OEL Fastrac Catalog

Milk thistle, Silybum marianum, is a tall edible plant and a member of the Aster family. The fruit is a strongly compressed, elongate-obovate achene, about 6 to 8 mm long, 3 mm broad and 1.5 mm thick. The outer surface is smooth and shiny with a grey or pale brown ground color variably streaked longitudinally with dark brown, which gives it an overall pale greyish or brown color. The fruit is tapering at the base and crowned at the apex with a glistening, pale yellow extension that forms a collar about 1 mm high surrounding the remains of the style. Cut transversely, the fruit shows a narrow, brown outer area and two large, dense, oily, white cotyledons.

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 Milk Thistle, just click the ADD TO CART button.

HBEL

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