OEL Fastrac Catalog

Horse chestnut seed extract (HCSE) is from the plant Aesculus hippocastanum L. Escin (also known as aescin, CAS# 6805-41-0) is the primary component of HCSE. It is a mixture of triterpene saponins present in alpha and beta forms, distinguished by their different levels of water solubility and melting points. Escin is indicated in adults for the oral treatment of chronic venous insufficiency and its associated symptoms, which include swelling of the lower limbs, varices, pain (generalized), feelings of weight of the lower limbs, itching, feelings of tension and cramps in the calves. Escin formulations are available as tablets and topical gel. It is marketed under the trade names Reparil®, Venocin® and Venitan® among others. Generic formulations are available.

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 Horse Chestnut Seed Extract, just click the ADD TO CART button.

HBEL

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