Target Organ and Levels of Evidence for TR-584
Toxicology Studies of Indole-3-Carbinol (CASRN 700-06-1) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Indole-3-Carbinol in Harlan Sprague Dawley Rats and B6C3F1/N Mice (Gavage Studies)
Chemical CASRN (Study Title) |
Peer Review Date |
Primary Uses |
Route/Exposure Levels |
Study Laboratory |
Indole-3-carbinol 700-06-1 |
05/22/2014 |
Natural component of brassica vegetables; marketed as a dietary supplement and cancer preventative agent |
Gavage R: 0, 75, 150, or 300 mg/kg; M: 0, 62.5, 125, or 250 mg/kg; 50/sex/species/dose |
Battelle Columbus Laboratory |
Levels of Evidence
Male Rats: No Evidence
Type |
Organ/Tissue (Lesion) |
Non-Neoplastic Lesions |
- Intestine small, duodenum: lymphatic, ectasia
- Intestine small, jejunum: lymphatic, ectasia
- Lymph node, mesenteric: lymphatic, ectasia
- Liver: bile duct, cyst
- Thyroid gland: follicular cell, hypertrophy
|
Female Rats: Some Evidence
Type |
Organ/Tissue (Lesion) |
Neoplastic Lesions |
- Uterus: adenocarcinoma (standard evaluation) 0/50 1/50 4/50 4/50 (standard and extended evaluations) combined 5/50 4/50 12/50 10/50
|
May Have Been Related |
- Skin: fibroma 1/50 0/50 0/50 4/50 fibrosarcoma 1/50 0/50 0/50 1/50 fibroma or fibrosarcoma 2/50 0/50 0/50 5/50
|
Non-Neoplastic Lesions |
- Uterus: endometrium, metaplasia, squamous (standard evaluation)
- Intestine small, duodenum: lymphatic, ectasia
- Intestine small, jejunum: lymphatic, ectasia
- Lymph node, mesenteric: lymphatic, ectasia
- Liver: clear cell focus; eosinophilic focus
|
Male Mice: Clear Evidence
Type |
Organ/Tissue (Lesion) |
Neoplastic Lesions |
- Liver: hepatocellular adenoma 26/50 32/50 31/49 41/50 hepatocellular carcinoma 12/50 11/50 29/49 14/50 hepatoblastoma 3/50 4/50 4/49 14/50 hepatocellular adenoma, hepatocellular carcinoma, or hepatoblastoma 36/50 36/50 44/49 45/50
|
Non-Neoplastic Lesions |
- Liver: clear cell focus
- Glandular stomach: epithelium, hyperplasia; inflammation, chronic; pigmentation
- Nasal Cavity: nerve, atrophy; olfactory epithelium, respiratory metaplasia; olfactory epithelium, atrophy; olfactory epithelium, necrosis; respiratory epithelium, accumulation, hyaline droplet; respiratory epithelium, hyperplasia
|
Female Mice: No Evidence
Type |
Organ/Tissue (Lesion) |
Non-Neoplastic Lesions |
- Liver: eosinophilic focus
- Glandular stomach: epithelium, hyperplasia; inflammation, chronic; pigmentation
- Nasal Cavity: nerve, atrophy; olfactory epithelium, respiratory metaplasia; olfactory epithelium, atrophy; respiratory epithelium, hyperplasia; inflammation
|