In Vitro Eye Irritation or Serious Eye Damage Test : Reconstructed human Cornea-like Epithelium (RhCE)

In Vitro eye irritation 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 ModelEpi Ocular Tissues
ReplicatesN=2 tissues per test condition
Assay ControlsNegative Control – Ultrapure Water
Positive Control – Methyl acetate
Exposure Time6 hours (±0.25 h) – Solids
30 min (±2 min) – Liquids
50 μL or 50mg of test material per tissue
Test Item Quantity0.5 ml or 500 mg
End PointMTT Tissue Viability Assay
Data Delivery% relative viability ± SD
Timeline15 days

Acceptable OD value for Epi derm Model:

  • Lower acceptance limit: ≥ 0.8
  • Upper acceptance limit: ≤ 2.8

Mean tissue
viability (%)
Data prediction
≤ 60%Irritant (I)
> 60% Non Irritant (NI)

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