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Related Experiment Videos

Genotoxicity studies with the antiestrogen toremifene

G M Williams1, P M Ross, A M Jeffrey

  • 1American Health Foundation, Valhalla, NY 10595, USA. williamsgm@pol.net

Drug and Chemical Toxicology
|December 5, 1998
PubMed
Summary

Toremifene, an antiestrogen drug, was evaluated for genotoxicity. Studies found no evidence of DNA damage or adverse effects, indicating it is not genotoxic.

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Area of Science:

  • Pharmacology
  • Toxicology
  • Oncology

Background:

  • Toremifene is a second-generation triphenylethylene antiestrogen used in cancer chemotherapy.
  • It differs toxicologically from tamoxifen, which causes DNA adducts and liver tumors in rats.
  • Toremifene has shown negative to weakly positive results for DNA adduct formation and does not induce liver tumors in rats.

Purpose of the Study:

  • To further evaluate the potential genotoxicity of toremifene.
  • To assess toremifene's safety profile in preclinical toxicology studies.

Main Methods:

  • In vitro assays: bacterial point mutation reversion, unscheduled DNA synthesis in rat hepatocytes, and human lymphocyte cytogenetics.
  • In vivo assay: mouse erythrocyte micronucleus test.
  • Testing included metabolic activation (rat liver S-9) and assessment up to cytotoxic limits.

Main Results:

  • Toremifene demonstrated no genotoxicity in bacterial mutation assays.
  • No unscheduled DNA synthesis was observed in rat hepatocytes.
  • Toremifene did not induce chromosomal aberrations in human lymphocytes.
  • The in vivo micronucleus assay in mice showed no evidence of genotoxicity or myelotoxicity.

Conclusions:

  • Toremifene lacks detectable genotoxicity across multiple in vitro and in vivo assays.
  • These findings, combined with previous data on DNA binding, support the conclusion that toremifene is not genotoxic.
  • This supports its clinical use in cancer treatment.

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