OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to benzethonium chloride (CAS RN 121-54-0), benzethonium chloride monohydrate (CAS RN 5929-09-9), methylbenzethonium chloride (CAS RN 25155-18-4; 101912-16-7; 1320-44-1), methylbenzethonium (CAS RN 72013-76-4), Benzethonium carbonate (CAS RN N.A.), and Benzethonium nitrate (CAS RN N.A.). Benzethonium is a synthetic quaternary ammonium salt with surfactant, antiseptic, and broad-spectrum antimicrobial properties. Its salt form, benzethonium chloride, is primarily used as a skin disinfectant at concentrations of 0.1% to 0.2%, which are safe and effective concentrations for the compound as specified by the United States (US) Food and Drug Administration (FDA). It is additionally found in cosmetics and toiletries such as mouthwashes and anti-itch ointments. It is shown to be effective in mediating its antimicrobial action against bacteria, fungi, mold, and viruses. There is evidence that benzethonium acts as a spermatocide but may cause vaginal irritation. Benzethonium was identified as a novel cancer-specific compound by cell-based small-molecule screen. There were no therapeutic indications for clinical use.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).

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 monograph for Benzethonium, just click the ADD TO CART button.

HBEL

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