Testing Status of Diphenhydramine hydrochloride 10040-R

 

CASRN: 147-24-0

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

Synonyms/Common Names

  • BAX

Known Uses

Antihistamine

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C56075)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C56075)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 156, OR 2500 M: 0, 78, OR 1250 PPM; 10/GROUP.

Long-Term Carcinogenicity

  • 113 weeks (Dosed-Feed)  (C56075)  Report Complete 
    • TR-355 (NIH Number: 89-2810)  (Peer Review Approval 10/03/1988A )
      Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CASRN 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats Equivocal Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: MR: 0, 313, OR 625 FR&M: 0, 156, OR 313 PPM; 50/GROUP.
  • 2 years (Dosed-Feed)  (C56075)  Report Complete 
    • TR-355 (NIH Number: 89-2810)  (Peer Review Approval 10/03/1988A )
      Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (CASRN 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 
      • Male Mice No Evidence 
      • Female Mice No 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 
    • Male 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
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Positive 
  • Mouse Lymphoma  (590709)  Completed 
    • Mice
    •  Negative 
  • Salmonella  (637175)  Completed 
    • Citation: Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987;9 Suppl 9:1-109.
    •  Negative 
  • She Cell Transformation  (A81866)  Completed 
    • SHE Cell Transformation  Negative 

Organ Systems Toxicity

  • 6 to 15 GD Conventional Teratology (Gavage)  (TER82067)  Completed 
    • Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride in CD Rats
    • Female Rats: Sprague Dawley
    • Rats Maternal Positive 
    • Rats Fetal Positive 
    • Dose: 25, 50, 100 MG/KG/DAY.
  • 11 to 14 GD Conventional Teratology (Gavage)  (TER82068)  Completed 
    • Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride Administered to CD-1 Mice on Gestational Days 11 through 14
    • Female Mice: Swiss
    • Mice Maternal Positive 
    • Mice Fetal Positive 
    • Dose: 80, 160, 200 MG/KG/DAY.
  • 6 to 15 GD Conventional Teratology (Gavage)  (TER82069)  Completed 
    • Citation: Teratologic Evaluation of Diphenhydramine Hydrochloride in CD-1 Mice
    • Female Mice: Swiss
    • Mice Maternal Positive 
    • Mice Fetal Positive 
    • Dose: 40, 80, 160 MG/KG/DAY.