Sodium C14-16 Olefin Sulfonate

The Food and Drug Administration (FDA) reviewed the safety of Alpha-Olefin Sulfonates and approved the use of ammonium, calcium magnesium, potassium and sodium salts of these ingredients (C10-18, with not less than 50% as C14-16)as indirect food additives as components of adhesives and as emulsifiers and/or surface-active agents.

The safety of Sodium Alpha-Olefin Sulfonates has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Sodium Alpha-Olefin Sulfonates (of chain lengths C12-14, C14-16, C14-18, and C16-18) were safe as used in rinse-off products and safe up to 2% in leave-on products. The concentration of the gamma sultone impurity of any formulation (leave-on or rinse-off) was limited to unsubstituted alkane sultones at 10 ppm or less; chlorosultones at 1 ppm or less; and unsaturated sultones at 0.1 ppm or less.CIR Safety Review: The CIR Expert Panel noted that Sodium Alpha-Olefin Sulfonates are poorly absorbed through normal skin, but are significantly absorbed through damaged skin. Short-term toxicity studies showed no consistent effects, even with exposures in the 0.5-1.0 g/kg range. Concentrations above 10% produced moderate ocular irritation and a concentration of 5% produced mild ocular irritation. In reproductive and developmental toxicity studies, fetal abnormalities were noted, but only at doses that were maternally toxic. Genotoxicity data were mostly negative and oral and dermal carcinogenicity studies were negative. Various studies found irritation and sensitization. Sensitization was attributed to low level gamma sultone residues. Because gamma sultones were sensitizers at very low levels, it was concluded that any product containing Sodium Alpha-Olefin Sulfonates should have very little gamma sultone residues. The gamma sultone levels should not exceed 10 ppm for saturated (alkane) sultones, 1 ppm for chlorosultones, and 0.1 ppm for unsaturated sultones. Sodium Alpha-Olefin Sulfonates are otherwise considered safe for use in rinse-off products. Based on concerns about irritation, the use of Sodium Alpha-Olefin Sulfonates in leave-on products, was limited to 2%.

Link to FDA Code of Federal Regulations for Alpha Olefin Sulfonate, Ammonium, Calcium, Magnesium, Potassium, and Sodium salts
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Sodium Alpha-Olefin Sulfonates may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...