ToxSci Advance Access originally published online on August 12, 2003
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Toxicological Sciences 76, 250-261 (2003)
Copyright © 2003 by the Society of Toxicology
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Neurobehavioral Assessment: A Survey of Use and Value in Safety Assessment Studies
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* Department of Psychiatry and Behavioral Science, Medical University of South Carolina, Charleston, South Carolina 29425;
Department of Physiology and Pharmacology, SUNY-Brooklyn, Brooklyn, New York 11203;
Exponent, Inc., San Francisco, California 94114,
International Life Sciences Institute, Health and Environmental Sciences Institute, Washington, District of Columbia 20005;
¶ Environmental Protection Agency, Washington, District of Columbia 20460;
|| Toxicology Department, Bayer CropScience, Stilwell, Kansas 66085;
||| Endo Pharmaceuticals, Inc., Chadds Ford, Pennsylvania 19317;
|||| Division of Neurotoxicology, National Center for Toxicological Research, Jefferson, Arkansas 72079;
# Central Research Division, Drug Safety Evaluation, Pfizer, Inc., Groton, Connecticut 06340;
** Merck Research Laboratories, West Point, Pennsylvania 19486; and
PAREXEL International, Durham, North Carolina 27713
This report describes the results of a survey designed to evaluate the contribution of F1 neurobehavioral testing to hazard identification and characterization in safety assessment studies. (To review the details of the distributed survey, please see the supplementary data for this article on the journal’s Web site.) The survey provided information about studies completed in industrial laboratories in the United States, Europe, and Japan since 1990 on 174 compounds. The types of compounds included were pharmaceutical (81%), agricultural (7%), industrial (1%), or were undefined (10%). Information collected included the intended use of the test agent, general study design and methodology, the types and characteristics of F1 behavioral evaluations, and the frequency with which agents affected neurobehavioral parameters in comparison to other F0 and F1 generation parameters. F1 general toxicology parameters such as mortality, pre- and postweaning body weight, and food intake were assessed in most studies and were affected more frequently than other parameters by the test agents. F1 behavioral parameters were assessed less consistently across studies, and were less frequently affected by the agents tested. Although affected by agents less often than general toxicology parameters, F1 behavioral parameters along with other parameters defined the no-observed-effect level (NOEL) in 17/113 (15%) of studies and solely defined the NOEL in 3/113 (2.6%) of studies. Thus, F1 behavioral parameters sometimes improved on the standard toxicological measures of hazard identification. While not detecting agent effects as readily as some measures, the F1 behavioral parameters provide information about agent effects on specialized functions of developing offspring not provided by other standard measures of toxicity. The survey results emphasize the need for further research into the methods of behavioral assessment as well as the mechanisms underlying the neurobehavioral alterations.
Key Words: developmental toxicology; neurobehavioral toxicology; F1 generation assessment; perinatal drug exposure.
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