The main objective of this study was to provide a conclusion concerning the comparative performance of the dimethylglyoxime (DMG) nickel-screening test and the EN 1811 synthetic sweat test based on the results of the two tests; that is, the nickel-release values (adjusted) obtained from the En 1811 tests and the pass/fail results from the nickel-screening tests (PD CR 12471:2002). These tests were used in testing compliance with the European Union Nickel Directive (94/27/EC, amended 2004/96/EC) for articles intended to come into direct and prolonged contact with the skin. In order to achieve this objective, a set of ten homogeneous materials (along with a nickel metal with well-characterized surfaces that covered a wide range of nickel-release rates from very low through moderate-to-high) were chosen. All were analyzed for their chemical composition and tested in replicate by four difference laboratories according to PD CR 12471:2002 and EN 1811:1998.

Author: Dippal Manchanda, Ian Bayley