ToxSci Advance Access published online on August 12, 2003
Toxicological Sciences, doi:10.1093/toxsci/kfg211
Toxicological Sciences © Society of Toxicology 2003; all rights reserved
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1 Dept of Psychiatry & Behavioral Science, Medical University of South Carolina, Charleston, SC
* To whom correspondence should be addressed. E-mail: middauld{at}musc.edu.
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. The survey provided information about studies completed in industrial laboratories in the United States, Europe, and Japan since 1990 on 174 compounds. Types of compounds included pharmaceuticals (81%), agricultural (7%), industrial (1%), or were undefined (10%). Information collected included: 1) intended use of the test agent, 2) general study design and methodology, 3) types and characteristics of F1 behavioral evaluations, and 4) 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 post-weaning 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%) studies, and solely defined the NOEL in 3/113 (2.6%) studies, and thus 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.
© 2003 Society of Toxicology
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Neurobehavioral Assessment: A Survey of Use and Value in Safety Assessment Studies
2 Dept of Physiology/Pharmacology, SUNY-Brooklyn, Brooklyn, NY
3 Exponent, Inc. San Francisco, CA 94114
4 International Life Sciences Institute, Health and Environmental Sciences Institute, Washington, DC
5 Environmental Protection Agency, Washington, DC
6 Toxicology Dept, Bayer CropScience, Stilwell, KS
7 Endo Pharmaceuticals, Inc., Chadds Ford, PA
8 Division of Neurotoxicology, National Center for Toxicological Research, Jefferson, AR
9 Central Research Division, Drug Safety Evaluation, Pfizer, Inc, Groton CT
10 Merck Research Laboratories, West Point, PA
11 PAREXEL International, Durham, NC
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