In vitro skin corrosivity test using human skin

Area of Science:

• Toxicology and Dermal Science
• In Vitro Testing Methodologies

Background:

• The in vitro skin corrosivity test (IVSCT) is a validated alternative to animal testing for classifying corrosive substances.
• The standard assay utilizes ex vivo rat skin to measure transcutaneous electrical resistance (TER) reduction by corrosive agents.

Purpose of the Study:

• To evaluate the efficacy of the IVSCT using human skin for direct assessment of human skin corrosivity.
• To establish a TER threshold for in vitro classification of corrosive substances using human skin.
• To compare in vitro human skin corrosivity classifications with existing animal-derived data.

Main Methods:

• Developed and validated an in vitro skin corrosivity test (IVSCT) utilizing human skin.
• Determined a transcutaneous electrical resistance (TER) threshold for classifying substances as corrosive.
• Tested 12 reference substances, 15 surfactants, and 8 fatty acid substances.

Main Results:

• Established a reliable TER threshold for in vitro corrosivity classification using human skin.
• The IVSCT correctly identified 3 out of 3 corrosive surfactants.
• The IVSCT did not identify any of the 4 corrosive fatty acids as corrosive in vitro, suggesting potential misclassification based on animal data.

Conclusions:

• The IVSCT using human skin is a promising method for assessing human skin corrosivity.
• This human-based approach may lead to more accurate classification of skin irritation potential compared to animal data.
• The IVSCT, combined with human patch testing, can contribute to reducing animal testing.