Predicting Chemically Induced Skin Sensitization by Using In Chemico / In Vitro Methods.

Area of Science:

• Toxicology
• Dermatology
• Chemical Safety

Background:

• The assessment of skin sensitization hazard is transitioning from animal testing to non-animal methods.
• These methods align with the OECD Adverse Outcome Pathway (AOP) for skin sensitization, focusing on protein reactivity.

Purpose of the Study:

• To present validated in chemico/in vitro methods for key events (KEs) 1-3 of the skin sensitization AOP.
• To illustrate defined approaches for combining these methods for hazard identification and assessment.

Main Methods:

• Utilizing validated and regulatory-adopted in chemico/in vitro assays targeting specific mechanistic events (key events) in skin sensitization.
• Applying defined approaches to combine data from individual test methods.

Main Results:

• Validated methods for KEs 1-3 are available and presented.
• Two examples of defined approaches for combining methods are provided to demonstrate practical application.

Conclusions:

• Individual non-animal methods address single mechanistic events, necessitating combination for comprehensive assessment.
• Defined approaches integrating validated methods offer a pathway for robust skin sensitization hazard identification and assessment, moving away from animal testing.