Thimerosal, also known as thiomersal, is an organomercury antiseptic and antifungal agent used as a preservative in vaccines, immunoglobulins, nasal sprays, and contact lens solutions. Thimerosal was used as a component of topical antiseptic solution and antiseptic ointment for treating cuts and as a component of nasal sprays, eye solutions, vaginal spermicides, and diaper rash treatments, but reevaluation of the drug in the 1980s demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and topical thimerosal was withdrawn from the market. Thimerosal is used as a preservative for influenza (flu) vaccines in multidose vials for adults. Thimerosal is also used during the manufacturing process for two childhood vaccines to prevent the growth of microbes, and it is removed later in the process. It had been removed from uses in vaccines and products that target immunoglobulins. In the United States of America (USA) and European Union countries, thiomersal is no longer used in childhood vaccines due to public fears, although the Food and Drug Administration (FDA) review of 1999 found no evidence of harm from the use of thimerosal as a vaccine preservative other than local hypersensitivity reactions.
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 Thimerosal, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.