Please note, this OEL/ADE monograph also applies to butoconazole nitrate (CAS RN 64872-77-1). Butoconazole is an imidazole derivative antifungal agent indicated for the local treatment of vulvovaginal candidiasis (yeast infection). The exact mechanism of the antifungal action of butoconazole is unknown; however, it is thought to function by inhibition of steroid synthesis like other imidazole derivatives. Imidazoles generally inhibit the conversion of lanosterol to ergosterol via the inhibition of the enzyme cytochrome P450 14α-demethylase causing a change in fungal cell membrane lipid composition. This structural change alters cell permeability and results in the osmotic disruption or growth inhibition of the fungal cell.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
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), and to obtain the following information:
The OEL/ADE monograph for Butoconazole is under development.
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Affygility Solutions’s 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.