Diazolidinyl Urea

The safety of Diazolidinyl Urea has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Diazolidinyl Urea was safe as a cosmetic ingredient up to a maximum concentration of 0.5%. In 2006, as part of the scheduled re-review of ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.CIR Safety Review: The CIR Expert Panel noted that Diazolidinyl Urea was relatively non-toxic in oral subchronic studies. At 5%, Diazolidinyl Urea was not an ocular or skin irritant. In three studies of sensitzation potential, Diazolidinyl Urea was a mild sensitizer, but was not a sensitizer in a fourth study. Diazolidinyl Urea was nonmutagenic when tested in the bacteria, or in the micronucleus assay.

At concentrations up to 0.4%, Diazolidinyl Urea was a mild cumulative skin irritant in humans. It was not a sensitizer in a repeat insult patch test on nonpatient volunteers. Diazolidinyl Urea was not a photosensitizer at 0.25%.

The CIR report noted that Diazolidinyl Urea was a formaldehyde releaser. The CIR Expert Panel previously concluded that the use of formaldehyde in cosmetics and personal care products was safe to the great majority of consumers. The CIR Expert Panel concluded that there was no indication that the use of Diazolidinyl Urea cosmetics and personal care products would release formaldehyde at concentrations which would exceed their previous recommended limits for formaldehyde (0.2%).

More information about formaldehyde

Diazolidinyl Urea is listed as N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N"-(hydroxymethyl) urea in the Cosmetics Directive of the European Union (Annex VI, Part I). Diazolidinyl Urea may be used in cosmetics and personal care products at a maximum authorized concentration of 0.5% and must be labeled "contains formaldehyde" if the concentration of formaldehyde in the finished product exceeds 0.05%.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...