Stearalkonium Hectorite
What Is It?
Stearalkonium Hectorite is a creamy white, fine powder. In cosmetics and personal care products, Stearalkonium Hectorite is used in a wide variety of products including lipstick, eye makeup, and nail polish and other manicuring products.
Why Is It Used?
Stearalkonium Hectorite functions as a suspending agent.
Scientific Facts
Stearalkonium Hectorite facilitates the dispersion of solids in liquids. It has a gel-like consistency that becomes more fluid-like when disturbed.
Safety Information
The safety of Stearalkonium Hectorite has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Stearalkonium Hectorite was safe for use in cosmetics and personal care products under the present practices of use.
CIR Safety Review:
The CIR Expert Panel had previously evaluated the safety of of Stearalkonium Chloride and Quaternium-18 Hectorite, compounds closely related to Stearalkonium Hectorite. Data on the related ingredients were included in the CIR assessment to permit a more complete appraisal of the safety of Stearalkonium Hectorite. Stearalkonium Hectorite was not a skin or eye irritant. It was not a mutagen. A related ingredient, myristalkonium chloride was not a developmental toxicant. Stearalkonium Hectorite is synthesized from Stearalkonium chloride, which has a positively charged nitrogen.
The CIR Expert Panel considered it unlikely that the nitrogen in Stearalkonium Hectorite would be available for nitrosation. Any quaternary chlorides or amine hydrochlorides present in the starting materials become strongly bound to the hectorite clay, as does excess Stearalkonium chloride, and are not readily available for nitrosation. The formation of N-nitrosamines was, therefore, considered not to be of concern. The CIR Expert Panel concluded that the available data were sufficient to support the safety of Stearalkonium Hectorite in cosmetics and personal care products.
Stearalkonium Hectorite may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
More Scientific Information
Stearalkonium Hectorite is the reaction product of stearalkonium chloride and hectorite, a montmorillonite mineral found in bentonite clay. Stearalkonium Hectorite is used as a suspending agent – nonsurfactant in cosmetics and personal care products. Stearalkonium Chloride is a quaternary ammonium salt with a long carbon chain attached to the nitrogen atom. The quaternary nitrogen carries a cationic (+) charge regardless of the pHA measurement of the acidity or basicity of a substance. pH is the negative logarithm (base 10) of the concentration of hydrogen ions in solution. Water has a concentration of hydrogen ions of 1.0 x 10-7, and thus has a pH of 7. A pH of 7 is considered neutral, a pH lower than 7 is considered acidic, and a pH higher than 7 is considered basic. of the system. At high pH, the anion may be in the form of hydroxyl, which may reduce the normally high water solubility of quaternary ammonium compounds.
Resources
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
Search the FDA Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm