OECD acceptance of Test Guideline 497 (TG 497)
The recent OECD acceptance of TG 497 for defined approaches for skin sensitization marks an important milestone. A defined approach to testing and assessment consists of a fixed data interpretation procedure used to interpret data generated with a defined set of information sources, that can either be used alone or together with other information sources, to satisfy a specific regulatory need. The initial acceptance of a voting procedure (2 out of 3) can be expected to be followed by evaluation and acceptance of further algorithms combined with assay data providing an increasing acceptance at the OECD level of integrated approaches to testing and assessment (IATAs).
Our initial launch of SaferSkin at SOT 2018 provided the first solution on the market supporting defined approaches for skin sensitization. Working with industry leaders we have incorporated advanced defined approaches such as Bayesian Networks as used at P&G, regression at Givaudan, and neural networks at Shiseido. We have also extended the IATA approach to include emerging advanced assays such as the kDPRA, SENS-IS, and GARD assays. Within our SaferSkin we have developed a partnership providing both the current OECD and emerging assays supporting the tiered testing of ingredients and formulations using a combination of in silico and in vitro approaches supported by a common harmonized data infrastructure. We hope our commitment to such advances in new approach methods will provide long-term value and knowledge infrastructure to our customers using all available tools on the market for both sound product decision making, risk assessment, and regulatory reporting.