What Is It?
5-Bromo-5-Nitro-1,3-Dioxane is a white powder. In cosmetics and personal care products, 5-Bromo-5-Nitro-1,3-Dioxane is used as a preservative in bath, hair and personal cleanliness products.
Why is it used in cosmetics and personal care products?
5-Bromo-5-Nitro-1,3-Dioxane functions as a preservative. It prevents or retards bacterial growth, and thus protects cosmetic and personal care products from spoilage. Follow this link for more information about how a preservatives protect cosmetics and personal care products.
The safety of 5-Bromo-5-Nitro-1,3-Dioxane has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that 5-Bromo-5-Nitro-1,3-Dioxane was safe as a cosmetic and personal care products ingredient at concentrations up to and including 0.1%, except under circumstances where its action with amines or amides can result in the formation of nitrosamines or nitrosamides. In 2007, as part of its regular re-review of cosmetic ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.
More safety Information:
CIR Safety Review: 5-Bromo-5-Nitro-1,3-Dioxane can be metabolized to 2-bromo-2-nitropropane-1,3-diol, a nitrosating agent, that has also been reviewed by CIR and found safe for use in cosmetic and personal care products. At concentrations of 0.5% and above, 5-Bromo-5-Nitro-1,3-Dioxane has been shown to be a skin and eye irritant but is neither a sensitizer nor a photosensitizer. This ingredient was neither mutagenic nor a developmental toxicant. Sensitization was observed in patients at 0.1% and 0.5%, but not in a study on volunteers. The CIR Expert Panel concluded that 5-Bromo-5-Nitro-1,3-Dioxane can be safely used in cosmetic and personal care products at concentrations up to and including 0.1%, except when it may react with amines and amides to form nitrosamines or nitrosamides. 5-Bromo-5-Nitro-1,3-Dioxane may be used as a preservative in rinse-off cosmetics and personal care products marketed in the Europe at concentrations up to 0.1% (see Annex VI). The formation of nitrosamines must be avoided.
Link to the EU Cosmetic Regulation:
In Canada, 5-Bromo-5-Nitro-1,3-Dioxane may be used in cosmetics and personal care products at a maximum concentraiton of 0.1%.
Llink to Health Canada website:
More Scientific Information:
The N-nitrosation potential of 5-Bromo-5-Nitro-1,3-Dioxane is similar to its metabolite, 2-bromo-2-nitropropane-1,3-diol. This link provides additional information about nitrosamines.
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/