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

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

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

Team Title

Designation

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