The in vitro skin corrosion test is used for the hazard identification of those chemicals and mixtures capable of inducing skin corrosion (UN Globally harmonized system of classification and labelling (GHS) category 1), and in some cases to partially subcategorize corrosives into UN GHS sub-categories 1A or 1B and 1C
| Test model | EpiDerm, MatTek |
| Replicates | N=2 tissues per test condition |
| Assay controls | Negative control: Ultrapure water Positive control: 8N KOH |
|
Exposure time |
1-hour topical exposure to EpiDerm 50 μL or 25 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 |
| 3 minutes < 50% | Corrosive (1A) |
| 3 min ≥ 50% and 1 hour < 15% |
Corrosive (1B and 1C) |
| 3 min ≥ 50% and 1 hour ≥ 15% |
Non-corrosive |
