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An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model
Published on: July 13, 2009
Skin sensitisation testing--new perspectives and recommendations
W Steiling1, D Basketter, K Berthold
1Henkel KGaA, Henkelstrasse 67, D-40191, Düsseldorf, Germany.
Summary
Reducing animal use in skin sensitization testing is possible. New guidelines improve hazard identification and animal welfare by optimizing guinea pig tests and validating the murine local lymph node assay (LLNA).
Area of Science:
- Toxicology
- Dermatology
- Regulatory Science
Background:
- Exploration of methodological aspects in skin sensitization testing.
- Focus on animal welfare, reliability, and sensitivity of test methods.
- Addressing current and proposed OECD guidelines for skin sensitization tests.
Framework:
- Recommendations for guinea pig maximization test (GPMT) and murine local lymph node assay (LLNA).
- Optimization of animal numbers, use of joint positive controls, and selection of control chemicals.
- Evaluation of rechallenge procedures and pretreatment protocols.
Implementation:
- Halving animal numbers in GPMT is acceptable.
- Joint positive control studies are suitable for coordinated laboratories.
- Alpha-hexyl cinnamic aldehyde is sufficient as a positive control.
- Rechallenge interpretation offers valuable confirmation.
- Discontinuation of sodium lauryl sulfate pretreatment in GPMT.
Implications:
- The LLNA is a validated alternative to traditional guinea pig tests.
- Recommendations enhance hazard identification and labeling accuracy.
- Improved animal welfare through reduced testing.
- Potential for more efficient and reliable skin sensitization assessments.
