Skip to Main Navigation
Skip to Page Content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Share This:
https://ntp.niehs.nih.gov/go/6237

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 DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
D & C yellow no. 11
8003-22-3
12/05/1995Color additive used in cosmetics and externally applied drugs. Also used in spirit lacquers, polystyrenes, polycarbonates, polyamides, acrylic resins, colored smokes, and hydrocarbon solvents. Contaminant of D&C yellow 10, a compound which FDA is currently considering for approval for contact lenses.Dosed-Feed
RATS: 0, 0.05, 0.17, OR 0.5%; 60/GROUP
Southern Research Institute

Levels of Evidence

Male Rats: Some Evidence
TypeOrgan/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
TypeOrgan/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