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Testing Status of Nalidixic acid 10045-K

 

CASRN: 389-08-2

Formula: C12-H12-N2-O3

Synonyms/Common Names

  • 1-Ethyl-1,4-dihydro-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acid (9CI)

Short-Term Toxicity

  • 13-Week (Dosed-Feed)  (C56199)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 1000, 2000, 4000, 8000, 16000/10 PER GROUP.

Long-Term Carcinogenicity

  • 107 weeks (Dosed-Feed)  (C56199)  Completed 
    • TR-368 (NIH Number: 89-2823)  (Peer Review Approval 03/13/1989A )
      Toxicology and Carcinogenesis Studies of Nalidixic Acid (CASRN 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
      • Female Rats Clear Evidence 
      • Male Mice Equivocal Evidence 
      • Female Mice No Evidence 
    • Dose: R&M: 0, 2000, 4000 PPM/50 PER GROUP.
  • 108 weeks (Dosed-Feed)  (C56199)  Completed 
    • TR-368 (NIH Number: 89-2823)  (Peer Review Approval 03/13/1989A )
      Toxicology and Carcinogenesis Studies of Nalidixic Acid (CASRN 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
      • Female Rats Clear Evidence 
      • Male Mice Equivocal Evidence 
      • Female Mice No Evidence 
    • Dose: R&M: 0, 2000, 4000 PPM/50 PER GROUP.

Special Studies

  • Absorption Distribution Metabolism Excretion (Gavage)  (S0209)  Completed 
    • Male Rats: F344/N; Male Mice: B6C3F1
    • Dose: 20, 200, 500 mg/kg [R,M].
  • Metabolism (Gavage)  (S0549)  Completed 
    • Citation: Nomeir AA, Markham P, Burka LT, Griffin RJ, Ghanayem BI. Species differences in the disposition and metabolism of nalidixic acid. J Pharmacol Exp Ther. 1996 Oct;279(1):222-30.Pubmed Abstract
    • Male Rats: F344/N; Male Mice: B6C3F1
    • Dose: 500 mg/kg bwt [R,M].

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (404155)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Negative 
  • Mouse Lymphoma  (803923)  Completed 
    • Mice
    •  Negative 
  • Salmonella  (253916)  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
    •  Negative 
  • Salmonella  (A06185)  Completed 
    •  Weakly Positive