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Human-Derived In Vitro Models Used for Skin Toxicity Testing Under REACh
Susanne N Kolle1, Robert Landsiedel2
1BASF SE, Experimental Toxicology and Ecology, Ludwigshafen am Rhein, Germany.
Handbook of Experimental Pharmacology
|November 2, 2020
Summary
Regulatory toxicology is shifting towards human-derived in vitro models for hazard assessment. Defined approaches combine multiple tests for comprehensive regulatory classification, moving beyond traditional in vivo studies.
Area of Science:
- Toxicology
- In vitro methods
- Regulatory science
Background:
- In vivo studies remain dominant in regulatory toxicology, with human-derived in vitro models primarily used for local toxicity assessments (skin, eyes).
- Single in vitro models have limitations in capturing complex cellular events leading to adverse outcomes.
- Defined approaches, combining multiple in vitro methods and data interpretation, are emerging for comprehensive hazard assessment.
Purpose of the Study:
- To provide an overview of the development and regulatory adoption of human-derived in vitro models in toxicology.
- To discuss the process from experimental method development to OECD test guidelines, including standardization and validation.
- To highlight the challenges and future directions of in vitro models in regulatory toxicology.
Main Methods:
- Overview of method development and validation processes for regulatory acceptance.
- Review of current human-derived in vitro models adopted as OECD test guidelines.
- Discussion of defined approaches utilizing batteries of in vitro methods for complex endpoints like skin sensitization.
Main Results:
- Human-derived in vitro models, including reconstructed human epidermis (RhE), are increasingly adopted for regulatory testing (e.g., skin corrosion, irritation, phototoxicity, eye irritation, skin sensitization).
- Defined approaches for skin sensitization are under discussion for regulatory adoption, representing a vanguard for future applications.
- RhE models for genotoxicity and dermal penetration/absorption are developed, validated, and nearing regulatory use.
Conclusions:
- Human-derived in vitro models and defined approaches are crucial for advancing regulatory toxicology beyond traditional animal testing.
- Standardization, validation, and regulatory adoption processes are key to integrating these new methods.
- Future applications will expand to more complex toxicological endpoints, enhancing human relevance and reducing animal use.
