Systematic evaluation of the evidence for identification of endocrine disrupting properties of Bisphenol F

Abstract

Identification of endocrine disruptors (EDs) is a highly prioritized issue in the EU. However, scientific criteria to identify EDs have so far only been implemented for biocidal and plant protection products. The European Commission is working on developing a horizontal approach to the identification of EDs across legislations, based on these scientific criteria. With this study, our aim was to evaluate evidence on endocrine disrupting properties of Bisphenol F (BPF) by applying the process set out for biocidal and plant protection products in Europe. BPF is not registered under REACH and therefore assumed not to be produced in the EU > 1 ton/year, yet the substance has been detected in urine, serum, and breast milk in populations from different countries in Europe. BPF is raising concern since it is an analogue of the known ED and reproductive toxicant Bisphenol A. Relevant evidence on endocrine disrupting properties of BPF from the open literature was collected using systematic review methodology. Pre-defined inclusion criteria were developed to select relevant studies, and data was extracted. The reliability of included studies was evaluated by the Science in Risk Assessment and Policy tool, and results were converted into Klimisch categories to allow for categorization of study reliability. A weight-of-evidence approach was used to analyze the evidence and draw conclusions on endocrine-related activity and/or endocrine adversity. We found that there is sufficient evidence to conclude on an endocrine mechanism, and while evidence for adversity was not considered sufficient, we still conclude that BPF could also cause endocrine-mediated adversity. Two modes of action were postulated based on the collected data for BPF. Challenges of performing the ED assessment for data-poor chemicals and the importance of adequate reporting of studies in the open literature, especially for new approach methods, are discussed.

Keywords: Bisphenol F; Endocrine disruptor; Pesticides regulation; REACH; Weight of evidence evaluation.