Pilot Study on Non-Animal Risk Assessment Methods

This technical report presents the findings of a pilot study that evaluated non-animal risk assessment methods for chemicals across various exposure scenarios. The study involved 10 chemicals and 24 benchmark exposure scenarios, with a risk classification assigned to each scenario. The objective was to optimize testing systems and data analysis processes while establishing a method for larger scale evaluations. A Bioactivity Exposure Ratio (BER) threshold was determined, indicating low risk for scenarios exceeding a BER of 11. The report details the workflow for integrating exposure and bioactivity data, which includes estimating internal exposure, determining bioactivity points of departure, and calculating BER. The study also discusses the selection process for test chemicals, ensuring a broad representation of chemistries and exposure scenarios. Results indicate that the non-animal toolbox is protective for a significant percentage of high-risk scenarios, although limitations and potential improvements are acknowledged.