Please note, this OEL/ADE monograph also applies to benzethonium chloride (CAS RN 121-54-0), benzethonium chloride monohydrate (CAS RN 5929-09-9), methylbenzethonium chloride (CAS RN 25155-18-4; 101912-16-7; 1320-44-1), methylbenzethonium (CAS RN 72013-76-4), Benzethonium carbonate (CAS RN N.A.), and Benzethonium nitrate (CAS RN N.A.). Benzethonium is a synthetic quaternary ammonium salt with surfactant, antiseptic, and broad-spectrum antimicrobial properties. Its salt form, benzethonium chloride, is primarily used as a skin disinfectant at concentrations of 0.1% to 0.2%, which are safe and effective concentrations for the compound as specified by the United States (US) Food and Drug Administration (FDA). It is additionally found in cosmetics and toiletries such as mouthwashes and anti-itch ointments. It is shown to be effective in mediating its antimicrobial action against bacteria, fungi, mold, and viruses. There is evidence that benzethonium acts as a spermatocide but may cause vaginal irritation. Benzethonium was identified as a novel cancer-specific compound by cell-based small-molecule screen. There were no therapeutic indications for clinical use.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL monograph for Benzethonium, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.