June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Performance assessment of QobuR-RhCE – a cruelty-free in vitro cornea model
Author Affiliations & Notes
  • Manuel Chacon
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Natalia Vázquez
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Mairobi Persinal-Medina
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Sergio Alonso-Alonso
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Ignacio Alcalde
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Jesus Merayo-Lloves
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Alvaro Meana
    Instituto Universitario Fernández-Vega - Fundación de Investigación Oftalmológica - Universidad de Oviedo, Oviedo, Spain
  • Footnotes
    Commercial Relationships   Manuel Chacon None; Natalia Vázquez None; Mairobi Persinal-Medina None; Sergio Alonso-Alonso None; Ignacio Alcalde None; Jesus Merayo-Lloves None; Alvaro Meana None
  • Footnotes
    Support  PID2019-111745RB-I00 - SAFECHEM
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 686 – F0140. doi:
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    • Get Citation

      Manuel Chacon, Natalia Vázquez, Mairobi Persinal-Medina, Sergio Alonso-Alonso, Ignacio Alcalde, Jesus Merayo-Lloves, Alvaro Meana; Performance assessment of QobuR-RhCE – a cruelty-free in vitro cornea model. Invest. Ophthalmol. Vis. Sci. 2022;63(7):686 – F0140.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To replace the Draize eye irritation test (OECD Test Guideline 404), several test methods based on reconstructed cornea-like epithelium (RhCE) have been developed and adopted in the OECD TG 492. The objective of this study was to define the essential structural, functional and procedural elements and to stablish the experimental procedures and evaluate the performance assessment of QobuR-RhCE, an in-house cruelty-free RhCE model to be used for the evaluation of eye hazard

Methods : QobuR-RhCE consists in normal human corneal epithelial cells cultured at the air-liquid interface forming a stratified squamous epithelium resembling a native human corneal epithelium
Essential test method components consisting of structural, functional and procedural elements were evaluated and standardized. These components included unique characteristics of the test method (i.e. histology), critical procedural details (i.e. barrier function) and quality control measures
Performance assessment was evaluated in accordance with the revised performance standards for the assessment of proposed similar or modified in vitro reconstructed human cornea-like epithelium and the minimum list of reference chemicals was evaluated on QobuR-RhCE. In addition to standard cell viability evaluation, we describe a secondary endpoint based on Transepithelial Electrical Resistance (TEER) that could be of use to better discriminate between irritants and non-irritants
Accuracy, specificity, sensitivity and within-laboratory reproducibility (WLR) were calculated according to the OECD Performance Standards for the assessment of proposed similar or modified in vitro RhCE test methods for Eye Hazard

Results : As result, the proposed method scored 93.3% sensibility, 60% specificity, 76.7% accuracy and 96.7% WLR, providing a similar performance in comparison to the validated reference methods. The inclusion of TEER as a barrier disruption predictor provided additional information for safety assessment that could be of interest during the evaluation of particular chemical products such as borderline chemical products, colored compounds or direct MTT reducers

Conclusions : The results of this study suggest that QobuR-RhCE test method is capable of fulfilling the performance standards as described in OECD TG 492 for similar in vitro RhCE test methods for eye hazard, suggesting that QobuR-RhCE is a reliable method for predicting eye irritation

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

 

Quality control analyses

Quality control analyses

 

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