Table 3.
Dose (mg/kg) | Hyperplasia | Hyperkerat osis | Inflammation | Fibrosis | Pigmentation | Sebaceous gland hyperplasia | Ulcer |
---|---|---|---|---|---|---|---|
Male F344/N rats | |||||||
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 6* (1.0) | 2 (1.0) | 0 | 0 | 0 | 0 | 0 |
20 | 20** (1.0) | 21** (1.0) | 0 | 0 | 0 | 12** (1.0) | 0 |
75 | 50** (1.2) | 48** (1.6) | 46** (1.3) | 0 | 0 | 48** (1.1) | 0 |
Female F344/N rats | |||||||
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 9** (1.0) | 6* (1.0) | 3 (1.0) | 0 | 0 | 0 | 0 |
20 | 11** (1.0) | 22** (1.0) | 6* (1.0) | 0 | 0 | 5* (1.0) | 0 |
75 | 49** (1.1) | 49** (1.8) | 49** (1.4) | 0 | 0 | 41** (1.7) | 0 |
Male B6C3F1/N mice | |||||||
0 | 8 (1.3) | 11 (1.5) | 2 (1.5) | 3 (2.0) | 0 | 1 (2.0) | 1 (2.0) |
5 | 24** (1.2) | 43** (1.3) | 6 (1.7) | 6 (1.7) | 0 | 6 (1.3) | 1 (3.0) |
20 | 47** (1.6) | 50** (1.9) | 37** (1.2) | 28** (1.4) | 9** (1.0) | 4 (1.3) | 2 (2.5) |
75 | 50** (2.5) | 50** (2.6) | 44** (2.4) | 47** (2.5) | 39** (1.5) | 24** (1.5) | 23** (3.0) |
Female B6C3F1/N mice | |||||||
0 | 20 (1.4) | 24 (1.5) | 12 (1.3) | 5 (1.8) | 0 | 1 (1.1) | 2 (3.0) |
5 | 31* (1.3) | 38** (1.4) | 14 (1.1) | 6 (1.3) | 0 | 2 (1.0) | 0 |
20 | 49** (1.9) | 49** (2.7) | 42** (1.2) | 31** (1.3) | 35** (1.0) | 6 (1.2) | 3 (1.3) |
75 | 49** (3.3) | 49** (3.4) | 48** (3.0) | 49** (3.1) | 40** (1.8) | 34** (1.5) | 33** (3.1) |
N = 50. Average severity grades indicated in parenthesis: 1=minimal, 2=mild, 3=moderate, 4=marked.
Significant differences from vehicle control group:
p ≤ 0.01 by Fisher exact test.