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In Vitro Skin Irritation Test: Reconstructed Human Epidermis (RHE)

In Vitro Skin Irritation Test: Reconstructed Human Epidermis (RHE)

The in vitro skin irritation test is used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally harmonized system of classification and labelling (GHS) Category 2. It helps predict the potential of test compound to cause dermal irritation.

Test Model EpiDerm, MatTek
Replicates N=3 tissues per test condition
Assay Controls Negative control: Sterile phosphate buffer
Positive control: 5% Sodium dodecyl sulphate
Exposure Time 1-hour topical exposure to EpiDerm
30μl or 25mg 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 10 days

Acceptable OD value for EpiDerm model:

  • Lower acceptance limit: ≥ 0.8
  • Upper acceptance limit: ≤ 2.8
Mean tissue viability (%) Category Data prediction
≤ 50% Category 2 Irritant (I)
> 50% No category Non Irritant (NI)

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