Experimental elicitation of contact allergy from a diazolidinyl urea-preserved cream in relation to anatomical region, exposure time and concentration

The elicitation potential of the cosmetic preservative diazolidinyl urea was studied in formaldehyde- and diazolidinyl urea-sensitized volunteer patients using a stepwise controlled exposure design. The test product was a facial moisturizer, preserved with varying concentrations of diazolidinyl urea, ranging from 0.05% to 0.6%. A repeated open application-like exposure test was performed on volunteers and a control group with the test product containing increasing preservative concentrations, on arm, neck and face, sequentially, for 2 weeks or until dermatitis developed. The preservative action in the cream at different test concentrations was tested in microbial challenge tests and was found effective at all concentrations tested. The study established a non-eliciting concentration of diazolidinyl urea of 0.05% in formaldehyde-sensitive patients and showed that the skin reactivity depends on the anatomical region, increasing from the upper arm to neck and, possibly, to the face. The study design, beginning on the upper arm and moving on to the neck and face seems to be relevant for the study of reactions to cosmetic products. A clear dose-response relationship was seen regarding preservative concentration in the product.