Target Organs and Levels of Evidence for TR-548
Toxicology and Carcinogenesis Studies of Ethinyl Estradiol (CASRN 57-63-6) in Sprague-Dawley Rats (Feed Studies)
Chemical (Study Title) CASRN |
Peer Review Date |
Route/Exposure Levels |
Study Laboratory |
Endocrine disruptor (Ethinyl estradiol) 57-63-6 |
05/16/2007 |
Dosed-Feed 0, 2, 10, or 50 ppb |
National Center for Toxicological Research |
Levels of Evidence
F1C Male Rats: No Evidence
Type |
Organ/Tissue (Lesion) |
Non-Neoplastic Lesions |
- Mammary Gland: alveolar hyperplasia (1/44, 4/45, 6/47, 18/44); ductal hyperplasia (0/44, 0/45, 2/47, 3/44)
- Liver: basophilic focus (1/49, 3/49, 3/50, 17/49); eosinophilic focus (3/49, 5/49, 8/50, 15/49)
|
F1C Female Rats: No Evidence
Type |
Organ/Tissue (Lesion) |
Non-Neoplastic Lesions |
- Uterus: endometrial hyperplasia (17/51, 18/50, 22/49, 25/50); squamous metaplasia (2/51, 6/50, 8/49, 13/50); atypical focal hyperplasia (6/51, 14/50, 16/49, 20/50)
- Liver: eosinophilic focus (1/51, 1/50, 1/49, 5/50)
|
Levels of Evidence
F1T140 Male Rats: No Evidence
Type |
Organ/Tissue (Lesion) |
Non-Neoplastic Lesions |
- Liver: basophilic focus (1/49, 3/50, 11/48, 6/49); eosinophilic focus (3/49, 11/50, 5/48, 10/49)
- Mammary gland: alveolar hyperplasia (1/44, 2/45, 6/47, 14/48); ductal hyperplasia (0/44, 0/45, 1/47, 3/48)
|
F1T140 Female Rats: Equivocal Evidence
Type |
Organ/Tissue (Lesion) |
May Have Been Related |
- Uterus: stromal polyp (2/51, 5/50, 6/50, 7/50)
|
Non-Neoplastic Lesions |
- Liver: basophilic focus (1/51, 1/50, 1/50, 6/50)
- Clitoral Gland: hyperplasia (2/50, 1/50, 2/49, 8/49)
|
Levels of Evidence
F3T21 Male Rats: Equivocal Evidence
Type |
Organ/Tissue (Lesion) |
May Have Been Related |
- Mammary Gland: adenoma or adenocarcinoma (0/42, 0/42, 0/40, 3/45)
- Preputial Gland: epithelial neoplasms (2/49, 4/49, 4/50, 8/49)
|
Non-Neoplastic Lesions |
- Mammary Gland: alveolar hyperplasia (2/42, 6/42, 4/40, 9/45)
|
F3T21 Female Rats: Equivocal Evidence
Type |
Organ/Tissue (Lesion) |
May Have Been Related |
- Uterus: stromal polyp (1/52,7/50, 2/50, 5/50)
|
Non-Neoplastic Lesions |
- Clitoral Gland: hyperplasia (0/50, 1/50, 2/49, 3/48)
- Uterus: squamous metaplasia (1/52, 4/50, 3/50, 11/50); atypical focal hyperplasia (6/52, 16/50, 15/50, 21/50)
|