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Mutagenicity studies on tiopronin.

F Dubini, P Sezzano, M A Berti

    Arzneimittel-Forschung
    |November 1, 1986
    PubMed
    Summary
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    Alpha-mercaptopropionylglycine (tiopronin) demonstrated no mutagenic activity in a comprehensive battery of in vitro and in vivo tests. This mucolytic drug is safe for genetic toxicity.

    Area of Science:

    • Pharmacology
    • Toxicology
    • Genetics

    Background:

    • Alpha-mercaptopropionylglycine (tiopronin) is recognized for its mucolytic properties.
    • Assessing the mutagenicity of pharmaceutical compounds is crucial for drug safety.

    Purpose of the Study:

    • To evaluate the potential mutagenic activity of tiopronin.
    • To determine if tiopronin poses a risk for genetic toxicity.

    Main Methods:

    • In vitro mutagenicity tests included bacterial reverse mutation assays (S. typhimurium) and yeast assays (S. cerevisiae, S. pombe) with and without metabolic activation.
    • In vivo assessments comprised a mouse micronucleus test, a mouse urinary assay, and a mouse host-mediated assay.

    Main Results:

    • Tiopronin did not induce mutations in bacterial or yeast assays.

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  • No evidence of genotoxicity was observed in the in vivo mouse studies.

    • Conclusions:

    • Tiopronin exhibits a lack of mutagenic activity across multiple in vitro and in vivo test systems.
    • The findings support the safety profile of tiopronin regarding genetic toxicity.