Octoxynols (Octoxynol-1, Octoxynol-3, Octoxynol-5, Octoxynol-6, Octoxynol-7, Octoxynol-8, Octoxynol-9, Octoxynol-10, Octoxynol-11, Octoxynol-12, Octoxynol-13, Octoxynol-16, Octoxynol-20, Octoxynol-25, Octoxynol-30, Octoxynol-33, Octoxynol-40, Octoxynol-70, Octoxynol-9 Carboxylic Acid, Octoxynol-20 Carboxylic Acid, Potassium Octoxynol-2 Ethane Sulfonate, Sodium Octoxynol-2 Ethane Sulfonate, Sodium Octoxynol-2 Sulfate, Sodium Octoxynol-6 Sulfate, Sodium Octoxynol-9 Sulfate) are a group of ethoxylated alkyl phenols. They are generally water white to light amber viscous liquids. In cosmetics and personal care products, Octoxynols are used principally in hair dyes and colors but can also be found in hair conditioners, permanent waves and other product types.
The safety of Octoxynols has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Octoxynol-9, -10, -11, -12, -13, -16, -20, -25, -30, -33, -40, and -70, Octoxynol-9 Carboxylic Acid, Octoxynol-20 Carboxylic Acid, Potassium Octoxynol-12 Phosphate, and Sodium Octoxynol-9 Sulfate were safe as used in rinse-off and leave-on cosmetics and personal care products. The CIR Expert Panel also concluded that Octoxynol-1, -3, -5, -6, -7, and -8, Sodium Octoxynol-2 Ethane Sulfonate, Sodium Octoxynol-2 Sulfate, and Sodium Octoxynol-6 Sulfate were safe in rinse-off products and safe at concentrations of 5% or less in leave-on products.CIR Safety Review: The CIR Expert Panel noted that the Octoxynols are chemically similar to Nonoxynols, the safety of which were previously reviewed. Long-chain Nonoxynols (9 and above) were considered safe as used, whereas short-chain Nonoxynols (8 and below) were considered safe as used in rinse-off products and safe at concentrations less than 5% in leave-on formulations.
Acute exposure to Octoxynol-9 by bronchopulmonary lavage produced pneumonia, pulmonary edema, and intra-alveolar hemorrhage. No significant effects were noted in short-term oral studies of Octoxynol-9, in subchronic oral studies of Octoxynol-40, or in chronic oral studies of Octoxynol-40.
In skin irritation studies, Octoxynols ranged from nonirritating to moderately irritating. Octoxynols were not eye irritants in one study, but in others some eye irritation was observed. The Octoxynols were not mutagenic.
Dermal exposure at three dose levels to Octoxynol-9 failed to induce any developmenta effects. No reproductive toxicity was seen in males which received 5% Octoxynol-40 in the diet daily for three months. Women who used Nonoxynol-9 or Octoxynol-9 as spermicides, but became pregnant, did not have an increase in the overall risk of fetal malformations.
In a human skin irritation study, formulations containing 2% Octoxynol-9 were classified as moderately irritating and minimally irritating, respectively, in a 24-hour single-insult, occlusive patch test. Octoxynol-9 (1%) was classified as a nonirritant in a clinical study of nine subjects patch tested for 4 consecutive days. The skin sensitization potential of Octoxynols-1, -3, -5, -9, and -13 was evaluated using 50 subjects. Octoxynol-1 induced sensitization in two subjects; all other results were negative. No sensitization was observed in the following studies: 8.0% Octoxynol-9 in 103 subjects, 0.5% Octoxynol-9 in 102 subjects, and 0.1% Octoxynol-9 in 206 subjects.
The limitations on the use of the short chain Octoxynols was based on concerns about potential skin sensitization, and the recognition that the short-chain Octoxynols could be absorbed into the skin more than the longer chain Octoxynols.
Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the Octoxynol ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.
Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
http://www.cfsan.fda.gov/~dms/cosdiox.html
Link to FDA Code of Federal Regulations for p-Octylphenol and Octylphenols
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Octoxynols 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...