Retrospective Evaluation of the Eye Irritation Potential of Agrochemical Formulations

Abstract

While multiple in vitro eye irritation methods have been developed and adopted as OECD health effects test guidelines, only one is considered a complete replacement for the in vivo rabbit eye test for classification and labelling for eye irritation hazard. Additionally, for most of the adopted methods there is a data gap on the applicability to predict the ocular irritation potential of agrochemical formulations. To overcome this data gap, a retrospective evaluation of 192 agrochemical formulations with in vivo (OECD TG 405) or in vitro (OECD TG 437, 439, or 492) data was conducted to determine if the in vitro methods could accurately assign United Nations Globally Harmonized System for Classification and Labelling of Chemicals (GHS) eye irritation hazard classifications. In addition, for each of the final formulations and their individual components, we also conducted an evaluation of the GHS concentration threshold (CT) approach. The results herein suggest that the four individual methods and GHS CT approach were highly predictive of formulations that would not require classification for eye irritation hazard. Given most agrochemical formulations fall into this category, methods that accurately identify not classified mixtures could significantly reduce the use of animals for this endpoint.