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D&C Yellow No. 11: Target Organs and Levels of Evidence for TR-463

Toxicology and Carcinogenesis Studies of D&C Yellow No. 11 (CASRN 8003-22-3) in F344 Rats (Feed Studies)

Chemical (Study Title) CASRN	Peer Review Date	Route/Exposure Levels	Study Laboratory
D & C yellow no. 11 8003-22-3	12/05/1995	Dosed-Feed RATS: 0, 0.05, 0.17, OR 0.5%; 60/GROUP	Southern Research Institute

Levels of Evidence

Male Rats: Some Evidence

Type

Organ/Tissue (Lesion)

Neoplastic Lesions

Liver: ADENOMA 1/50 2/51 1/51 7/54
Kidney Tubular Cell: (SINGLE SECTIONS) ADENOMA 0/50 0/51 0/51 2/54 OR CARCINOMA 0/50 0/51 1/51 0/54 COMBINED 0/50 0/51 1/51 2/54; (SINGLE AND STEP SECTIONS) ADENOMA 0/50 2/51 4/51 4/54 OR CARCINOMA 0/50 0/51 1/51 0/54 COMBINED 0/50 2/51 5/51 4/54
Oral Cavity: SQUAMOUS CELL PAPILLOMA 1/50 1/51 2/51 4/54 OR SQUAMOUS CELL CARCINOMA 0/50 1/51 1/51 1/54 COMBINED 1/50 2/51 3/51 5/54

Non-Neoplastic Lesions

LIVER: CLEAR CELL FOCUS; MIXED CELL FOCUS; BILE DUCT, HEPATOCYTE AND KUPFFER CELL PIGMENTATION; CYTOLOGIC ALTERATIONS
KIDNEY: TUBULE HYPERPLASIA; TUBULE PIGMENTATION; TRANSITIONAL EPITHELIAL HYPERPLASIA; INCREASED SEVERITY OF NEPHROPATHY

Female Rats: Some Evidence

Type	Organ/Tissue (Lesion)
Neoplastic Lesions	Liver: ADENOMA 0/50 2/51 5/50 4/51 OR CARCINOMA 0/50 0/51 0/50 1/51 COMBINED 0/50 2/51 5/50 5/51
May Have Been Related	Oral Cavity: SQUAMOUS CELL CARCINOMA 0/50 0/51 0/50 1/51
Non-Neoplastic Lesions	LIVER: CLEAR CELL FOCUS; BILE DUCT, HEPATOCYTE AND KUPFFER CELL PIGMENTATION; CYTOLOGIC ALTERATIONS KIDNEY: TUBULE PIGMENTATION; TRANSITIONAL EPITHELIAL HYPERPLASIA; SEVERITY OF NEPHROPATHY