title: Porcine Corneal Ocular Reversibility Assay (PorCORA) predicts ocular damage and recovery for global regulatory agency hazard categories.
abstract: In this study, we examined the capacity of the Porcine Corneal Ocular Reversibility Assay (PorCORA) to classify the reversibility of ocular effects for 32 test compounds (20 reversible, 12 irreversible) from various chemical classes. PorCORA predicted 28 of 32 compounds correctly when compared to historical rabbit eye test data. The correlation coefficient for PorCORA versus historical rabbit test data was 0.84, based on the last day of damaged cornea reversal. These results demonstrate a high correlation between corneal irritation recovery time in the PorCORA and the rabbit eye. When compared to historical Modified Maximal Average Score (MMAS) in rabbit eyes, PorCORA yielded a correlation coefficient of 0.80, demonstrating ability to predict MMAS. PorCORA was highly predictive of regulatory agency ocular hazard classification categories, resulting in 91% accuracy for EU R41 and GHS Category 1. PorCORA was also predictive of EPA Category I (88% accuracy). Overall, the accuracy (88-91%), sensitivity (79-86%), specificity (94%), positive predictivity (94%), and negative predictivity (85-89%) for all three regulatory classifications indicate that ocular irritation hazardous effects were well predicted by the PorCORA. This study suggests that PorCORA could help discriminate between EU R36 and R41, GHS Categories 1 and 2, and EPA Categories I and II.
authors.affiliation: MB Research Laboratories, 1524 Wentz Road, Spinnerstown, PA 18968, United States. info@mbresearch.com
authors.forename: Michelle
authors.initials: M
authors.lastname: Piehl
authors.forename: Micheal
authors.initials: M
authors.lastname: Carathers
authors.forename: Rachel
authors.initials: R
authors.lastname: Soda
authors.forename: Daniel
authors.initials: D
authors.lastname: Cerven
authors.forename: George
authors.initials: G
authors.lastname: DeGeorge
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D003315:Cornea / Q000187:drug effects*; D005062:European Union; D005123:Eye / Q000187:drug effects*; D007509:Irritants / Q000633:toxicity*; D011237:Predictive Value of Tests; D011817:Rabbits; D015203:Reproducibility of Results; D012926:Social Control, Formal; D013501:Surface-Active Agents / Q000633:toxicity; D013552:Swine; D018675:Toxicity Tests / Q000379:methods*; D014480:United Nations / Q000331:legislation & jurisprudence; D014481:United States; D014484:United States Environmental Protection Agency / Q000331:legislation & jurisprudence
chemical_list: D007509:Irritants; D013501:Surface-Active Agents