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Testing Status of Elmiron (sodium pentosanpolysulfate) M882471

 

CASRN: 37319-17-8

Formula: H2-O4-S.x-Na.x-Unspecified

Synonyms/Common Names

  • Xylan, hydrogen sulfate, sodium salt

Short-Term Toxicity

  • 2 weeks (Gavage)  (C88122B)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 33, 111, 333, 1000, OR 3000 MG/KG, 5/SEX/DOSE.
  • 13 weeks (Gavage)  (C88122)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 63, 125, 250, 500, OR 1000 MG/KG; 10/SEX/DOSE.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C88122)  Completed 
    • TR-512 (NIH Number: 04-4446)  (Peer Review Approval 09/05/2002A )
      Toxicology and Carcinogenesis Studies of Elmiron® (CASRN 37319-17-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice Some Evidence 
      • Female Mice Some Evidence 
    • Dose: MR: 0, 14, 42, OR 126 MG/KG FR: 0, 28, 84, OR 252 MG/KG MICE: 0, 56, 168, 504 MG/KG; 50/SEX/DOSE.

Genetic Toxicology

  • Micronucleus  (A40595)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (A76890)  Completed 
    • Rats: Fischer 344
    • Male Negative 
  • Micronucleus  (A91531)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (A84754)  Completed 
    •  Negative 

Organ Systems Toxicity

  • 28 days Immunotoxicity (Gavage)  (IMM20404)  Completed 
    • Female Mice: B6C3F1
    • Dose: 0, 63, 125, 250, 500, or 1000 mg/kg.
  • 28 days Immunotoxicity (Gavage)  (IMM20502)  Completed 
    • Female Mice: B6C3F1
    • Dose: 0, 6, 125, 250, 500, or 1000 mg/kg.
  • 18 weeks Continuous Breeding (Legacy) (Gavage)  (RACB94012)  Completed 
    • Male and Female Rats: Sprague Dawley
    • Dose: 0, 111, 333, OR 1000 MG/KG/DAY.