Application of Spectro‐DPRA, KeratinoSens™ and h‐CLAT to estimation of the skin sensitization potential of cosmetics ingredients. Issue 2 (3rd November 2019)

• Record Type: Journal Article
• Authors: Cho, Sun‐A; Choi, Minseok; Park, Sae‐Ra; An, Susun; Park, Jae‐Hak
• Is Part Of: Journal of applied toxicology. Volume 40:Issue 2(2020)
• Page Start: 300
• Page End: 312
• Publication Date: 2019-11-03
• Subjects: adverse outcome pathway -- integrated approaches -- skin sensitization -- (AOP), animal alternative, spectrophotometric DPRA; Toxicology -- Periodicals; Industrial toxicology -- Periodicals; Environmentally induced diseases -- Periodicals; Toxicology -- Periodicals; 615.9005
• DOI: 10.1002/jat.3904
• Languages: English
• ISSNs: 0260-437X

Abstract

Abstract: Ethical issues in animal toxicity testing have led to the search for alternative methods to determine the skin sensitization potential of cosmetic products. The emergence of ethical testing issues has led to the development of many alternative methods that can reliably estimate skin sensitization potentials. However, a single alternative method may not be able to achieve high predictivity due to the complexity of the skin sensitization mechanism. Therefore, several prediction assays, including both in chemico and in vitro test methods, were investigated and integrated based on the skin sensitization adverse outcome pathway. In this study, we evaluated three different integrated approaches to predict a human skin sensitization hazard using data from in vitro assays (KeratinoSens™ and human cell line activation test [h‐CLAT]), and a newly developed in chemico assay (spectrophotometric direct peptide reactivity assay [Spectro‐DPRA]). When the results of the in chemico and in vitro assays were combined, the predictivity of human data increased compared with that of a single assay. The highest predictivity was obtained for the approach in which sensitization potential was determined by Spectro‐DPRA followed by final determination using the result of KeratinoSens™ and h‐CLAT assays (96.3% sensitivity, 87.1% specificity, 86.7% positive predictive value, 96.4% negative predictive value and 91.4% accuracy compared with human data). While further optimization is needed, we believe this integrated approach may provide useful predictive data when determining the human skin sensitization potential of chemicals. Abstract : We evaluated three different integrated approaches to predict human skin sensitization hazard using data from in vitro assays (KeratinoSens™ and h‐CLAT), and a newly developed in chemico assay (Spectro‐DPRA). When the results of the in chemico and in vitro assays were combined, the predictivity of human data increased compared to that of a single assay. The highest predictivity was obtained for the approach in which sensitization potential was determined by the Spectro‐DPRA assay followed by final determination using the result of KeratinoSens™ and h‐CLAT assays (96.3% sensitivity, 87.1% specificity, 86.7% positive predictive value, 96.4% negative predictive value, and 91.4% accuracy compared to human data). While further optimization is needed, we believe this integrated approach may provide useful predictive data when determining human skin sensitization potential of chemicals.