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

Posted: June 17, 2008

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Re-reviews
The CIR Expert Panel agreed to not re-open the safety assessment reports for:

Acetamide MEA
No new safety test data were found for acetamide MEA. The CIR Expert Panel noted that the safety assessment of MEA itself did restrict usage to rinse-off products based on a concern about skin irritation. Acetamide MEA, however, is considered to be a stable compound and not likely to dissociate and release MEA. The available data demonstrate that acetamide MEA is safe for use in rinse-off cosmetics and in leave-on products, if the concentration is limited to 7.5%. That conclusion was confirmed.

Chlorhexidine, Chlorhexidine Dihydrochloride, Chlorhexidine Digluconate and Chlorhexidine Diacetate
The CIR Expert Panel recognized the ongoing concern regarding potential hypersensitivity reactions to chlorhexidine-impregnated medical devices. These reactions are indicative of an IgE-mediated allergic reaction and are considered serious. The concentration limits imposed in the CIR Expert Panel safety assessment on these ingredients, however, are sufficient to ensure safety of their use in cosmetics and the original conclusion was confirmed.

Methenamine
The newly available safety test data regarding this preservative were consistent with those data in the original safety assessment. Methenamine functions as a formaldehyde releaser. As previously noted by the CIR Expert Panel, a fundamental equilibrium exists between these releasers and free formaldehyde itself, resulting in a steady state of availability of formaldehyde in aqueous solutions. If the level of preservative is kept low, then the level of formaldehyde will not present any safety concerns. The conclusion that methenamine is safe at concentrations up to 0.16% was confirmed. Consideration was given to adding methenammonium chloride to this safety assessment. The CIR Expert Panel determined that the chemical structure was dissimilar (methyl group added to the organic amine ring structure) and that the safety test data for methenamine could not be extrapolated to methenammonium chloride.

Quaternium-15
Most recent patch-testing publications have documented that the sensitization rate for quaternium-15 in the general population has risen to almost 10%. The CIR Expert Panel determined, therefore, to reopen this safety assessment to establish a limit of 0.2% (shown to not sensitize) for the safe use of quaternium-15.