Target Organs and Levels of Evidence for TR-560
Toxicology and Carcinogenesis Studies of Androstenedione (CASRN 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
Chemical (Study Title)
CASRN |
Peer Review Date |
Route/Exposure Levels |
Study Laboratory |
Androstenedione
63-05-8 |
02/25/2009 |
Gavage
RATS & MALE MICE: 0, 10, 20, OR 50 MG/KG FEMALE MICE: 0, 2, 10, OR 50 MG/KG; 50/SEX/SPECIES |
Southern Research Institute |
Levels of Evidence
Male Rats: Equivocal Evidence
| Type |
Organ/Tissue (Lesion) |
| May Have Been Related |
- Lung: Alveolar/bronchiolar adenoma 0/50 0/50 5/50 2/50 alveolar/bronchiolar adenoma or carcinoma (combined) 0/50 0/50 5/50 3/50
|
| Non-Neoplastic Lesions |
- Liver: Basophilic focus; clear cell focus; eosinophilic focus
|
| Decreased Incidences |
- Testis: Interstitial cell adenoma
- Mononuclear cell leukemia
|
Female Rats: Equivocal Evidence
| Type |
Organ/Tissue (Lesion) |
| May Have Been Related |
- All Organs: Mononuclear cell leukemia 5/50 11/50 18/50 15/50 (choose all organs until programmer intervention)
|
| Non-Neoplastic Lesions |
- Pancreatic Islets: Hyperplasia
- Exocrine Pancreas: Atrophy
|
| Decreased Incidences |
- Mammary Gland: Fibroadenoma
|
Male Mice: Clear Evidence
| Type |
Organ/Tissue (Lesion) |
| Neoplastic Lesions |
- Liver: Hepatocellular adenoma, multiple 16/50 27/50 23/50 34/50 hepatocellular adenoma (includes multiples) 32/50 38/50 29/50 43/50 hepatocellular carcinoma multiple 7/50 12/50 10/50 17/50 hepatocellular adenoma or hepatocellular carcinoma (combined includes multiples) 41/50 47/50 42/50 48/50 hepatoblastoma 3/50 8/50 7/50 8/50 hepatocellular adenoma, carcinoma, or hepatoblastoma (combined) 41/50 47/50 43/50 48/50
- Pancreas Islet Cell: Adenoma (includes multiples) 2/50 2/50 2/50 5/49
|
| Non-Neoplastic Lesions |
- Liver: Eosinophilic focus
|
Female Mice: Clear Evidence
| Type |
Organ/Tissue (Lesion) |
| Neoplastic Lesions |
- Liver: Adenoma 14/50 16/50 18/50 28/50 carcinoma 5/50 13/50 15/50 15/50 adenoma or carcinoma 17/50 23/50 27/50 32/50
- Pancreas Islet Cell: Adenoma 0/49 2/50 4/49 4/48
|
| Non-Neoplastic Lesions |
- Liver: Mixed cell focus; hepatocyte, cytoplasmic vacuolization
- Clitoral Gland: Hyperplasia; duct dilatation
- Kidney: Glomerulus, metaplasia
- Submandibular salivary gland: Cytoplasmic alteration
|
| Decreased Incidences |
|
