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Review of In Vitro Endocrine Disruptor Screening Assays

Poster for May 2002 Expert Panel Evaluation of In Vitro Test Methods for Detecting Endocrine Disruptors

ICCVAM developed recommendations for minimum procedural standards and test methods for future validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays. These recommendations were published in a test method evaluation report, and included:

  • Assay development emphasizing the use of recombinant-derived ER and AR rather than animal-derived proteins
  • More detailed research and study of methods for making statistical inferences with in vitro endocrine disruptor data
  • Review of the available information on the degree to which metabolism is known to alter estrogenic and androgenic activity in vivo

The ICCVAM report also included a list of 78 reference substances that should be used to standardize and validate these assays. ICCVAM recommended that all 78 substances be used in the validation of each in vitro assay to more accurately assess the predictive value of the assay. ICCVAM also recommended establishment of a central repository of samples of the 78 substances with verified purity. The list of 78 reference substances was subsequently modified because of cost and availability considerations and published in a separate addendum to the test method evaluation report. Read More

Nomination and Expert Panel Meeting

In April 2000, the U.S. Environmental Protection Agency nominated four types of in vitro test methods for detecting substances with potential endocrine disrupting activity for review by ICCVAM. These types of test methods were proposed as possible components of the EPA Endocrine Disruptor Screening Program. NICEATM subsequently compiled available relevant data and prepared a comprehensive background review document for each of the four types of assay. An independent expert panel review concluded that there were no adequately validated in vitro endocrine disruptor screening assays. ICCVAM considered the expert panel's conclusions and recommendations as well as comments from the public as it developed the test method evaluation report.

Expert Panel Report on the Current Status of In Vitro Test Methods for Detecting Endocrine Disruptors 
September 2002
View minutes from Expert Panel meeting , May 21-22, 2002, RTP, NC

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