Integrated strategy for eye irritation assessment of agrochemical formulations

RIVERO, MARTIN NICOLAS; LENZE, MARIELA; IZAGUIRRE, MERCEDES; PINA, JUAN IGNACIO; WIKINSKI, SILVIA; GUTIÉRREZ, MARÍA LAURA

Maastricht

Congreso; 11th World Congress; 2021

For the registration of agrochemical formulations, acute eye toxicity assessment is required by regulatory agencies. The Draize rabbit eye test (OECD TG 405) has worldwide acceptance to assess eye irritation, even it has been increasingly questioned. The test distinguishes four categories considering reversible and non-reversible ocular lesions according to UN GHS Category 1 (severe eye damage), 2A and 2B (reversible eye damage) and No Category (minimal effects). Bovine Corneal Opacity and Permeability (BCOP) and Short Time Exposure (STE) are methods for identifying Cat. 1 and No Cat. products, according to OECD TG 437 and TG 491 respectively. The limitation of both methods is to classify in the middle-range categories (2A and 2B). The aim of this work was to integrate the results of different methodologies to identify these categories. The BCOP and STE methods were used to test 17 pesticides manufactured by ATANOR SCA. These products had been previously classified in categories 1, 2A, 2B or No Cat. using the Draize eye irritation test. Using the BCOP test, liquid products were tested neat and at 10% and then corneal histopathological analysis was performed. By STE test, 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 the sensitivity and specificity of each method, we have distinguished the products into three categories: 1, 2A+2B and No Cat. with an accuracy of 76.5% (13 of 17). The remaining 23,5% corresponds to products whose damage was overestimated with respect to the in vivo test (there were no cases of low estimation). Finally, we successfully established an in-house strategy for testing agrochemicals eye irritation.