Integrated strategy fo reye irritation assessment of agrochemical formulations

MARTÍN NICOLÁS RIVERO; MERCEDES IZAGUIRRE; MARIELA LENZE; JUAN IGNACION PINA; SILVIA WIKINSKI; MARÍA LAURA GUTIÉRREZ

Maastricht

Congreso; 11th WORLD CONGRESS ON ALTERNATIVES AND ANIMAL USE IN THE LIFE SCIENCES; 2021

For the registration of agrochemical formulations, acute eye toxicity assessment isrequired by regulatory agencies. The Draize rabbit eye test (OECD TG 405) hasworldwide acceptance to assess eye irritation, even it has been increasingly questioned.The test distinguishes four categories considering reversible and non-reversible ocularlesions according to UN GHS Categories 1 (severe eye damage), 2A and 2B (reversibleeye damage) and No Category (minimal effects).Bovine Corneal Opacity and Permeability (BCOP) and Short Time Exposure (STE) aremethods for identifying Cat. 1 and No Cat. products, according to OECD TG 437 and TG491 respectively. The limitation of both methods is to classifying in the middle-rangecategories (2A and 2B). The aim of this work was to integrate the results of differentmethodologies to identify these categories.The BCOP and STE methods were used to test 17 pesticides manufactured by ATANORSCA. These products had been previously classified in categories 1, 2A, 2B or No Cat.using the Draize eye irritation test.By the BCOP test, liquid products were tested neat and at 10% and solids at 10%. By STEtest, all formulations were tested at 5 and 0.05%.It is known that BCOP and STE methods have low false negatives to classify No-Cat.products. The STE also has low false positives to classify Cat I. Taking into account thesensitivity and specificity of each method, we have distinguished the products into threecategories: 1, 2A+2B and No Cat. with an accuracy of 76.5% (13 of 17). The remaining23,5% corresponds to products whose damage was over-estimated with respect to the invivo test; there were no cases of low-estimation. The accuracy could improve with thecorneal histopathological analysis data that is still in progress.Finally, we successfully established an in house strategy for testing agrochemicals eyeirritation.