What Is It?
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.
Why Is It Used?
The Octoxynols help to form emulsions by reducing the surface tension of the substances to be emulsified. Many of the Octoxynols, and the Octoxynol acids and salts, clean skin and hair by helping water to mix with oil and dirt so that they can be rinsed away. The longer chain Octoxynols help other ingredients to dissolve in a Substances, usually liquids, that are used to dissolve other substances. in which they would not normally dissolve. Potassium Octoxynol-12 Phosphate has the ability to enhance the water solubility of other surfactants.
Octoxynols vary in chain length from Octoxynol-1 to Octoxynol-70. The numerical value represents the average number of units of ethylene oxide added to produce the specific Octoxynol ingredient. For example, Octoxynol-9 is made by reacting p-(1,1,3,3-tetraemethylbutyl)phenol with 5-18 units of ethylene oxide, resulting in an average value of 9. The Octoxynol salts and organic acids are then produced from these Octoxynol compounds.
The Food and Drug Administration (FDA) has reviewed the safety of Octoxynols and approved their use as indirect food additives as components of adhesives, and paper and paperboard in contact with food. The safety of Octoxynols has been assessed by the The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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.
Link to FDA Code of Federal Regulations for p-Octylphenol and Octylphenols
Octoxynols may be used in cosmetics and personal care products marketed in Europe according to the Under the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
Link to the EU Cosmetic Regulation:
More Scientific Information
Some studies suggest that environmental breakdown products of Octoxynols may mimic the activity of the hormone estrogen. This type of effect is sometimes called endocrine disuruption.
More information about endocrine disruptors.
In cosmetics and personal care products, the shorter chain Octoxynols (-1 to -20), function as surfactants – emulsifying agents. Octoxynols-16, -25, -30, -33, -40, and -70 are used mainly as surfactants – cleansing and solubilizing agents. The Octoxynol acids and salts also function as surfactants – cleansing agents and Potassium Octoxynol-12 Phosphate is also used as a An ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – hydrotrope.
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/