Evaluation of the eye hazard potential of manganese chelate of lysine using the Bovine Corneal Opacity and Permeability test

A new product is developed by Metex Noovistago (Metex) aimed for animal nutrition. The new product is a manganese chelate of lysine. This report describes the evaluation of the eye hazard potential, relevant to workers safety aspects for the handling of this product, which is an important aspect for Metex. Following the previous study using the EpiOcular™ Cornea Epithelial model, where no predictions could be made regarding the items’ classification [11], a representative sample of the manganese chelate of lysine was evaluated for the eye hazard potential as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea. The study design that was used is based on the most recent OECD Guideline (437 - Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants). Based on experiments performed on control samples, it was concluded that the test conditions were adequate and that the test system functioned properly. The manganese chelate of lysine induced ocular irritation through one endpoint (opacity), resulting in a mean in vitro irritancy score of 13 after 240 minutes of treatment. According to the classification UN GHS, the score falls to the range IVIS > 3; ≤ 55, and based on that no prediction on the classification of the test item’s eye hazard potential can be made. Therefore, the results of this test method are not conclusive. In line with EFSA recommendation for the risk assessment of the eye hazard potential, the test item should further investigated using a more sensitive method (Eye Irritation Study OECD 405).