Journal of Clinical Toxicology
Open Access

CON4EI: Consortium for in vitro eye irritation testing strategy

9^th Euro-Global Summit on Toxicology and Applied Pharmacology

June 22-24, 2017 Paris, France

An R Van Rompay, Els Adriaens, Nathalie Alepee, Helena Kandarova, Przemyslaw Fochtman, Robert Guest, Jamin A Willoughby and Sandra Verstraelen

Flemish Institute for Technological Research, Belgium
Adriaens Consulting BVBA, Belgium
Lâ��Or�©al Research and Innovation, France
MatTek In Vitro Life Sciences Laboratories, Slovakia
Institute of Industrial Organic Chemistry Branch Pszczyna, Poland
Envigo, UK
Cyprotex, USA

Posters & Accepted Abstracts: J Clin Toxicol

Abstract :

Measurement of ocular irritancy is a necessary step in the safety evaluation of industrial and consumer products. Assessment of the acute eye irritation potential is therefore part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI project is to identify strategic combinations of alternative test methods within a tiered-testing strategy in order to replace the in vivo Draize eye test. Therefore, a set of 80 reference chemicals covering the most important in vivo drivers of classification, balanced according to the physical form (38 liquids and 42 solids) and representing different chemical classes, was tested in eight in vitro test methods. The set was composed of 15 chemicals not requiring classification (No Cat) and 65 chemicals requiring classification (27 Cat 2 and 38 Cat 1). The performance with regard to the in vivo drivers of classification of the following methods was evaluated individually: BCOP and BCOP-LLBO, ICE, EpiOcular EIT, EpiOcular ET-50, HCE EIT, STE and SMI test method. In a second step, two by two agreement between test methods was evaluated to identify similarities between methods. Finally, different test methods were combined into a testing strategy and the performance was evaluated. These analyses provided evidence that different testing strategies are possible. For example, a combination of the BCOP and HCE EIT test method resulted in an accuracy of 81% with a Cat 1 sensitivity of 86.3%, Cat 2 sensitivity of 63% and 100% specificity. Furthermore, none of the Cat 1 chemicals were identified as No Cat. This was an improvement over the stand alone assays that cannot differentiate between the different categories. Similar results were obtained when the BCOP was combined with HCE EIT or EpiOcular EIT.

Biography :

Email: an.vanrompay@vito.be