Office of Research and Development Publications

Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Estrogen Receptor Active Chemicals (OECD)

Citation:

Judson, R. AND M. Gwinn. Case Study on the Use of an Integrated Approach to Testing and Assessment for Identifying Estrogen Receptor Active Chemicals (OECD). Presented at Webinar to the IATA Case Studies Project group (OECD), RTP, NC, April 09, 2019. https://doi.org/10.23645/epacomptox.8104700

Impact/Purpose:

The intended application of this IATA is for screening of environmental chemicals based on their ER agonist activity, and for determining whether further evaluation of endocrine-related activity in higher tier in vivo tests (e.g., female pubertal assay, two generation reproductive toxicity study) is needed. The purpose is to use a combination of 4 to 16 in vitro high throughput screening (HTS) assays and a computational model for estrogen receptor (ER) agonist activity, as an alternative to low and medium throughput in vitro and in vivo tests for ER activity. Presentation for the Integrated Approach to Testing and Assessment (IATA) Case Studies Project group (OECD) Webinar held April 2019.

Description:

The Integrated Approach to Testing and Assessment (IATA) has been clarified further to demonstrate that a subset of as few as 4 assays is recommended as an alternative approach to the current guideline. The subset of assays can be any assays that fit into specific criteria as described (ie., the subset of assays interrogates different points on the ER pathway and incorporate different technologies). Included in this case study is an annex that describes the 9 subset models with 7 or fewer assays that achieve ≥94% balanced accuracy for all chemicals and the in vitro and in vivo reference chemical sets. (Annex III). We have also further articulated the benefits of using a subset of assays in the defined approach, specifically the flexibility it gives users by allowing the use of any assays that fit the described criteria. The views expressed in this presentation do not represent the views and/or policies of the US EPA.

Record Details:

Record Type:DOCUMENT( PRESENTATION/ SLIDE)
Product Published Date:04/09/2019
Record Last Revised:05/28/2019
OMB Category:Other
Record ID: 345025