Endocrine disrupting chemicals (EDCs) are increasingly linked to various human diseases acting via the endocrine system. Protection of public health from the potentially harmful effects of exposure to EDCs requires robust and human-relevant testing strategies. Despite the societal and political urgency to reduce animal testing, current testing strategies for assessing the endocrine disrupting properties of chemicals rely on resource-intensive and invasive animal models. Although these animal models are ethically debated and limited due to the challenges of translating effects in rodents to the human situation, the development of animal-free alternatives faces serious hurdles to move along the path towards regulatory acceptance, including processes of standardization and validation. The goal of our project is therefore to facilitate the pathways to regulatory acceptance of existing models for endocrine disruption that are both animal-free and human-relevant. This project will identify the challenges and opportunities within the existing European legal and regulatory frameworks for the use of animal-free models for EDC identification. It will apply these lessons to inform further development and validation of animal-free models by model developers for identification of two classes of EDCs which are insufficiently addressed in current test strategies, namely thyroid disrupting chemicals (TDCs) and metabolism disrupting chemicals (MDCs). Ultimately our diverse and interdisciplinary consortium will ensure that model developers and other stakeholders in the ED field have increased ability to work on the pathways to regulatory acceptance of animal-free methods for EDC identification. We do so by combining academic expertise across the natural sciences (toxicologists), social sciences (science, technology and innovation studies) and humanities (ethics and law) with key public sector expertise on EDC regulation. We work together with industry, NGOs, regulatory authorities and model developers to achieve better protection of citizens from EDC-related harm and reduce the use of animal testing.
