The BlueScreen HC Assay to Predict the Genotoxic Potential for Fragrance Materials

BlueScreen HCTM is a mammalian cell-based assay for measuring the genotoxicity and cytotoxicity of chemical compounds and mixtures. In this assay a genetically modified strain of cultured human lymphoblastoid TK6 cells is used (GLuc-T01). Incorporated into this strain is a patented Gaussia luciferase (GLuc) reporter system that exploits the regulation of the GADD45a gene, which mediates the adaptive response to genotoxic stress. BlueScreenHCTM has been utilized at the Research Institute for Fragrance Materials (RIFM) in a safety assessment program as a screening tool to prioritize materials for testing, as supporting evidence when using a read-across approach, and as evidence to adjust the threshold of toxicological concern (TTC). Predictive values (positive and negative) for the BlueScreen HCTM assay were calculated based on the ability of the assay to conclude whether the materials are genotoxic or non-genotoxic, determined by the outcome in regulatory approved assays. A set of 379 fragrance materials were assessed in the BlueScreen HCTM assay along with regulatory approved assays conducted in compliance with GLP regulations and in accordance with appropriate OECD guidelines. BlueScreen HCTM results were highly predictive of positive and negative outcome from regulatory compliant genotoxicity assays for this set of fragrance materials. The BlueScreen HCTM negative results for genotoxicity were in 100% alignment with negative results obtained in regulatory compliant genotoxicity assays. In addition, fragrance materials which exhibited a positive result in the BlueScreen HCTM assay were in 100% alignment with positive results in regulatory compliant genotoxicity assays. Based on this analysis the BlueScreen HCTM assay is a useful high throughput screening approach in the fragrance safety assessment program.

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