Please note, this OEL/ADE monograph also applies to zinc oxide hydrate (CAS RN 55204-38-1). Zinc oxide is an inorganic compound used in a number of manufacturing processes. Zinc oxide occurs naturally as the mineral zincite, but most zinc oxide is produced synthetically. Zinc oxide can be found in rubbers, plastics, ceramics, glass, cement, lubricants, paints, white glue, ointments, adhesives, sealants, pigments, foods, batteries, ferrites, fire retardants, cosmetics, dental cements and first-aid tapes. It is also widely used to treat a variety of skin conditions, in products such as baby powder and barrier creams to treat diaper rashes, calamine cream, anti-dandruff shampoos, and antiseptic ointments. Zinc oxide nanoparticles are also used in transparent sunscreens. Zinc compounds, including zinc oxide, are also known to be used in dietary supplements.
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.