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Testing Status of Oxytetracycline hydrochloride 10080-X

 

CASRN: 2058-46-0

Formula: C22-H24-N2-O9.Cl-H

Synonyms/Common Names

  • (4S-(4-a,4a-a,5-a,5a-a,6-b,12a-a))-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12-a-heahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide HCl

Short-Term Toxicity

  • 14-Day (Dosed-Feed)  (C56473)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C56473)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: 0, 3100, 50000 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C56473)  Completed 
    • TR-315 (NIH Number: 87-2571)  (Peer Review Approval 12/09/1985A )
      Toxicology and Carcinogenesis Studies of Oxytetracycline Hydrochloride (CASRN 2058-46-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats Equivocal Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: R: 0, 25000, 50000 M: 0, 6300, 12500 PPM/50 PER GROUP.

Genetic Toxicology

  • Drosophila  (377666)  Completed 
    • Citation: Foureman, P., Mason, J.M., Valencia, R., Zimmering, S. Chemical Mutagenesis Testing in Drosophila. IX. Results of 50 coded compounds tested for the National Toxicology Program. Environ. Molec. Mutagen. Vol. 23 (1994) 51-63
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
  • In Vitro Cytogenetics (CA/SCE)  (604406)  Completed 
    • Citation: Anderson, B.E., Zeiger, E., Shelby, M.D., Resnick, M.A., Gulati, D.K., Ivett, J.L., and Loveday, K.S. Chromosome aberration and sister chromatid exchange test results with 42 chemicals. Environ. Molec. Mutagen. Vol. 16 (Suppl 18) (1990) 55-137
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (682810)  Completed 
    • Citation: Anderson, B.E., Zeiger, E., Shelby, M.D., Resnick, M.A., Gulati, D.K., Ivett, J.L., and Loveday, K.S. Chromosome aberration and sister chromatid exchange test results with 42 chemicals. Environ. Molec. Mutagen. Vol. 16 (Suppl 18) (1990) 55-137
    • Sister Chromatid Exchange Not a Valid Test 
    • Chromosome Aberrations Negative 
  • Mouse Lymphoma  (739218)  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
    • Citation: Myhr B.C., McGregor, D., Bowers, L., Riach, C., Brown, A., Edwards, I., McBride, D., Martin, R., and Caspary, W.J. L5178Y mouse lymphoma cell mutation assay results with 41 compounds. Environ. Molec. Mutagen. Vol. 16 (Suppl 18) (1990) 138-167
    • Mice
    •  Positive 
  • Salmonella  (463949)  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 

Organ Systems Toxicity

  • 6 to 15 GD Conventional Teratology (Gavage)  (TER82094)  Completed 
    • Female Rats: Sprague Dawley
    • Rats Maternal Positive 
    • Rats Fetal Positive 
    • Dose: 1200, 1350, 1500 MG/KG/DAY.
  • 6 to 15 GD Conventional Teratology (Gavage)  (TER82095)  Completed 
    • Female Mice: Swiss
    • Mice Maternal Negative 
    • Mice Fetal Negative 
    • Dose: 1325, 1670, 2100 MG/KG/DAY.