1,4-Dioxane Chemistry, Uses, and Occurrence - Environmental Investigation and Remediation - page 93

TABLE 2.11
FDA Analytical Survey Results for 1,4-Dioxane in U.S. Ethoxylated Raw Materials and
Finished Cosmetics

1,4-Dioxane Concentration (ppm)

Raw Ethoxylated Surfactants/Alkyl Sulfate Surfactants Finished Cosmetic Products

Year Average/Number of Analyses Range Average Range

1979 49/229 71-580 — —

1980 280/226 6-1410 — —

1981 — — 50 2-279

1982 — — 19 2-36

1983 — — 2 1-8

1991 — — — 3-108

1992 — — 41 5-141

1993 71/80 16-243 79 50-112

1994 — — 45 20-107

1995 — — 74 42-90

1996 180/188 20-653 14 6-34

1997 348/NA 45-1102 19 6-34

Sources: Food and Drug Administration (FDA), 1981, Progress report on the analysis of cosmetics raw materi-
als and i nished cosmetics products for 1,4-dioxane. Division of Cosmetics Technology, Food and
Drug Administration 15; Italia, M.P. and Nunes, M.A., 1991, Journal of the Society of Cosmetics
Chemistry 42: 97-103; Black, R.E., Hurley, F.J., and Havery, D.C., 2001, Journal of AOAC [Association
of Ofi cial Analytical Chemists] International 84(3): 666-670; and ATSDR, 2004, Draft toxicological
proi le for 1,4-dioxane. Division of Health Assessment and Consultation, U.S. Department of Health
and Human Services.
NA = not available .

The FDA conducted periodic surveys of 1,4-dioxane levels in ethoxylated raw materials; results are
summarized in Table 2.11.
Upon learning that 1,4-dioxane was a contaminant of nonionic surfactants, the U.S. Cosmetic,
Toiletry and Fragrance Association commissioned a pharmacology and toxicology committee
review of 1,4-dioxane contamination in cosmetics and concluded that the levels found are below a
“virtually safe dose.” The association nevertheless conducted a survey of suppliers of ethoxylated
products to obtain data and information on specii cations and processing. The goal was to work
toward achieving acceptable levels and controls for 1,4-dioxane and to establish a standard for 1,4-
dioxane-containing ingredients (Jass, 1989).
AES compounds and related surfactants have many varieties and many applications beyond
detergents and personal care products. Secondary alcohol ethoxylate is used in crop protection
agents, metal working and processing, textile processing, paints and coating compositions, and as a
conditioning agent for pulp and paper processing (Kosswig, 2002). 1,4-Dioxane residuals may be
present in ethoxylated C 12 -C 14 secondary alcohols, according to available MSDS. 1,4-Dioxane is
also reportedly used in the dissolution of polymers to produce a coating for laminated paper prod-
ucts (USEPA, 1996c). Soil surfactants use ethoxylated surfactant compounds to improve irrigation
of golf courses, athletic i elds, and other turf and agricultural applications. MSDS listings for some
varieties of soil surfactants note the trace presence of 1,4-dioxane.
Manufacturers of ethoxylated surfactants were challenged to both optimize surfactant produc-
tion and minimize formation of 1,4-dioxane. The amount of 1,4-dioxane formed in AES compounds
is a function of the mole ratio of sulfur trioxide fed to the reactor to the ethoxylated alcohol stock