Please note, this OEL/ADE monograph also applies to borax (CAS RN 1303-96-4). Boric acid is typically utilized in industrial processing and manufacturing but is also used as an additive in pharmaceutical products, cosmetics, lotions, soaps, mouthwash, toothpaste, astringents, and eyewashes. It is also used as a pesticide against ants and cockroaches and as a preservative for urine samples. It is known to exhibit some antibacterial activity against infections such as bacterial vaginosis and candidiasis. Information regarding the mechanism of action of boric acid in mediating its antibacterial or antifungal actions is limited. Boric acid inhibits biofilm formation and hyphal transformation of Candida albicans, which are critical virulence factors. Additionally, arrest of fungal growth was observed with the treatment of boric acid.
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.