Table 1.
Number of Animals with Lesion (severity) | ||||||
---|---|---|---|---|---|---|
Dose (mg/kg) | Mean change in body weight (g) | Final weight relative to controls (%) | Squamous hyperplasia | Hyperkeratosis | Chronic active inflammation | Ulcer |
Male F344/N rats | ||||||
0 | 224 ± 5 | 1 (1.0) | 0 | 0 | 0 | |
9.5 | 225 ± 9 | 100 | 10** (1.0) | 10** (1.1) | 9** (1.1) | 0 |
18.75 | 231 ± 6 | 102 | 10** (1.0) | 10** (1.3) | 9** (1.2) | 0 |
37.5 | 226 ± 6 | 101 | 10** (1.0) | 10** (1.7) | 10** (1.0) | 0 |
75 | 215 ± 6 | 97 | 10** (1.5) | 10** (2.2) | 10** (1.8) | 0 |
150 | 215 ± 5 | 97 | 10** (1.4) | 10** (2.0) | 10** (1.9) | 1 (2.0) |
Female F344/N rats | ||||||
0 | 103 ± 4 | 0 | 0 | 0 | 0 | |
9.5 | 105 ± 3 | 102 | 10** (1.0) | 10** (1.0) | 8** (1.0) | 0 |
18.75 | 102 ± 3 | 100 | 10** (1.0) | 10** (1.4) | 10** (1.5) | 0 |
37.5 | 95 ± 4 | 97 | 10** (1.0) | 10** (1.4) | 9** (1.8) | 0 |
75 | 97 ± 4 | 98 | 10** (1.3) | 10** (1.9) | 10** (2.0) | 0 |
150 | 90 ± 3* | 95 | 10** (1.1) | 10** (2.1) | 10** (1.8) | 0 |
Male B6C3F1/N mice | ||||||
0 | 12.3 ± 0.6 | 0 | 0 | 0 | 0 | |
38 | 12.7 ± 0.6 | 103 | 10** (1.0) | 10** (1.0) | 10** (1.3) | 0 |
75 | 11.7 ± 0.6 | 99 | 10** (1.0) | 10** (1.0) | 10** (1.4) | 0 |
150 | 12.1 ± 0.6 | 102 | 10** (1.1) | 10** (1.0) | 10** (1.5) | 0 |
300 | 10.3 ± 0.9 | 96 | 10** (1.6) | 10** (1.2) | 10** (1.7) | 1 (2.0) |
600 | 10.5 ± 0.6 | 96 | 10** (2.2) | 10** (1.5) | 10** (2.2) | 2 (2.0) |
Female B6C3F1/N mice | ||||||
0 | 11.3 ± 0.6 | 0 | 0 | 0 | 0 | |
38 | 12.7 ± 1.1 | 103 | 10** (1.0) | 10** (1.0) | 10** (1.9) | 0 |
75 | 12.0 ± 0.7 | 102 | 10** (1.1) | 10** (1.0) | 10** (2.1) | 0 |
150 | 11.3 ± 0.6 | 98 | 10** (1.0) | 10** (1.0) | 10** (2.0) | 0 |
300 | 9.4 ± 0.7 | 93 | 10** (1.4) | 10** (1.1) | 10** (2.1) | 0 |
600 | 9.8 ± 0.6 | 94 | 10** (1.8) | 10** (1.4) | 10** (2.1) | 3 (2.0) |
N = 10. Average severity grades indicated in parenthesis: 1=minimal, 2=mild, 3=moderate, 4=marked.
Significant differences from vehicle control group:
p ≤ 0.05 by Williams' test;
p ≤ 0.01 by Fisher exact test.