The safety of cetrimonium chloride, cetrimonium bromide and steartrimonium chloride has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that all three ingredients were safe for use in rinse-off products and were safe for use at concentrations of up to 0.25% in leave-on products.
Expert Panel for Cosmetic Ingredient Safety Review:
The Expert Panel reviewed data that indicated that cetrimonium bromide given orally is poorly absorbed from the intestine. Cetrimonium bromide applied dermally was absorbed into the skin, but not rapidly. Dermal irritation and sensitization and ocular irritation were seen with these quaternary ammonium salts.
Repeated insult patch tests of concentrations of up to 0.25% cetrimonium chloride produced no sensitization reactions, although irritation was observed during induction.
Cetrimonium bromide caused developmental effects following intraperitoneal injection of 35 or 10 mg/kg. Dermal exposure to 2% cetrimonium chloride produced no evidence of developmental effects; nor did 2.5% steartrimonium chloride. All mutagenesis assays used were negative.
Cetrimonium bromide, cetrimonium chloride, and steartrimonium chloride are listed as alkyl (C12-C22) trimethyl ammonium bromide and chloride in the Cosmetics Regulation of the European Union. These ingredients may be used as preservatives at a maximum concentration of 0.1%.