National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-m200013

Testing Status of Promethazine hydrochloride - M200013

 

CASRN: 58-33-3

Related: PROMETHAZINE 60-87-7

Formula: C17-H20-N2-S.Cl-H

Synonyms/Common Names

  • 10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, monohydrochloride (9CI)

Known Uses

Antihistaminic

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Gavage)  (C60673A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Gavage)  (C60673A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0,3.7,300, M: 0,5,405 MG/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C60673B)  Report Complete 
    • TR-425 (NIH Number: 94-3156)  (Peer Review Approval 12/01/1992A )
      Toxicology and Carcinogenesis Studies of Promethazine Hydrochloride (CASRN 58-33-3) 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: R: 0,8.3,16.6,33.3, FM: 0,3.75,7.5,15.0, MM: 0,11.25,22.5,45.0 MG/KG.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (641980)  Completed 
    • Citation: Galloway, S., Armstrong, M., Reuben, C., Colman, S., Brown, B., Cannon, C., Bloom, A., Nakamura, F., Ahmed, M., Duk, S., Rimpo, J., Margolin, B., Resnick, M., Anderson, B., and Zeiger, E. Chromosome aberration and sister chromatid exchanges in Chinese hamster ovary cells: Evaluations of 108 chemicals. Environ. Molec. Mutagen. Vol. 10 (Suppl 10) (1987) 1-176
    • Sister Chromatid Exchange Equivocal 
    • Chromosome Aberrations Negative 
  • Drosophila  (251954)  Completed 
    • Citation: Yoon, J.S., Mason, J.M., Valencia, R., Woodruff, R.C., and Zimmering, S. Chemical mutagenesis testing in Drosophila: IV. Results of 45 coded compounds tested for the National Toxicology Program. Environ. Mutagen. Vol. 7 (1985) 349-367
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
  • Salmonella  (488601)  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 
  • Salmonella  (767991)  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 
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