OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to dibucaine hydrochloride (CAS RN 61-12-1). Dibucaine is indicated for use as a local anesthesia, to relieve pain, itching, and inflammation associated with minor skin disorders. Dibucaine shares the pharmacologic effects of other local anesthetics, and acts by blocking nerve conduction first in the autonomic, then in sensory, and finally motor nerve fibers. Nerve conduction appears to be blocked by dibucaine as a result of a decrease in the permeability of the nerve cell membrane to sodium ions. Competition with calcium ions for membrane binding sites also appears to be involved. Local anesthetics may also reduce the permeability of resting nerves to potassium, as well as to sodium ions.

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 Dibucaine, just click the ADD TO CART button.

HBEL

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