The in vitro eye irritation test is used to evaluate the eye hazard potential of a test chemical based on its ability to induce cytotoxicity in a RhCE tissue construct as measured by the tetrazolium dye.
| Test model | EpiOcular Tissues |
| Replicates | N=2 tissues per test condition |
| Assay controls | Negative control: Ultrapure water Positive control: Methyl acetate |
| Exposure time | 6 hours (±0.25 h) – Solids 30 min (±2 min) – Liquids 50 μL or 50 mg of test material per tissue |
| Test item quantity | 0.5 ml or 500 mg |
| End point | MTT Tissue viability assay |
| Data delivery | % relative viability ± SD |
| Timeline | 15 days |
Acceptable OD value for EpiDerm model:
- Lower acceptance limit: ≥ 0.8
- Upper acceptance limit: ≤ 2.8
| Mean tissue viability (%) | Data prediction |
| ≤ 60% | Irritant (I) |
| > 60% | Non-irritant (NI) |
