Deadline Friday 20th November 2015
A new project on a feasibility study for enhancements of Test Guideline (TG) 414 (Prenatal Developmental Toxicity Study) with endocrine disrupter relevant endpoints has been proposed by Denmark and launched in April 2015.
The objective of this project is to examine the feasibility of inclusion of sensitive endpoints for the detection of chemicals with endocrine disrupting (ED) properties in TG 414. This project follows on from a previous project for the update of TGs 421/422 (Reproduction/Developmental Toxicity Screening Test) / (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) with the inclusion of sensitive endocrine endpoints (project which led to the WNT approval in April 2015 of the updated TG 421 and TG 422 and subsequent Council adoption on 28 July 2015).
As was done for the update of TGs 421/422, a preliminary analysis of studies performed in a research context will be conducted. This initial step will enable identification of the most promising endpoints to be included in the revised TG. Data from studies performed in Denmark are presently being collected, and the objective of this call for data is to collect a broader set of data to base the analysis on.
The information will be used by the lead (Denmark), who will perform a statistical analysis aiming at evaluating which new endpoints have relevance and good reliability for the identification of endocrine active chemicals.
Submission of available data (as Excel files) from studies that examine ED related parameters as additional parameters to the standard TG 414 protocol, would contribute effectively to this project. These ED related parameters include assessment of testosterone levels and/or anogenital distance (AGD) in female/male foetuses, or any other ED related parameter. Also data from non-guideline studies with examinations of these ED related parameters would be useful. A table is provided below to help in the harmonisation of the data collection, and enable easiest use of the data. Also submission of research papers or references with the data could be useful.
Denmark will collect the data and remove identifying information for those who wish to provide data anonymously. Please send tabulated data (see annex 1) to Sofie Christiansen (email@example.com) by Friday 20 November 2015.
Please also circulate this call for data to laboratories you may know, who may conduct this kind of studies and have relevant data. Your help is greatly appreciated.