Defined approaches to classify agrochemical formulations into EPA hazard categories developed using EpiOcular TM reconstructed human corneal epithelium and bovine corneal opacity and permeability assays

• Published in: Cutaneous and ocular toxicology Vol. 43; no. 1; pp. 58 - 68
• Main Authors: van der Zalm, Anna J, Daniel, Amber B, Raabe, Hans A, Choksi, Neepa, Flint Silva, Tara, Breeden-Alemi, Julie, O'Dell, Lindsay, Kleinstreuer, Nicole C, Lowit, Anna B, Allen, David G, Clippinger, Amy J
• Format: Journal Article
• Language: English
• Published: England 01-03-2024
• Subjects: Agrochemicals - toxicity; Animal Testing Alternatives; Animals; Cattle; Corneal Opacity - chemically induced; Corneal Opacity - pathology; Epithelium, Corneal - pathology; Eye; Humans; Irritants - toxicity; Permeability; Rabbits; scientific confidence; agrochemicals; human relevance; EpiOcular; EPA; in vitro; regulatory; Draize; BCOP; Eye irritation
• ISSN: 1556-9527; 1556-9535
• DOI: 10.1080/15569527.2023.2275029

Many sectors have seen complete replacement of the
rabbit eye test with reproducible and relevant
and
methods to assess the eye corrosion/irritation potential of chemicals. However, the
rabbit eye test remains the standard test used for agrochemical formulations in some countries. Therefore, two defined approaches (DAs) for assessing conventional agrochemical formulations were developed, using the EpiOcular
Eye Irritation Test (EIT) [Organisation for Economic Co-operation and Development (OECD) test guideline (TG) 492] and the Bovine Corneal Opacity and Permeability (OECD TG 437; BCOP) test with histopathology. Presented here are the results from testing 29 agrochemical formulations, which were evaluated against the United States Environmental Protection Agency's (EPA) pesticide classification system, and assessed using orthogonal validation, rather than direct concordance analysis with the historical
rabbit eye data. Scientific confidence was established by evaluating the methods and testing results using an established framework that considers fitness for purpose, human biological relevance, technical characterisation, data integrity and transparency, and independent review. The
and
methods used in the DAs were demonstrated to be as or more fit for purpose, reliable and relevant than the
rabbit eye test. Overall, there is high scientific confidence in the use of these DAs for assessing the eye corrosion/irritation potential of agrochemical formulations.