Final report on the safety assessment of Ceteareth -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -12, -13, -14, -15, -16, -17, -18, -19, -20, -21, -22, -23, -24, -25, -27, -28, -29, -30, -33, -34, -40, -50, -55, -60, -80, and -100
Summary. Ceteareths, used in cosmetics as surfactants, are the polyethylene glycol (PEG) ethers of Cetearyl Alcohol (q.v.). In addition to limited safety test data on Ceteareths, the report summarizes findings from the CIR reports on PEGs, Cetearyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, and Steareths. Ceteareths were used in a total of 680 formulations in 1996. Data from 1984 indicated use at up to 50% (Ceteareth-12); recent data from one company indicated that Ceteareth-15 was used up to 10% (5% had been the maximum concentration reported in 1984). Creams containing Ceteareth-20 enhanced drug absorption. Ceteareth-15 (10% in formulation) was minimally irritating to rabbits after a single dermal exposure. In ocular studies, ethoxylated Cetearyl Alcohol solution was a severe irritant to unrinsed rabbit eyes and moderately irritating to rinsed eyes.
In clinical studies, Ceteareth-15 (1.5% in formulation) produced minimal irritation when tested in both a 4- and 21-day patch test, and was not a sensitizer when tested (1.35% in formulation) in an RIPT. Conclusion. Based on the available data, the CIR Expert Panel concludes that Ceteareth-2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -12, -13, -14, -15, -16, -17, -18, -20, -22, -23, -24, -25, -27, -28, -29, -30, -33, -34, -40, -50, -55, -60,-80, and -100 are safe as used in cosmetic formulations. Ceteareths should not be used on damaged skin.