Safety Information

The safety of 5-bromo-5-nitro-1,3-dioxane has been assessed by Expert Panel for Cosmetic Ingredient Safety. The 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 Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.

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 the Expert Panel 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 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.

In Canada, 5-bromo-5-nitro-1,3-dioxane may be used in cosmetics and personal care products at a maximum concentration of 0.1%.



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?

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 preservatives protect cosmetics and personal care products.

Scientific Facts

5-Bromo-5-nitro-1,3-dioxane is a cyclic aliphatic ether. It is also used as a preservative in water systems, paints, cutting oils and in leather processing.

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.