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Testing Status of Hydroxyurea 10871-K

 

CASRN: 127-07-1

Formula: C-H4-N2-O2

Synonyms/Common Names

  • SQ 1089

Short-Term Toxicity

  • 14-Day (Intraperitoneal Injection)  (C04831)  Completed 
    • Rats: Sprague Dawley; Mice: Swiss
  • 13-Week (Intraperitoneal Injection)  (C04831)  Completed 
    • Rats: Sprague Dawley; Mice: Swiss

Long-Term Carcinogenicity

  • 2-Year (Intraperitoneal Injection)  (C04831)  Completed 
    •   (Peer Review Approval NA) Citation: EK Weisburger, Bioassay Program for Carcinogenic Hazards of Cancer Chemotherapeutic Agents. Cancer 40:1935-1949 (1977)
    • Rats: Sprague Dawley; Mice: Swiss
    • Dose: 0, 125, 250 MG/KG/25 PER GROUP.

Modified One-Generation

  • GD 17 to PND 28 (dams) twice daily; PND 10 to PND 28 (pups) twice daily Dose Range Finding (Gavage)  (MOG006)  Completed 
    • Citation: Huang MC, Turner KJ, Vallant M, Robinson VG, Lu Y, Price CJ, Fennell TR, Silinski MA, Waidyanatha S, Ryan KR, Black SR, Fernando RA, McIntyre BS. Tolerability and age-dependent toxicokinetics following perinatal hydroxyurea treatment in Sprague Dawley rats. J Appl Toxicol. 2020 Nov 25;. doi: 10.1002/jat.4087. [Epub ahead of print].
    • Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 37.5, 75, 100, 150 mg/kg/day.

Special Studies

  • Preliminary Toxicokinetic Study (Gavage)  (K10871)  Completed 
    • Citation: Huang MC, Turner KJ, Vallant M, Robinson VG, Lu Y, Price CJ, Fennell TR, Silinski MA, Waidyanatha S, Ryan KR, Black SR, Fernando RA, McIntyre BS. Tolerability and age-dependent toxicokinetics following perinatal hydroxyurea treatment in Sprague Dawley rats. J Appl Toxicol. 2020 Nov 25;. doi: 10.1002/jat.4087. [Epub ahead of print].Pubmed Abstract
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 18.8 and 75 mg/kg/day..

Genetic Toxicology

  • Comet Assay (Gavage)  (G10871B)  Completed 
    • Mice: B6C3F1
  • Drosophila  (337254)  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 
  • Micronucleus  (G10871)  Completed 
    • Mice: B6C3F1
    • Male Positive 
  • Salmonella  (855066)  Completed 
    • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
    •  Negative