A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides.
A review of publications on pesticides assessing the need for 1-year toxicity studies in dogs was performed. Four key peer-reviewed papers with different approaches investigated the value of a 1-year dog study in addition to a 3-month study. Despite different databases and approaches, each concluded with the recommendation to limit the testing of pesticides in dogs to a duration of 3 months. The combined weight of evidence presented in this review reinforces these independent conclusions. Therefore, the routine inclusion of a 1-year dog study as a mandated regulatory requirement for the safety assessment of pesticides is no longer justifiable and a globally harmonized approach should be taken to match the latest legislation of the European Union and the US EPA.
Kobel
Werner
W
ToxAdvice GmbH, Reinach BL, Switzerland. werner.kobel@toxadvice.com
Fegert
Ivana
I
Billington
Richard
R
Lewis
Richard
R
Bentley
Karin
K
Bomann
Werner
W
Botham
Phil
P
Stahl
Bernhard
B
Ravenzwaay
Bennard van
Bv
Spielmann
Horst
H
D000818:Animals; D004285:Dogs; D005062:European Union; D006801:Humans; D007391:International Cooperation; D010575:Pesticides / Q000633:toxicity*; D013045:Species Specificity; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods*; D014481:United States; D014484:United States Environmental Protection Agency
D010575:Pesticides