Chemical analysis and risk assessment of prohibited colouring agents in face paint with special regard to CI 15585 (D&C Red No. 9, Pigment Red 53:1)

• Published in: International journal of cosmetic science 2015-04, Vol.37 (2), p.187-195
• Main Authors: Keck-Wilhelm, A., Kratz, E., Mildau, G., Ilse, M., Schlee, C., Lachenmeier, D. W.
• Format: Article
• Language: English
• Subjects: chemical analysis; Chromatography; Chromatography, High Pressure Liquid; Chromatography, Thin Layer; Coloring Agents - analysis; Coloring Agents - toxicity; colour cosmetics; Cosmetics; Face; Germany; HPLC; Humans; Magnetic Resonance Spectroscopy; make-up; NMR; Nuclear magnetic resonance; nuclear magnetic resonance spectroscopy; Paints; Professional soccer; Risk Assessment; safety testing; spectroscopy; Tandem Mass Spectrometry; thin-layer chromatography
• ISSN: 0142-5463; 1468-2494
• DOI: 10.1111/ics.12181

Synopsis Objectives Face painting in the colours of the national flags has become a mass phenomenon during international mega sporting events. Face paints, belonging to the group of lipophilic decorative cosmetics, pose an analytical challenge, especially in the sample preparation steps to obtain sample extracts of the colouring agents of low solubility. Methods In the context of official cosmetics control, a sample of German flag‐coloured face paints (n = 42) offered during the soccer world cup 2014 was analysed. Sample‐clean‐up of hydroalcoholic and dichloromethane sample extracts was conducted using preparative thin‐layer chromatography (TLC). For identification, analytical TLC, spectrophotometry considering bathochromic effects, and high‐performance liquid chromatography (LC) with diode array detector were applied. Nuclear magnetic resonance (NMR) spectroscopy and LC–tandem mass spectrometry (LC‐MS/MS) were used in positive cases for confirmatory analysis. NMR spectroscopy was also applied to determine the identity and purity of reference substances. Risk assessment was provided using the margin of exposure (MOE) methodology. Results The prohibited red colouring agent CI 15585 (D&C Red No. 9, Pigment Red 53:1), which is carcinogenic in animals, was positively identified in 40% of the analysed samples. Per face painting event, about 0.04 mg kg−1 bw (adult) or 0.11 mg kg−1 bw (child) of CI 15585 is systemically absorbed. Assuming an annual use of five times (adult) or 20 times (child), the exposure would be 5.8E‐04 mg kg−1 bw per day (adult) or 5.8E‐03 mg kg−1 bw per day (child). The MOE in these worst‐case scenarios would be 6871 (adult) and 695 (child). Because the mechanism of CI 15585 is non‐genotoxic and the MOE is higher than a safety factor of 100, CI 15585 does not pose a serious health risk to the consumer, but should be avoided for reasons of precautionary public health protection. Conclusion An analytical strategy to determine colouring agents in face paints was developed and non‐compliance with the European Union (EU) cosmetic products regulation in a considerable number of products was detected. An increased control frequency especially at the points of entry into the EU is recommended. Résumé Objectif La peinture de visage dans les couleurs des drapeaux nationaux est devenu un phénomène de masse au cours des manifestations sportives internationales. Les peintures pour le visage, appartenant au groupe de cosmétiques décoratifs lipophiles, po