Quantitative repeated open application testing with a rinse-off product in methyldibromo glutaronitrile-sensitive patients: Results of the IVDK

Background: While the use of methyldibromo glutaronitrile (MDBGN) in leave-on products is clearly associated with high sensitization or elicitation risk, such a clear-cut relation could be questioned with regard to rinse-off products. Objective: The objective of this study was to find a maximum non-eliciting concentration for rinse-off products in MDBGN patch test-positive patients. Patients and methods: We performed a use-related test [repeated open application test (ROAT)] in patients sensitized to MDBGN with a liquid soap containing three concentrations of MDBGN (50, 200, and 400 p.p.m. MDBGN, respectively). The soap at 50 p.p.m. was used twice daily for 4 weeks. If no reaction of the skin was observed, the product with the next higher concentration was used for another 4 weeks, etc. Results: In total, 32/37 evaluated cases [86.5%; lower exact one-sided 95% confidence limit (CL): 73.7%] did not react to any of the preparations. The remaining reacted as follows: 1/37 reacted to 50 p.p.m., 3/37 to 200 p.p.m., and 1/37 to 400 p.p.m. The cumulative non-response to 50 p.p.m. was 97.3% (lower CL: 87.8%). Conclusions: The majority of subjects sensitized to MDBGN-tolerated rinse-off products containing a maximum concentration of 400 p.p.m. A concentration in rinse-off products in the range of 50 p.p.m. could be regarded as safe for most individuals already sensitized. These concentrations will presumably prevent induction (sensitization) also.