Testing Status of Phenylbutazone 10354-F

CASRN: 50-33-9

Formula: C19-H20-N2-O2

Synonyms/Common Names

• 4-Butyl-1,2-diphenyl-3,5-pyrazolidinedione (9CI)

Short-Term Toxicity

• 2 weeks (Gavage)  (C56531)  Completed 
  • Rats: F344/N; Mice: B6C3F1
• 13 weeks (Gavage)  (C56531)  Completed 
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R: 0, 25, 50, 100, 200, OR 300 MG/KG M: 0, 40, 80, 150, 300, OR 600 MG/KG.

Long-Term Carcinogenicity

• 2 years (Gavage)  (C56531)  Completed 
  • TR-367 (NIH Number: 89-2822)  (Peer Review Approval 03/13/1989A )
    Toxicology and Carcinogenesis Studies of Phenylbutazone (CASRN 50-33-9) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R: 0, 50, 100, M: 0, 150, 300 MG/KG/50 PER GROUP.
  • Carcinogenesis Results
    • Male Rats Equivocal Evidence 
    • Female Rats Some Evidence 
    • Male Mice Some Evidence 
    • Female Mice No Evidence 

Genetic Toxicology

• In Vitro Cytogenetics (CA/SCE)  (534081)  Completed 
  • Citation: Galloway SM, Armstrong MJ, Reuben C, Colman S, Brown B, Cannon C, Bloom AD, Nakamura F, Ahmed M, Duk S, Rimpo J, Margolin B, Resnick M, Anderson B, and Zeiger E. Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: evaluations of 108 chemicals. Environ Mol Mutagen. 1987;10 Suppl 10:1-175. doi: 10.1002/em.2850100502
  • Sister Chromatid Exchange Negative 
  • Chromosome Aberrations Positive 
• Micronucleus  (476079)  Completed 
  • Mice: B6C3F1
  • Male Negative 
• Mouse Lymphoma  (421302)  Completed 
  • Mice
  •  Positive 
• Salmonella  (030078)  Completed 
  • Citation: Mortelmans K, Haworth S, Lawlor T, Speck W, Tainer B, Zeiger E. Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals. Environ Mutagen. 1986;8 Suppl 7:1-119
  •  Negative