Evaluation of the EYTEX(TM) system in the COLIPA eye irritation program

Area of Science:

• Cosmetic Science
• Toxicology
• In Vitro Testing

Background:

• European Directive 6th Amendment mandates in vitro tests for cosmetic ocular risk assessment.
• Industry research focuses on developing validated alternative methods to animal testing.
• The European Cosmetic Toiletry and Perfumery Association (COLIPA) initiated a validation study for in vitro eye irritation tests.

Purpose of the Study:

• To validate available in vitro methods for assessing eye irritation potential of cosmetic ingredients and products.
• To evaluate the performance of the EYTEX assay within an international, multicentric validation study.
• To identify limitations and areas for improvement in the EYTEX assay for ocular risk assessment.

Main Methods:

• International multicentric study involving three laboratories.
• Assessment of alternative in vitro methods, including the EYTEX assay.
• Analysis of prediction models and protocols used in the COLIPA validation study.

Main Results:

• The EYTEX assay demonstrated low relevance and reliability in two laboratories and limited compatibility in another.
• Inconsistent sample qualification across laboratories highlighted issues with the assay's qualification process.
• The study found that criteria for prediction models were not rigorous enough, and mixing EYTEX protocols was unsuitable.

Conclusions:

• The EYTEX assay is not suitable for assessing eye irritation potential of surfactants and surfactant-based formulations.
• The EYTEX assay is not ready for validation studies requiring well-defined mathematical prediction models.
• Further internal studies with specific benchmarks on emulsions may be more adaptable for the EYTEX assay.