National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-8003223

Testing Status of D&C Yellow No. 11 - 8003223

 

CASRN: 8003-22-3

Formula: C18-H11-N-O2

Synonyms/Common Names

  • C.I. Solvent Yellow 33 (9CI)
  • Yellow No. 11, D & C

Known Uses

Color 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.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 2 weeks (Dosed-Feed)  (C61789)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13 weeks (Dosed-Feed)  (C61789)  Report Complete 
    • TOX-08 (NIH Number: 91-3127)
      Toxicity Studies of D&C Yellow No. 11 in F344/N Rats and B6C3F1 Mice (Feed Studies) (CASRN 8003-22-3)
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R,M:0,500,1700,5000,17000,50000 PPM.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C61789B)  Report Complete 
    • TR-463 (NIH Number: 97-3379)  (Peer Review Approval 12/05/1995A )
      Toxicology and Carcinogenesis Studies of D&C Yellow No. 11 (CASRN 8003-22-3) in F344 Rats (Feed Studies)
    • Rats: F344/N
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
    • Dose: RATS: 0, 0.05, 0.17, OR 0.5%; 60/GROUP.

Special Studies

  • Absorption Disposition Metabolism Elimination (Dosed-Feed; Intravenous)  (S0085)  Completed 
    • Citation: el Dareer SM, Kalin JR, Tillery KF, Hill DL. Disposition of 2-(2-quinolyl)-1,3-indandione (D. C. yellow #11) in rats dosed orally or intravenously. J Toxicol Environ Health. 1988;23(3):385-93.Pubmed Abstract
    • Male Rats
    • Dose: DF:4.5,37,379,4110 IV: 0.932 MG/KG.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (296632)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Positive 
  • Micronucleus  (A51491)  Completed 
    • Citation: Witt, K.L., Knapton, A., Wehr, C.M., Hook, G.J., Mirsalis, J., Shelby, M.D., and MacGregor, J.T. Micronucleated Erythrocyte Frequency in Peripheral Blood of B6C3F1 Mice from Short-Term, Prechronic, and Chronic Studies of the NTP Carcinogenesis Bioassay Program. Environ. Molec. Mutagen. Vol. 36 (2000) 163-194
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (231115)  Completed 
    • Citation: Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., and Mortelmans, K. Salmonella mutagenicity tests. IV. Results from the testing of 300 chemicals Environ. Molec. Mutagen. Vol. 11 (Suppl 12) (1988) 1-158
    •  Weakly Positive 
  • Salmonella  (686247)  Completed 
    • Citation: Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., and Mortelmans, K. Salmonella mutagenicity tests. IV. Results from the testing of 300 chemicals Environ. Molec. Mutagen. Vol. 11 (Suppl 12) (1988) 1-158
    •  Equivocal 
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.