Isostearamide MEA

What Is It?

Stearamide Diethanolamine (DEA), Stearamide Monoethanolamine (MEA), Isostearamide DEA, Isostearamide MEA, Myristamide DEA and Myristamide MEA are waxy solids that vary in color from white to tan. In cosmetics and personal care products, these ingredients are used in the formulation of deodorants, shampoos, makeup, bath products, and hair and skin care products.

Why Is It Used?

Stearamide DEA and MEA, Isostearamide DEA and MEA, and Myristamide DEA and MEA increase the thickness of the aqueous (water) portion of cosmetics and personal care products. They also increase foaming capacity or stabilize foams.

Scientific Facts

Stearamide DEA, Stearmide MEA, Isostearamide DEA, Isostearmide MEA, Myristamide DEA and Myristamide MEA are mixtures of ethanolamides of the fatty acids stearic acid, isostearic acid, and myristic acid. The DEA ingredients are mixtures primarily of diethanolamides, while the MEA ingredients are mixtures primarily of monoethanolamides.

Safety Information

The safety of these six ingredients has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Isostearamide DEA and MEA, Myristamide DEA and MEA, and Stearamide DEA and MEA were safe for use in rinse-off products. In leave-on products, the CIREP concluded that these ingredients were safe for use at concentrations that will limit the release of free ethanolamines to 5%, but with a maximum use concentration of 17% for Isostearamide, Myristamide and Stearamide MEA and of 40% for Isostearamide, Myristamide and Stearamide DEA.

CIR Safety Review: The clinical tests showed some irritation with formulations containing Stearamide MEA, but no sensitization. The CIR Expert Panel relied on data on the components of Stearamide DEA, Stearamide MEA, Isostearamide DEA, Isostearamide MEA, Myristamide DEA and Myristamide MEA to support the safety of these ingredients. The principle toxicity concern was for the ethanolamines, diethanolamine (DEA) and monoethanolamine (MEA). The CIR Expert Panel noted the potential for DEA to form the potentially carcinogenic nitrosamine compounds.

Data on DEA and MEA were previously reviewed by the CIR Expert Panel with the conclusion that concentration and other limits were needed to assure their safe use in cosmetic formulations. Estimates of the amounts of ethanolamines that may be released on hydrolysis of Stearamide DEA and MEA, Isostearamide DEA and MEA, and Myristamide DEA and MEA were made and generally expected to be below the concentration limit of 5% previously established. Because only certain concentrations of Stearamide DEA and MEA, Isostearamide DEA and MEA, and Myristamide DEA and MEA were actually tested clinically, these concentrations were considered as the maximum values for which safety could be concluded.

More information about nitrosamines.

More information about Diethanolamine in cosmetic products.

When complying to European Union animal by-products regulations, Stearamide MEA, Isostearamide MEA and Myristamide MEA may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. In addition to complying with animal by-products regulations, fatty acid dilakylamides and dialkanolamides, including Stearamide DEA, Isostearamide DEA and Myristamide DEA, are specifically listed in the Cosmetics Directive of the European Union (see Annex III).

These ingredients may be used if the finished product contains a maximum secondary amine content of 0.5%, they may not be used with nitrosating systems, the secondary amine content of the raw material may not exceed 5%, 50 microg/kg is the maximum nitrosamine content, and the products containing these ingredients must be kept in nitrite free containers.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

Stearamide DEA, Stearamide MEA, Isostearamide DEA, Isostearamide MEA, Myristamide DEA and Myristamide MEA are all ethanolamides of stearic, isostearic, and myristic acids, respectively. In cosmetics and personal care products, these ingredients function as surfactants – foam boosters and viscosity increasing agents – aqueous.

Resources

The European Commission’s opinion concerning Dialkyl- and Dialkanolamines and Their Salts in Cosmetic Products
http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out144_…

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/