OEL Fastrac Catalog

Sesamum indicum (sesame) seed oil is the oil obtained from the seeds of Sesamum indicum. Other names for this ingredient include gingilli oil, sesame oil, sesame seed oil, and sesami oleum. Sesamum indicum seed oil has also been defined as the refined fixed oil obtained from the seed of one or more cultivated varieties of Sesamum indicum L. The oil has been described as the oil bodies of plant seeds as containing a triacylglycerol matrix surrounded by a monolayer of phospholipids embedded with alkaline proteins termed oleosins. The monounsaturated, diunsaturated, and triunsaturated triglycerides of sesame oil consist principally of oleic acid, linoleic acid, and other fatty acids in smaller amounts. Sesame oil contains nonsaponifiable substances that are not removed by refining. Sesamol, sesamin, and sesamolin have been detected in sesame oil but have not been detected in other fats. Sesame oil contains 0.4% to 1.1% sesamin, 0.3% to 0.6% sesamolin, and traces of sesamol.

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 Sesame Oil, just click the ADD TO CART button.

HBEL

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