Table 7 Histopathological findings
From: A 13-Week Repeated Oral Dose Toxicity Study of ChondroT in Sprague-Dawley Rats
Organs | Histopathological findings | G1(0)* | G4(2000)* | ||||||
|---|---|---|---|---|---|---|---|---|---|
13week | 17week# | 13week | 17week# | ||||||
M | F | M | F | M | F | M | F | ||
Liver | NAD** | 8 | 9 | 4 | 5 | 9 | 10 | 5 | 5 |
Inflammatory cell foci - Minimal, multifocal | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | |
Kidney | NAD | 9 | 8 | 4 | 2 | 8 | 7 | 5 | 4 |
Tubular basophilia - Minimal, multifocal | 1 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | |
Tubular casts - present | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Medullary mineralization - Minimal, multifocal | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 1 | |
Focal nephropathy - Slight, focal | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | |
Inflammatory cell infiltration, interstitial - Minimal, Multifocal | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
Adrenal Gland | NAD | 7 | 10 | 5 | 5 | 6 | 10 | 5 | 5 |
Cortical vacuolation - Minimal, multifocal | 3 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | |
Heart | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Lung (bronchus) | NAD | 10 | 10 | 4 | 5 | 10 | 10 | 5 | 5 |
Inflammatory cell infiltration, perivascular - Minimal, multifocal | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | |
Brain## | NAD | 10 | 10 | 4 | 5 | 10 | 10 | 4 | 5 |
Pituitary: Cyst, pars distalis - Present | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
Spinal Cord | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Spleen | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Seminal Vesicle | NAD | 10 | - | 5 | - | 10 | - | 5 | - |
Prostate gland | NAD | 9 | - | 5 | - | 9 | - | 4 | - |
Inflammatory cell infiltration, interstitial - Minimal, Multifocal | 1 | - | 0 | - | 1 | - | 1 | - | |
Testis | NAD | 9 | - | 5 | - | 10 | - | 5 | - |
Tubular atrophy in left testis - Severe, diffuse | 1 | - | 0 | - | 0 | - | 0 | - | |
Epididymis | NAD | 9 | - | 5 | - | 10 | - | 5 | - |
Oligospermia in left epididymis - Severe, diffuse | 1 | - | 0 | - | 0 | - | 0 | - | |
Ovary | NAD | - | 9 | - | 4 | - | 9 | - | 5 |
Cyst - Present | - | 1 | - | 1 | - | 0 | - | 0 | |
Cysts - Present | - | 0 | - | 0 | - | 1 | - | 0 | |
Uterus | NAD | - | 10 | - | 5 | - | 10 | - | 5 |
Vagina | NAD | - | 10 | - | 5 | - | 10 | - | 5 |
Trachea | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Esophagus | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Thymus | NAD | 10 | 10 | 5 | 4 | 10 | 10 | 5 | 5 |
Cysts - Present | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | |
Thyroid gland | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Tongue | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Stomach | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Urinary bladder | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Intestine†| NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Eye | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Harderian gland | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Skin | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Mammary gland | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Submandibular gland | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Skeletal muscle | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Sciatic nerve | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Pancreas | NAD | 10 | 10 | 4 | 5 | 10 | 10 | 5 | 5 |
Islet fibrosis - Minimal, multifocal | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | |
Sternum | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |
Femur | NAD | 10 | 10 | 5 | 5 | 10 | 10 | 5 | 5 |