TR 106 – Guidance on Identifying Endocrine Disrupting Effects
TR 106 : Guidance on Identifying Endocrine Disrupting Effects | June 2009
Recent revision of the European directive on plant protection products (Directive 91/414/EEC) and new regulations concerning chemicals (Regulation (EC) No. 1907/2006 ?REACH?) only support the marketing and use of chemical products on the basis that they do not induce endocrine disruption in humans and/or non-target species. However, there is currently no agreed guidance on how to identify and evaluate endocrine activity and disruption. Consequently, this ECETOC task force was formed to provide scientific based criteria that may be used within the context of the plant protection products directive and REACH.
This report reviews and summarises existing definitions for an endocrine disrupter as well as the test methods currently available to identify endocrine activity and/or toxicity. Specific scientific criteria for the determination of endocrine disrupting properties that integrate information from both regulatory (eco)toxicity studies and mechanistic/screening studies are proposed. These scientific criteria rely on the nature of the adverse effects detected in regulatory (eco)toxicity study(ies) that give concern for endocrine toxicity and the description/understanding of the mode of action of toxicity which scientifically support and explain the adverse effects. The criteria developed are presented in the form of flow charts for assessing relevant effects for both human and environmental species. These charts are illustrated using example substances. In addition since all chemicals having endocrine disrupting properties may not represent the same hazard, an element or assessment of potency is also proposed to discriminate chemicals of high concern from those of lower concern.