Testing Status of Phenazopyridine hydrochloride 10587-C

 

CASRN: 136-40-3

Formula: C11-H11-N5.Cl-H

Synonyms/Common Names

  • 3-(Phenylazo)-2,6-pyridinediamine monohydrochloride (9CI)
  • Pyridium

Known Uses

Urinary analgesic (Merck 1989); azo dye.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C01672)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C01672)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: MR: 0, 300, 6000, FR: 0, 7500, 15000, M:0, 500, 10000 PPM/5 PER GROUP.

Long-Term Carcinogenicity

  • 2-Year (Dosed-Feed)  (C01672)  Report Complete 
    • TR-099 (NIH Number: 78-1349)  (Peer Review Approval 04/26/1978A )
      Bioassay of Phenazopyridine Hydrochloride for Possible Carcinogenicity (CASRN 136-40-3)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Positive 
      • Female Rats Positive 
      • Male Mice Negative 
      • Female Mice Positive 
    • Dose: R: 0, 3700, 7500, M: 0, 600, 1200 PPM/35 PER GROUP.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (693896)  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 Positive 
    • Chromosome Aberrations Positive 
  • Drosophila  (229192)  Completed 
    • Citation: Mason, J.M., Valencia, R., and Zimmering, S. Chemical mutagenesis testing in Drosophila. VIII. Reexamination of equivocal results. Environ. Molec. Mutagen. Vol. 19 (1992) 227-234
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Equivocal 
  • Drosophila  (513664)  Completed 
    • Citation: Woodruff, R.C., Mason, J.M., Valencia, R., and Zimmering, S. Chemical mutagenesis testing in Drosophila: V. Results of 53 coded compounds tested for the National Toxicology Program. Environ. Mutagen. Vol. 7 (1985) 677-702
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Equivocal 
  • Mouse Lymphoma  (051415)  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
    • Mice
    •  Positive 
  • Salmonella  (052770)  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
    •  Equivocal 
  • Salmonella  (945906)  Completed 
    •  Positive