The endocrine system plays a crucial role in maintaining human homeostasis and is often affected by exogenous stimuli. A range of synthetic as well as naturally occurring agents have been identified as interacting with the endocrine system. Those substances are generally referred to as hormonally active substances. If this interaction leads to adverse health effects in humans or animals, these substances are called endocrine disruptors. Scientific knowledge in this area is still growing and the understanding of what an endocrine disruptor constitutes, continues to be the subject of scientific and public debate. Most recently, the European Food Safety Authority (EFSA) and the European Chemical Agency (ECHA) published in June 2018 a joint guidance for the science-based identification of endocrine disruptors in the context of the EU Biocidal and Plant Protection Product Regulations.
ToxMinds scientists have been involved in this debate at technical and regulatory level for many years. In various projects, we systematically evaluated the toxicological or ecotoxicological relevance and reliability of identified data and the evidence for endocrine activity of industrial chemicals, biocides or agrochemicals. On the basis of our findings, we recommended testing strategies to verify possible modes of actions (MoA) and strategic options from a client’s business point of view.
Our services to identify and assess endocrine disrupting chemicals for humans and the environment include:
- Comprehensive literature and desktop searches using public and commercial databases
- Topline screening and feasibility assessment of lead candidates from an ED perspective
- QSAR modelling to predict endocrine activity based on chemical structures
- Systematic review of the data based on pre-defined relevance and reliability criteria
- Matrix-based collation of identified data based on relevance, reliability and lines of evidence
- Assessment of endocrine-mediated adversity and Mode of Action (MoA) analysis
- Design and management of testing programmes to evaluate or verify any endocrine activity
- Preparation of an ECHA-guideline compliant ED assessment reports in response to competent authority requests