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

Posted: June 17, 2008

page 13 of 16

3. Reports Tabled

Calendula officinalis extract, Calendula officinalis flower, Calendula officinalis flower extract, Calendula officinalis flower oil, and Calendula officinalis seed oil
The CIR Expert Panel noted that the report had been expanded to include information from applicable existing CIR safety assessments (e.g., pyrogallol) and information from RIFM safety assessments (e.g., triterpenes). Additional publications also will be included in the draft document. The panel, however, expressed several concerns about data gaps and tabled further discussion to allow interested parties the opportunity to provide such data. This data includes:

(1) Since tannins comprise 6-10% of material derived from Calendula, how much of the catechol component would be pyrocatechol? This is important because the panel previously has determined that pyrocatechol is unsafe for use in leave-on cosmetic products.
(2) How much of the material derived from Calendula are quinones? The panel has restricted the concentration in cosmetics of related chemicals.
(3) How much of the material derived from Calendula are coumarins? The panel is concerned about the limited evidence in animals regarding carcinogenicity.

The panel noted that, if thisdata is not available, limits on the concentration of these components may be established to assure that Calendula extracts are safe for use in cosmetics. Interested parties should use this opportunity to provide additional available unpublished data for inclusion in the draft document. The panel will review at its Sept. 22-23, 2008, meeting.

Sodium myreth sulfate, ammonium capryleth sulfate, ammonium laureth sulfate, ammonium C12-15 pareth sulfate, ammonium myreth sulfate, magnesium coceth sulfate, magesium laureth sulfate, magnesium myreth sulfate, magensium oleth sulfate, sodium coceth sulfate, sodium C10-15 pareth sulfate, sodium C12-13 pareth sulfate, sodium C12-15 pareth sulfate, sodium deceth sulfate, sodium laneth sulfate, sodium laureth sulfate, sodium oleth sulfate, sodium trideceth sulfate and zinc coceth sulfate
Sodium myreth sulfate is a cleansing and emulsifying agent previously reviewed. The CIR Expert Panel determined that the available data in the original safety assessment are sufficient to support the safety of an additional 19 ingredients. At this meeting, the panel acknowledged that much of the safety test data that support this group of related chemicals come from studies of ammonium laureth sulfate and sodium laureth sulfate.