National Toxicology Program

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

Short-Term Toxicity

• 14-Day (Gavage)  (C60673A) Completed 
  • NTIS No. PB94-210192
    Citation: Toxicology and Carcinogenesis Studies of Promethazine Hydrochloride (CAS No. 58-33-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Gavage)  (C60673A) Completed 
  • NTIS No. PB94-210192
    Citation: Toxicology and Carcinogenesis Studies of Promethazine Hydrochloride (CAS No. 58-33-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R: 0,3.7,300, M: 0,5,405 MG/10 PER GROUP

Long-Term Carcinogenicity

• 2-YEAR (Gavage)  (C60673B) Report Complete 
  • TR-425 (NTIS No. PB94-210192)  (Peer Review 12/01/1992)
    Toxicology and Carcinogenesis Studies of Promethazine Hydrochloride (CAS No. 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
  • Chromosome Aberation Negative 
  • Sister Chromatid Exchange Inconclusive 
• 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