Table 5.
Histopathological changes of male and female rats
| Organs | Lesions | Male Dose (mg/kg/day) |
Female Dose (mg/kg/day) |
||
|---|---|---|---|---|---|
| 0 | 2000 | 0 | 2000 | ||
| Adrenal gland | Hypertrophy, zona glomerulosa, multifocal | 1 | 1 | 0 | 0 |
| Vacuolation, cortical, diffuse | 2 | 0 | 0 | 0 | |
| Eye | Atrophy, retinal, focal | 1 | 0 | 1 | 1 |
| Dysplasia, retinal, focal | 1 | 1 | 1 | 0 | |
| Harderian gland | Infiltrate, lymphocytic inflammatory | 0 | 1 | 1 | 0 |
| Heart | Infiltrate, mononuclear, myocardium | 1 | 1 | 0 | 1 |
| Kidneys | Hyperplasia, oncocytic, focal | 1 | 0 | 1 | 1 |
| Tubular basophilia, focal | 2 | 1 | 1 | 2 | |
| Dilation, tubule, focal | 0 | 0 | 1 | 0 | |
| Mineralization, tubular | 0 | 0 | 0 | 1 | |
| Liver | Extramedullary hematopoiesis | 1 | 0 | 0 | 0 |
| Fatty change, periportal | 0 | 1 | 0 | 1 | |
| Infiltration, mononuclear, multifocal | 2 | 3 | 2 | 3 | |
| Necrosis, hepatocyte, multifocal | 0 | 1 | 0 | 0 | |
| Lung including bronchi | Mineralization, arterial wall, focal | 2 | 0 | 1 | 0 |
| Hyperplasia, bronchiolo-alveolar, focal | 0 | 0 | 0 | 1 | |
| Prostate | Concretions | 1 | 0 | – | – |
| Infiltrtion, lymphocytic, interstitial | 0 | 1 | – | – | |
| Salivary gland | Basophilic hypertrophic focus | 0 | 1 | 0 | 0 |
| Infiltrate, lymphocytic, focal | 0 | 0 | 1 | 0 | |
| Spleen | Extramedullary hematopoiesis | 3 | 1 | 1 | 1 |
| Congestion | 1 | 0 | 0 | 1 | |
| Thyroid | Fibrosis, unilateral | 0 | 1 | 0 | 0 |
| Ultimobranchial cyst | 0 | 0 | 0 | 1 | |
| Trachea | Inflammation, acute, submucosa | 1 | 0 | 0 | 0 |
| Ileum | Mineralization, Peyer’s patch, focal | 0 | 0 | 0 | 1 |
| Pancreas | Atrophy, acinar, focal | 0 | 0 | 0 | 1 |
| Stomach | Regeneration, mucous neck cell, focal | 0 | 0 | 0 | 1 |
| Uterus | Cyst, squamous, cervix | – | – | – | 1 |
| Ovary | Cyst, luteal | – | – | 0 | 2 |
| Decreased number/absent corpora lutea | – | – | 0 | 1 | |
| No. of animals | 10 | 10 | 10 | 10 | |
–Not applicable