Genotoxic evaluation of terbinafine in human lymphocytes in vitro

Danielle Tolomeotti1, Marialba Avezum Alves de Castro-Prado, Juliane Rocha de Sant'Anna

  • 1Departamento de Biotecnologia, Genética e Biologia Celular and.

Drug and Chemical Toxicology
|September 19, 2014
PubMed

Insights

Terbinafine, an antifungal drug, was evaluated for genotoxic effects in human lymphocytes. The study found no evidence of genotoxicity or cytotoxicity at tested concentrations, suggesting safety for human cells.

Area of Science:

  • Toxicology
  • Genetics
  • Pharmacology

Background:

  • Terbinafine is an established antimycotic agent with emerging potential in cancer therapy.
  • Limited data exists on the genotoxic effects of terbinafine in mammalian cells.

Purpose of the Study:

  • To investigate the genotoxic potential of terbinafine in cultured human peripheral blood lymphocytes.
  • To assess terbinafine's effects on chromosomal aberrations and other genetic endpoints.

Main Methods:

  • Human peripheral blood lymphocytes were exposed to terbinafine at various concentrations, including peak plasma levels.
  • Genetic endpoints analyzed included chromosomal aberrations (CA), sister chromatid exchanges (SCE), micronuclei (MN), nucleoplasmic bridges (NP), and nuclear buds (NB).
  • Statistical analysis using the Kruskal-Wallis test was performed to determine significance.

Main Results:

  • No significant differences were observed in CA, SCE, MN, NP, or NB frequencies at any tested concentration (p > 0.05).
  • Mitotic, replication, and cytokinesis-block proliferation indices remained unaffected by terbinafine exposure.
  • The results indicated no genotoxic or cytotoxic effects of terbinafine under the experimental conditions.

Conclusions:

  • Terbinafine demonstrated a lack of genotoxic and cytotoxic activity in cultured human peripheral blood lymphocytes.
  • These findings suggest terbinafine is safe concerning genotoxicity in human lymphocytes at the tested concentrations.