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Occurrence of 1,4-dioxane in cosmetic raw materials and finished cosmetic products

R E Black1, F J Hurley, D C Havery

  • 1US Food and Drug Administration, Washington, DC 20204, USA.

Journal of AOAC International
|June 22, 2001
PubMed

Insights

The U.S. FDA monitors the carcinogen 1,4-dioxane in cosmetics. Analysis found 1,4-dioxane in raw materials and products, necessitating ongoing safety assessments.

Area of Science:

  • Cosmetic Science
  • Analytical Chemistry
  • Toxicology

Background:

  • The U.S. Food and Drug Administration (FDA) has a long history of monitoring cosmetic products for contaminants.
  • 1,4-Dioxane is a known carcinogen that can be present in ethoxylated cosmetic ingredients and finished products.

Purpose of the Study:

  • To describe analytical methods for detecting 1,4-dioxane in cosmetic raw materials and finished products.
  • To report the levels of 1,4-dioxane found in these products.

Main Methods:

  • Azeotropic atmospheric distillation followed by gas chromatography with n-butanol as an internal standard.
  • Solid-phase extraction method adapted for cosmetic finished products.

Main Results:

  • 1,4-Dioxane was detected in ethoxylated raw materials at concentrations up to 1410 ppm.
  • Levels of 1,4-dioxane in finished cosmetic products reached up to 279 ppm.
  • Children's shampoos showed levels exceeding 85 ppm.

Conclusions:

  • The presence of 1,4-dioxane in cosmetic products, particularly children's shampoos, warrants continued monitoring.
  • Established analytical methods are effective for quantifying 1,4-dioxane in cosmetic matrices.
  • Regulatory oversight is crucial for ensuring consumer safety regarding carcinogenic contaminants in cosmetics.

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