Ingredient Review Update from CTFA

Posted: April 22, 2006

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The CIR Expert Panel re-reviewed three ingredient safety assessments previously considered in the 1980s to determine if there is new safety test data. CIR staff compiled the available new information and the panel reviewed the material. In considering sorbic acid and potassium sorbate, the panel noted that the available safety test data in the original safety assessment are likely sufficient to support the safety of sodium sorbate as well.

If a procedure was developed to ensure adequate notice and availability for public comment, CIR concluded it likely would be scientifically correct to include sodium sorbate. The same likely would be true for the steareth group and the addition of higher molecular weight steareth-21, -25, -27, -30, -40, -50, -80 and -100.

The CIR expert panel reviewed the re-review summaries for methylene chloride and the cetearyl alcohol group considered at the December 2005 meeting and offered no suggested changes.

New Data

Benzyl alcohol, benzoic acid and sodium benzoate: In 2000, the CIR expert panel published its final safety assessment of these ingredients concluding that they are safe up to a concentration of 5%, except that there was insufficient data to support their use where inhalation would be a primary route of exposure. Benzyl alcohol was considered safe up to a concentration of 10% in hair dye products. Inhalation toxicity data were needed to resolve the insufficient data conclusion. A four-week inhalation toxicity study of benzoic acid using rats was provided, along with an inhalation toxicity risk assessment. While the CIR expert panel was divided as to the adequacy of the data provided, they agreed that a new draft report should be prepared that incorporates the newly available data, along with any new published data. In the meantime, additional unpublished data or comments that would address the significance of the interstitial fibrosis found that at the lowest dose studied, and the use of lowest observable adverse effect dose, in a risk assessment would be useful. A draft report incorporating the new data will be considered at the Aug. 14-15, 2006, meeting.