Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid
N Alépée1, V Leblanc1, E Adriaens2
1L'Oréal Research & Innovation, Aulnay Sous Bois, France.
Summary
The SkinEthic™ HCE in vitro test method effectively identifies chemicals for eye damage classification. This reproducible assay demonstrates high accuracy and sensitivity, making it a valuable tool for eye irritation risk assessment.
Area of Science:
- Toxicology and In Vitro Testing
- Chemical Safety and Risk Assessment
Background:
- The need for reliable in vitro methods to assess chemical eye irritation is critical for regulatory compliance and safety.
- Existing methods require validation for transferability, reproducibility, and predictive capacity across different laboratories and chemical datasets.
Purpose of the Study:
- To evaluate the reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) for classifying chemicals regarding serious eye damage/eye irritation (UN GHS).
- To demonstrate the transferability and reproducibility of the SkinEthic™ HCE Eye Irritation Test for Liquids (EITL) protocol.
- To define the predictive capacity of the SkinEthic™ HCE EITL assay.
Main Methods:
- A prospective multicentric study involving 60 chemicals tested in triplicate (double-blinded) across three laboratories.
- An extended dataset included an additional 45 chemicals tested in triplicate within a single laboratory.
- Statistical analysis, including bootstrap resampling, was used to determine accuracy, sensitivity, and specificity.
Main Results:
- High within-laboratory reproducibility was achieved: 88.3% (53/60) and 92.4% (97/105) for the extended dataset.
- Overall concordance between laboratories was excellent at 93.3% (56/60).
- The assay demonstrated strong predictive capacity with an accuracy of 84.4% (95% CI: 81.9%–87.6%), sensitivity of 99.0% (95% CI: 96.4%–100%), and specificity of 68.5% (95% CI: 64.0%–74.0%).
Conclusions:
- The SkinEthic™ HCE EITL assay is an efficient, transferable, and reproducible method for eye irritation testing.
- The assay meets acceptance criteria for predictive capacity, supporting its use in regulatory risk assessments.
- This in vitro method is a promising tool for integration into a battery of assays for comprehensive eye irritation risk assessment.
