APPENDIX DHEALTH ADVISORY
Health Advisory - An Overview for the Public
1,4-Dioxane
August 2007
Why is 1,4-dioxane currently a potential health concern?
View in own window
| Conflicting reports regarding 1,4-dioxane exposure from use of some bath and cosmetic products | Recent reports in the media about 1,4-dioxane contamination of children’s bath products prompted ATSDR to reexamine its recommendations to families on reducing risks of exposure to 1,4-dioxane. Note: The acute effects described in this document are not likely to occur at concentrations of 1,4-dioxane that are normally found in the U.S. environment. |
Why has the Agency for Toxic Substances and Disease Registry (ATSDR) provided this health advisory for 1,4-dioxane?
View in own window
| ATSDR provides trusted health information to the public | ATSDR’s mission is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related exposures to toxic substances. |
What is 1,4-dioxane?
View in own window
| 1,4-Dioxane is used in manufacturing and in household products | 1,4-Dioxane (also called dioxane) is produced in large amounts (between 10 million and 18 million pounds in 1990) by three companies in the United States. Companies use dioxane:
for a solvent for paper, cotton, and textile processing for chemical manufacturing, and in automotive coolant liquid.
|
How are people exposed to 1,4-dioxane?
View in own window
| Transmission through inhalation, ingestion, or skin contact | 1,4-Dioxane enters the body when people breathe air or consume water or food contaminated with 1,4-dioxane. People can also be exposed following contact with cosmetics, shampoo, or bubble bath that contain certain ingredients in which 1,4-dioxane may be a contaminant. 1,4-Dioxane does not remain in the body because it breaks down into chemicals that are removed quickly. |
Where is 1,4-dioxane found ?
View in own window
| Food | Traces of 1,4-dioxane can be ingested from:
|
| Ground Water | A few communities’ water supplies are contaminated with 1,4-dioxane. Information on the concentrations of 1,4-dioxane in groundwater, surface waters and drinking water are limited. |
| Household products | 1,4-Dioxane may be present as a trace contaminant in household products such as:
|
| Industrial solvents | 1,4-Dioxane is primarily used as an industrial solvent in several manufacturing processes. |
| Spermicidal agents | 1,4-Dioxane is found in some over-the-counter spermicidal sponges. |
What are the health effects of 1,4-dioxane exposure?
Effects of 1,4-dioxane on human health and the environment depend on how much 1,4-dioxane is present and the length and frequency of exposures. Note: The acute effects described below are not likely to occur at concentrations of 1,4-dioxane that are normally found in the U.S. environment.
View in own window
| Short-term exposure to 1,4-dioxane |
Breathing: 1,4-Dioxane for short periods of time causes irritation of the eyes, nose and throat in humans. Exposure to large amounts of 1,4-dioxane can cause kidney and liver damage. Accidental worker exposure to large amounts of 1,4-dioxane has resulted in several deaths. Symptoms associated with these industrial deaths suggest 1,4-dioxane causes adverse nervous system effects.
|
| Long-term exposure to 1,4-dioxane |
Animal studies: Laboratory studies show that repeated exposure to large amounts of 1,4-dioxane in drinking water, in air, or on the skin causes liver and kidney damage in animals Laboratory studies also show that oral exposure to 1,4-dioxane over a lifetime causes cancer in animals. Skin exposure of animals to 1,4-dioxane has shown that it can increase the cancer-causing properties of other chemicals. Human studies: There is little specific information regarding the non-cancer outcomes in workers following repeatedly breathing small amounts of 1,4-dioxane over long periods of time. Cancer classifications: (based on inadequate evidence in humans and sufficient evidence in animals):
|
| Reproductive health/infants and 1,4-dioxane |
Miscarriage and stillbirths: There are studies that show elevated rates of spontaneous abortion and stillbirths associated with occupational exposure to a combination of chemicals that included 1,4-dioxane, but the role of 1,4-dioxane, if any, is unknown. Breast milk transfer: A nursing mother exposed to a high amount of 1,4-dioxane might pass it to the infant through her breast milk. This concern is based on scientific models, not on actual data from the breast milk of women exposed to 1,4-dioxane.
|
Is there a medical test to show whether I've been exposed to 1,4-dioxane?
View in own window
| 1,4-Dioxane and its breakdown products can be measured in your blood and urine | 1,4-Dioxane and its breakdown products can be measured in your blood and urine, and positive results indicate you have been exposed to 1,4-dioxane. The tests are not routinely available at your doctor’s office because they require special equipment, but the doctor can collect the samples and send them to a special laboratory. The tests need to be conducted within days after the exposure because 1,4-dioxane and its breakdown products leave the body fairly rapidly. These tests do not predict whether exposure to 1,4-dioxane will produce harmful health effects. |
What levels of 1,4-dioxane are considered acceptable by regulatory agencies?
View in own window
| 1,4-Dioxane levels in food set by the Food and Drug Administration (FDA) |
The National Academy of Sciences (NAS) specified a maximum limit of 10 ppm (parts per million) for 1,4-dioxane in the ingredient polysorbate, a food additive ( NAS 2003). FDA also set a limit on 1,4-dioxane at 10 ppm in approving glycerides and polyglycerides in products such as dietary supplements. This regulation is located at 21 CFR 172.736. The FDA regulation for 1,4-dioxane as an indirect food additive is also 10 ppm and refers to its use as an adhesive component in packaging material.
|
| 1,4-Dioxane levels in cosmetics-voluntary cooperation |
FDA’s regulatory legal authority over the cosmetics is different from other products regulated by the agency such as drugs, biologics, and medical devices. Consequently, FDA must rely, in part, on voluntary industry cooperation. Whereas the press has recently reported that FDA recommends 10 ppm for 1,4-dioxane in cosmetic products, the FDA does not have a recommendation for 1,4-dioxane in cosmetic products.
|
| 1,4-Dioxane levels in ground water |
The Environmental Protection Agency (EPA) recommends that the levels of 1,4-dioxane in drinking water that children drink for 1 day not exceed 4 milligrams per liter (mg/L) or 0.4 mg/L, if they drink water for 10 days. However, EPA has not established a federal drinking water standard (maximum contaminant level or MCL).
|
What do studies show about the levels of 1,4-dioxane in shampoos and bubble baths?
Note: Much of the information in this section is from: Black RE, Hurley FJ, Havery DC. 2001. Occurrence of 1,4-dioxane in cosmetic raw materials and finished cosmetic products. J AOAC Int 84(3):666–670.
View in own window
| 1979: 1,4-Dioxane identified in raw materials used in the manufacture of cosmetic products | In 1979–1980, the FDA urged the cosmetic industry to monitor their raw materials for 1,4-dioxane. |
| 1980s-Downward trend in levels of 1,4-dioxane. | The results of surveys suggested a downward trend in the levels of 1,4-dioxane in cosmetic finished products analyzed between 1981 and 1984. Changes in the manufacturing process may be responsible for the apparent trend. FDA surveys were then suspended in 1984 but were resumed in 1992. |
| 1990s-Levels increase | Ninety-nine products were analyzed between 1992 and 1997. The products analyzed since 1994 focused on children’s shampoos because the process used in their manufacturing was linked to 1,4-dioxane. The downward trend in the levels of 1,4-dioxane previously observed in products analyzed in the 1980s was no longer evident in the products analyzed in the 1990s. Of particular concern were levels of 1,4-dioxane observed in children’s shampoos analyzed in 1994/95 manufactured by two companies. 1,4-Dioxane was frequently present at levels in excess of 85 ppm. |
Can high levels of 1–4-dioxane be avoided in cosmetics, bath products and shampoos?
View in own window
| High levels can be avoided | The low levels of 1,4-dioxane observed in some raw materials and finished products demonstrate that with current technology, excessive levels of 1,4-dioxane are avoidable. Continued periodic monitoring of cosmetic ingredients and cosmetic finished products for the presence of 1,4-dioxane is necessary. |
What can I do to ensure that my family is not exposed to 1,4-dioxane?
View in own window
| Check ingredients listed on product packaging | Given the expanding range of consumer products that may contain 1,4-dioxane as a contaminant, families should exercise caution in selecting products that do not clearly specify the ingredients that contain 1,4-dioxane. |
| The ingredients that may be listed on cosmetics, detergents, and shampoos include:
|
| These ingredients are most likely to contain 1,4-dioxane. |
Atlanta Journal and Constitution. 2007. Chemical in bath product for children raises alarms. By Carlene Olsen colsen@coxnews.com. Atlanta Journal and Constitution, February 12, 2007.
ATSDR. 1986. Health Consultation on Gelman Sciences, Ann Arbor, Michigan. Written communication (May 22) to Louise A. Fabinski, Public Health Advisor, EPA Region V, Chicago, IL from Jeffrey A. Lybarger, M.D., Acting Director, Office of Health Assessment. Atlanta, GA: U.S. Department of Health and Human Services. Public Health Service. Agency for Toxic Substances and Disease Registry,.
ATSDR. 1989. Written communication (September 14) to Raj M. Wiener, Director, Michigan Department of Public Health, Lansing, MI from Barry L. Johnson, Ph.D., Assistant Administrator. Atlanta, GA: U.S. Department of Health and Human Services. Public Health Service Agency for Toxic Substances and Disease Registry.
ATSDR. 1994. Chemical specific health consultation for 1,4-Dioxane. Atlanta, GA: U.S. Department of Health and Human Services. Public Health Service. Agency for Toxic Substances and Disease Registry.
ATSDR. 2007. Toxicological Profile for 1,4-Dioxane. U.S. Department of Health and Human Services. Public Health Service. Atlanta, GA: Agency for Toxic Substances and Disease Registry.
Black RE, Hurley FJ, Havery DC. Occurrence of 1,4-dioxane in cosmetic raw materials and finished cosmetic products.
J AOAC Int. 2001;84:666–670. [
PubMed: 11417628]
Cosmetic Handbook. 1992. U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. FDA/IAS Booklet: 1992.
DeRosa CT, Wilbur S, Holler J, et al. Health evaluation of 1,4-dioxane.
Toxicol Ind Health. 1996;12:1–43. [
PubMed: 8713712]
Environment News Service. 2007. Cosmetics industry approves controversial chemicals. By Cat Lazaroff. Environment News Service, February 14, 2007.
FDA. Indirect food additives: Adhesives and components of coatings. Food and Drug Administration. Fed Regist. 1998. pp. 56786–56789.
NAS. Food chemicals codex. 5th ed. Washington, DC: National Academy of Sciences; 2003. Polysorbate 20; pp. 346–347.
