OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Adapalene sodium (CAS RN 911110-93-5). Adapalene is used to treat acne. The exact mechanism is not known. Adapalene exhibits some retinoic acid-like activity but it also has additional effects. It is thought that adapalene reduces important features of the pathology of acne vulgaris by normalizing the differentiation of follicular epithelial cells and keratinization to prevent microcomedone formation, similar to the mechanism of retinoic acid. Unlike retinoic acid, adapalene selectively binds to some nuclear retinoic acid receptors and does not bind to cellular receptors called cytosolic retinoic acid binding proteins. It is hypothesized that by selectively binding to certain nuclear retinoic acid receptors and not others, adapalene enhances keratinocyte differentiation without inducing epidermal new growth and severe irritation, such as is seen with retinoic acid. Also, adapalene may help reduce cell-mediated inflammation, an effect demonstrated by in vitro studies. Adapalene decreases formation of comedones and inflammatory and noninflammatory acne lesions.

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 Adapalene, just click the ADD TO CART button.

HBEL

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