Please note, this OEL/ADE monograph also applies to Sodium triclosan (CAS RN 42409-10-9) and Potassium triclosan (CAS RN 94087-36-2).Triclosa n is a chlorinated bisphenol antiseptic, effective against Gram-positive and most Gram-negative bacteria but with variable or poor activity against Pseudomonas. It is also active against fungi. It is used in soaps, creams, and solutions in concentrations of up to 2% for disinfection of the hands and wounds, and for disinfection of the skin before surgery, injections, or vena puncture. It is also used in oral hygiene products and in preparations for acne. The mechanism of action of triclosan involves a significantly decreased activity of adenylyl cyclase enzyme which was followed by a decreased synthesis of cAMP. This decreased cAMP level resulted in the disruption of the entire steroidogenic cascade causing a depressed synthesis of testosterone.
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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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.