OEL Fastrac Catalog

Polyporus umbellatus is a medicinal mushroom in the family Polyporaceae of class Basidiomycetes. Polyporus umbellatus is commonly referred to as Grifola umbellata and more infrequently as Dendropolyporus umbellatus. Its common names include Zhu Ling (Hog Tuber) in Chinese, Chorei-Maitake (wild boar dung Maitake) or Tsuchi-maitake (Earth Maitake) in Japanese, Eichhase in German, polypore en ombelle in French, and umbrella polypore in English. Polyporus umbellatus is one of the commonly used and valued medicinal fungi, with sclerotia having been widely used for many years as an antidiuretic agent as well as an antidote in east Asian countries, most notably China, Korea, and Japan. Over the past few decades, researchers have found this taxon to contain numerous bioactive compounds shown to be responsible for antitumor, anticancer, antioxidant, nephroprotective, free radical scavenging, immune system enhancement, and antimicrobial activities. It was also reported that sclerotia of P. umbellatus had potent effects, suppressing the cytotoxic activity of leukemia and hepatitis.

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 Polyporus umbellatus, just click the ADD TO CART button.

HBEL

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