CIR Reaches Verdicts on Butyl Myristate, HC Red No. 3 and More

Posted: June 17, 2008

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2. This safety assessment was re-opened in April 2007 based on safety concerns that relate to the sensitization potential of this ingredient in both leave-on and rinse-off products. The expert panel acknowledged that the sensitization potential of this ingredient likely relates to the presence of two impurities that have allergenic potential: amidoamine and 3-dimethylaminopropylamine [DMAPA] . The expert panel also noted new uses of this ingredient in sprays and powders that could be inhaled but that data was available suggesting that, in general, cosmetic product sprays do not produce respirable particle sizes.

Data needed to include: 1) the levels of amidoamine and DMAPA impurities that reasonably can be achieved in the cocamidopropyl betaine manufacturing process; 2) additional sensitization data for DMAPA and amidoamine, if available; and 3) inhalation toxicity data for cocamidopropyl betaine, in the new use formulations such as sprays and powders, or updated information on particle size in cosmetic sprays, if available.

To contact the Cosmetic Ingredient Review (CIR), send e-mail to: cirinfo@cir-safety.org.