Concept Life Sciences has experience in designing and running studies that provide robust read across data in a cost-effective way.
Data is required to provide a credible and plausible read across hypothesis, in order to provide regulators with the confidence that the proposed approach is acceptable and meets the requirements of REACH.
Conceptually, our approach involves using short-term mechanistic studies to characterise all of the (structurally related) substances in a category for key attributes such as absorption and metabolism, then grouping substances based on this and selecting a small subset of chemicals for further characterisation, e.g. combined screening studies for reproduction and repeat dose toxicity. This can be further extended to include toxicogenomic screening, if required, to elucidate any toxicological effects that may be seen in the screening studies or longer-term studies on the selected category members. Toxicogenomic studies allow the identification of putative pathways of toxicity and the remaining compounds can then be tested specifically for their ability to perturb these pathways. Based on this mechanistic approach, a representative subset of substances can be selected for full toxicology testing.