Table 4.
Four-weeks repeated dose toxicity: urinalysis of male rats and female rats
| Summary of urinalysis (sex: male) | ||||
|---|---|---|---|---|
| Test item | Group (mg/kg/day) | |||
| G1 (0) | G2 (500) | G3 (1000) | G4 (2000) | |
| Glucose | ||||
| Negative | 5/5 | 5/5 | 5/5 | 4/5 |
| Trace | 0/5 | 0/5 | 0/5 | 1/5 |
| Bilirubin* | ||||
| Negative | 5/5 | 5/5 | 2/5 | 0/5 |
| 1+ | 0/5 | 0/5 | 2/5 | 2/5 |
| 2+ | 0/5 | 0/5 | 1/5 | 3/5 |
| Ketone body | ||||
| Trace | 3/5 | 3/5 | 2/5 | 0/5 |
| 1+ | 2/5 | 2/5 | 3/5 | 5/5 |
| Specific gravity | ||||
| 1.010 | 1/5 | 1/5 | 0/5 | 0/5 |
| 1.015 | 2/5 | 1/5 | 3/5 | 0/5 |
| 1.020 | 2/5 | 3/5 | 2/5 | 2/5 |
| 1.025 | 0/5 | 0/5 | 0/5 | 2/5 |
| ≥ 1.030 | 0/5 | 0/5 | 0/5 | 1/5 |
| Occult blood | ||||
| Negative | 5/5 | 5/5 | 3/5 | 1/5 |
| Trace | 0/5 | 0/5 | 2/5 | 3/5 |
| 1+ | 0/5 | 0/5 | 0/5 | 1/5 |
| pH | ||||
| 7.0 | 0/5 | 1/5 | 0/5 | 3/5 |
| 7.5 | 1/5 | 2/5 | 2/5 | 2/5 |
| 8.0 | 1/5 | 1/5 | 1/5 | 0/5 |
| Protein | ||||
| Negative | 2/5 | 3/5 | 1/5 | 1/5 |
| Trace | 3/5 | 2/5 | 3/5 | 2/5 |
| 1+ | 0/5 | 0/5 | 1/5 | 2/5 |
| Urobilinogen | ||||
| 0.2 | 5/5 | 5/5 | 4/5 | 3/5 |
| 1 | 0/5 | 0/5 | 1/5 | 2/5 |
| Nitrite | ||||
| Negative | 5/5 | 5/5 | 5/5 | 4/5 |
| Positive | 0/5 | 0/5 | 0/5 | 1/5 |
| Leukocytea | ||||
| – | – | – | – | – |
| Color** | ||||
| Straw | 5/5 | 5/5 | 2/5 | 1/5 |
| Yellow | 0/5 | 0/5 | 2/5 | 0/5 |
| Dark yellow | 0/5 | 0/5 | 1/5 | 4/5 |
| Summary of urinalysis (sex: female) | ||||
|---|---|---|---|---|
| Test item | Group (mg/kg/day) | |||
| G1 (0) | G2 (500) | G3 (1000) | G4 (2000) | |
| Glucose* | ||||
| Negative | 5/5 | 5/5 | 5/5 | 5/5 |
| Trace | 0/5 | 0/5 | 3/5 | 0/5 |
| Bilirubin** | ||||
| Negative | 5/5 | 5/5 | 0/5 | 1/5 |
| 1+ | 0/5 | 0/5 | 3/5 | 1/5 |
| 2+ | 0/5 | 0/5 | 2/5 | 3/5 |
| Ketone body** | ||||
| Negative | 5/5 | 4/5 | 0/5 | 0/5 |
| Trace | 0/5 | 1/5 | 4/5 | 3/5 |
| 1+ | 0/5 | 0/5 | 1/5 | 2/5 |
| Specific gravity* | ||||
| 1.010 | 4/5 | 2/5 | 0/5 | 0/5 |
| 1.015 | 1/5 | 1/5 | 0/5 | 0/5 |
| 1.020 | 0/5 | 2/5 | 4/5 | 2/5 |
| 1.025 | 0/5 | 0/5 | 1/5 | 0/5 |
| ≥ 1.030 | 0/5 | 0/5 | 0/5 | 3/5 |
| Occult blood* | ||||
| Negative | 5/5 | 5/5 | 2/5 | 1/5 |
| Trace | 0/5 | 0/5 | 3/5 | 3/5 |
| 1+ | 0/5 | 0/5 | 0/5 | 1/5 |
| pH* | ||||
| 5.0 | 0/5 | 0/5 | 0/5 | 1/5 |
| 6.5 | 0/5 | 0/5 | 0/5 | 3/5 |
| 7.0 | 0/5 | 3/5 | 3/5 | 1/5 |
| 7.5 | 1/5 | 0/5 | 1/5 | 0/5 |
| 8.0 | 0/5 | 1/5 | 1/5 | 0/5 |
| 8.5 | 4/5 | 1/5 | 0/5 | 0/5 |
| Protein | ||||
| Negative | 5/5 | 5/5 | 2/5 | 1/5 |
| Trace | 0/5 | 0/5 | 3/5 | 2/5 |
| 1+ | 0/5 | 0/5 | 0/5 | 1/5 |
| 2+ | 0/5 | 0/5 | 0/5 | 1/5 |
| Urobilinogen | ||||
| 0.2 | 5/5 | 5/5 | 4/5 | 3/5 |
| 1 | 0/5 | 0/5 | 1/5 | 2/5 |
| 2 | 0/5 | 0/5 | 0/5 | 1/5 |
| Nitrite | ||||
| Negative | 5/5 | 5/5 | 3/5 | 3/5 |
| Positive | 0/5 | 0/5 | 2/5 | 2/5 |
| Leukocytea | ||||
| – | – | – | – | – |
| Color** | ||||
| Straw | 5/5 | 5/5 | 2/5 | 0/5 |
| Yellow | 0/5 | 0/5 | 0/5 | 2/5 |
| Dark yellow | 0/5 | 0/5 | 0/5 | 3/5 |
Number of animals with the sign/number of animals examined
aLeukocyte was examined by urine sediment observation because it could not be detected through examination using an urine stick
Significant difference among groups: *p < 0.05, **p < 0.01