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DIRECT DOSING OF PRE-WEANING RODENTS IN TOXICITY TESTING AND RESEARCH: DELIBERATIONS OF AN ILSI RSI EXPERT WORKING GROUP.
Citation:
Moser, V C., I. Walls, AND T. Zoetis. DIRECT DOSING OF PRE-WEANING RODENTS IN TOXICITY TESTING AND RESEARCH: DELIBERATIONS OF AN ILSI RSI EXPERT WORKING GROUP. INTERNATIONAL JOURNAL OF TOXICOLOGY. Taylor & Francis, Inc., Philadelphia, PA, 24:87-94, (2005).
Description:
Laboratory animal studies that are designed to assess the effects of exposure of a test substance during postnatal development are commonly utilized in basic research and to evaluate potential hazard to children for chemical and pharmaceutical regulation. Direct dosing, defined here as the administration of a test substance directly to a pre-weaning mammal, has been identified as a useful tool that can be used in the conduct of such studies. The International Life Sciences Institute Risk Science Institute (ILSI RSI) convened an Expert Working Group to develop guidance on the design and implementation of direct dosing regulatory studies on pre-weaning mammals, which was published as an ILSI monograph in 2003 (Zoetis and Walls). A summary of the Working Group conclusions regarding direct dosing studies with rodents are presented here. The ILSI Expert Working Group concluded that direct dosing of pre-weaning animals is a commonly used methodology that is applicable for use in toxicity testing during postnatal development for risk assessment. Care must be taken to select the appropriate species, route of administration, dose levels, dosing methodologies, and timing and duration of exposure. Successful study design and implementation must also include consideration of pharmaco/toxicokinetic data and knowledge of critical windows of development for the specific organ systems or processes being evaluated. Good experimental design, minimizing confounding variables, and appropriate statistical analyses are required for interpretable studies.