PREDICTING EYE IRRITATION OF AGROCHEMICAL FORMULATIONS ACCORDING TO DIFFERENT CLASSIFICATION SCHEMES BY IN VITRO METHODS (BOVINE CORNEAL OPACITY AND PERMEABILITY AND EPIOCULAR EYE IRRITATION TEST).

The bovine corneal opacity and permeability (BCOP) test has been adopted by OECD for the identification of corrosive and severe ocular irritants (GHS category 1) for single component substances and multicomponent formulations. Eye irritation tests with human (EIT) reconstructed tissue models (such as EpiOcular) are capable to predict ocular non‐irritants (GHS no category). Thus the ultimate replacement of the Draize rabbit eye irritation test (OECD TG 405) by a combined or tiered testing strategy could be possible. The purpose of this study was to evaluate whether the BCOP with additional corneal histology together with the EIT could be used to predict eye irritancy of agrochemical formulations according to different classification schemes including UN GHS and EPA systems. We have performed the BCOP (including histology) and the EIT of 50 agrochemical formulations for which in vivo eye irritation data were already available (for registration purposes). Using the OECD TG guideline evaluation scheme for opacity and permeability in the BCOP was not predictive for the agrochemical formulations assessed here, while corneal histology grades and the EpiOcular relative tissue viabilities were useful predictors of eye irritancy potencies and could be applied for the different classification schemes.

Agrochemical, BCOP, Bovine Corneal Opacity and Permeability, Brazilian Classification, Classification schemes, EPA Classification, EpiOcular Eye Irritation Test, UN GHS Classification

Agrochemical formulations