Diethanolamine

What is Diethanolamine?

Diethanolamine (DEA) and DEA-related ingredients are organic substances that function as emulsifiers to produce foam and bubbles in cosmetics. These ingredients can also be used to adjust a product's pH. In discussing the use of DEA and DEA-related ingredients in cosmetics and personal care products, it is important to understand that there are several different substances - not just one. First, DEA itself is rarely used in products. When it is used, it is added at small levels to make sure the product is not harsh when applied to the skin (adjusts the acidity). DEA is mostly combined with other substances and converted into a new ingredient that is no longer chemically identical with DEA. This “chemical reaction” leads to a new substance that is very stable and does not easily come apart. Cocamide DEA is one example of such a chemical. It should be noted that DEA and DEA-Derivatives are used in other products besides cosmetics and personal care products. For example, DEA and DEA-derivatives have been approved for several food-related applications, primarily food packaging. As with chemical reactions, there may be unavoidable small amounts of the starting materials carried into the final product. These do not impact on the use and performance of the new ingredients and the levels can be controlled during manufacture. There have been reports in the news and the scientific literature about Diethanolamine and some of the DEA-derivatives and possible health effects.

What is The National Toxicology Program (NTP) study of DEA and DEA-related compounds?

The NTP develops, evaluates and disseminates scientific information about potentially toxic and hazardous chemicals. NTP conducts studies that are intended to identify a potential hazard but does not assess the risk posed by the material under conditions of use. More information about these studies can be obtained at the following links: http://ntp.niehs.nih.gov/index.cfm?objectid=070AAE68-0C37-7929-9780A12F1... Link to information about the National Toxicology Program: http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=720163E9-BDB7-... The possible carcinogenicity of DEA was also reviewed by the International Agency for Research on Cancer (IARC), which is part of the World Health Organization. The IARC review took place in 2000 and considered all of the available evidence on DEA in reaching a conclusion on its carcinogenicity. The outcome of that review was that there was “inadequate evidence in humans for the carcinogenicity of Diethanolamine” and “limited evidence in experimental animals for the carcinogenicity of Diethanolamine.” IARC concluded that DEA was “not classifiable as to its carcinogenicity to humans.” The IARC conclusion with the NTP study results, help support the safety of DEA and DEA-derivative ingredients.

Link to FDA discussion about the safety of DEA: http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm109655.htm

As a result of these thorough assessments, the FDA has noted that “[t]he NTP study did not establish a link between DEA and the risk of cancer in humans.” And that “FDA believes that at the present time there is no reason for consumers to be alarmed based on the use of these substances in cosmetics.” The agency has advised that consumers wishing to avoid cosmetics containing DEA or DEA-related ingredients may determine whether these ingredients are in a cosmetic product by reviewing the ingredient statement on the outer container label. If FDA determines that there is a possible risk from these ingredients, they “will advise the industry and the public and will consider its legal options under the authority of the Food, Drug and Cosmetic Act in protecting the health and welfare of consumers.”

What about the Federation of American Societies for Experimental Biology (FASEB) study?

A study published in the FASEB scientific journal in 2006 raised concerns that Diethanolamine (DEA), "an ingredient found in many shampoos and other personal care products, appears to interfere with normal brain development in baby mice when applied to the skin of pregnant mice." Although the report noted that DEA may be present in shampoos, DEA itself is rarely used in cosmetic or personal care products. Instead, small amounts of DEA may be present in products as a residue in other ingredients, such as cocamide DEA, lauramide DEA and stearamide DEA, which are primarily used in rinse-off applications such as shampoos and hair dyes. These are very stable derivatives of DEA, that are not the same as DEA and have not been shown to break apart or penetrate through the skin. The report speculated that, because the shampoo is applied to the scalp, there might be an association between the use of shampoo and potential adverse effects. This conclusion is highly speculative in nature. Any potential exposure to DEA in shampoos, soaps and other rinse-off products is thousands of times lower than what is reported in the FASEB study and far below the levels at which an effect was observed in the rodents in this study. Because of the highly alarming assertions in this study, the report received considerable attention in the news. Even so, the lead researcher, Dr. Steven Zeisel, acknowledged in a news release, stated that "the finding needs further study and should not cause undue alarm."

More Information:

Link to the FDA discussion about DEA and the DEA-derivatives: http://www.cfsan.fda.gov/~dms/cos-dea.html Link to the NTP Website: http://ntp-server.niehs.nih.gov/ Find out more about the FASEB Publication: FASEB Article: http://www.fasebj.org/cgi/content/abstract/20/10/1635?maxtoshow=&HITS=10... Response: http://www.fasebj.org/cgi/content/full/21/1/295