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An in vitro human skin test for assessing sensitization potential
S S Ahmed1, X N Wang2, M Fielding2
1Alcyomics Ltd, Bulman House, Regent Centre, Gosforth, Newcastle-upon-Tyne, NE3 3LS, UK.
Journal of Applied Toxicology : JAT
|August 8, 2015
Summary
A novel human in-vitro skin explant test accurately identifies skin sensitization hazards and potency. This animal-free method shows high concordance with established assays, offering a reliable alternative for chemical safety assessment.
Area of Science:
- Toxicology
- Dermatology
- In vitro methods
Background:
- Chemical sensitization leading to allergies is a significant public health concern.
- The mouse local lymph node assay (LLNA) is the current standard for identifying skin sensitizers but raises ethical concerns due to animal use.
- There is a critical need for validated, animal-free alternatives for assessing chemical sensitization hazards.
Purpose of the Study:
- To introduce and validate a human in-vitro skin explant test for identifying skin sensitization hazards.
- To assess the relative potency of skin sensitizing chemicals using this novel in-vitro method.
- To establish the reliability and accuracy of the skin explant test compared to existing methods and human data.
Main Methods:
- A human in-vitro skin explant test was developed, measuring histological damage in human skin explants as an indicator of immune response.
- The test was applied to 44 diverse chemicals, including known sensitizers, non-sensitizers, and irritants.
- Results were compared against the mouse local lymph node assay (LLNA) and published human sensitization data.
Main Results:
- The skin explant test demonstrated high accuracy, achieving 95% specificity and 95% sensitivity with 95% concordance (correlation coefficient 0.9) against the LLNA.
- Comparable accuracy (95% specificity, 95% sensitivity, correlation coefficient 0.91) was observed when compared to human sensitization data.
- The test correctly identified nickel sulfate as a sensitizer, a compound misclassified by the LLNA, and correlated with T cell proliferation and IFNγ production.
Conclusions:
- The human in-vitro skin explant test is a reliable and accurate animal-free method for identifying skin sensitization hazards and assessing potency.
- This novel approach offers a promising alternative to animal testing for the initial stages of chemical risk assessment.
- The test's ability to correctly classify challenging compounds like nickel sulfate highlights its potential to improve chemical safety evaluations.
