5-Bromo-5-Nitro-1,3-Dioxane

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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.

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.

Safety Information:

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: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

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: 
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…

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.