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A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment 

Authors: Ralph L. Cooper a;  James C. Lamb IV b;  Sue M. Barlow c;  Karin Bentley d;  Angela M. Brady e;  Nancy G. Doerrer f;  David L. Eisenbrandt g;  Penelope A. Fenner-Crisp h;  Ronald N. Hines i;  Lorraine F. H. Irvine j;  Carole A. Kimmel k;  Herman Koeter l;  Abby A. Li m;  Susan L. Makris k;  Larry P. Sheets n;  Gerrit J. A. Speijers o; Karen E. Whitby p
Affiliations:   a U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory, Research Triangle Park, North Carolina, USA
b THE WEINBERG GROUP, INC., Washington, DC, USA
c Independent Consultant in Toxicology, Brighton, United Kingdom
d DuPont Crop Protection, Newark, Delaware, USA
e Syngenta CTL, Macclesfield, United Kingdom
f ILSI Health and Environmental Sciences Institute, Washington, DC, USA
g Dow AgroSciences LLC, Indianapolis, Indiana, USA
h ILSI Risk Science Institute, Washington, DC, USA
i Medical College of Wisconsin, Milwaukee, Wisconsin, USA
j toXcel International Ltd, Cheltenham, United Kingdom
k U.S. Environmental Protection Agency, National Center for Environmental Assessment, Washington, DC, USA
l European Food Safety Authority, Parma, Italy
m Exponent, San Francisco, California, USA
n Bayer Corporation, Stilwell, Kansas, USA
o National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands
p U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC, USA
DOI: 10.1080/10408440500541367
Publication Frequency: 10 issues per year
Published in: journal Critical Reviews in Toxicology, Volume 36, Issue 1 January 2006 , pages 69 - 98
Subject: Toxicology;
Formats available: HTML (English) : PDF (English)
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Abstract

Aproposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studies are scientifically appropriate and necessary without being redundant, and that tests emphasize toxicological endpoints and exposure durations that are relevant for risk assessment. The ACSA Life Stages Task Force proposes a tiered approach to toxicity testing that assesses a compound's potential to cause adverse effects on reproduction, and that assesses the nature and severity of effects during development and adolescence, with consideration of the sensitivity of the elderly. While incorporating many features from current guideline studies, the proposed approach includes a novel rat reproduction and developmental study with enhanced endpoints and a rabbit development study. All available data, including toxicokinetics, ADMEdata, and systemic toxicity information, are considered in the design and interpretation of studies. Compared to existing testing strategies, the proposed approach uses fewer animals, provides information on the young animal, and includes an estimation of human exposure potential for making decisions about the extent of testing required.
Keywords: Agricultural Chemicals; Developmental; Life Stages; Reproductive; Risk Assessment; Tiered Testing
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