Exposure of young German adults to the anti-dandruff agent climbazole from 2002 to 2022: Analysis of specific biomarkers in urinary samples

Abstract

The fungicide climbazole is mainly used as an anti-dandruff (AD) agent in cosmetics, such as shampoos or other hair care products. Consequently, an exposure of the general population seems likely because many people suffer from dandruff. We have analyzed urine samples from the German Environmental Specimen Bank (ESB) for two specific climbazole biomarkers, namely (OH)₂-climbazole and cx–OH–climbazole, in samples collected in the years 2002, 2007, 2012, 2017 and 2022. (OH)₂-Climbazole was determined diastereoselectively, hence three analytes are discussed ((OH)₂-climbazole 1, (OH)₂-climbazole 2 and cx–OH–climbazole). The study population consisted of 300 students (150 male, 150 female) aged between 20 and 29 at the time of sampling from Halle/Saale in Germany. Most samples under scrutiny did not contain any climbazole metabolites in levels above the limit of quantification (LOQ, 0.5 μg/L for either analyte), only in 16 samples at least one analyte could be quantitated. Even the sample with the highest metabolite concentrations (10.23 μg/L (OH)₂-climbazole and 2.53 μg/L cx–OH–climbazole) barely reached the urinary concentrations found in an excretion kinetics study after the typical application of a climbazole-containing shampoo in three volunteers. As a result, estimated daily intakes (max. 1.8 μg/kg bw/d) lay below the subchronic NOAEL (15 mg/kg bw/d) and NOEL (5 mg/kg bw/d) by a factor of more than 8300 and 2700, respectively. The evaluation of the climbazole burden of the general population gives valuable insights for the authorities on the effect of legal restrictions.