Please note, this OEL/ADE monograph also applies to chlorhexidine gluconate (CAS RN 18472-51-0). Chlorhexidine is an antimicrobial agent indicated for the use in skin cleansing procedures, oral rinsing, and to treat gum conditions. Chlorhexidine is an antiseptic antimicrobial with bactericidal activity that is used as a topical skin cleanser or as a dental mouth rinse to reduce plaque. The drug is a base and is stable as a salt, the most commonly studied being chlorhexidine gluconate. At physiologic pH, chlorhexidine salts dissociate releasing a positively charged component. The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.
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.