OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sodium triclosan (CAS RN 42409-10-9) and Potassium triclosan (CAS RN 94087-36-2).Triclosa n is a chlorinated bisphenol antiseptic, effective against Gram-positive and most Gram-negative bacteria but with variable or poor activity against Pseudomonas. It is also active against fungi. It is used in soaps, creams, and solutions in concentrations of up to 2% for disinfection of the hands and wounds, and for disinfection of the skin before surgery, injections, or vena puncture. It is also used in oral hygiene products and in preparations for acne. The mechanism of action of triclosan involves a significantly decreased activity of adenylyl cyclase enzyme which was followed by a decreased synthesis of cAMP. This decreased cAMP level resulted in the disruption of the entire steroidogenic cascade causing a depressed synthesis of testosterone.

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 Triclosan, just click the ADD TO CART button.

HBEL

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