CIR Assesses Aminomethyl Propanol and More

The Cosmetic, Toiletry and Fragrance Association's (CTFA) Cosmetic Ingredient Review (CIR) panel summarized safety assessments and reviews made at its June 5, 2007 meeting.

Aminomethyl propanol and aminomethyl propanediol were deemed safe in the practices of use and concentration as described in the safety assessment.

Thioglycolates including: ammonium thioglycolate, butyl thioglycolate, calcium thioglycolate, ethanolamine thioglycolate, ethyl thioglycolate, glyceryl thioglycolate, isooctyl thioglycolate, isopropyl thioglycolate, magnesium thioglycolate, methyl thioglycolate, potassium thioglycolate, sodium thioglycolate and thioglycolic acid are considered safe for use in hair straighteners, permanent waves, tonics, dressings and other hair grooming aids, wave sets, other noncoloring hair products, and hair dyes and colors, as described in this safety assessment, at concentrations up to 15.4% (as thioglycolic acid). Hairdressers should avoid skin contact and minimize consumer skin exposure.

Calcium thioglycolate, potassium thioglycolate, sodium thioglycolate and thioglycolic acid in depilatories were determined to be safe when formulated to be nonirritating under conditions of recommended use.

According to the CIR panel, in regards to tentative amended safety assessments, interested persons are given 60 days to comment, provide information, and/or request an oral hearing. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings and are available at the CIR office for review by any interested party. These ingredient reports are next scheduled for review by the CIR Expert Panel at its September 24-25, 2007 meeting.

The CIR also performed re-reviews on some materials. The panel agreed to reopen the safety assessment reports for:
2,4-diaminophenoxyethanol HCl. The original conclusion for this ingredient was reaffirmed but also considered that the safety test data in the original safety assessment and the new data that were presented for both the ingredient and its sulfate salt support the safety of 2,4-diaminophenoxyethanol sulfate as well. Accordingly the panel agreed to reopen this safety assessment to add the sulfate salt. This ingredient report will again be considered at the September 24-25, 2007 meeting. Industry was requested to provide data it has developed relating to these two ingredients for inclusion in the draft report.

The CIR Expert Panel agreed to not reopen the safety assessment reports for: Steapyrium Chloride and Lapyrium Chloride Hydroxybenzomorpholine. According to the CIR, there were no new safety test data published regarding these materials and uses have decreased while use concentrations remain in the same range. There were no additional ingredients that could be considered to be addressed by the original safety assessment.

The Expert Panel noted that the European Scientific Committee on Consumer Products (SCCP) has published its opinion on the safety of Hydroxybenzomorpholine stating that the use of this ingredient at a maximum concentration of 1% is safe, if the nitrosamine content is less than 50 ppb and it is not used in combination with nitrosating agents. The Expert Panel noted that its original discussion and conclusion raised the same issues, so there was no need to reopen this safety assessment. The Expert Panel did agree that is was appropriate to reiterate the need to limit nitrosamine content and to avoid use in formulations with nitrosating agents.

The panel tabled the discussion of Disperse Violet 1 and Pyrogallol. In the case of Disperse Violet 1, the panel wanted industry to provide data it has developed on this hair dye. For pyrogallol, CIR wanted to await the availability of the National Toxicology Program (NTP) final report on its safety testing of this chemical.

Finally, the CIR Expert Panel approved the re-review summaries for the following, with only editorial comments: 5-bromo-5-nitro-1,3-Dioxane, t-butyl hydroquinone (TBHQ) and Phenoxyethanol.

For more information, visit the CIR Web site at

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