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) |
