Please note, this OEL/ADE monograph also applies to garlic extract (CAS RN 8008-99-9) and garlic oil (CAS RN 8000-78-0). Garlic contains a volatile oil (0.1 - 0.36%). The major components are sulfur compounds like alliin. It also contains proteins (amino acids, glutamyl peptides), glucides and enzymes (alliinase, peroxidase, myrosinase). Allicin is formed from alliin by alliinase. It is considered that 1 mg of alliin is equivalent to 0.45 mg of allicin. Organosulfur compounds, flavonoids, sapogenins and saponins, selenium compounds and/or fructosamines have been recognized as major biologically active constituents in raw garlic, garlic supplements and medicinal products (depending on the applied processing, i.e., garlic powder, garlic oil obtained either with steam distillation or maceration in vegetable oil, aqueous/alcoholic extracts). Evidence from several investigations suggests that the biological and medical functions of garlic are mainly due to the high content of organosulfur compounds, formed from alliin and allicin.
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.