National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-10537-l

Testing Status of Chlorpheniramine maleate - 10537-L

 

CASRN: 113-92-8

Related: CHLORPHENIRAMINE (CAS 132-22-9)

Formula: C16-H19-Cl-N2.C4-H4-O4

Synonyms/Common Names

  • 2-Pyridinepropanamine, gamma-(4-chlorophenyl)-N,N-dimethyl-, (2Z)-2-butenedioate (1:1)

Known Uses

Antihistamine

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Gavage)  (C55265)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Gavage)  (C55265)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 3.75, 60, M: 0, 12.5, 200 MG/KG/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C55265)  Report Complete 
    • TR-317 (NIH Number: 86-2573)  (Peer Review Approval 12/09/1985A )
      Toxicology and Carcinogenesis Studies of Chlorpheniramine Maleate (CASRN 113-92-8) 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 No Evidence 
      • Female Mice No Evidence 
    • Dose: MR: 0, 15, 30 MG/KG, FR: 0, 30, 60 MG/KG, MM: 0, 25, 50 MG/KG, FM: 0, 100, 200 MG/KG/50 PER GROUP.

Special Studies

  • Absorption Disposition Metabolism Elimination (Gavage; Intravenous)  (S0129)  Completed 
    • Citation: Pharmacokinetics of Xenobiotics
    • Male Rats
    • Dose: PO: 2, 20 MG/KG IV: 2 MG/KG.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (982295)  Completed 
    • Citation: Anderson, B.E., Zeiger, E., Shelby, M.D., Resnick, M.A., Gulati, D.K., Ivett, J.L., and Loveday, K.S. Chromosome aberration and sister chromatid exchange test results with 42 chemicals. Environ. Molec. Mutagen. Vol. 16 (Suppl 18) (1990) 55-137
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Positive 
  • Mouse Lymphoma  (501757)  Completed 
    • Citation: McGregor, D., Brown, A., Howgate, S., McBride, D., Riach, C., and Caspary, W. Responses of the L5178Y tk+/tk- mouse lymphoma cell forward mutation assay. IV: 27 coded chemicals. Environ. Molec. Mutagen. Vol. 17 (1991) 196-219
    • Citation: Myhr B.C., McGregor, D., Bowers, L., Riach, C., Brown, A., Edwards, I., McBride, D., Martin, R., and Caspary, W.J. L5178Y mouse lymphoma cell mutation assay results with 41 compounds. Environ. Molec. Mutagen. Vol. 16 (Suppl 18) (1990) 138-167
    • Mice
    •  Negative 
  • Micronucleus  (A45472)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (A98719)  Completed 
    • Rats: Fischer 344
    • Male Negative 
  • Salmonella  (543950)  Completed 
    • Citation: Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.