Campaign For Safe Cosmetics: Myth vs. Fact: 1,4-Dioxane

Myth vs. Fact:
1,4-Dioxane (Diethylene Oxide) and Cosmetic Safety

MYTH: A small amount of a chemical carcinogen in a children’s product isn’t dangerous because the level is so low. Low doses of cancer-causing chemicals are safe because there is a threshold for cancer induction.

FACT: When experimental animals are tested at the lowest parts per billion level—over the animal’s lifetime—they develop cancer. The levels found in these children’s products are one thousand times greater and measured in parts per million. The gold standard for cancer protection widely used by federal agencies is that an isolated chemical should not be estimated to cause more than one excess cancer per one million persons. This is called a one-in-one-million risk.

However, in this case, several products’ cancer risks from exposure to 1,4-Dioxane exceed this gold standard. A strong argument can be made we are not even talking about “low levels” of 1,4-Dioxane.

Furthermore, life is a mixture. The combined effects of our lifetime exposure to dioxane and other carcinogens can create synergistic effects, so that what look like low levels for any one compound adds up and even multiplies. [1]

MYTH: Because we have no human studies we really can’t tell that this chemical is a hazard. Animal studies are irrelevant to identifying probable human carcinogens.

FACT: Because we cannot ethically test carcinogens on a human population, the World Health Organization and other groups have advised that chemicals that are found to induce cancer in rodents should be considered to cause cancer in humans.2 This sound public policy is strongly supported by subsequent findings. Roy Hertz, M.D., Ph.D., of the National Institutes of Health, noted at the First National Conference on Breast Cancer, in Washington, D.C., “It is also noteworthy that all known carcinogenic agents for man have been shown to be also carcinogenic in animals and frequently in the same site. Hence, common pathogenetic factors are clearly involved in the development of cancer in man and in animals. [3], [4]

MYTH: The contamination of products with 1,4-Dioxane is an isolated occurrence.

FACT: In fact, cosmetics contaminated with 1,4-Dioxane might also have traces of formaldehyde, nitrosamines, phthalates and other contaminants. [5] According to David Steinman, author of Safe Trip to Eden: Ten Steps to Save Planet Earth from the Global Warming Meltdown: “I can go into any store and at least half if not more than three fourths of the products with suspect ingredients will actually be found to contain a number of known and suspected carcinogens.”

MYTH: 1,4-Dioxane is a weak carcinogen.

FACT: Carcinogenic chemicals are assigned potency factors by federal regulatory agencies, particularly the federal Integrated Risk Information System (IRIS). The federal government’s cancer potency (oral slope) factor for 1,4-diethylene oxide is 0.011; this is equivalent to or greater than the oral slope factor for many pesticides considered to be dangerous to human health and whose residues are found at much lower levels in the food supply. [6]

The Environmental Protection Agency classifes 1,4-Dioxane as a “Group B2, probable human carcinogen,” based on “induction of nasal cavity and liver carcinomas in multiple strains of rats, liver carcinomas in mice, and gall bladder carcinomas in guinea pigs.” [7]

In federally funded National Toxicology Program studies, the chemical has induced cancer in both sexes of rats and both sexes of mice. [8] That is usually a telltale sign that something is amiss—two species and all sexes. “There is sufficient evidence for the carcinogenicity of 1,4-Dioxane in experimental animals,” notes the most recent Eleventh Annual Report on Carcinogens, published by the U.S. Department of Health and Human Services, National Toxicology Program, which generally lists chemicals reasonably anticipated to cause human cancer. [9]

The federal Consumer Product Safety Commission (CSPC) reports that “the presence of 1,4-Dioxane, even as a trace contaminant, is cause for concern.”

The State of California’s Environmental Protection Agency lists 1,4-Dioxane on its publicly mandated annual list of chemicals known to cause cancer or reproductive toxicity. [10]

According to the International Agency for Research on Cancer, 1,4-Dioxane is “possibly carcinogenic to humans (Group 2B).” [11]

European Union members Belgium and Germany were involved in a 2006 voluntary recall of Disney Finger Puppet Bath Theatre (set comprising shower gel, foam bath, shower and bath gel for skin and hair). The reason? “Chemical risk. This product presents a chemical risk to children because it contains 1,4 dioxane. This product does not comply with the Cosmetic Directive.” [12]

According to the New Jersey Department of Health and Senior Services 1,4-Dioxane “should be handled as a CARCINOGEN—WITH EXTREME CAUTION.” [13]

According to a California state health official’s memorandum 1,4-Dioxane “is readily adsorbed through the lungs, skin and gastrointestinal tract of mammals.” [14]

In fact, because dioxane causes cancer in animals, workers in both California and New Jersey and other states have a right to take commonsense protections. One of these is to be informed they are handling or exposed to a cancer-causing chemical. But when it comes to our homemakers, caregivers and children who are exposed regularly if not daily to this chemical and without protective gear—in fact, their skin is made even more permeable by the very nature of bathing and shampooing—manufactures are not required by law to label it as a carcinogen due to federal regulatory loopholes in the Food Drug and Cosmetic Act. Ironically, the very method of its use with our children, where detergents and warm water of the bath or shampoo, enhances penetration and absorption in the skin.

MYTH: We are protected, thanks to the FDA, which has established a recommended level of no more than 10 parts per million in consumer products.

FACT: A September 2004 Public Health Statement from the U.S. Toxic Substances and Disease Registry, accessed online prior to the release of our test results on baby products in February 2007, stated: "In 1985, the Food and Drug Administration (FDA) requested that manufacturers limit the level of 1,4 dioxane in cosmetic products to levels not greater than 10 milligrams of 1,4 dioxane per kilogram of product (10 mg/kg or 10 ppm)."

However, after the release of these test results, the FDA said it had no recommended limit for 1,4-Dioxane in cosmetics. The Public Health Statement was updated in September 2007, without reference to the 10 ppm limit for cosmetics—and without explanation as to why it's acceptable for cosmetics to contain a known carcinogen. Today, the FDA only limits 1,4-Dioxane in a spermicide in contraceptive sponge products, and in certain components of dietary supplements, both at a level of 10 ppm.

So what does the new statement say about children? It acknowledges that no data is available on the effects of 1,4-Dioxane on children or unborn babies. In a sorely lacking effort at protection, "FDA issued a regulation that the label of foaming detergent bath products, except for those labeled as intended for use exclusively by adults, bear adequate directions for safe use and the following caution: 'Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of the reach of children.' In the case of products intended for children’s use, the phrase 'except under adult supervision' may be added (FDA 1986)."

But since FDA limits are only voluntary, if there were a limit for cosmetics it would not be enforced. Safe Trip to Eden: Ten Steps to Save Planet Earth from the Global Warming Meltdown and additional studies after the book was published show around 15 percent of products sampled exceed 10 ppm.

What’s more, the work commissioned on behalf of the book demonstrated that even products falling within the FDA guidelines would produce a cancer risk exceeding one excess cancer per one million people, which is significant for public healthy policy standard. One product could theoretically lead to 970 excess cancers in one million according to a risk calculation performed using guidelines from the State of California under the Safe Drinking Water and Toxic Enforcement Act of 1986. Even if this were off by a factor of ten the risk would still be 97 excess cancers, and this remains noteworthy—especially for a cosmetic product.

This calls into question the FDA guidelines—especially given the fact that 1,4-Dioxane is not a functional chemical in products and that the cost of removing it completely from raw materials is extremely minimal.

MYTH: 1,4-Dioxane poorly absorbed through the skin.

FACT: One study cited by industry uses non-occluded Rhesus monkey skin to test absorption and found absorption of four percent or less. According to a California state health official’s memorandum 1,4-Dioxane “is readily adsorbed through the lungs, skin and gastrointestinal tract of mammals.” [15] The FDA has stated that although dioxane in a lotion vehicle may escape into the air, “Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles.”

In real life, however, a child’s skin is completely occluded, warmed, pores opened, and then soaked in the contaminated water and likely to breathe in what escapes to the air of the enclosed area. The same could be said for adults who use such products in showers where inhalation could be significant. In addition, skin is a far more efficient route of absorbing some chemicals since they enter the bloodstream and do not go through the digestive process where they could bind to fiber and other natural transport nutrients and be removed from the food.

MYTH: Cosmetics are regulated.

FACT: No pre-market safety testing is required. Industry is allowed to review the safety of its own product ingredients by funding scientific review boards comprised of doctors and toxicologists it selects. Once a product is on the market, the burden of legal proof required for its removal is extremely high. Since cancer and birth defects are often latent occurrences it is difficult if not impossible to prove causation in the judicial system, and it is nearly impossible to remove a potentially dangerous product.

MYTH: Cancer rates are going down.

FACT: Patterns of cancer remain unexplained. Deaths from all cancers are declining. This is because fewer people are smoking and more are getting screened for colo-rectal cancer. But, a number of specific types of cancer have continued to increase, including non-Hodgkin’s lymphoma and childhood cancer. Childhood cancer is the second largest cause of death to children ages 0-15 in the United States (second only to accidents), and more than 8,000 cases are diagnosed each year. While improvements in treatment have reduced deaths from childhood cancer, incidence rates increased nearly 21% between 1975 and 1998—approximately 1% each year, [16] and have continued to increase up to 2003. This is due not to improved detection or smoking or an aging population but to real environmental influences.

The American Cancer Society reports that African-American men and women have 40% and 20% higher death rates from all cancers combined compared with whites. The use of hormone-containing personal care products may lay behind the fact that young African American women get more breast cancer than do their white counterparts and African American women of all ages fare more poorly once they have the disease.

MYTH: Most cancers are genetic in nature and there’s little we can do to protect ourselves.

FACT: In fact, an expert panel convened by Mt. Sinai Hospital recently concluded that genetic predisposition accounts for no more than 20% of all childhood cancers and that the environmental attributable fraction of childhood cancer could be between 5% and 90%, depending on the type of cancer. [17] This means that a potentially large percentage of childhood cancers are preventable.

One study of pesticide exposures testifies to the detrimental effects of toxic chemicals on children’s health, specifically in relation to cancers. In this study, children with leukemia were 4 to 7 times as likely to have been exposed to pesticides used in the yard or garden compared to children without the disease. Another study found that children with leukemia were 11 times as likely to have mothers who were exposed to pesticide sprays or foggers during pregnancy compared to healthy children. A report released by the Lowell Center for Sustainable Production concluded that instituting measures to reduce parental and childhood exposures to these and other substances suspected of causing cancer, including development of safer substitutes, should play an important role in a cancer prevention strategy. [18]

MYTH: It is good public policy to allow the cosmetic and personal care product industry to continue to sell contaminated products because it helps the companies to profit and sell their products more cheaply.

FACT: Sound public policy doesn’t make exceptions for one chemical carcinogen because of its alleged low dose and so that private industry can make more profits and people can get their children’s bubble baths for a few cents. (Besides, as the FDA itself says, the cost to greatly reduce 1,4-Dioxane is minimal.) [19]

MYTH: But cleaning up these chemicals could cost companies a lot of money!

FACT: In this case, it probably won’t. The cost of vacuum stripping out this chemical carcinogen is extremely low, and the raw materials are readily available. [20]

Included in the fastest growing categories in consumer retail are green and organic products including cosmetics, personal care, and household products. Companies that can guarantee greater product purity can use this as a powerful positive marketing tool. For companies with this chemical carcinogen in their products, we urge them to acknowledge it and not fight it because that battle is lost. Companies should commit to do better and promise a pure product and remove it and use that in their marketing.

MYTH: All activists do is scare people.

FACT: In truth, this is democracy at its best. By supplying information to citizens, an informed citizenry can use this information and based on their own values make informed decisions. Such behavior, as reflected in the way consumers choose to spend their money, often creates new markets, improves technologies, and expands opportunity for all. Although some members of the food and agriculture industries have consistently cried foul and Steinman himself has been branded a “domestic food terrorist” by industry-funded groups, the truth is that thanks to work like this, new markets were created and some of the fastest growth segments today in food include the organic categories. This has fostered support for smaller family farms and ranches, which support the backbone of American agriculture.

This has to do with everything good for America and what America needs now is a strong dose of activism. There’s an important message in all of this. We need great investigative reporters bringing light to dark areas. Many times this public knowledge leads to really good outcomes. In this case, with new knowledge about the contamination of bubble bath products and shampoos, new markets will be created and new consumer segments enhanced. This will allow more companies to enter the marketplace and help to democratize the market.

But this will also help the big companies too who are seeking ways to extend their brand. There is no reason why a Fortune 500 personal care product company cannot join the Green revolution and be a “Green Patriot,” in Steinman’s words. Many large cosmetics companies have refused to sign the Compact for Safe Cosmetics, a pledge to replace ingredients known or suspected to cause cancer, birth defects or other serious health problems with safer alternatives.

This is not about fear. It is about knowledge and thinking of what is possible and how much better we can be as individuals, corporations, and a nation. All of us do better and the net result is not only improved public health but new markets and improved standards. The consumer dollar is a powerful and effective way of voting. People can direct their dollars to better products and create more markets and more opportunity.

Shedding light on the chemical contamination that the industry refused to acknowledge will lead to improvements in public health and product quality. Should consumers fear a little bit of this carcinogen? In the end that is a personal decision. But many will indeed switch their shopping dollars to safer products if only as a means of ensuring they are doing everything possible to raise healthy children and keep themselves healthy—and because this is a real carcinogen. It is not a play thing or inconsequential. So perhaps people should stop using these products and switch to safer brands—if only to send a message to businesses to adopt higher standards.

References

[1] Reif, A.E. “Synergism in carcinogenesis.” J Natl Cancer Institute, 1984 Jul;73(1): 25-39.

[2] Fitzhugh, O.G., et al. “Chronic oral toxicity of aldrin and dieldrin in rats and dogs.” Fd. Cosmet. Toxicol., 1964; 2: 551-562; Walker A.I.T., et al. “The toxicology and pharmacocdynamics of dieldrin: two year oral exposure of rats and dogs,” Toxicol. Appl. Pharmacol., 1960; 15: 345-373; National Cancer Institute, Bioassay of Chlordane for Possible Carcinogenicity, Carcinogenesis Technical Report Series No. 8, 1977; Japanese Research Institute for Animal Science and Biochemistry and Toxicology, Thirty Month Chronic Toxicity and Tumorigenicity Tests in Rats with Chlordane Technical, Confidential Report to Velsicol Chemical Co., December 1983.

[3] Hertz, R. “The problem of possible effects of oral contraceptives on cancer of the breast.” Cancer, December 1969: 1140-1145.

[4] Hertz, R. “The estrogen-cancer hypothesis with special emphasis on DES.” In Origins of Human Cancer, edited by H.H. Hiatt, J.D. Watson, and J.A. Winston, pp. 1665-1682. Vol. 4 of Cold Spring Harbor Conference on Cell Proliferation. Cold Spring Harbor Laboratory, 1977.

[5] Steinman, D. & Epstein, S. The Safe Shopper’s Bible. New York, NY: Macmillan, 1995, pp. 190-196.

[6] “1,4-Dioxane (1,4-Diethyleneoxide). Hazard Summary-Created in April 1992; Revised in January 2000.” Viewed at: http://www.epa.gov/ttn/atw/hlthef/dioxane.html. Compare with oral slope factor for another probable human carcinogen, captan: “Captan. Hazard Summary-Created in April 1992; Revised in January 2000.” Viewed at: http://www.epa.gov/ttnatw01/hlthef/captan.html.

[7] “1,4-Dioxane (1,4-Diethyleneoxide). Hazard Summary—Created in April 1992; Revised in January 2000.” U.S. Environmental Protection Agency. Viewed at: http://www.epa.gov/ttn/atw/hlthef/dioxane.html.

[8] “Bioassay of 1,4-Dioxane for possible carcinogenicity (CAS No. 123-91-1).” National Toxicology Program, TR-80.

[9] Report on Carcinogens, op cit.

[10] “Chemicals Known to the State to Cause Cancer or Reproductive Toxicity.” December 8, 2006. Viewed at: http://www.oehha.ca.gov/prop65/prop65_list/files/P65single120806.pdf.

[11] “1,4-Dioxane (Group 2B).” International Agency for Research on Cancer. Volume 71, 1999: 589.

[12] Viewed at: http://ec.europa.eu/consumers/dyna/rapex/create_rapex.cfm?rx_id=99.

[13] “Hazardous Substance Fact Sheet.” New Jersey Department of Health and Senior Services. Viewed at: http://www.state.nj.us/health/eoh/rtkweb/0789.pdf.

[14] Spath, D.P. “1,4-Dioxane Action Level.” March 24, 1998. Memorandum from Spath, Chief of the Division of Drinking Water and Environmental Management, Department of Health Services, 601 North 7th Street, Sacramento, California 95814 to George Alexeeff, Deputy Director for Scientific Affairs, Office of Environmental Health Hazard Assessment. Viewed at: http://www.oehha.ca.gov/water/pals/pdf/PAL14DIOXAN.pdf.

[15] Spath, D.P., op cit.

[16] Gouveia-Vigeant, T. & Tickner, J. “Toxic chemicals and childhood cancer: A review of the evidence.” Lowell Center for Sustainable Production, University of Massachusetts Lowell, One University Avenue, Lowell, Massachusetts 01854. Viewed at: http://www.sustainableproduction.org/downloads/Child%20Canc%20Exec%20Summary.pdf.

[17] Ibid.

[18] Ibid.

[19] U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, FDA/IAS* Booklet: 1992 Cosmetic Handbook. Viewed at: http://www.cfsan.fda.gov/~dms/cos-hdb3.html.

[20] Cosmetic Handbook, op cit.