OBJECTIVE: The use of antiseptics in the treatment of genital infections has become a systematic alternative to antibiotics. Their use has been also supported for the treatment of virus-induced genital infections. Cationic compounds, such as polyhexamethylene biguanide (PHMB) and chlorhexidine, represent useful treatment options given their high therapeutic index and broad-spectrum activity. However, concerns have been raised since some compounds have developed bacterial resistance. Contrasting results have been reported on the mutagenic potential of PHMB products and safety concerns have been raised for their clinical use. Given the paucity of data on PHMB mutagenic potential, we performed a mutagenic test on Monogin^®-isotonic gynecological solution (Monogin^®; Lo.Li. Pharma S.r.l., Rome, Italy), a PHMB solution used for the treatment of genital tract infections.

MATERIALS AND METHODS: We used the bacterial reverse mutation assay (Ames test), an in vitro assay testing the mutagenic potential of new chemicals and drugs, on multiple Salmonella typhimurium strains. The test was performed in compliance with the principles of Good Laboratory Practice (GLP).

RESULTS: Monogin^® solution did not cause any mutation in all the strains tested, compared to positive controls.

CONCLUSIONS: Monogin^® solution does not carry any mutagenic potential and although further investigations are needed, it can be considered a safe and useful therapeutic approach for the treatment of genital tract infections.