National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-m910058

Testing Status of Scopolamine hydrobromide trihydrate - M910058

 

CASRN: 6533-68-2

Related: SCOPOLAMINE HYDROBROMIDE (114-48-8)

Formula: C17-H21-N-O4.Br-H.3H2-O

Synonyms/Common Names

  • Benzeneacetic acid, alpha-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(sup 2,4))non-7-yl ester, hydrobromide, trihydrate, (7(S)-(1alpha,2beta,4beta,5alpha,7beta))-
  • Hyoscine hydrobromide

Known Uses

Anticholinergic -- used in ophthalmic preparations and as a preanesthetic sedative. Its major use is in transdermal patches for the treatment of motion sickness.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Gavage)  (C03098A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 14-Day (Dosed-Water)  (C03098B)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Gavage)  (C03098A)  Completed 
    • Rats: F344/N; Mice: B6C3F1

Long-Term Carcinogenicity

  • 2 & 3 years (Gavage)  (C03098C)  Report Complete 
    • TR-445 (NIH Number: 97-3361)  (Peer Review Approval 06/20/1995A )
      Toxicology and Carcinogenesis Studies of Scopolamine Hydrobromide Trihydrate (CASRN 6533-68-2) in F344 Rats and B6C3F1 Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats No Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
      •  Mice No Evidence 
    • Dose: R&M: 0,1,5, OR 25 MG/KG; 70/GROUP DIET RESTRICTION MICE: 0 OR 25 MG/KG;70/GROUP.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (243331)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Weakly Positive 
  • Salmonella  (907250)  Completed 
    • Citation: Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., and Mortelman, K. Salmonella Mutagenicity Tests V. Results from the Testing of 311 Chemicals Environ. Molec. Mutagen. Vol. 19 (Suppl 21) (1992) 2-141
    •  Negative 
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