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Target Organs and Levels of Evidence for TR-558

Toxicology and Carcinogenesis Studies of 3,3',4,4'-Tetrachloroazobenzene (CASRN 14047-09-7) in Harlan Sprague-Dawley Rats and B6C3F1 Mice (Gavage Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
3,3',4,4'-Tetrachloroazobenzene 14047-09-7	02/25/2009	Gavage 0, .1, .3, 1, 10, 30, OR 100 MG/KG; 10/SEX/DOSE	Battelle Columbus Laboratory

Levels of Evidence: None

Chemical (Study Title) CASRN	Peer Review Date	Primary Uses	Route/Exposure Levels	Study Laboratory
3,3',4,4'-Tetrachloroazobenzene 14047-09-7	02/25/2009	Impurity in dichloroaniline and herbicides derived from DCA. 3,3',4,4'-TCAB is not commercially manufactured but is formed as an unwanted byproduct in the manufacture of 3,4-DCA & its herbicidal derivatives. In addition, environmental contamination by 3,3',4,4'-TCAB occurs from the degradation of chloranilide herbicides & the photolysis and biolysis of 3,4-DCA.	Gavage R: 0, 10, 30, OR 100 MG/KG AND M: 0, 3, 10, OR 30 MG/KG; 50/SEX/SPECIES/DOSE	Battelle Columbus Laboratory

Levels of Evidence

Male Rats: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Lung: Cystic keratinizing epithelioma 0/50 14/50 31/50 37/50 Liver: Cholangiocarcinoma 0/50 4/50 4/50 6/50 Oral Cavity: Mucosa: Gingival squamous cell carcinoma 1/50 5/50 4/50 5/50 Thyroid Gland: Follicular cell adenoma 0/50 3/50 4/50 4/50
May Have Been Related	Thoracic Cavity: Malignant Schwannoma: 0/50 0/50 1/50 3/50
Non-Neoplastic Lesions	Lung: Pigmentation; alveolar epithelium metaplasia, squamous; alveolar epithelium, metaplasia, bronchiolar; alveolus infiltration cellular, histiocyte Liver: Hepatocyte hypertrophy; centrilobular degeneration; necrosis; pigmentation; diffuse fatty change; oval cell hyperplasia; hematopoietic cell proliferation; eosinophilic focus; bile duct cyst; toxic hepatopathy Oral Mucosa: Gingival squamous hyperplasia; gingival cystic keratinizing hyperplasia Thyroid Gland: Follicular cell hypertrophy; follicular cell hyperplasia; inflammation Forestomach: Epithelium, hyperplasia Adrenal Cortex: Degeneration; cytoplasmic vacuolization; zona fasciculata, hyperplasia; necrosis Pancreas: Atrophy; acinar cytoplasmic vacuolization; inflammation Blood Vessel: Inflammation Spleen: Lymphoid follicle atrophy Lymph Node, Mesenteric: Pigmentation; atrophy Testis: Germinal epithelial degeneration

Female Rats: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Lung: Cystic keratinizing epithelioma 0/50 6/50 26/49 39/49 Liver: Cholangiocarcinoma 1/50 1/50 1/49 3/49 Oral Cavity: Mucosa: Gingival squamous cell carcinoma 0/50 0/50 4/50 6/50 Forestomach: Squamous cell papilloma or carcinoma 0/50 1/50 0/50 4/50
May Have Been Related	Adrenal Gland Cortex: Ademona 1/50 1/50 3/50 4/49
Non-Neoplastic Lesions	Lung: Pigmentation; alveolar epithelium, metaplasia, squamous; alveolar epithelium, metaplasia, bronchiolar Liver: Hepatocyte hypertrophy; centrilobular degeneration; necrosis; pigmentation; focal fatty change; diffuse fatty change; bile duct hyperplasia; oval cell hyperplasia; nodular hyperplasia; hematopoietic cell proliferation; eosinophilic focus; mixed cell focus; bile duct cyst; multinucleated hepatocyte; toxic hepatopathy; cholangiofibrosis Oral Mucosa: Gingival squamous hyperplasia; gingival cystic keratinizing hyperplasia Forestomach: Epithelium, hyperplasia Adrenal Cortex: Cytoplasmic vacuolization; zona fasciculata, hyperplasia Pancreas: Atrophy; acinar cytoplasmic vacuolization Blood Vessel: Inflammation Spleen: Lymphoid follicle atrophy; pigmentation Lymph Node, Mesenteric: Pigmentation; atrophy Nasal Cavity: Inflammation

Male Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Urinary System: Urethra: Transitional epithelial gland carcinoma 0/50 32/50 46/49 49/50 Lung: Alveolar/bronchiolar adenoma 5/50 16/50 12/49 6/50 alveolar/bronchiolar adenoma or carcinoma 7/50 17/50 15/49 6/50 Forestomach: Squamous cell carcinoma 0/50 1/50 1/49 3/50
May Have Been Related	Ureter: Transitional epithelial carcinoma: 0/43 0/45 1/47 0/50
Non-Neoplastic Lesions	Urethra: Transitional epithelial gland hyperplasia Ureter: Dilatation; chronic active inflammation Urinary Bladder: Transitional epithelial hyperplasia Forestomach: Epithelial hyperplasia Glandular Stomach: Focal epithelial hyperplasia; gland epithelium cyst; lymphoid cellular infiltration; mineralization Skin: Chronic active inflammation; dermal fibrosis; epidermal hyperplasia; epidermal ulcer; hair follicle dilatation; sebaceous gland atrophy Spleen: Atrophy Thymus: Atrophy Liver: Hematopoietic cell proliferation Heart: Cardiomyopathy Blood Vessel: Aorta mineralization

Female Mice: Clear Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Skin: Fibrosarcoma 1/50 6/50 5/50 8/50 fibrosarcoma or malignant schwannoma 2/50 8/50 7/50 12/50 Urinary System: Urethra: Transitional epithelial gland carcinoma 0/50 0/50 0/50 2/50 Lung: Alveolar/bronchiolar adenoma or carcinoma 0/49 2/50 1/50 4/50 alveolar/bronchiola adenoma or carcinoma 3/49 8/50 5/50 10/50 cystic keratinizing epithelioma 0/49 0/50 0/50 2/50 Forestomach: Squamous cell carcinoma 0/50 1/50 1/50 4/50
May Have Been Related	All Organs: Malignant Lymphoma: 2/50 5/50 8/50 7/50 Ureter: Transitional epithelial carcinoma: 0/0 0/1 0/0 1/2
Non-Neoplastic Lesions	Urinary Bladder: Transitional epithelial hyperplasia Lung: Chronic active inflammation Forestomach: Epithelial hyperplasia Glandular Stomach: Focal epithelial hyperplasia; gland epithelial cyst; lymphoid cellular infiltration Skin: Chronic active inflammation; dermal fibrosis; epidermal hyperplasia epidermal ulcer; hair follicle dilatation; sebaceous gland atrophy Clitoral Gland: Atrophy; duct cyst; chronic inflammation Ovary: Atrophy Bone Marrow: Hyperplasia Spleen: Hematopoietic cell proliferation Thymus: Atrophy Liver: Hematopoietic cell proliferation Heart: Cardiomyopathy