Notice to the Reader: ATSDR Toxicological Profile for 1,4-Dioxane
Issued: April 2007
The Agency for Toxic Substances and Disease Registry (ATSDR) issued a final Toxicological Profile for 1,4-Dioxane in July, 2006. This document referred to an FDA recommended limit for 1,4-dioxane in cosmetic products of 10 mg/kg (10 ppm).
In February, 2007, ATSDR was informed by the Director of the Food and Drug Administration’s (FDA) Office of Cosmetics and Colors, that an error was present in the Public Health Statement of the toxicological profile. The FDA pointed out to ATSDR that FDA had not recommended a limit for 1,4-dioxane in cosmetic products.
ATSDR’s mention of an FDA recommended level for 1,4-dioxane in cosmetic products appears in three places in the Toxicological Profile for 1,4-Dioxane issued in July, 2006, and should be deleted from each place:
- Chapter 1 (Public Health Statement), section 1.3, appearing on page 3 of the printed document;
- Chapter 1 (Public Health Statement), section 1.7, appearing on page 6 of the printed document;
- Chapter 2 (Relevance to Public Health), section 2.1, appearing on page 11 of the printed document.
References to an FDA recommended level for 1,4-dioxane in cosmetic products should also be removed from the ToxFAQs™ for 1,4-dioxane that accompanies the toxicological profile.
1,4-Dioxane may be found as a contaminant of certain ingredients found in cosmetics, detergents, and shampoos. The listed ingredients on the product label that may have 1,4 dioxane as a contaminant include:
- PEG
- polyethylene
- polyethylene glycol
- polyoxyethylene
There is evidence that 1,4-dioxane is absorbed through the skin, through inhalation, and through ingestion. As noted in the Toxicological Profile, this is a health concern because 1,4-dioxane has been associated with cancer in animals and with other adverse health effects. Families wishing to avoid exposure to 1,4-dioxane can choose cosmetic products that do not contain the ingredients listed above.
For additional information you may contact:
Division of Toxicology and Environmental Medicine
Agency for Toxic Substances and Disease Registry
1600 Clifton Road NE, MS F-32
Atlanta, GA 30333