Overview of Projects
In April 2000, the EPA asked ICCVAM to evaluate the validation status of in vitro estrogen receptor (ER) and
androgen receptor (AR) binding and transcriptional activation (TA) assays, which were proposed as possible components of the
EPA's Endocrine Disruptor Screening Program. NICEATM subsequently compiled available relevant data and prepared a comprehensive
Background Review Document (BRD) for each of the four types of assay.
An independent expert panel review concluded that
there were no adequately validated in vitro ER- or AR-based test methods.
Based on the expert panel’s
conclusions and recommendations,
along with comments from the public, ICCVAM developed test method recommendations that included minimum procedural standards
and a list of 78 reference substances that should be used to standardize and validate
in vitro ER and AR binding and TA test methods. These recommendations were made publicly
available in the report: ICCVAM Evaluation
of the In Vitro Methods for Detecting Potential
Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional
Activation Assays (NIH No: 03-4503). The list of 78 reference substances was subsequently modified because
of cost and availability considerations and published in a separate
Addendum.
Validation Studies of Nominated Endocrine Disruptor Screening Assays
ICCVAM has invited the nomination for validation studies of in vitro test methods that
meet the published recommendations and for which there are standardized test method protocols,
prevalidation study data, or proposed validation study designs.
Data obtained during the validation of in vitro ER- and AR-based test methods will help
assess how individual in vitro endocrine disruptor test methods, or batteries of these methods,
might reduce the numbers of animals needed to screen potential endocrine
disruptors.
ICCVAM subsequently received and evaluated background review documents submitted in support of the LUMI-CELL®
ER assay (Xenobiotic Detection Systems, Inc.) and the MCF-7 Cell Proliferation Assay of Estrogenic Activity developed
by CertiChem, Inc. and recommended both as a high priority for validation. NICEATM has recently completed a protocol
standardization study for the LUMI-CELL® ER assay. The links above lead to pages describing current ICCVAM activities
supporting the validation of these assays.
NICEATM/ICCVAM actively participates in the development of OECD Guidelines for the testing of
chemicals. OECD Test Guidelines are based on the most relevant internationally agreed testing methods
used by government, industry, and independent laboratories. Current NICEATM/ICCVAM activities for
Test Guidelines involving test methods for the detection of endocrine disrupting chemicals can be
found on the "ICCVAM Participation in OECD Test Guidelines for the Detection of Endocrine-Disrupting Substances" page.
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