OEL Fastrac Catalog

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Garlic, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.