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Testing Status of Chlorpheniramine maleate 10537-L

 

CASRN: 113-92-8

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

Synonyms/Common Names

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

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)  Completed 
    • 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 Distribution Metabolism Excretion (Gavage; Intravenous)  (S0129)  Completed 
    • Male Rats
    • Dose: 2 mg/kg. 2, 20 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 
  • Micronucleus  (A45472)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (A98719)  Completed 
    • Rats: Fischer 344
    • Male Negative 
  • 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 
  • 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