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Testing Status of Salicylazosulfapyridine 11177-H

CASRN: 599-79-1

Formula: C18-H14-N4-O5-S

Synonyms/Common Names

  • 2-Hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azobenzoic acid (9CI)
  • SASP
  • Sulfasalazine

Short-Term Toxicity

  • 14-Day (Gavage)  (C61552)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13 weeks (Gavage)  (C61552)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 84, 169, OR 337 M: 0, 675, 1350, OR 2700 MG/KG.

Long-Term Carcinogenicity

  • 2 & 3 years (Gavage)  (C61552B)  Completed 
    • TR-457 (NIH Number: 97-3373)  (Peer Review Approval 06/20/1995A )
      Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CASRN 599-79-1) in F344 Rats and B6C3F1 Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 84, 168, OR 337.5 MG/KG; 70/GROUP M: 675, 1350, OR 2700 MG/KG; 60/GROUP.
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 

Special Studies

  • Toxicokinetic Study (Gavage; Intravenous; Gavage; Intravenous)  (S0312)  Completed 
    • Citation: Zheng W, Winter SM, Mayersohn M, Bishop JB, Sipes IG. Toxicokinetics of sulfasalazine (salicylazosulfapyridine) and its metabolites in B6C3F1 mice. Drug Metab Dispos. 1993 Nov-Dec;21(6):1091-7.Pubmed Abstract
    • Male Rats [R]: F344/N; Male and Female Mice [M]: B6C3F1
    • Dose: (gavage) 67.5, 675 mg/kg [R]. (intravenous) 5 mg/kg [R,M]. (gavage) 67.5, 675, 1350, 2700 mg/kg (single dose); 675, 1350, 2700 mg/kg/day (3-day repeat dose) [M].

Genetic Toxicology

  • Chromosome Aberrations  (459882)  Completed 
    • Citation: Bishop JB, Witt KL, Gulati DK, MacGregor JT. Evaluation of the mutagenicity of the anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis. 1990 Nov;5(6):549-54. doi: 10.1093/mutage/5.6.549
    • Mice
    •  Negative (Nonstandard Protocol) 
  • Chromosome Aberrations  (724355)  Completed 
    • Mice
    •  Negative (Nonstandard Protocol) 
  • Chromosome Aberrations  (A93691)  Completed 
    • Mice
    •  Negative (Nonstandard Protocol) 
  • In Vitro Cytogenetics (CA/SCE)  (291257)  Completed 
    • Citation: Bishop JB, Witt KL, Gulati DK, MacGregor JT. Evaluation of the mutagenicity of the anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis. 1990 Nov;5(6):549-54. doi: 10.1093/mutage/5.6.549
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Negative 
  • Micronucleus  (107236)  Completed 
    • Rats: Fischer 344
    • Male Equivocal 
  • Micronucleus  (459882)  Completed 
    • Citation: Bishop JB, Witt KL, Gulati DK, MacGregor JT. Evaluation of the mutagenicity of the anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis. 1990 Nov;5(6):549-54. doi: 10.1093/mutage/5.6.549
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (724355)  Completed 
    • Mice: B6C3F1
    • Male Not a Valid Test 
  • Micronucleus  (A66124)  Completed 
    • Citation: Bishop JB, Witt KL, Gulati DK, MacGregor JT. Evaluation of the mutagenicity of the anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis. 1990 Nov;5(6):549-54. doi: 10.1093/mutage/5.6.549
    • Citation: Witt KL, Knapton A, Wehr CM, Hook GJ, Mirsalis J, Shelby MD, MacGregor JT. Micronucleated erythrocyte frequency in peripheral blood of B6C3F(1) mice from short-term, prechronic, and chronic studies of the NTP carcinogenesis bioassay program. Environ Mol Mutagen. 2000;36(3):163-94
    • Mice: B6C3F1
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A72306)  Completed 
    • Mice: B6C3F1
    • Male Positive 
  • Micronucleus  (A93691)  Completed 
    • Mice: B6C3F1
    • Male Positive (Nonstandard Protocol) 
    • Female Positive 
  • Salmonella  (031562)  Completed 
    • Citation: Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K. Salmonella mutagenicity tests: IV. Results from the testing of 300 chemicals. Environ Mol Mutagen. 1988;11 Suppl 12:1-157
    •  Negative 
  • Sister Chromatid Exchanges  (724355)  Completed 
    • Mice
    • Sister Chromatid  Negative (Nonstandard Protocol) 

Organ Systems Toxicity

  • greater than 120 days Continuous Breeding (Legacy) (Gavage)  (RACB90002)  Completed 
    • Rats: Sprague Dawley
    • Dose: 0, 100, 200, 400, 600, 800 MG/KG; 0, 100, 200, 400 MG/KG/DAY; 0, 100, 200, 400 MG/KG/DAY; 0, 100, 200, 400 MG/KG/DAY.