Table 15.
Summary of notable histopathology findings in the 90-day repeated oral toxicity study.
| Organs | Observations | Dose groups (mg/kg bw/day) | |||||
|---|---|---|---|---|---|---|---|
| Control | 100 | 360 | 720 | ||||
| Main | Recovery | Main | Recovery | ||||
| Male | |||||||
| Adrenal gland | Increased cytoplasmic vacuolation | 0/10 | 0/5 | 0/10 | 0/10 | 6/10 | 0/5 |
| Kidney | Cyst | 1/10 | 0/5 | 0/1 | / | 0/10 | 0/5 |
| Mineral deposits | 0/10 | 0/5 | 1/1 | / | 0/10 | 0/5 | |
| Lungs | Alveolar emphysema | 0/10 | 0/5 | / | / | 1/10 | 1/5 |
| Alveolar histiocytosis | 2/10 | 0/5 | / | / | 1/10 | 0/5 | |
|
| |||||||
| Female | |||||||
| Adrenal gland | Increased cytoplasmic vacuolation | 0/10 | 0/5 | 0/10 | 0/10 | 8/10 | 0/5 |
| Kidneys | Focal fibrosis | 0/10 | 0/5 | 1/1 | 0/1 | 0/10 | 0/5 |
| Lungs | Alveolar emphysema | 1/10 | 0/5 | / | / | 0/10 | 1/5 |
| Acute hemorrhage | 0/10 | 1/5 | / | / | 0/10 | 0/5 | |
| Alveolar histiocytosis | 1/10 | 0/5 | / | / | 3/10 | 0/5 | |
| Uterus | Dilatation | 4/10 | 3/5 | / | / | 2/10 | 1/5 |
/, not examined.
Data represent the number of animals with observation per number of animals observed.