OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to racemic menthol (CAS RN 89-78-1), L-menthol (CAS RN 2216-51-5), and D-menthol (CAS RN 15356-60-2). Menthol is used to treat minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritant. Menthol is a monocyclic terpenoid alcohol obtained from various mint oils or prepared synthetically. The compound has a peppermintlike odor and is the primary active agent in peppermint oil. Menthol is used on the skin as a single agent and within various combination products for external analgesia. It may also be used in oral lozenges for the treatment of cough or pharyngitis.

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 Menthol, just click the ADD TO CART button.

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