Use restrictions (high), Non-reproductive organ system toxicity (high), and Irritation (skin, eyes, or lungs) (high)
The carcinogen 1,4-dioxane contaminates up to 46% of personal care products tested (OCA 2008, EWG 2008). The chemical is an unwanted byproduct of an ingredient processing method called ethoxylation used to reduce the risk of skin irritation for petroleum-based ingredients. Though 1,4-dioxane can easily be removed from products before they are sold, its widespread presence in products indicates that many manufacturers fail to take this simple step.<br /><br />In 2001, FDA scientists detected the carcinogenic impurity 1,4-dioxane at levels up to 1410 parts per million (ppm) in cosmetic raw materials, and at levels up to 279 ppm in personal care products (Black 2001). Testing data suggested significant cause for concern: 'Levels of 1,4-dioxane in excess of 85 ppm in children's shampoos indicate that continued monitoring of raw materials and finished products is warranted' (Black 2001). The federal agency responsible for the safety of consumer goods, the Consumer Product Safety Commission (CPSC), agreed that the presence of 1,4- dioxane, even as a trace contaminant, is cause for concern (NTP 2005). <br /><br />The Agency for Toxic Substances and Disease Registry (ATSDR) has found that many products on the market today contain 1,4-dioxane, and some body care products may contain 1,4-dioxane at levels higher than recommended by FDA for other types of products (ATSDR 2007). ATSDR recommends limiting children’s exposure to consumer products that may contain this carcinogenic impurity:<br /><br />Families wishing to avoid cosmetics containing the ingredients listed above may do so by reviewing the ingredient statement that is required to appear on the outer container label of cosmetics offered for retail sale. Also, families may look for cautionary statements on the labels of foaming detergent bath products with directions for safe use, the need to keep out of the reach of children, or the need for adult supervision. — ATSDR 2007<br /><br />A consumer can identify products that may contain 1,4-dioxane by scanning ingredient lists for the common ingredients that may contain the impurity, identifiable by the prefix or designations of 'PEG,' '–eth–,' 'Polyethylene,' 'Polyethylene glycol' 'Polyoxyethylene,' or '–oxynol–' (FDA 2007).<br /><br />The U.S. National Toxicology Program has concluded that 1,4-dioxane is 'reasonably anticipated to be a human carcinogen' based on numerous animal studies (NTP 2005). IARC classifies 1,4-dioxane as 'possibly carcinogenic to humans' (IARC 1999), and the U.S. Environmental Protection Agency (EPA) considers 1,4-dioxane a probable human carcinogen (EPA 2003). Exposures to this impurity are linked to tumors of the liver, gallbladder, nasal cavity, lung, skin, and breast (IARC 1999; NTP 2005). Presence of 1,4-dioxane in cosmetics is of special concern, since it can be absorbed through the skin in toxic amounts. <br /><br />In a review conducted in 1982, the industry-funded Cosmetic Ingredient Review panel noted that the cosmetic industry was aware of the problem of 1,4-dioxane in cosmetics and was making an effort to reduce or remove the impurity (CIR 2006). But decades later, FDA expresses continuing concerns about 1,4-dioxane, noting its potential to contaminate a wide range of products, and its ready penetration through the skin (FDA 2007). FDA notes that 1,4-dioxane can be removed 'by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost' (FDA 2007), but such treatment would be voluntary on the part of industry.<br /><br />It is clear from an examination of ingredient assessments published by the Cosmetic Ingredient Review that this industry panel routinely approves ingredients in the absence of impurity data. In a review of a large class of ingredients called ceteareths, for example, the panel stressed 'the importance of purification procedures to remove... impurities' noting that '...in the absence of impurities data, the Panel caution[s] that a Ceteareth preparation should not contain 1,4-dioxane or ethylene oxide which are possible oxidation products' (CIR 2006). FDA exhibits the same toothless concern regarding 1,4-dioxane in body care products, refusing to establish purity standards for this carcinogen despite awareness of broad-scale contamination.<br /><br />ATSDR (Agency for Toxic Substances and Disease Registry). 2007. Public Health Statement for 1,4 Dioxane Available: http://www.atsdr.cdc.gov/toxprofiles/phs187.html [accessed April 16 2008].<br /><br />Black RE, Hurley FJ, Havery DC. 2001. Occurrence of 1,4-dioxane in cosmetic raw materials and finished cosmetic products. Journal of AOAC International 84(3): 666-670.<br /><br />CIR (Cosmetics Ingredient Review). 2006. 2006 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.<br /><br />EPA (Environmental Protection Agency). 2003. 1,4-Dioxane (CASRN 123-91-1). Integrated Risk Information System. Available: http://www.epa.gov/IRIS/subst/0326.htm.<br /><br />EWG (Environmental Working Group). 2008. EWG Research Shows 22 Percent of All Cosmetics May Be Contaminated With Cancer-Causing Impurity. Available: http://www.ewg.org/node/21286.<br /><br />FDA (Food and Drug Administration). 2007. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors: 1,4-Dioxane. Available: http://www.cfsan.fda.gov/~dms/cosdiox.html [accessed April 17, 2008].<br /><br />IARC (International Agency for Research on Carcinogens). 1999. 1,4-Dioxane. IARC monographs on the evaluation of carcinogenic risks to humans / World Health Organization, International Agency for Research on Cancer 71 Pt 2: 589-602.<br /><br />NTP (National Toxicology Program). 2005. National Toxicology Panel 11th Report on Carcinogens: 1,4-Dioxane. Available: http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s080diox.pdf [Accessed April 16, 2008].<br /><br />OCA (Organic Consumer Association). 2008. Consumer alert. Cancer-causing 1,4-dioxane found in personal care products misleadingly branded as natural and organic. Available: http://www.organicconsumers.org/bodycare/DioxaneRelease08.cfm [accessed March 14, 2008].
1,4-DIOXANE
