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Our purpose was to investigate the eliciting threshold concentration of formaldehyde in formaldehyde-sensitive individuals in the occluded and non-occluded patch test, and to evaluate the relationship to repeated open application test (ROAT) with a product containing a formaldehyde releaser. 20 formaldehyde-sensitive patients and a control group of 20 healthy volunteers were included in the study. Occluded and non-occluded patch tests with formaldehyde solutions from 25 to 10,000 ppm, and ROAT for 1 week with a leave-on cosmetic product containing on average 300 ppm formaldehyde, were carried out simultaneously on each subject. In the occluded patch test, 1/2 of the 20 patients only reacted to 10,000 ppm formaldehyde, 9 reacted to 5,000 ppm, 3 reacted to 1,000 ppm, 2 reacted to 500 ppm and 1 reacted to 250 ppm. No definite positive reactions were observed in the non-occluded patch test or in the ROAT. No positive reactions were observed in the control group to any of the test procedures. We concluded that the threshold concentration for occluded patch test to formaldehyde in formaldehyde-sensitive patients was 250 ppm. The threshold in occluded patch test corresponded to the degree of sensitivity. Definite positive reactions in the ROAT were not seen, either indicating that they are unlikely to happen with the type of product used or that the exposure time was too short.

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