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Development of an in vitro method for skin corrosion testing
M A Perkins1, R Osborne, G R Johnson
1Procter & Gamble Company, Human Safety Department, Cincinnati, Ohio 45253-8707, USA.
Summary
This study developed an in vitro skin corrosion test using reconstructed human skin cultures. The new method accurately distinguishes corrosive chemicals from irritants, offering a promising alternative to traditional rabbit tests for chemical safety assessment.
Area of Science:
- Toxicology
- Dermatology
- In Vitro Testing
Background:
- Chemical safety regulations mandate accurate skin corrosion assessments.
- Traditional in vivo rabbit skin tests are ethically and practically challenging.
- Development of reliable in vitro alternatives is crucial for regulatory compliance and animal welfare.
Purpose of the Study:
- To develop and validate an in vitro skin corrosion test using reconstructed human skin cultures.
- To establish a reliable alternative to in vivo rabbit testing for chemical classification.
- To assess the predictive accuracy of the in vitro method for distinguishing corrosive from irritant chemicals.
Main Methods:
- Application of test chemicals to the stratum corneum of reconstructed human skin cultures.
- Measurement of cytotoxicity via 3-[4,5-dimethylthiazol-2-yl] 2,5-diphenyltetrazolium bromide (MTT) vital dye metabolism.
- Calculation of the time to 50% reduction in MTT metabolism (t50) and histological grading of epidermal necrosis.
Main Results:
- The in vitro method accurately distinguished 9 corrosive chemicals from 15 irritants with a t50 cutoff of < 3 minutes.
- Histological examination correlated well with chemical corrosivity and cytotoxicity measurements.
- The assay demonstrated consistent predictivity across skin culture models from different suppliers.
Conclusions:
- The in vitro assay using human skin equivalent cultures is a viable and promising alternative to in vivo rabbit skin corrosion tests.
- This method provides a reliable tool for assessing chemical corrosivity to human skin.
- The utility of the assay is independent of the commercial source of the skin cultures, enhancing its applicability.