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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