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

Known Uses

Drug used for the prevention of thrombosis and hyperlipidemia in foreign countries and for the treatment of interstitial cystitis in the us.

Chemical Properties

Toxicity Effects (HSDB)

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)  Report Complete 
    • 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 
    • Citation: Final Report on the Reproductive Toxicity of Elmiron Administered by Gavage to Sprague-Dawley Rats
    • Male and Female Rats: Sprague Dawley
    • Dose: 0, 111, 333, OR 1000 MG/KG/DAY.