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A Two-Tiered-Testing Decision Tree for Assays in the USEPA-EDSP Screening Battery: Using 15 years of experience to improve screening and testing for endocrine active chemicals
Citation:
Gray, E. AND G. Ankley. A Two-Tiered-Testing Decision Tree for Assays in the USEPA-EDSP Screening Battery: Using 15 years of experience to improve screening and testing for endocrine active chemicals. Presented at Toxicology Excellence for Risk Assessment (TERA) Meeting: Learned, RTP, NC, April 23 - 24, 2013.
Impact/Purpose:
Invited presentation at TERA meeting on EPA's Endocrine Screening Program: lessons learned. new information on a simplified approach to endocrine screening that would refine some assays, reduce animals use and replace some assays with assays not requiring animal use. The Decison Logic Tree approach to conducting screening assays for endocrine activity also would save resources (money, time and animal use)
Description:
Outline of the presentationEDCs – from 1991 to 1996 – Wingspread and Our Stolen Future 1996 – FQPA and SDWA mandates endocrine screening 1996-1998 – EDSTAC (the assays, debates over modes of action included) The final battery – EAT in vivo and in vitro The next – 15 years and a significant increase in the database on effects of EDCs in EDSP assays and assay validation Implementation on the first round of chemicals Cautions on interpretation of Tier 1 Screening data and recommendations for data interpretation of the data. Recommendations of structuring Tier 1 screening assays on a decision-logic-tree basis with two in vivo assays as the “Gatekeepers” Description of the value of Tier 1.5 before going to Tier 2 testing. Using the information from Tier 1 Screening to tailor/enhance Tier 2 testing by adding additional endpoints sensitive to specific modes of endocrine action What are the endpoints sensitive to disruption that are not specifically included in tier 2 testing? What is the shape of the dose response curve for EDCs in the low dose range for these sensitive endpoints - where dose it matter: In tier 1 or Tier 2?