The OptiSafeTM test is a shelf-stable, test tube-based test that can be used to rapidly discriminate ocular irritants/corrosives from nonirritants.
· It does not use or harm animals.
· It has the lowest false-negative rate and highest comparative accuracy of any other nonanimal ocular irritation test.
OptiSafe can be used to determine whether an unknown substance is an ocular nonirritant or ocular corrosive using chemical models of three variables: 1) damage to the corneal stroma, 2) damage to phospholipid bilayers, and 3) the potential to induce pH extremes in a system (pH buffering system of the eye). Optical density (OD) measurements and pH are used to calculate a score that is applied to prediction models for labeling substances based on the Globally Harmonized System of Ocular Irritation Classification (GHS) as not classified (NC) or GHS category 1 (ocular corrosive). The score can also be used to classify substances using the Environmental Protection Agency (EPA) classification system for categories IV (nonirritant) and I (ocular corrosive).
Previously, we compared the Bovine Corneal Opacity and Permeability, EpiOcular™, Isolated Chicken Eye, Ocular Irritection®, OptiSafe, and Short Time Exposure tests, and found that OptiSafe had the lowest false-negative rate (OptiSafe was the only test to show no FNs) and highest comparative accuracy (Lebrun et al., 2020). Overall, OptiSafe performed better than all other test methods to which it was compared with differences in performance attributable to the superior sensitivity of the OptiSafe method.
OptiSafe was validated in collaboration with NICEATM, ICCVAM, and the NTP. The NTP provided coded vials of the selected test chemicals to three independent laboratories. Interlaboratory reproducibility, accuracy, and false-negative rates were 91%, 89%, and 0%, respectively, for both the EPA and GHS classification systems. The false-positive rates were 23% for the GHS classification system and 25% for the EPA classification system. There was low variation in irritation scores with similar final classifications, with transferability greater than 90%. These findings demonstrate reproducibility and reliability in the manufacturing processes with little or no lot-to-lot variability. The validation study’s data are consistent with the initial prevalidation data submitted to NICEATM and reviewed by ICCVAM, in which it was concluded that OptiSafe compares favorably with other nonanimal test methods.
Read More Same-chemical comparison of nonanimal eye irritation test methods: Bovine Corneal Opacity and Permeability, EpiOcular™, Isolated Chicken Eye, Ocular Irritection®, OptiSafe™, and Short Time Exposure
OptiSafe was developed by Lebrun Labs LLC with funding from a National Institute of Environmental Health Sciences (NIEHS) Small Business Innovative Research Grant: “Non-Animal Test Method to Determine the Ocular Safety of Consumer Products and Chemicals: Phase II.” This research was supported by the NIEHS of the National Institutes of Health under Award Number R44ES025501. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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