OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to lanolin oil (CAS RN 8038-43-5; 70321-63-0), asnd lanolin wax (CAS RN 68201-49-0). Lanolin (crude) is an ointment-like material isolated from wool that is sheared from sheep. Lanolin can be separated into lanolin oil (a liquid phase), and lanolin wax (a solid phase). Lanolin is used as a skin protectant and to relieve dryness and irritation of the skin. It helps prevent and treat diaper dermatitis. Lanolin is frequently used in protective baby skin treatment and for sore nipples in breastfeeding mothers. Lanolin is found in cosmetic products such as eye creams, lip balm, lotions and creams for dry skin, makeup and makeup removers, medicated shampoos, mustache wax, shaving cream, and baby oil. Lanolin is used as a direct and indirect food additive. Lanolin has also been studied for use in coatings and synthetic membranes for drug delivery systems for oral and transdermal drug treatments, respectively. Lanolin has been evaluated in multiple studies for use in wound treatment and barrier cream for barrier deficient skin, such as that found in neonates.

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 Lanolin, just click the ADD TO CART button.

HBEL

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