1,4-Dioxane Analysis

What is 1,4-dioxane?

1,4-dioxane a volatile organic compound found at residual levels as an impurity in many cosmetics, personal care products and household cleaners. It is not an intentional additive or serve a functional purpose within these products, however, it is a by-product as part of the manufacturing ethoxylation processes for some intentionally added ingredients. These ingredients may include sodium laureth sulfate, polyethylene glycol or PEG, polypropylene glycol or PPG, polyoxyethylene ether sulfate, polyethylene, polysorbate and ingredients with suffixes that include –oxynol–, –ceteareth– and –oleth–. A non-exhaustive list of consumer products where these compounds can be found include:

Why should you be concerned?

1,4-dioxane has been identified as a potential carcinogen to humans according to the International Agency for Research on Cancer (IARC) as well as the Department of Health and Human Services National Toxicology Program (NTP). A scientific opinion was published from the Scientific Committee on Consumer Safety (SCCS) in 2015 based on the report, Principles for Handling Traces in Cosmetics, published in 2011, which an ICCR working group recommended an acceptable and safe trace level to be 10 ppm in finished cosmetic products. Studies have been performed on several routes of exposure including inhalation, ingestion and dermal absorption for animals as well as in-vitro penetration of human skin and it had been determined that 1,4-dioxane rapidly and completely absorbs once inhaled and ingested. The in-vitro dermal study concluded an absorption of 3.4%, however, it evaporates quickly when exposed to an open atmosphere.

What are legislators doing about it?

California’s Office of Environmental Health Assessment (OEHHA) has listed 1,4-dioxane as a carcinogen on the California Proposition 65 list with a 30 µg/day No Significant Risk Level (NRSL). This is an exposure level for which a maximum concentration level can be calculated based on product and real life anticipated exposure assessments. Also, California’s Department of Toxic Substances Control (DTSC) identified 1,4-dioxane as a chemical of concern under the Safe Consumer Products Regulations for personal care and cleaning products. Further consideration and research will be conducted to ensure current levels found in these products are safe or if additional regulation will be needed. New York recently signed into law New York Senate Bill No. S.4389-B/A.6295-A on December 9, 2019 which limits the concentration of 1,4-dioxane in consumer products. The schedule of implementation of concentration levels for specific product categories are found below:

Why choose a Eurofins company?

Eurofins Consumer Product Testing network of laboratories use highly sophisticated instrumental techniques for analyzing impurities for trace level analysis to get the best detection limits achievable by todays technological advancements and restraints. At Eurofins Product Testing US Inc., we utilize automated multi-purpose samplers with Headspace In-Tube Extraction (ITEX) Gas Chromatography-Mass Spectrometry for our volatiles and residual solvent analyses. Please contact us today to find out more.

Chemical testing and analysis are conducted at Eurofins Product Testing US Inc. internationally accredited chemical testing laboratory based in the Greater Seattle area, which is accredited by PJLA (L18-186), ILAC and CPSC (1556) to ISO/IEC 17025 standards.

References:

(1) Montemayor, Beta, et al. Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products. ICCR, 2017, https://iccr-cosmetics.org/files/2414/8717/1555/ICCR_14-Dioxane_Final_2017.pdf

(2) SCCS (Scientific Committee on Consumer Safety), Opinion on the Report of the ICCR Working Group: Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products, 15 December 2015, SCCS/1570/15, https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_194.pdf

(3) Center for Food Safety and Applied Nutrition. “1,4-Dioxane in Cosmetics.” S. Food and Drug Administration, FDA, 29 Jan. 2019, www.fda.gov/cosmetics/potential-contaminants-cosmetics/14-dioxane-cosmetics-manufacturing-byproduct

(4) Duvall, Mark N., et al. “New York, California, and EPA Tackle 1,4-Dioxane.” The National Law Review, 16 Jan. 2020, natlawreview.com/article/new-york-california-and-epa-tackle-14-dioxane