Spec. Issue 2006 - Article Summary

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ICCVAM’s role in validating in vitro test methods for endocrine disruptor screening

Marilyn Wind1, Bradley Blackard2, Raymond Tice2, William Stokes3, David Hattan4 and
Leonard M. Schechtman4

1US Consumer Product Safety Commission, Bethesda, Maryland, USA; 2Integrated Laboratory Systems, Inc./NICEATM,
Research Triangle Park, North Carolina, USA; 3National Toxicology Program Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM)/National Institute of Environmental Health Sciences Research, Research Triangle Park,
North Carolina, USA; 4US Food and Drug Administration, Rockville, Maryland, USA

Estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays have been proposed as part of Tier 1 of the two-tiered endocrine disruptor screening battery the U.S. Environmental Protection Agency (EPA) is developing. ICCVAM
comprehensively reviewed all in vitro ER and AR binding and TA assays and concluded that none were adequately validated. Minimum procedural standards such as dose selection criteria, number of replicates per test, appropriate positive and negative controls and criteria for an acceptable test were proposed that should be incorporated into standardised protocols for each of the four types of assays evaluated.

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