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non-mutagenic when tested in the Ames test

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Diazolidinylurea was mildly toxic to rats in acute oral studies but was relatively nontoxic in subchronic studies. At 5%, diazolidinyl urea was not an ocular or skin irritant to rabbits. Diazolidinyl urea was a mild sensitizer in guinea pigs in three studies using a maximizing procedure bu

Diazolidinyl urea, a heterocyclic substituted urea, is used as a preservative in various cosmetic products at concentrations of 0.2 to 0.4% and up to 1.0% in normal products.
Diazolidinylurea was mildly toxic to rats in acute oral studies but was relatively nontoxic in subchronic studies. At 5%, diazolidinyl urea was not an ocular or skin irritant to rabbits. Diazolidinyl urea was a mild sensitizer in guinea pigs in three studies using a maximizing procedure but not in a fourth study using a non-maximizing procedure.
Diazolidinyl urea was non-mutagenic when tested in the Ames test or the micronucleus test.
Diazolidinyl urea is a mild cumulative skin irritant in humans at concentrations up to 0.4%. In RIPT studies in non-patient volunteers, In was not a sensitizer. Hypersensitivity reactions to diazolidinyl urea 1.0% were reported in 57 of 2385 patients. It is not a photosensitizer at 0.25%.
The report pointed out that diazolidinyl urea is a formaldehyde releasing agent. It has been previously concluded that the use of formaldehyde in cosmetics is safe for the vast majority of consumers. There is no indication that the use of diazolidinyl urea in cosmetics releases formaldehyde in concentrations above the recommended limit for formaldehyde. The report concluded that diazolidinyl urea can be safely used in cosmetics at a minimum effective concentration of no more than 0.5%.
Diazolidinyl Urea is a fine white powder with a slight characteristic odour. It is soluble in water and insoluble in fat. Diazolidinyl urea has a nitrogen content of 19% to 21%, a maximum loss on drying of 3%, a maximum residue on ignition of 3%, and a maximum heavy metal concentration of 10 ppm^.

Diazolidinyl Urea is prepared from the reaction of the wallantoin and formaldehyde. The allantoin is treated with 37% formaldehyde and 10% Natural sodium to form Diazolidinyl Urea.”
Diazolidinyl urea is compatible with most cosmetic ingredients. It is not inactivated by anionic, cationic or nonionic surfactants or proteins. (6)
Formaldehyde release from diazolidinyl urea in proteinaceous and non-proteinaceous shampoos was studied. Diazolidinyl urea was added at concentrations of 0.1, 0.2, 0.4 and 0.8% to anionic shampoos with and without protein. Measure the amount of formaldehyde at 23 and 60 °C.

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