OEL Fastrac Catalog

Benzyl alcohol, also known as benzenemethanol and hydroxytoluene, is an aromatic alcohol that consists of benzene bearing a single hydroxymethyl substituent (1). Benzyl alcohol is reported to function as a fragrance, pH adjuster, preservative, solvent, antioxidant, viscosity decreasing agents, and external analgesics. It is also used as a food additive, cosmetic ingredient, chemical in photographic developing systems, disinfectant, and antibacterial agent in a variety of pharmaceutical formulations intended for intravenous (IV) administration. Benzyl alcohol is a Food and Drug Administration (FDA)-approved diluent in color additive mixtures for external drug use As an active ingredient, benzyl alcohol lotion, 5%, is used as a prescription medication for the treatment of head lice (Pediculosis capitis) (2, 3, 4). It is also used as an oral pain reliever for the temporary relief of pain caused by cold sores/fever blisters, canker sores, mouth sores, gum irritations, toothaches, minor irritation of the mouth and gum, sore mouth, and sore throat.

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.

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 Benzyl Alcohol, just click the ADD TO CART button.

HBEL

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