AltTox Digest
June/July 2012

Alternative Assay Announced for EPA's EDSP Tier 1 Battery

One of the Environmental Protection Agency's objectives regarding its Endocrine Disruptor Screening Program (EDSP) Tier 1 test battery is to review the performance of the current assays individually and the battery as a whole. Additionally, new in vitro assays that are in the validation pipeline can be considered, especially ones that can be adapted to high-throughput screening (HTS) platforms for use in the Tox21 program.

The BG1 Luc ER TA (Lumi-Cell) assay, an in vitro method, has now been considered for use in the EDSP Tier 1 battery. The assay was reviewed by NICEATM-ICCVAM in 2011 and recommended by ICCVAM to US agencies earlier this year as a screening test method that can be used to identify substances that interact with and modulate the activity of the estrogen receptor (ER) in vitro. The performance of this method was reported by the ICCVAM to be at least as good or better than another in vitro ER TA assay that is currently part of the EDSP Tier 1 battery (OCSPP 890.1300). Additional strengths of the BG1 Luc ER TA test method are its ability to identify both ER agonists and antagonists, and that its performance has been assessed over a wider range of substances.

Since ICCVAM's review of its validation status, the BG1 Luc ER TA test method has been submitted to the Tox21 program for adaptation to their HTS platform. Tox21 is a consortium of four government agencies: National Institute of Environmental Health Sciences/National Toxicology Program; US Environmental Protection Agency; NIH Center for Translational Therapeutics (NCTT); and US Food and Drug Administration.

NICEATM reports on its website that "The BG1Luc ER TA test method has been adapted to a HTS format using 1536-well plates by the ... NCTT; formerly the NIH Chemical Genomics Center... Preliminary results are promising, and it is expected that this method will be incorporated into the Tox21 screening paradigm in 2012."

The BG1 HTS data will be made available on the NTP Chemical Effects in Biological Systems (CEBS) database, but is not there at this time. NIEHS has indicated that all 10,000 chemicals in the Tox21 screening list have been run in triplicate in both the agonist and antagonist BG1 assay. Additionally, results from 78 chemicals that were run in the validated (manual) method are being compared with the HTS method. Those results will be presented on September 5, 2012 at the NTP's annual Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting.

On July 17, the EPA responded to the ICCVAM recommendations on the validation status of the BG1 assay by stating that the agency "...regards the BG1 Luc assay as an alternative to the OCSPP 890.1300 test guideline for transcriptional activation currently used in the [EDSP]." The response also includes the latest information on the OECD's review of the BG1 assay, as follows. "The BG1Luc assay has been approved by the OECD's Working Group of National Coordinators…. When adopted by OECD as an international test guideline for detecting ER agonist and antagonist activity of chemicals, all 34 member countries, including the United States, will accept testing data generated in accordance with the BG1 Luc ER TA Test Guideline." The EPA response concludes saying that "Adequately performed studies using the BG1 Luc assay will satisfy the Estrogen Receptor Transcriptional Activation requirement of the EDSP."

For further information on the EPA's EDSP:
The US EPA's Endocrine Disruptor Screening Program: Part 1
The US EPA's Endocrine Disruptor Screening Program: Part 2

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