CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals

Adriaens, Els; Verstraelen, Sandra; Alépée, Nathalie; Kanďárová, Helena; Drzewiecka, A.; Gruszka, K.; Guest, Robert; Willoughby, Jamin A.; Rompay, An R. Van

doi:10.1016/j.tiv.2017.09.008

Cited by 15 publications

(11 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The three-tiered strategy utilizes the SMI method in conjunction with the corneal epithelial and BCOP methods (classification of Cat 1). For the proposed strategies, 71.1-82.9% Cat 1, 64.2-68.5% Cat 2, and ≥ 80% No Cat chemicals were correctly identified (Adriaens et al 2018b). Important conclusions were that the EpiOcular-EIT and the SkinEthic HCE EIT test methods were able to predict the immediate disruptive effects to the corneal epithelium (corneal opacity), and they were also able to identify chemicals that are classified based on the persistence of the effects at day 21 and or due in part to conjunctival effects (Kandarova et al 2018b;Van Rompay et al 2018).…”

Section: Drivers Of Classification and Tiered Testing Approaches In Eye Irritation Testingmentioning

confidence: 98%

“…For the proposed strategies, 71.1-82.9% Cat 1, 64.2-68.5% Cat 2, and ≥ 80% No Cat chemicals were correctly identified (Adriaens et al 2018b). Important conclusions were that the EpiOcular-EIT and the SkinEthic HCE EIT test methods were able to predict the immediate disruptive effects to the corneal epithelium (corneal opacity), and they were also able to identify chemicals that are classified based on the persistence of the effects at day 21 and or due in part to conjunctival effects (Kandarova et al 2018b;Van Rompay et al 2018). The combination of in vitro 3D corneal epithelial test methods (EpiOcular-EIT and SkinEthic HCE EIT) and ex vivo BCOP LLBO test method grouped with physicochemical analysis in a two-step, bottom-up approach was shown to be applicable for neat liquid materials and resulted in improved specificity (Alépée et al 2019).…”

Section: Drivers Of Classification and Tiered Testing Approaches In Eye Irritation Testingmentioning

confidence: 98%

“…In the last two decades, the development and implementation of an alternative to Draize test methods have been encouraged and substantial effort has focused on the development of both in vitro and ex vivo methods (Hartung 2009;Hartung 2010;Abdelkader et al 2015;Adriaens et al 2018b). In 2004, the 7th amendment to the EU Cosmetics Directive was implemented which prohibited the use of animal testing for finished products (CD_76/768/EEC 2004).…”

Section: Introduction: From Animal Models To Alternative Approachesmentioning

confidence: 99%

See 2 more Smart Citations

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

Kaluzhny

Klausner

2021

In Vitro Cell.Dev.Biol.-Animal

View full text Add to dashboard Cite

Testing of all manufactured products and their ingredients for eye irritation is a regulatory requirement. In the last two decades, the development of alternatives to the in vivo Draize eye irritation test method has substantially advanced due to the improvements in primary cell isolation, cell culture techniques, and media, which have led to improved in vitro corneal tissue models and test methods. Most in vitro models for ocular toxicology attempt to reproduce the corneal epithelial tissue which consists of 4-5 layers of non-keratinized corneal epithelial cells that form tight junctions, thereby limiting the penetration of chemicals, xenobiotics, and pharmaceuticals. Also, significant efforts have been directed toward the development of more complex threedimensional (3D) equivalents to study wound healing, drug permeation, and bioavailability. This review focuses on in vitro reconstructed 3D corneal tissue models and their utilization in ocular toxicology as well as their application to pharmacology and ophthalmic research. Current human 3D corneal epithelial cell culture models have replaced in vivo animal eye irritation tests for many applications, and substantial validation efforts are in progress to verify and approve alternative eye irritation tests for widespread use. The validation of drug absorption models and further development of models and test methods for many ophthalmic and ocular disease applications is required.

show abstract

Section: Drivers Of Classification and Tiered Testing Approaches In Eye Irritation Testingmentioning

confidence: 98%

Section: Drivers Of Classification and Tiered Testing Approaches In Eye Irritation Testingmentioning

confidence: 98%

Section: Introduction: From Animal Models To Alternative Approachesmentioning

confidence: 99%

See 1 more Smart Citation

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

Kaluzhny

Klausner

2021

In Vitro Cell.Dev.Biol.-Animal

View full text Add to dashboard Cite

show abstract

“…Therefore, the criteria that were set during the CONsortium for in vitro Eye Irritation testing strategy (CON4EI) project were used initially to develop DAL-1 and DAL-2. 10 Following the introduction of the DAs to the OECD expert group on eye/skin irritation/corrosion and phototoxicity, Cosmetics Europe proposed target values to assess the performance of DAs for eye hazard identification to distinguish between the three UN GHS categories. The proposed target values considered the uncertainty of the Draize eye test by taking into account the within-and between-test variability.…”

Section: Introductionmentioning

confidence: 99%

“…The proposed target values considered the uncertainty of the Draize eye test by taking into account the within-and between-test variability. [9][10][11] After discussion with the OECD expert group, a con-sensus was reached on the performance criteria to assess the predictivity of DAs.…”

Section: Introductionmentioning

confidence: 99%

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

Alépée

Abo

Adriaens³

et al. 2021

Applied In Vitro Toxicology

View full text Add to dashboard Cite

Introduction: Cosmetics Europe develops two defined approaches (DAs) for eye hazard identification, that is, addressing serious eye damage (Cat. 1), eye irritation (Cat. 2), and the absence thereof (No Cat.), for nonsurfactant liquid test substances. DAL-1 combines four physicochemical properties, the reconstructed human cornea-like epithelium (EpiOcularÔ eye irritation test [EIT]: VRM1 and SkinEthicÔ human corneal epithelium EIT: VRM2) test method (OECD test guideline [TG] 492), and bovine corneal opacity and permeability (BCOP) test method (OECD TG 437). DAL-2 combines the short time exposure test method (OECD TG 491) and the BCOP test method (OECD TG 437). In both DAs, the BCOP with the laser light-based opacitometer is used, however, only opacity is used to identify liquids that cause serious eye damage. Materials and Methods: The performance of the DAs to distinguish between the three United Nations Globally Harmonized System of Classification (UN GHS) categories was compared against the minimum performance values proposed by Cosmetics Europe to the Organisation for Economic Co-operation and Development expert Group on eye/skin irritation/corrosion and phototoxicity and agreed upon by the experts. Furthermore, the classspecific performance metrics are also provided for each DA. Results: The balanced accuracy of DAL-1 with validated reference method-EpiOcular EIT (VRM1), DAL-1 with validated reference method-SkinEthic HCE EIT (VRM2), and DAL-2 was 69.

show abstract

SkinEthic™ HCE Eye Irritation Test: Similar performance demonstrated after long distance shipment and extended storage conditions

Leblanc

Yokota²,

Grandidier

et al. 2019

Toxicology in Vitro

View full text Add to dashboard Cite

CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals

Cited by 15 publications

References 17 publications

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

Performance Statistics of Defined Approaches for Eye Hazard Identification of Non-Surfactant Liquids to Distinguish Between the Three United Nations Globally Harmonized System Categories

SkinEthic™ HCE Eye Irritation Test: Similar performance demonstrated after long distance shipment and extended storage conditions

Contact Info

Product

Resources

About