10 Final Report on the Safety Assessment of 5-Bromo-5-Nitro-1,3-Dioxane

Abstract

5-Bromo-5-Nitro-1,3-Dioxane is used as a preservative in cosmetic products. The chemical can be metabolized to 2-bromo-2-nitropropane-1,3-diol, a nitrosating agent, whose safety of use has already been substantiated. 5-Bromo-5-Nitro-1,3-Dioxane has an LD50 of 455 mg/kg for rats and 590 mg/kg for mice. Significant skin and eye irritation was observed in animal studies at 0.5%, but not at 0.1%. The compound was neither a sensitizer nor a photosensitizer in guinea pig studies. This ingredient was neither mutagenic nor teratogenic. Sensitization was observed in clinical patients at 0.1 and 0.5%, but not in a study on nonclinical volunteers. It is concluded that 5-Bromo-5-Nitro-1,3-Dioxane can be safely used in cosmetic products at concentrations up to and including 0.1 %, except when it may react with amines and amides to form nitrosamines or nitrosamides.