OEL Fastrac Catalog

Bilberry (Vaccinium myrtillus L.) is a species of shrubby perennial plant of the heather family (Ericaceae) reaching from 15 to 60 cm in height. It has many common names, including European blueberry. It is widespread in Asia, Europe and North America in the areas with a temperate and arctic climate. The flowers, blooming from April to June, are pollinated by insects. The time from pollination to full ripeness of the fruit is about two months. The plant occurs from lowlands to high mountain positions (even above the tree line) and the plant prefers strongly acidic soil in the pine forests, other coniferous forests, oak woods, beech forests and moors. The fruits are the black berries with a bluish, waxy bloom with a sweet and slightly astringent taste Dried bilberry fruits are traditionally used in therapy of digestive disorders, particularly in diarrhea. The traditional use and some not controlled studies from 1960 and 1970 suggested the potential benefits of bilberry preparations for improvement of night vision, but more recent, well-designed studies did not show any advantage. Bilberry has been used in alternative medicines as a possibly effective aid to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances and to relieve symptoms of cutaneous capillary fragility.

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 Bilberry Extract, just click the ADD TO CART button.

HBEL

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