EFSA new guidance on endocrine disruptors: comments, critical aspects and a case study

The EFSA Endocrine Disruptors guidance has been developed to help assessors of the regulatory authorities on the definition of the scientific criteria for the determination of endocrine-disrupting properties in the context of Regulations (EU) No 16 528/2012 and (EC) No 1107/2009. The overall objective resulting from the present project was the compilation of a specific database for a pesticide active substance (named x) and its metabolites, which is comprising all available parameters that are considered relevant when investigating the ED properties. The database represented a practical tool to help assessors in assessing and analyze the evidence for endocrine disrupting properties. A useful-friendly client-side Form of the database was created. The Microsoft Access database was selected as suitable for this specific data collection due to the number of predicted records to be stored in and the ability of the toxicologist to work with this specific platform. To facilitate the data entry phase of the operators and to limit the data entry typos, most of the field were constrained with menu combo boxes and several queries were prepared to check the quality of the inserted data. The list of toxicity study type for mammalian toxicology and wild life toxicology comprises more than 10 different type of studies. Out of 55 studies that were scrutinized, 27 were performed on the active substance and 28 were performed on metabolites (4 metabolites) thus representing more than 50% of the total. In this particular case, the number of toxicity studies performed on metabolites was larger than normal; this is due to particular toxicity potential of three (non mammalian) metabolites that show higher chronic (specifically reproductive toxicity) toxicity than the parent. Studies on mammals (intact organism/cells) were 49 (23 on active substance and 26 on metabolites), while studies on wildlife (fish, amphibians) were 6 (4 on active substance and 2 on metabolites) Wilde life studies to investigate ED properties of active substances were not routinely performed in the past year. Please note that for substance X dossier year of study range from 1979 to 2012. Collection of data from substance x dossier represented a new exercise related to new approach for evaluating ED properties of active substances.