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ToxSci Advance Access published online on September 29, 2004
Toxicological Sciences, doi:10.1093/toxsci/kfh299
Toxicological Sciences © Society of Toxicology 2004; all rights reserved
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Received April 26, 2004
Accepted August 30, 2004

Forum

A Proposed Testing Framework for Developmental Immunotoxicology (DIT)

Michael P. Holsapple 1*, Leigh Ann Burns-Naas 2, Kenneth L. Hastings 3, Gregory S. Ladics 4, Amy L. Lavin 1, Susan L. Makris 5, Yung Yang 5, and Michael I. Luster 6

1 ILSI Health and Environmental Sciences Institute, Washington, DC 20005
2 Pfizer Global Research & Development, San Diego, CA 92121
3 U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Rockville, MD 20857
4 DuPont Co., Haskell Laboratory, Newark, DE 19714
5 U.S. Environmental Protection Agency, Washington, DC 20460
6 NIOSH, Centers for Disease Control, Morgantown, WV 26505

* To whom correspondence should be addressed. E-mail: mholsapple{at}ilsi.org.


  Abstract

A group of thirty immunotoxicology experts from the U.S. and E.U. representing government, industry and academia met in May 2003, in Washington, D.C., to reach consensus regarding the most appropriate methods to assess developmental immunotoxicology (DIT) for hazard identification, including under what conditions such testing might be required. The following points represent the major conclusions from this roundtable discussion: (1) the rat is the preferred model; (2) any DIT protocol should be based on immune assays already validated; (3) DIT methods should be incorporated into standard developmental and reproductive toxicity protocols to the extent possible rather than a [stand-alone] protocol; (4) the approach to address DIT potential should be similar for chemicals and drugs, but the experimental design should be flexible and should reflect the specific questions to be answered; (5) it is possible to utilize a study design that assesses all critical windows in one protocol, with the results leading to further study of specific effects, as warranted; (6) animals should be exposed throughout the treatment protocol; (7) the triggers for DIT may include structure-activity-relationships, results from other toxicity studies, the intended use of a drug/chemical and/or its anticipated exposure of neonates and/or juveniles.

Keywords: developmental immunotoxicology; DIT; immune system; developmental and reproductive toxicology; risk assessment; roundtable; study design; testing methods.
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