Please note, this OEL/ADE monograph also applies to racemic menthol (CAS RN 89-78-1), L-menthol (CAS RN 2216-51-5), and D-menthol (CAS RN 15356-60-2). Menthol is used to treat minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritant. Menthol is a monocyclic terpenoid alcohol obtained from various mint oils or prepared synthetically. The compound has a peppermintlike odor and is the primary active agent in peppermint oil. Menthol is used on the skin as a single agent and within various combination products for external analgesia. It may also be used in oral lozenges for the treatment of cough or pharyngitis.
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:
To order an OEL/ADE monograph for Menthol, just click the ADD TO CART button.
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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.