Risk Analysis

Risks of Allergic Contact Dermatitis Elicited by Nickel, Chromium, and Organic Sensitizers: Quantitative Models Based on Clinical Patch Test Data

Journal Article

Abstract

Risks of allergic contact dermatitis (ACD) from consumer products intended for extended (nonpiercing) dermal contact are regulated by E.U. Directive EN 1811 that limits released Ni to a weekly equivalent dermal load of ≤0.5 μg/cm2. Similar approaches for thousands of known organic sensitizers are hampered by inability to quantify respective ACD‐elicitation risk levels. To help address this gap, normalized values of cumulative risk for eliciting a positive (“≥+”) clinical patch test response reported in 12 studies for a total of n = 625 Ni‐sensitized patients were modeled in relation to observed ACD‐eliciting Ni loads, yielding an approximate lognormal (LN) distribution with a geometric mean and standard deviation of GMNi = 15 μg/cm2 and GSDNi = 8.0, respectively. Such data for five sensitizers (including formaldehyde and 2‐hydroxyethyl methacrylate) were also ∼LN distributed, but with a common GSD value equal to GSDNi and with heterogeneous sensitizer‐specific GM values each defining a respective ACD‐eliciting potency GMNi/GM relative to Ni. Such potencies were also estimated for nine (meth)acrylates by applying this general LN ACD‐elicitation risk model to respective sets of fewer data. ACD‐elicitation risk patterns observed for Cr(VI) (n = 417) and Cr(III) (n = 78) were fit to mixed‐LN models in which ∼30% and ∼40% of the most sensitive responders, respectively, were estimated to exhibit a LN response also governed by GSDNi. The observed common LN‐response shape parameter GSDNi may reflect a common underlying ACD mechanism and suggests a common interim approach to quantitative ACD‐elicitation risk assessment based on available clinical data.

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