1,4-Dioxane
What is it?
1,4-Dioxane is an impurity found in minute amounts in some cosmetic and personal care products. It is a by-product of some chemical ingredient manufacturing processes, such as the production of sodium laureth sulfate from sodium lauryl sulfate, for use in products such as shampoo, body wash and bubble bath.
1,4-Dioxane is not used as an ingredient in cosmetic products.
The International Agency for Research on Cancer (IARC) has classified 1,4-dioxane as possibly carcinogenic to humans (Group 2B), as there is inadequate evidence in humans for its carcinogenicity. IARC has found that there is sufficient evidence that 1,4-dioxane can cause cancer in experimental animals when administered at high doses orally or via injection .
What’s the myth?
It has been suggested that the fact that 1,4-dioxane can be detected at very low levels in some cosmetic and personal care product puts consumers at risk of cancer.
FACT: The mere presence of 1,4-dioxane does not mean that the product poses a health risk.
It is nonsense to talk about adverse health effects without considering the level of exposure and the route by which a substance enters the body.
For example, the alarmist news story “Toxins found in children’s shampoos”[1] reported that 1,4-dioxane was present in some of the baby products tested at levels of approximately one part per million (1 ppm). This is equivalent to 0.0001% - a very low level that poses no risk to human health.
The Canadian Health Dept has concluded that you would need to wash your baby’s hair 620 times a day, every day, to get close to a harmful level of exposure to 1,4-dioxane from baby shampoo.[2]
It should also be noted that, in addition to the very low levels of 1,4-dioxane in cosmetic and personal care products, these products are applied to the external surface of the body only, and are washed off.
And furthermore, 1,4-dioxane is poorly absorbed through the skin – a study found that only 0.3% of an applied dose of pure 1,4-dioxane was found to penetrate human skin.[3] Skin absorption studies by the US regulator using leave-on lotions also showed poor skin penetration, as well as evaporation from the skin surface.[4]
FACT: 1,4-dioxane is regulated for safety in Australia
In addition to its regulation as an industrial chemical by AICIS, the Australian Industrial Chemicals Introduction Scheme, in Australia, 1,4-dioxane is included in Schedule 6 of the Poison Standard[5]. This means that there are requirements for labelling of products that have been formulated with this ingredient. However, 1,4-dioxane is not used as an ingredient in cosmetic and personal care products in Australia.
According to the Federal Department of Health, the impurities of 1,4-dioxane present are well under the safe permissible levels.[1]
And, according to the US Food & Drug Administration, “the 1,4-dioxane levels we have seen in our monitoring of cosmetics do not present a hazard to consumers”.[4]
FACT: Manufacturers often go beyond safety requirements to meet consumer desires
Companies value highly the bond of trust they have with their customers.
This means that companies will often look into alternative ingredients or methods in order to reduce or eliminate ingredients that cause consumers concern - even in the absence of credible scientific evidence for these concerns.
Accordingly, some companies are reformulating to further reduce the trace levels of 1,4-dioxane impurities in their cosmetic and personal care products.
The bottom line: You can continue to use cosmetic and personal care products with confidence, knowing that only safe levels of substances such as 1,4-dioxane are present.
Sources
[1] “Toxins found in children’s shampoos”, March 29, 2009, Sydney Morning Herald.
[2] Canadian Cosmetic, Toiletry and Fragrance Association, The Safety/Risk Equation. www.youtube.com/watch?v=7YrNdWofE80
[3] International Agency for Research on Cancer, 1,4-Dioxane, pages 593 and 599. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-25.pdf
[4] US Food & Drug Administration, 1,4-Dioxane. www.fda.gov/Cosmetics/ProductsIngredients/PotentialContaminants/ucm101566.htm
[5] Department of Health and Ageing, Therapeutic Goods Administration, The Poisons Standard 2016. https://www.tga.gov.au/publication/poisons-standard-susmp
1,4-Dioxane is an impurity found in minute amounts in some cosmetic and personal care products. It is a by-product of some chemical ingredient manufacturing processes, such as the production of sodium laureth sulfate from sodium lauryl sulfate, for use in products such as shampoo, body wash and bubble bath.
1,4-Dioxane is not used as an ingredient in cosmetic products.
The International Agency for Research on Cancer (IARC) has classified 1,4-dioxane as possibly carcinogenic to humans (Group 2B), as there is inadequate evidence in humans for its carcinogenicity. IARC has found that there is sufficient evidence that 1,4-dioxane can cause cancer in experimental animals when administered at high doses orally or via injection .
What’s the myth?
It has been suggested that the fact that 1,4-dioxane can be detected at very low levels in some cosmetic and personal care product puts consumers at risk of cancer.
FACT: The mere presence of 1,4-dioxane does not mean that the product poses a health risk.
It is nonsense to talk about adverse health effects without considering the level of exposure and the route by which a substance enters the body.
For example, the alarmist news story “Toxins found in children’s shampoos”[1] reported that 1,4-dioxane was present in some of the baby products tested at levels of approximately one part per million (1 ppm). This is equivalent to 0.0001% - a very low level that poses no risk to human health.
The Canadian Health Dept has concluded that you would need to wash your baby’s hair 620 times a day, every day, to get close to a harmful level of exposure to 1,4-dioxane from baby shampoo.[2]
It should also be noted that, in addition to the very low levels of 1,4-dioxane in cosmetic and personal care products, these products are applied to the external surface of the body only, and are washed off.
And furthermore, 1,4-dioxane is poorly absorbed through the skin – a study found that only 0.3% of an applied dose of pure 1,4-dioxane was found to penetrate human skin.[3] Skin absorption studies by the US regulator using leave-on lotions also showed poor skin penetration, as well as evaporation from the skin surface.[4]
FACT: 1,4-dioxane is regulated for safety in Australia
In addition to its regulation as an industrial chemical by AICIS, the Australian Industrial Chemicals Introduction Scheme, in Australia, 1,4-dioxane is included in Schedule 6 of the Poison Standard[5]. This means that there are requirements for labelling of products that have been formulated with this ingredient. However, 1,4-dioxane is not used as an ingredient in cosmetic and personal care products in Australia.
According to the Federal Department of Health, the impurities of 1,4-dioxane present are well under the safe permissible levels.[1]
And, according to the US Food & Drug Administration, “the 1,4-dioxane levels we have seen in our monitoring of cosmetics do not present a hazard to consumers”.[4]
FACT: Manufacturers often go beyond safety requirements to meet consumer desires
Companies value highly the bond of trust they have with their customers.
This means that companies will often look into alternative ingredients or methods in order to reduce or eliminate ingredients that cause consumers concern - even in the absence of credible scientific evidence for these concerns.
Accordingly, some companies are reformulating to further reduce the trace levels of 1,4-dioxane impurities in their cosmetic and personal care products.
The bottom line: You can continue to use cosmetic and personal care products with confidence, knowing that only safe levels of substances such as 1,4-dioxane are present.
Sources
[1] “Toxins found in children’s shampoos”, March 29, 2009, Sydney Morning Herald.
[2] Canadian Cosmetic, Toiletry and Fragrance Association, The Safety/Risk Equation. www.youtube.com/watch?v=7YrNdWofE80
[3] International Agency for Research on Cancer, 1,4-Dioxane, pages 593 and 599. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-25.pdf
[4] US Food & Drug Administration, 1,4-Dioxane. www.fda.gov/Cosmetics/ProductsIngredients/PotentialContaminants/ucm101566.htm
[5] Department of Health and Ageing, Therapeutic Goods Administration, The Poisons Standard 2016. https://www.tga.gov.au/publication/poisons-standard-susmp