CIR Final Report on the Safety Assessment of Ceteareth Compounds

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International Journal of Toxicology

Volume 18, Supplement 3/November 1, 1999

Pages: 41 - 49

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, -20, -22, -23,

-24, -25, -27, -28, -29, -30, -33, -34 -40, -50, -55, -60, -80, and

-100

Abstract:

Ceteareths, used in a large number of cosmetics as surfactants, are the

polyethylene glycol (PEG) ethers of Cetearyl Alcohol (q.v.). To

supplement the limited available data on Ceteareths, previous findings

from the safety assessment of Polyethylene Glycol (PEG), several fatty

alcohols (Cetearyl Alcohol, Cetyl Alcohol, and Stearyl Alcohol), and

Steareths were considered. These data indicate little evidence of

toxicity. Although various metabolites of monoalkyl ethers of ethylene

glycol are reproductive and developmental toxins, given the methods of

manufacture of Ceteareth compounds, there is no likelihood of such

compounds being present as impurities. Further, there would be only

limited ethylene glycol monomer linked by an ether group to the

Ceteareth moiety for the PEG-5 compounds, little for the PEG-10

compounds, and virtually none for the PEG-20 and higher compounds. Even

if linked to ethylene glycol monomer, it was considered unlikely that

the Ceteareth moieties would be metabolized (e.g., via beta-oxidation)

to simple methyl, ethyl, propyl, or butyl alkyl groups. As the current

data indicate, such short alkyl chains are needed in order for the

production of toxic alcohol or aldehyde dehydrogenase metabolites. For

longer alkyl chains there is evidence of diminishing toxicity, and

extrapolation to much longer chains such as expected in the Ceteareth

moieties suggests that there is no reproductive or developmental hazard

posed by these Ceteareth compounds. The principal clinical finding

related to PEGs is based on data in bum patients-PEGs were mild

irritants/sensitizers and there was evidence of nephrotoxicity. No such

effects were seen in animal studies on intact skin. Cosmetic

manufacturers should adjust product formulations containing

Polyethylene Glycol to minimize any untoward effects when products are

used on damaged skin. In the absence of specific impurities data, the

possible presence of 1,4-dioxane and ethylene oxide impurities was of

concern. The importance of using the necessary purification procedures

to remove these impurities was stressed. 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 a repeat

insult patch test. Based on the limited data on Ceteareths and the

extensive data on chemically related ingredients, it was concluded that

these ingredients are safe as used in cosmetic formulations. These

ingredients, however, should not be used on damaged skin.

Maurice

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Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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