OEL Fastrac Catalog

Myroxylon is a genus of two species of Central American and South American trees in the Fabaceae. The tree is well known in the western world as the source for Peru balsam and Tolu balsam. The tree is often called Quina or Balsamo. Other names include Tolu in Colombia, Quina quina in Argentina; in lumber trade, sometimes named Santos Mahogany. Its sweetish scent, reminiscent of vanilla and green olives, has caused it to be used in the manufacture of perfumes as a source for Balsam. Balsam of Peru is used as a flavoring and fragrance in many products and can cause allergic reactions

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.

Inquiries on monograph availability

The OEL/ADE monograph for Balsam Peru is under development.

You can contact us and let us know if you'd like to be notified when this document becomes available.

HBEL

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