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
|
