Bio-Terge 804 is a blend of Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate and Lauramide DEA (see below)

Lauramide DEA is a fatty acid derivative of diethanolamine (DEA*).  It is a nonionic surfactant used in the formulation of shampoos, hair dyes, bath products and lotions as a viscosity booster and, to increase and stabilize the foaming capacity of a formula.  Lauramide DEA also thickens the aqueous portion of a formula.  Lauramide DEA is produced from naturally occurring lauric acid. 

The CIR Expert Panel concluded that Lauramide DEA was safe as a cosmetic ingredient.  The CIR Expert Panel reviewed data on Lauramide DEA showing that: it is slightly toxic to nontoxic via acute oral administration; it is not a dermal toxin in acute and sub-chronic studies; it is a mild skin irritant but not a sensitizer or photosensitizer; it is a mild to moderate eye irritant; it does not demonstrate mutagenic activity.

Lauramide DEA  is listed under Fatty Acid Dialkylamides and Dialkanolamides in the Cosmetics Directive of the European Union (see Annex III, Part I) and may be used with a maximum secondary amine concentration of 0.5%.  It may not be used with nitrosating systems.  In the Cosmetics Directive of the European Union, Lauramide DEA was lumped into the Fatty Acid Dialkylamides and Dialkanolamides along with Cocamide DEA, Linoleamide DEA and Oleamide DEA.  The CIR Expert Panel determined that only Cocamide DEA should not be used with nitrosating systems. 

*Since Lauramide DEA is a fatty acid derivative of diethanolamine (DEA) I wanted to take a moment to address the safety data regarding DEA.  DEA has been assessed by the CIR Expert Panel and concluded they that DEA is safe for use in cosmetics and personal care products designed for discontinuous, brief use followed by thorough rinsing from the surface of the skin. In products intended for prolonged contact with the skin, the concentration of DEA should not exceed 5%.

Sodium C14-16 Olefin Sulfonate (a Sodium Alpha-Olefin Sulfonate) is a mixture of long chain sulfonate salts prepared by the sulfonation of alpha olefins. The numbers (14-16) indicate the average lengths of the carbon chains of the alpha olefins.  It is most commonly used in shampoos and bath and shower products.  Sodium C14-16 Olefin Sulfonate helps clean the skin and hair by helping the water from your shower or bath to mix with the oil and dirt on your body and hair so they can be rinsed away. 

The FDA reviewed the safety of Sodium C14-16 Olefin Sulfonate as indirect food additives, as components of adhesives, and as emulsifiers and/or surface-active agents.  The safety of Sodium C14-16 Olefin Sulfonate has been assessed by the CIR Expert Panel and they concluded that it was safe as used in rinse-off products and safe up to 2% in leave-on products.

The CIR Expert Panel noted that Sodium Alpha-Olefin Sulfonates are poorly absorbed through normal skin but significantly absorbed through damaged skin. Short-term toxicity studies showed no consistent effects. High concentrations produced moderate to mild ocular irritation.  At doses that were maternally toxic they found fetal abnormalities in animal studies. Genotoxicity, oral and dermal studies were negative.

Some studies found irritation and sensitization. This 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. The use of Sodium Alpha-Olefin Sulfonates in leave-on products is limited to 2% in a formula. 

According to the general provisions of the Cosmetics Directive of the European Union, Sodium C14-16 Olefin Sulfonate may be used in cosmetics and personal care products marketed in Europe.