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

M Wind¹, BC Blackard², RR Tice², WS Stokes³, LM Schechtman⁴

1. U.S. CPSC, Bethesda, MD, USA
2. Integrated Laboratory Systems, Inc./NICEATM, RTP, NC, USA
3. NICEATM/NIEHS, RTP, NC, USA
4. U.S. FDA, Rockville, MD, USA

Evidence linking exposure to natural and man-made substances in the environment to adverse effects on the endocrine and reproductive systems of a variety of animal species resulted in concerns about the possibility of similar adverse health effects in humans. The U.S. Congress enacted provisions to safeguard public health from exposure to pesticides in foods and drinking water and required the EPA to develop and validate a screening and testing program to identify substances with endocrine disrupting activity. There are an estimated 87,000 chemicals produced today which have insufficient scientific data to allow evaluation of their potential for endocrine disruption. The EPA is developing a two-tiered screening and testing process. Estrogen receptor (ER) and androgen receptor (AR) binding assays and transcriptional activation assays (TA) have been proposed as part of the Tier 1 screening battery. ICCVAM comprehensively reviewed all the 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 standardized protocols for each of the four types of assays evaluated.

*This abstract reflects the views of the author, has not been reviewed or approved by, and may not necessarily reflect the views of the Commission. This abstract was prepared as part of the author's official duties and is in the public domain and may be freely copied. Supported by NIEHS Contract N01-ES 35504

Date: Monday, August 22, 2005, 15.00-17.00 h, ECC Hall D

5.1 Session: Strategies for Using Non-animal Methods in Relation to HPV, Endocrine Disruptors, and REACH Legislation