A tiered approach to life stages testing for agricultural chemical safety assessment.
A proposal 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, ADME data, 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.
Cooper
Ralph L
RL
U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory, Research Triangle Park, North Carolina, USA.
Lamb
James C
JC
Barlow
Sue M
SM
Bentley
Karin
K
Brady
Angela M
AM
Doerrer
Nancy G
NG
Eisenbrandt
David L
DL
Fenner-Crisp
Penelope A
PA
Hines
Ronald N
RN
Irvine
Lorraine F H
LF
Kimmel
Carole A
CA
Koeter
Herman
H
Li
Abby A
AA
Makris
Susan L
SL
Sheets
Larry P
LP
Speijers
Gerrit
G
Whitby
Karen E
KE
D016573:Agrochemicals / Q000633:toxicity*; D000818:Animals; D006801:Humans; D012098:Reproduction / Q000187:drug effects; D017751:Safety Management; D018675:Toxicity Tests / Q000379:methods
D016573:Agrochemicals