (mean ± standard deviation): 33/1,508 (2.2% ± 2.7%), range 0%−10%

^bHistorical incidence: 39/1,508 (2.6% ± 2.8%), range 0%−10%

^cHistorical incidence: 151/1,507 (9.9% ± 5.0%), range 4%−24%

^dHistorical incidence: 308/1,508 (19.7% ± 13.3%), range 6%−58%