Devising a Tier-based Skin Sensitisation Screening Strategy for Personal Care and Cosmetic Products.

ABSTRACT

Concerns regarding the use of potential skin sensitisers in personal care and cosmetic products continue to grow. The goal of this study was to develop a proof-of-concept tier-based screening strategy for the assessment of skin sensitisation potential by using non-animal methodologies. As a case example, this screening framework was applied to three WEN® by Chaz Dean cleansing conditioners. The first tier of testing utilised the Organisation for Economic Co-operation and Development (OECD) Quantitative Structure Activity Relationship Toolbox profiler to evaluate the skin sensitisation potential of individual ingredients within the formulation; a literature review was performed on the substances that generated in silico alerts. Tier 2 testing utilised the OECD in chemico Test Guideline (TG) 442C to evaluate these substances. Tier 3 testing adapted OECD TG442C to evaluate the formulated product. The literature review on the four substances that generated in silico alerts revealed that they were not sensitising at the concentrations reported in the formulated products. Tier 2 testing demonstrated that these substances were not sensitising at the concentrations tested. Finally, Tier 3 testing revealed that the evaluated cleansing conditioners had low mean percentage peptide depletion at the concentrations tested. Together, the results obtained suggest that the products tested are unlikely to induce skin sensitisation under the given experimental conditions. These findings are in agreement with other in vitro and clinical studies. The proposed tier-based testing approach may be used as a conceptual framework for the prospective safety screening of other personal care and cosmetic products. However, to establish the validity of the proposed testing strategy, further studies must be performed, including comparisons with established models.