Oleamide DEA

The Food and Drug Administration (FDA) includes Fatty AcidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides. Diethanolamides on its list of indirect food additives. For example, Fatty Acid Diethanolamides may be used in paper and paperboard in contact with dry food.

The safety of Cocamide DEA, Lauramide DEA, Linoleamide DEA and Oleamide DEA has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that these ingredients were safe as cosmetic ingredients.

To prevent the formation of possibly carcinogenic nitrosamines, these ingredients should not be used in cosmetics and personal care products containing nitrosating agents. Since the original review, the CIR Expert Panel considered available new data on Cocamide DEA and clarified its original conclusion.

The CIR Expert Panel concluded that Cocamide DEA was safe as used in rinse-off products and safe at concentrations of less than or equal to 10% in leave-on products. The CIR Expert Panel reaffirmed that Cocamide DEA should not be used as an ingredient in cosmetics and personal care products containing nitrosating agents.

CIR Safety Review: The CIR Expert Panel reviewed data showing that these four fatty acid alkanolamides were slightly toxic to nontoxic via acute oral administration. Cocamide DEA, Lauramide DEA, and Linoleamide DEA were not dermal toxins in acute and subchronic studies.

Lauramide DEA and Linoleamide DEA were mild to moderate eye irritants and mild to severe skin irritants. Undiluted Oleamide DEA was not an eye irritant and was a moderate skin irritant in single and multiple applications. Lauramide DEA did not demonstrate mutagenic activity in three different assay systems. No data were available on the mutagenic or carcinogenic activity of Linoleamide DEA and Oleamide DEA.

The clinical information on these ingredients was confined to Cocamide DEA, Lauramide DEA, and Linoleamide DEA. Generally, these products were mild skin irritants but not sensitizers or photosensitizers. Based on these data the CIR Expert Panel concluded that these ingredients were safe as cosmetic ingredients. To prevent the formation of possibly carcinogenic nitrosamines, these ingredients should not be used in cosmetics and personal care products containing nitrosating agents.

The CIR Expert Panel’s decision to reevaluate the safety of Cocamide DEA in cosmetics and personal care products was based on occupational studies indicating that this ingredient may have sensitization potential. However, the CIR Expert Panel determined that these studies were not relevant to cosmetic use. Furthermore, the CIR Expert Panel agreed that its original conclusion on Cocamide DEA should be clarified relative to use of this ingredient in rinse-off and leave-on products. Clarification of the original conclusion is based on the results of a skin irritation test in which volunteers were tested with a surfactantAn ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. solution containing 10% Cocamide DEA, the highest concentration tested in predictive patch tests. Based on this test, the CIR Expert Panel concluded that Cocamide DEA was safe as used in rinse-off products and safe at concentrations of less than or equal to 10% in leave-on products. The CIR Panel reaffirmed that Cocamide DEA should not be used as an ingredient in cosmetics and personal care products containing nitrosating agents.

More information about Diethanolamine.

More information about Nitrosamines.

Link to the FDA Code of Federal Regulations for Fatty Acid Diethanolamides

• FDA Regulation #1
• FDA Regulatoin #2

All four ingredients are listed under Fatty Acid Dialkylamides and Dialkanolamides in the Cosmetics Regulation of the European Union (see Annex III, Part I) and may be used with a maximum secondary amine concentration of 0.5%. They may not be used with nitrosating systems, in addition to other limitations.

EU Cosmetic Regulation