Safety Assessment of Diethanolamine and Its Salts as Used in Cosmetics

Abstract

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of diethanolamine and its salts as used in cosmetics. Diethanolamine functions as a pH adjuster; the 16 salts included in this rereview reportedly function as surfactants, emulsifying agents, viscosity increasing agents, hair or skin conditioning agents, foam boosters, or antistatic agents. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports. Since data were not available for each individual ingredient, and since the salts dissociate freely in water, the Panel extrapolated from previous reports to support safety. The Panel concluded that diethanolamine and its salts are safe for use when formulated to be nonirritating. These ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

ToxCast chemical library screen identifies diethanolamine as an activator of Wnt signaling

“…In animal models, DEA exposure has effects on several tissue/organ systems. Mice treated with DEA for two years develop higher rates of kidney and liver tumors (data reviewed in(65)). These tumors had high rates of mutations in exon two of the β-catenin gene, and demonstrated abnormal nuclear localization of β-catenin, indicative of constitutively active Wnt signaling(76).…”

“…The FDA and the National Toxicology Program have likewise found an association between DEA and cancer in lab animals, and provide information on the use of DEA and its derivatives in cosmetics (https://www.fda.gov/cosmetics/cosmetic-ingredients/diethanolamine). However, as of this writing, DEA is approved in the United States as long as it does not comprise >5% of the total product composition(65). To our knowledge there have been no epidemiological studies suggesting a role, or lack thereof, of DEA in increasing risk for neurodevelopmental disorders.…”

Safety Assessment of Amino Acid Alkyl Amides as Used in Cosmetics

“…The issue of levels of free diethanolamine (DEA) that could be present as an impurity in the ingredients containing triethanolamine (TEA), and the potential of TEA to act as a precursor in nitrosamine formation by undergoing nitrosative cleavage, has been previously reviewed by the Panel. 18,19 Use Cosmetic Table 5A contains the current product formulation data for amino acid alkyl amides. These ingredients function primarily as skin and hair conditioning agents and surfactants.…”

“…The issue of levels of free diethanolamine (DEA) that could be present as an impurity in the ingredients containing triethanolamine (TEA), and the potential of TEA to act as a precursor in nitrosamine formation by undergoing nitrosative cleavage, has been previously reviewed by the Panel. 18,19…”

Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics

“…Diethanolamine and its salts and TEA and TEA-containing ingredients have been found safe in the present practices of use and concentration when formulated to be nonirritating, with the caveat that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. 3,4…”