Integration of New Approach Methods in Read Across Case Study

This document is a case study that focuses on the integration of new approach methodologies (NAMs) in the read-across process for assessing the sub-acute toxicity of Fatty Acids, C12-18 and C18-unsaturated, 2-sulfoethyl esters, sodium salts (DEFI). The study aims to fill a data gap for a 28-day repeated dose toxicity study using a read-across approach, which is essential in regulatory toxicology to predict the toxicological properties of one chemical based on data from similar chemicals. The hypothesis is that the target and source substances share similar components and biological properties despite minor differences in physicochemical properties. The document details the physicochemical, toxicokinetic, and toxicodynamic similarities and differences between DEFI and its analogue, Fatty acids, coco, 2-sulfoethyl esters, sodium salts (SCI). It concludes that SCI is suitable for reading across to DEFI, thereby supporting the use of read-across as a scientifically valid approach to meet regulatory requirements.