Please note, this OEL/ADE monograph also applies to butenafine hydrochloride (CAS RN 101827-46-7).Butenafine hydrochloride is an antifungal, over the counter drug (OTC) indicated for topical treatment of several dermatologic infections including tinea (pityriasis) versicolor due to M. furfur, athlete’s foot, ringworm and jock itch due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans, respectively. Butenafine hydrochloride mechanism of action has not been fully established; however, it has been suggested that butenafine interferes with sterol biosynthesis, particularly ergosterol, by inhibiting squalene monooxygenase, an enzyme responsible for converting squalene to 2,3-oxydo squalene. Ergosterol is an essential component of the fungal cell membrane and inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Blockage of squalene monooxygenase also leads to a subsequent accumulation of squalene. When a high concentration of squalene is reached, it is thought to have fungicidal activity, directly killing fungal cells.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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