OEL Fastrac Catalog

Edible mushrooms are the fruiting bodies of macroscopic fungi of certain species used as a source of food. The edible mushrooms under cultivation for production fall into two major groups; the Ascomycetes and the Basidiomycetes. Commonly known mushrooms that are both edible and present with functional properties include Auricularia, Flammulina, Grifola (maitake), Hericium, Lentinus (shiitake), Pleurotus (oyster), and Tremella (yin er). Regarding bioactive compounds present in shiitake mushrooms, the β-glucan lentinan, which is thermolabile and found in very low concentrations in fresh mushrooms (approximately 0.02%), seems to be the most important, with known immunomodulatory activity. Lentinan injection is, in fact, a clinically approved drug in several countries in Asia. Eritadenine, a hypocholesterolemic compound, is also present in shiitake mushrooms, although its content in different strains is highly variable.

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 Lentinula edodes, just click the ADD TO CART button.

HBEL

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