National Toxicology Program

CASRN: 37319-17-8

Related: C10 H12 O5 (OSO3 NA)

Formula: C10 H12 O5 (OSO3NA)2

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.

Nomination Background

Short-Term Toxicity

• 2-WEEK (Gavage)  (C88122B) Completed 
  • NTIS No. PB2004-106612
    Citation: Toxicology and Carcinogenesis Studies of Elmiron® (CAS No. 37319-17-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R&M: 0, 33, 111, 333, 1000, OR 3000 MG/KG, 5/SEX/DOSE
• 13-WEEK (Gavage)  (C88122) Completed 
  • NTIS No. PB2004-106612  (Peer Review 09/05/2002)
    Citation: Toxicology and Carcinogenesis Studies of Elmiron® (CAS No. 37319-17-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R&M: 0, 63, 125, 250, 500, OR 1000 MG/KG; 10/SEX/DOSE

Long-Term Carcinogenicity

• 2-YEAR (Gavage)  (C88122) Report Complete 
  • TR-512 (NTIS No. PB2004-106612)  (Peer Review 09/05/2002)
    Toxicology and Carcinogenesis Studies of Elmiron® (CAS No. 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: F344
  • Male Negative 
• Micronucleus  (A91531) Completed 
  • Mice: B6C3F1
  • Male Negative 
  • Female Negative 
• Salmonella  (A84754) Completed 
  •  Negative 

Organ Systems Toxicity

• 28 DAYS Immunotoxicity (Gavage)  (IMM20404) Report in Preparation 
  • F Mice: B6C3F1
  • Dose: 0, 63, 125, 250, 500, OR 1000 MG/KG
• 28 DAYS Immunotoxicity (Gavage)  (IMM20502) Report in Preparation 
  • F Mice: B6C3F1
  • Dose: 0, 6, 125, 250, 500, OR 1000 MG/KG
• 18 WEEK Continuous Breeding (Gavage)  (RACB94012) Completed 
  • NTIS No. PB97-182604
    Citation: Final Report on the Reproductive Toxicity of Elmiron Administered by Gavage to Sprague-Dawley Rats
  • M/F Rats: Sprague Dawley
  • Dose: 0, 111, 333, OR 1000 MG/KG/DAY