| Autor: |
Spöler, Felix, Kray, Oya, Kray, Stefan, Panfil, Claudia, Schrage, Norbert F. |
| Zdroj: |
Alternatives to Laboratory Animals; July 2015, Vol. 43 Issue: 3 p163-179, 17p |
| Abstrakt: |
Ocular irritation testing is a common requirement for the classification, labelling and packaging of chemicals (substances and mixtures). The in vivoDraize rabbit eye test (OECD Test Guideline 405) is considered to be the regulatory reference method for the classification of chemicals according to their potential to induce eye injury. In the Draize test, chemicals are applied to rabbit eyes in vivo, and changes are monitored over time. If no damage is observed, the chemical is not categorised. Otherwise, the classification depends on the severity and reversibility of the damage. Alternative test methods have to be designed to match the classifications from the in vivoreference method. However, observation of damage reversibility is usually not possible in vitro.Within the present study, a new organotypic method based on rabbit corneas obtained from food production is demonstrated to close this gap. The Ex VivoEye Irritation Test (EVEIT) retains the full biochemical activity of the corneal epithelium, epithelial stem cells and endothelium. This permits the in-depth analysis of ocular chemical trauma beyond that achievable by using established in vitromethods. In particular, the EVEIT is the first test to permit the direct monitoring of recovery of all corneal layers after damage. To develop a prediction model for the EVEIT that is comparable to the GHS system, 37 reference chemicals were analysed. The experimental data were used to derive a three-level potency ranking of eye irritation and corrosion that best fits the GHS categorisation. In vivodata available in the literature were used for comparison. When compared with GHS classification predictions, the overall accuracy of the three-level potency ranking was 78%. The classification of chemicals as irritating versusnon-irritating resulted in 96% sensitivity, 91% specificity and 95% accuracy. |
| Databáze: |
Supplemental Index |
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