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|Title:||Prospective Validation Study of Reconstructed Human Tissue Models for Eye Irritation Testing|
|Authors:||FREEMAN Stuart; ALEPEE Nathalia; VIEGAS BARROSO JOAO FILIPE; COLE Thomas; COMPAGNONI ANNA; RUBINGH Carina; ESKES Chantra; LAMMERS Jan; MCNAMEE Pauline; PFANNENBECKER Uwe; ZUANG Valerie|
|Citation:||ALTEX-ALTERNATIVEN ZU TIEREXPERIMENTEN vol. 27 no. Special issue p. 255-260|
|Publisher:||SPEKTRUM AKAD VERLAG|
|Type:||Articles in periodicals and books|
|Abstract:||A prospective validation study of two in vitro test methods using Reconstructed human Tissue (RhT) models (MatTek EpiOcular and SkinEthic Human Reconstructed Corneal Epithelium (HCE)) for the detection of eye irritation effects by chemicals, is currently being conducted by Colipa and ECVAM. Pre-validation studies with both test methods have served to optimise protocols and refine prediction models, and have been shown to predict eye irritant properties of test substances with a high degree of accuracy, approximately 80% overall. The current validation study, managed by ECVAM and co-sponsored by Colipa and ECVAM , will evaluate the eye irritant properties of 104 test substances identifying them as either not classified for eye irritancy (NC) or irritant (Cat 1 and Cat 2) within the United Nations Globally Harmonised System (UN GHS). The test methods will not differentiate between moderate (GHS Cat.2) and severe (GHS Cat.1) irritants but will seek to establish the relevance and reliability of the two test methods in an integrated testing strategy that will allow appropriate labelling of novel chemicals without the need for animal testing.|
|JRC Institute:||Institute for Health and Consumer Protection|
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