In 2014, the European Chemical Industry Council (Cefic) launched a research initiative to investigate in vitro testing strategies for eye irritation. Based on this initiative, a consortium, led by the Flemish Institute for Technological Research (VITO), has been formed and is named the Consortium for in vitro Eye Irritation testing strategy, or CON4EI.
In total, eight different groups including Adriaens Consulting bvba, L’Oréal Research & Innovation, Institute of Industrial Organic Chemistry, Envigo, MatTek, In Vitro Life Science Laboratories, Ghent University – Laboratory of Pharmaceutical Sciences and Cyprotex are part of the Consortium, and these partners are conducting eight test methods, with results to-date being presented at Eurotox 2015 in Porto, Portugal and the EUSAAT congress in Linz, Austria. Both conferences take place next month.
80 chemicals have been selected based on existing in vivo data and will be testing in the following test methods:
- Distinguish between UN GHS Category 1 and No Category
- Bovine Corneal Opacity and Permeability (BCOP) – OECD Test Guideline 437
- Isolated Chicken Eye (ICE) – OECD Test Guideline 438
- Short Time Exposure (STE) – OECD Test Guideline 491
- Distinguish between UN GHS Category 1/Category 2 and Not Classified
- EpiOcular™ Eye Irritation Test (EIT) – OECD Test Guideline 492
- SkinEthic™ Human Corneal Epithelial (HCE)
- Distinguish between UN GHS Category 1 and Category 2
- Histopathology in association with BCOP and ICE
- EpiOcular™ ET-50 (time-to-toxicity test)
- Slug Mucosal Irritation (SMI)
- BCOP-laser light-based opacitometer (BCOP-LLBO)
Cyprotex US has been selected to perform the Short Time Exposure (STE) for Serious Eye Damage on these 80 test articles on the behalf of CON4EI.
Following test completion and data delivery, the reliability of the in vitro methods will be evaluated, areas of applicability will be assigned and the strengths and limitations of each method will be assessed. Ultimately, a tiered approach will be created based on applicable test methods that can distinguish UN GHS No Category versus Category 1 and Category 2 versus Category 1.