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

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. Predict the potential of test compound to cause dermal irritation

Test ModelEpi Derm, Mattek
ReplicatesN=3 tissues per test condition
Assay ControlsNegative Control – Sterile Phosphate buffer
Positive Control – 5% Sodium dodecyl Sulphate
Exposure Time1 hour topical exposure to Epi derm
30μl or 25mg of test material per tissue
Test Item Quantity0.5 ml or 500 mg
End PointMTT Tissue Viability Assay
Data Delivery% relative viability ± SD
Timeline10 days

Acceptable OD value for Epi derm Model:

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

Mean tissue
viability (%)
CategoryData
prediction
≤ 50%Category 2Irritant (I)
> 50% No CategoryNon Irritant
(NI)

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