National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-11177-h

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

Known Uses

Treatment of ulcerative colitis and Crohn's disease; psoriasis and rheumatoid arthritis; granulomatous colitis (veterinary medicine). Antibacterial.

Chemical Properties

Toxicity Effects (HSDB)

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)  Report Complete 
    • 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
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 
    • Dose: R: 84, 168, OR 337.5 MG/KG; 70/GROUP M: 675, 1350, OR 2700 MG/KG; 60/GROUP.

Special Studies

  • Toxicokinetic Study (Gavage)  (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: F344/N; Male and Female Rats: F344/N; Male and Female Mice: B6C3F1

Genetic Toxicology

  • Chromosome Aberrations  (459882)  Completed 
    • Citation: Bishop, J.B., Witt, K.L., Gulati, D.K., and MacGregor, J.T. Evaluation of the mutagenicity of the Anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis Vol. 5 (1990) 549-554
    • 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, J.B., Witt, K.L., Gulati, D.K., and MacGregor, J.T. Evaluation of the mutagenicity of the Anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis Vol. 5 (1990) 549-554
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Negative 
  • Micronucleus  (107236)  Completed 
    • Rats: Fischer 344
    • Male Equivocal 
  • Micronucleus  (459882)  Completed 
    • Citation: Bishop, J.B., Witt, K.L., Gulati, D.K., and MacGregor, J.T. Evaluation of the mutagenicity of the Anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis Vol. 5 (1990) 549-554
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (724355)  Completed 
    • Mice: B6C3F1
    • Male Not a Valid Test 
  • Micronucleus  (A66124)  Completed 
    • Citation: Bishop, J.B., Witt, K.L., Gulati, D.K., and MacGregor, J.T. Evaluation of the mutagenicity of the Anti-inflammatory drug salicylazosulfapyridine (SASP). Mutagenesis Vol. 5 (1990) 549-554
    • 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 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., 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 
  • Sister Chromatid Exchanges  (724355)  Completed 
    • Mice
    • Sister Chromatid  Negative (Nonstandard Protocol) 

Bioassay

  • 2 & 3 years Chronic Special (Gavage)  (C61552B)  Report Complete 
    • Rats: F344/N; Mice: B6C3F1

Organ Systems Toxicity

  • greater than 120 days Continuous Breeding (Legacy) (Gavage)  (RACB90002)  Completed 
    • Citation: Final Report on the Reproductive Toxicity of Salicylazosulfapyridine in CD Sprague-Dawley Rats ?
    • 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.
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