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.

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• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
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• 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

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