Table 3.
Incidence of nonneoplastic lesions exhibiting significant change in rats
| Effect | Vehicle Control | 5 mg/kg | 25 mg/kg | 50 mg/kg | |
|---|---|---|---|---|---|
| Male | |||||
| Pancreatic Islet Hyperplasia | ↑ | 13/50 (1.2)a | 13/50 (1.7) | 17/50 (1.8) | 26/50** (1.4) |
| Pancreatic Acinar Cell Hyperplasia | ↑ | 4/50 (2.0) | 6/50 (1.7) | 15/50** (1.9) | 12/50 * (1.8) |
| Pancreatic Acinar Atrophy | ↓ | 43/50 (2.1) | 31/50 **(1.8) | 35/50* (2.0) | 32/50* (1.9) |
| Splenic Hematopoietic Cell Proliferation | ↑ | 11/50 (1.5) | 12/50 (2.0) | 17/50 (1.5) | 20/50* (1.7) |
| Splenic Capsular Fibrosis | ↑ | 1/50 (1.0) | 7/50* (1.3) | 12/50** (1.5) | 30/50** (1.8) |
| Female | |||||
| Splenic Capsular Fibrosis | ↑ | 8/49 (1.0) | 17/48* (1.1) | 12/49** (1.1) | 20/49** (1.0) |
| Mammary Gland Hyperplasia | ↓ | 18/50 (2.3) | 19/49 (2.1) | 9/50* (2.0) | 7/50* (2.6) |
*
Significantly different (P≤0.05) from vehicle control by the Poly−3 test
**
(P≤0.01)
a
Average severity grade of lesions in affected animals: 1=minimal, 2=mild, 3=moderate, 4=marked