Final report on the safety assessment of 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, potassiumoctoxynol-12 phosphate, sodium octoxynol-2 ethanesulfonate, sodium octoxynol-2 sulfate, sodiumoctoxynol-6 sulfate, and sodium octoxynol-9 sulfate1
Octoxynols are ethoxylated alkylphenols in which the size of the molecule is related to the number of moles of ethylene oxide used in synthesis. Reactions are performed at elevated temperature, under pressure, and in the presence of NaOH. It is possible that the synthesis may leave trace amounts of ethylene oxide, 1,4-dioxane, and unreacted C9 phenols. Octoxynols of various chain lengths as well as octoxynol salts and organic acids function in cosmetics either as surfactants—emulsifying agents, surfactants—cleansing agents, surfactant—solubilizing agents, or surfactants—hydrotropes in a wide variety of cosmetic products at concentrations ranging from 0.0008% to 25%, with most less than 5.0%. The octoxynols are chemically similar to nonoxynols, the safety of which were previously considered. 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.
ANIMAL; acute toxicity; subacute toxicity; subchronic toxicity; chronic toxicity; irritancy; immunotoxicity; genetic toxicity; reproductive and developmental tests; embryo-fetal toxicity; reproductive effect; toxicokinetics; respiratory system; eye; HUMAN; epidemiological study; human exposure; irritancy; hypersensitivity; eye; skin; mucous membrane