National Toxicology Program

CASRN: 147-24-0

Formula: C17-H21-N-O.CL-H

Synonyms/Common Names:

• BAX

Known Uses:

ANTIHISTAMINE

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C56075) Completed 
  • NTIS No. PB90-219437  (Peer Review 10/03/1988)
    Citation: Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CAS No. 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Dosed-Feed)  (C56075) Completed 
  • NTIS No. PB90-219437  (Peer Review 10/03/1988)
    Citation: Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CAS No. 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: R: 0, 156, OR 2500 M: 0, 78, OR 1250 PPM; 10/GROUP

Long-Term Carcinogenicity

• 113-WEEK (Dosed-Feed)  (C56075) Report Complete 
  • TR-355 (NTIS No. PB90-219437)  (Peer Review 10/03/1988)
    Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CAS No. 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Mice: B6C3F1
  • Carcinogenesis Results
  • Male Mice No Evidence 
  • Female Mice No Evidence 
  • Dose: MR: 0, 313, OR 625 FR&M: 0, 156, OR 313 PPM; 50/GROUP
• 2-YEAR (Dosed-Feed)  (C56075) Report Complete 
  • TR-355 (NTIS No. PB90-219437)  (Peer Review 10/03/1988)
    Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CAS No. 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N
  • Carcinogenesis Results
  • Male Rats Equivocal Evidence 
  • Female Rats Equivocal Evidence 
  • Dose: MR: 0, 313, OR 625 FR&M: 0, 156, OR 313 PPM; 50/GROUP

Special Studies

• Absorption Disposition Metabolism Elimination (Dosed-Feed)  (S0099) Completed 
  • M Rats: F344/N
  • Dose: 313, 625 PPM FOR 30 DAYS

Genetic Toxicology

• In Vitro Cytogenetics (CA/SCE)  (195192) Completed 
  • Citation: Loveday, K.S., Lugo, M.H., Resnick, M.A., Anderson, B., and Zeiger, E. Chromosome aberration and sister chromatid exchange tests in Chinese hamster ovary cells in vitro II: Results with 20 chemicals Environ. Molec. Mutagen. Vol. 13 (1989) 60-94
  • Chromosome Aberation Positive 
  • Sister Chromatid Exchange Negative 
• Mouse Lymphoma  (590709) Completed 
  •  Negative 
• Salmonella  (637175) Completed 
  • Citation: Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K., and Speck, W. Salmonella mutagenicity tests. III. Results from the testing of 225 chemicals Environ. Mutagen. Vol. 9 (Suppl 9) (1987) 1-109
  •  Negative 
• She Cell Transformation  (A81866) Completed 
  • SHE Cell Transformation  Negative 

Organ Systems Toxicity

• GD 6-15 Conventional Teratology (Gavage)  (TER82067) Completed 
  • NTIS No. PB83-180612
    Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride in CD Rats
  • F Rats: Sprague Dawley
  • Rats Maternal Positive 
  • Rats Fetal Positive 
  • Dose: 25, 50, 100 MG/KG/DAY
• GD 11-14 Conventional Teratology (Gavage)  (TER82068) Completed 
  • NTIS No. PB83-148684
    Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride Administered to CD-1 Mice on Gestational Days 11 through 14
  • F Mice: Swiss
  • Mice Maternal Positive 
  • Mice Fetal Positive 
  • Dose: 80, 160, 200 MG/KG/DAY
• GD 6-15 Conventional Teratology (Gavage)  (TER82069) Completed 
  • NTIS No. PB83-163055
    Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride in CD-1 Mice
  • F Mice: Swiss
  • Mice Maternal Positive 
  • Mice Fetal Positive 
  • Dose: 40, 80, 160 MG/KG/DAY