CIR Approves Ingedients and Comments on the Moisturizer/Tumor Article at its 108th Meeting

At the the Cosmetic Ingredient Review's (CIR) 108th Expert Panel meeting, it approved fumaric acid at 5%; requested more data on Basic Violet 3, 1 and 4; deemed licorice extract and allantoin safe; reviewed the article claiming a link between moisturizers and UVB-induced tumors; and requested a carcinogenicity study on toluene-3,4-diamine as a hair dye ingredient.

The panel approved the use of the fumaric acid group in cosmetic formulations not exceeding a concentration of 5%. Though this concentration is below the 24% of diisostearyl fumarate reported in lipsticks, the panel noted that, "for such a high concentration to be considered safe, interested parties should provide human repeat insult patch test data demonstrating that such a concentration in formulation is not sensitizing.”

The CIR made final safety assessments of Basic Violet 3, allantoin, Glycyrrhiza glabra (licorice) leaf extract, maltitol, maltitol laurate, methylisothiazolinone, and Zea mays (corn) oil. The reviewers found allantoin, licorice extract, maltitol, maltitol laurate, methylisothiazolinone and Zea mays (corn) oil and their related complexes safe as cosmetic ingredients in the practices of use and concentrations given in the assessment. Basic Violet 3, 1 and 4 were found to have insufficient data to support their safety in hair dye. The review called for more information.

The reviewers also made final amended safety assessments on Cocos nucifera (coconut) oil, Simmondsia chinensis (jojoba) seed oil, sodium cetearyl sulfate, sodium picramate, picramic acid and tall oil acid. All of these ingredients and their complexes were deemed safe as cosmetic ingredients in the practices of use and concentration given in the assessment.

Tentative amended safety assessments were made on cocamidopropyl betaine, cellulose, cellulose polymers, sodium myreth sulfate and toluene-2,5-diamine. Cocamidopropyl betaine was found safe in the present concentrations, provided that the content of DMAPA and amidoamine are not high enough to induce sensitization. Cellulose and cellulose polymers and their complexes were deemed safe in current concentrations. Similarly, sodium myreth sulfate and its complexes were found to be safe at current concentrations, provided that they are formulated to be non-irritating. Although the panel found toluene-2,5-diamine and toluene-2,5-diamine sulfate safe as hair dye ingredients at current concentrations, it found insufficient data to support the safety of toluene-3,4-diamine as a hair dye ingredient. The panel called for a 2-year dermal carcinogenicity studying using the methods of the National Toxicology Program.

The panel will re-review ethylester of PVM/MA copolymer, sesame oil ans sodium dodecylbenzenesulfonate and their complexes. In addition re-review summaries were approved for chlorhexidine group, acetamide MEA and methenamine. There are new scientific literature reviews available for quaternijm-15 and xylene. Persons interested in reviewing or commenting on the reviews of available safety tests and related data on these ingredients have 60 days to do so.

The panel reviewed the Le et al. article titled "Tumorigenic Effect of Some Commonly Used Moisturizing Creams when Applied Topically to UVB-Pretreated High-Risk Mice" in the Journal of Investigative Dermatology and noted, "The hairless mice used in the study have skin that is not at all like human skin, and, as the study authors state, making any suggestion about the implications for human skin isn't possible."

Two reports on butyl myristate and dilauryl thiodipropionate and their complexes were tabled. The next CIR meeting will take place on Dec. 8-9, 2008, at which time the panel will review a numbe of PEGs, sodium cocoyl isethionate and HC Yellow No. 2. For more information, visit


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