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Genotoxicity studies on sertaconazole.

A Romero1, C Palacín, P Mosesso

  • 1Research Centre, Ferrer Group, Barcelona, Spain.

Arzneimittel-Forschung
|May 1, 1992
PubMed
Summary
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Sertaconazole, an antifungal medication, was evaluated for genotoxicity across six studies. Results indicate sertaconazole does not exhibit mutagenic, clastogenic, or chromosomal segregation interference, suggesting it is safe for genetic material.

Area of Science:

  • Pharmacology
  • Toxicology
  • Genetics

Background:

  • Sertaconazole is an imidazole antifungal agent used topically.
  • Evaluating the genotoxic potential of pharmaceutical compounds is crucial for drug safety.
  • Previous assessments of sertaconazole's genotoxicity were limited.

Purpose of the Study:

  • To comprehensively assess the genotoxic potential of sertaconazole.
  • To determine if sertaconazole induces gene mutations or chromosomal damage.
  • To investigate sertaconazole's effects on prokaryotic and eukaryotic genetic material.

Main Methods:

  • Bacterial reverse mutation assay (Ames test) in Salmonella typhimurium.
  • Sex-linked recessive lethal mutation assay in Drosophila melanogaster.

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  • In vitro and in vivo cytogenetic assays: chromosomal aberration, micronucleus test, and sister chromatid exchange in cultured mammal cells and human lymphocytes.

    • Main Results:

    • Sertaconazole did not induce gene mutations in Salmonella typhimurium or cultured mammal cells.
    • No evidence of sex-linked recessive lethal mutations was observed in Drosophila.
    • In vitro and in vivo assays showed no induction of chromosomal aberrations, micronuclei, or sister chromatid exchanges.
    • Sertaconazole did not interfere with chromosomal segregation.

    Conclusions:

    • Sertaconazole demonstrates a lack of genotoxic activity across a range of assays.
    • The compound is not promutagenic, mutagenic, or clastogenic.
    • These findings support the safety profile of sertaconazole concerning genetic toxicity.