Stearalkonium Chloride

The safety of Stearalkonium Chloride has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Stearalkonium Chloride was safe for use in cosmetics and personal care products. In 2001, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.CIR Safety Review: Data on two compounds closely related to Stearalkonium Chloride, Cetalkonium and Myristalkonium Chlorides, were included in the report to permit a more complete appraisal of the safety of Stearalkonium Chloride. Single application dermal studies of Stearalkonium Chloride produced minor irritation. Stearalkonium Chloride was an eye irritant at high concentrations while low concentrations were slightly and transiently irritating.

A repeated insult patch test with a 1% aqueous solution of Stearalkonium Chloride showed the material to be neither a primary irritant nor a sensitizer. A single 48-hour patch test with challenge two weeks later indicated that 20% Stearalkonium Chloride was not a sensitizer.

In the 2001 re-evaluation, new studies, along with the updated information regarding uses and use concentrations, were considered by the CIR Expert Panel. The CIR Expert Panel determined to not reopen this safety assessment.

Stearalkonium Chloride may be used with restrictions in cosmetics and personal care products marketed in the European Union:
• Hair Care, rinse off products: < 3 % – Avoid contact with eyes.
• Other products: 0.1 % maximum – Avoid contact with eyes.
• If Stearalkonium Chloride is derived from raw materials of animal origin, it must comply with European Union animal by-products regulations.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...