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