Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation

Alépée, Nathalie; Bessou‐Touya, S.; Cotovio, José; Smedt, Ann De; Wever, Bart De; Faller, Claudine; Jones, Penelope; Varlet, Béatrice Le; Marrec-Fairley, Monique; Pfannenbecker, U.; Tailhardat, M.; Goethem, Freddy Van; Maiello, Pauline

doi:10.1016/j.tiv.2013.02.009

Cited by 34 publications

(24 citation statements)

References 8 publications

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“…Changes in acidity in response to an irritant are measured using a pH meter, ocular toxicity is evaluated by calculating the reduction in metabolic rate caused by the addition of a test chemical to the culture media compared to the basal metabolic state. CM has been recommended for the identification of GHS Category 1, severe irritants and GHS non irritants (Alépée et al, 2013;OECD, 2012a). The test is limited for use with test substances which do not settle or separate during analysis, primarily water soluble surfactants and surfactant-containing mixtures, but also some non-water-soluble solids, viscous chemicals or suspensions that maintain uniformity during analysis (OECD, 2012a).…”

Section: Cytotoxicity Assessmentmentioning

confidence: 99%

An overview of current techniques for ocular toxicity testing

2015

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Given the hazardous nature of many materials and substances, ocular toxicity testing is required to evaluate the dangers associated with these substances after their exposure to the eye. Historically, animal tests such as the Draize test were exclusively used to determine the level of ocular toxicity by applying a test substance to a live rabbit's eye and evaluating the biological response. In recent years, legislation in many developed countries has been introduced to try to reduce animal testing and promote alternative techniques. These techniques include ex vivo tests on deceased animal tissue, computational models that use algorithms to apply existing data to new chemicals and in vitro assays based on two dimensional (2D) and three dimensional (3D) cell culture models. Here we provide a comprehensive overview of the latest advances in ocular toxicity testing techniques, and discuss the regulatory framework used to evaluate their suitability.

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Section: Cytotoxicity Assessmentmentioning

confidence: 99%

An overview of current techniques for ocular toxicity testing

2015

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“…However, there is a criticism for using viability cutoff point as a sole decision criterion of eye irritation, since moderate or weak eye irritants may be falsely determined as nonirritants, reflecting that sensitive biomarkers for eye irritation are necessary. Indeed, HCE of SkinEthic determined 14 of 38 Category 2A/B substances (UN GHS class, weak or moderate eye irritants) as non-irritants, demonstrating the compromised accuracy for weak or moderate irritants (Alepee et al 2013). In this regard, new biomarkers of eye irritation may be necessary to improve the sensitivity of eye irritation tests using 3D reconstructed cornea models.…”

Section: Introductionmentioning

confidence: 99%

Identification of cornifelin and early growth response-1 gene as novel biomarkers for in vitro eye irritation using a 3D reconstructed human cornea model MCTT HCE™

Choi

Lee²,

Lee

et al. 2014

Arch Toxicol

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Evaluation of the eye irritation is essential in the development of new cosmetic products. Draize rabbit eye irritation test has been widely used in which chemicals are directly applied to rabbit eye, and the symptoms and signs of eyes are scored. However, due to the invasive procedure, it causes substantial pain and discomfort to animals. Recently, we reported in vitro eye irritation test method using a 3D human corneal epithelial model (MCTT HCE™) which is reconstructed from remaining human tissues after a corneal transplantation. This model exhibited an excellent predictive capacity for 25 reference chemicals (sensitivity 100%, specificity 77% and accuracy 88% vs. GHS). To improve the test performance, we explored new biomarkers for the eye irritation through transcriptomic approach. Three surfactants were selected as model eye irritants that include sodium lauryl sulfate, benzalkonium chloride and triton X-100. After test chemicals were treated, we investigated differentially expressed genes through a whole-gene microarray (Affymetrix GeneChip(®) Human Gene 2.0 ST Array, 48,000 probes). As a result, we identified that mRNAs of cornifelin (CNFN), a constituent of the insoluble cornified cell envelope of stratified squamous epithelia, and early growth response-1 (EGR1), a nuclear transcriptional regulator, were significantly up-regulated by all three irritants. Up-regulation of CNFN and EGR1 was further confirmed by Q-RT-PCR, and immunohistochemistry revealed increased level of CNFN in irritant-treated tissues, supporting the relevance of CNFN and EGR1 as new biomarkers for eye irritation.

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“…Two test methods, BCOP and the ICE test, were approved as scientifically valid within a top-down approach to identify "ocular corrosives and severe irritants" (ICCVAM, 2007;ESAC, 2007), which lead to two OECD guidelines in 2009 (OECD, 2009a,b). The BCOP assay appears to be the only suitable assay for the identification of non-classified materials (ICCVAM, 2010).…”

Section: The In Vivo Draize Eye Test To Assess Eye Irritationmentioning

confidence: 99%

Alternative methods for the replacement of eye irritation testing

Lotz¹

2016

ALTEX

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SummaryIn the last decades significant regulatory attempts were made to replace, refine and reduce animal testing to assess the risk of consumer products for the human eye. As the original in vivo Draize eye test is criticized for limited predictivity, costs and ethical issues, several animal-free test methods have been developed to categorize substances according to the global harmonized system (GHS) for eye irritation. This review summarizes the progress of alternative test methods for the assessment of eye irritation. Based on the corneal anatomy and current knowledge of the mechanisms causing eye irritation, different ex vivo and in vitro methods will be presented and discussed with regard to possible limitations and status of regulatory acceptance. In addition to established in vitro models, this review will also highlight emerging, full thickness cornea models that might be suited to predict all GHS categories.

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Cosmetics Europe multi-laboratory pre-validation of the SkinEthic™ reconstituted human corneal epithelium test method for the prediction of eye irritation

Cited by 34 publications

References 8 publications

An overview of current techniques for ocular toxicity testing

An overview of current techniques for ocular toxicity testing

Identification of cornifelin and early growth response-1 gene as novel biomarkers for in vitro eye irritation using a 3D reconstructed human cornea model MCTT HCE™

Alternative methods for the replacement of eye irritation testing

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