Please note, this OEL/ADE monograph also applies to ciclopirox olamine (CAS RN 41621-49-2). Ciclopirox is indicated for the treatment of fungal infections in the skin. Ciclopirox chelates polyvalent cations resulting in inhibition of enzymes responsible for degradation of peroxides in the fungal cell and prevention of cell growth (2, 3, 4, 5, 7). The anti-inflammatory action of ciclopirox is likely due to the inhibition of 5-lipoxygenase and cyclooxygenase. Ciclopirox may exert its effect by disrupting DNA repair, cell division signals and structures, and some elements of intracellular transport.
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:
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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.