ToxSci Advance Access originally published online on September 29, 2004
Toxicological Sciences 2005 83(1):18-24; doi:10.1093/toxsci/kfh299
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Toxicological Sciences vol. 83 no. 1 © Society of Toxicology 2005; all rights reserved.
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A Proposed Testing Framework for Developmental Immunotoxicology (DIT)
* ILSI Health Science and Environmental Sciences Institute, Washington, DC 20005; Pfizer Global Research and Development, San Diego, California 92121; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Rockville, Maryland 20857; DuPont, Co., Haskell Laboratory, Newark, Delaware 19714; ¶ ILSI Health and Environmental Sciences Institute, Washington, DC 20005; || U.S. Environmental Protection Agency, Washington, DC 20460 and ||| NIOSH, Centers for Disease Control, Morgantown, West Virginia 26505
Received April 26, 2004; accepted August 30, 2004
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.
Key Words: developmental immunotoxicology; DIT; immune system; developmental and reproductive toxicology; risk assessment; roundtable; study design; testing methods.
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