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An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model

An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model

Published on: July 13, 2009

In vitro skin corrosivity test using human skin.

E Whittle¹, D A Basketter

¹Unilever Environmental Safety Laboratory, Sharnbrook, Beds. MK44 1LQ, UK.

Toxicology in Vitro : an International Journal Published in Association with BIBRA

|August 10, 2010

Summary

The in vitro skin corrosivity test (IVSCT) using human skin reliably identifies corrosive surfactants but not all corrosive fatty acids. This human-based assay may reduce animal testing and improve human skin irritation classification.

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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.

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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.