Amended Final Report on the Safety Assessment of Cocamide DEA

Cocamide DEA is a mixture of ethanolamides of Coconut Acid that is used as a surfactant-foam booster and viscosity-increasing agent-aqueous in cosmetic products. Production formulation data submitted to the Food and Drug Administration in 1994 indicated that this ingredient was used in 745 products. The Cosmetic Ingredient Review (CIR) Expert Panel had previously evaluated the safety of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA in cosmetics and concluded that they were safe as cosmetic ingredients at the concentrations that were currently being used (50%). CIR's decision to reevaluate the safety of Cocamide DEA in cosmetics is based on occupational studies indicating that this ingredient may have sensitization potential; however, the Expert Panel has determined that these studies are not relevant to cosmetic use. Furthermore, the 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 15 volunteers were tested with a surfactant solution containing 10% Cocamide DEA, the highest concentration tested in predictive patch tests. Additional comments that were made during the Panel's review of other data in the present report include that the severe ocular irritation reactions induced by a chemical (p H 9–10.5) containing >64% Cocamide DEA were likely a result of p H; that the renal effects noted in Fischer 344 rats in the National Toxicology Program (NTP) subchronic dermal toxicity study may be species-related and not test substance-related; and with reference to an ongoing NTP two-year chronic study that was initiated in 1993, that the results will be reviewed when the study is available. On the basis of the animal and clinical data presented in the present report, the Expert Panel concluded that Cocamide DEA is safe as used in rinse-off products and safe at concentrations 10% in leave-on cosmetic products. It was also concluded that Cocamide DEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed.

Final Report on the Safety Assessment of Butoxyethanol

Butoxyethanol is an ether alcohol used as a solvent in hair and nail products at concentrations up to 10%. This ingredient is absorbed through the skin, metabolized to butoxyacetic acid, and excreted in urine. Acute inhalation toxicity was related to concentration and duration of exposure; pathological changes occur in the kidneys, liver, and lungs. Butoxyethanol was only slightly toxic in an acute oral study in rats and in a dermal study in rabbits. Butoxyethanol was nephrotoxic in an intravenous study in rats, but not when administered intraperitoneally. No evidence of genotoxicity was seen in a battery of tests with metabolic activation, but positive and negative effects were seen in the absence of metabolic activation. A dermal study of a cosmetic product containing 10% Butoxyethanol was not carcinogenic in rats, whereas a rust-preventive product containing 2.5% Butoxyethanol was carcinogenic (90.9% of the rust preventive was a petroleum distillate). There is some evidence for reproductive and developmental toxicity in oral and inhalation studies involving rats, rabbits, and mice, but no such effects in dermal studies in rats. Clinical tests and reports from occupational exposures indicate Butoxyethanol to be an irritant when inhaled. Butoxyethanol was not a sensitizer or photosensitizer in clinical tests. Undiluted Butoxyethanol is recognized to be a severe ocular irritant, but aqueous concentrations of 15 and 5% produced only moderate and no corneal injury, respectively. In consideration of these data, the Cosmetic Ingredient Review Expert Panel concluded that this ingredient may be used safely in hair and nail cosmetic products at concentrations up to 10%.