February 19, 2019 by Becky Brown
At wca we specialise in Endocrine Disrupter (ED) assessments for chemicals. In recent years we have conducted ED assessments for pharmaceuticals, general chemicals under REACH, and for multiple plant protection products (PPPs). The European Commission (EC) is strengthening regulation in this area through the introduction of ED criteria for biocides1 and PPPs2, with associated guidance3. The draft new guidelines for the environmental risk assessment of pharmaceuticals also includes special provision for endocrine active substances4.
Within the new guidance documents there is an increased demand for chronic life-cycle toxicity tests with fish and amphibians to either demonstrate that the oestrogen, androgen, steroidogenesis and thyroid mediated adversity has been sufficiently investigated or to derive predicted no effect concentrations (PNEC) based on endocrine endpoints. At wca we can provide advice on the specific ED testing strategy required for your substance and help design studies to focus on the endocrine endpoints of concern. We can also provide a study monitoring service to ensure that these complex studies meet the relevant regulatory standards.
Dr Grace Panter, an experienced fish ecotoxicologist, recently joined wca as a Principal Consultant. Grace has worked in both the pharmaceutical and agrochemical sectors with a focus on high tier ecotoxicology testing. She has particular experience in the design, running and reporting of bespoke fish studies, to address specific questions/areas of concern 5,6. If you would like to find out more about how wca can help with your ED assessments, please contact us and we would be happy to help.
1Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012
2Regulation (EU) 2018/605 of 19 April 2018 setting out scientific criteria for the determination of endocrine disrupting and amending Annex II to Regulation (EC) 1107/2009;
3Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009;
4Guideline on the environmental risk assessment of medicinal products for human use (draft) EMEA/CHMP/SWP/4447/00 Rev. 1. 15 November 2018;
5Panter GH, Hutchinson TH, Hurd KS, Bamforth J, Stanley RD, Duffell S, Hargreaves A, Gimeno S, Tyler CR. 2006. Development of chronic tests for endocrine active chemicals. Part 1. An extended fish early-life stage test for oestrogenic active chemicals in the fathead minnows (Pimephales promelas). Aquatic Toxicology, 77: 279-290;
6Panter GH, Glennon Y, Robinson J, Hargreaves A, Murray-Smith R. 2012. Effects of the anti-androgen, bicalutamide, in a reduced life-cycle study with the fathead minnow (Pimephales promelas). Aquatic Toxicology, 114-115: 31-38