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Testing Status of 5,5-Diphenylhydantoin (phenytoin) 10156-D

 

CASRN: 57-41-0

Formula: C15-H12-N2-O2

Synonyms/Common Names

  • 2,4-Imidazolidinedione, 5,5-diphenyl-
  • Phenytoin

Known Uses

Drug; therapeutic agent used as anticonvulsant, antiepileptic; antiarrhythmic drug

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C55765)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C55765)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 300, 4800, M: 0, 75, 1200 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C55765)  Completed 
    • TR-404 (NIH Number: 94-2859)  (Peer Review Approval 06/24/1992A )
      Toxicology and Carcinogenesis Studies of 5,5-Diphenylhydantoin (Phenytoin) (CASRN 57-41-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice Clear Evidence 
    • Dose: R: 0, 240, 800, 2400, MM: 0, 30, 100, 300, FM: 0, 60, 200, 600 PPM/50 PER GROUP.

Special Studies

  • Absorption Disposition Metabolism Elimination (Dosed-Feed)  (S0450)  Completed 
    • Citation: Colburn WA, Matthews HB. Pharmacokinetics in the interpretation of chronic toxicity tests: the last-in, first-out phenomenon. Toxicol Appl Pharmacol. 1979 May;48(3):387-95.Pubmed Abstract
    • Male Rats: Sprague Dawley
  • C. elegans  (S0923)  Completed 
    • C. elegans
    • Dose: Feed ( 0, .05, .063, .79, .1, .13, .16, .2, .25. .32. .4, .5 mM) 6/27/06 Repro (0, .025, .032, .04, .05, .063, .079, .1, .13, .16, .20, .25 mM) 6/18/06 Growth (0, .025, .032, .04, .05, .063, .079, .1, .13, .16, .20, .25 mM).

Genetic Toxicology

  • Chromosome Aberrations  (252423)  Completed 
    • Mice
    •  Negative 
  • In Vitro Cytogenetics (CA/SCE)  (335957)  Completed 
    • Citation: Galloway, S., Armstrong, M., Reuben, C., Colman, S., Brown, B., Cannon, C., Bloom, A., Nakamura, F., Ahmed, M., Duk, S., Rimpo, J., Margolin, B., Resnick, M., Anderson, B., and Zeiger, E. Chromosome aberration and sister chromatid exchanges in Chinese hamster ovary cells: Evaluations of 108 chemicals. Environ. Molec. Mutagen. Vol. 10 (Suppl 10) (1987) 1-176
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Negative 
  • Drosophila  (486572)  Completed 
    • Citation: Woodruff, R.C., Mason, J.M., Valencia, R., and Zimmering, S. Chemical mutagenesis testing in Drosophila: V. Results of 53 coded compounds tested for the National Toxicology Program. Environ. Mutagen. Vol. 7 (1985) 677-702
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
  • Mouse Lymphoma  (404495)  Completed 
    • Mice
    •  Negative 
  • Micronucleus  (110489)  Completed 
    • Mice: BALB/c
    • Male Negative 
  • Micronucleus  (252424)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female NA 
  • Salmonella  (255790)  Completed 
    • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
    •  Negative 
  • Salmonella  (599479)  Completed 
    • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
    •  Negative 
  • Sister Chromatid Exchanges  (252423)  Completed 
    • Mice
    • Sister Chromatid  Equivocal