OEL Fastrac Catalog

Tea tree oil (also known as Melaleuca alternifolia (tea tree) leaf oil) is classified as a traditional herbal medicinal product indicated for the treatment of minor superficial wounds, insect bites, small boils (including furuncles and mild acne), and for the relief of itching and irritation in mild cases of athlete’s foot, as well as for the symptomatic treatment of minor inflammation of the oral mucosa. Tea tree oil is widely recognized for its multiple applications, particularly in supporting the health of skin, hair, and nails. The dermatological use of tea tree oil has been investigated by various studies, and several studies have suggested the uses of this oil for the treatment of acne vulgaris, seborrheic dermatitis, and chronic gingivitis.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Tea Tree Oil, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.