In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic™ HCE model: Application to 435 substances from consumer products industry

Cotovio, José; Grandidier, Marie-Hélène; Lelièvre, Damien; Bremond, C.; Amsellem, Carolle; Maloug, Saber; Ovigne, Jean-Marc; Loisel-Joubert, Sophie; Lee, Aline Van Der; Minondo, Anne-Marie; Capallere, C.; Bertino, Béatrice; Alépée, Nathalie; Tinois-Tessonneaud, Estelle; Fraissinette, Anne de Brugerolle de; Meunier, Jean‐Roch; Leclaire, Jacques

doi:10.1016/j.tiv.2009.11.010

Cited by 42 publications

(22 citation statements)

References 22 publications

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“…According to Cotovio et al (2010), the assessment of ocular irritation is also one of the primary procedures to evaluate and hazard classify a new substance. The in vivo Draize irritation rabbit eye test continues to be described in the current OECD test guidelines, but ethical questions are lead-ing to the development of in vitro alternative tests, such as Human Corneal Epithelial Model (SkinEthic TM HCE), which are still under validation by ECVAM.…”

Section: Tm Tory For Alternatives To Animal Testing (Ecvam) As Replacmentioning

confidence: 99%

“…The tissue is represented by a multilayered epithelium, with five to seven cell layers and a surface area of 0.5 cm 2 . The assay was performed according to the manufacturer instructions (Alépée et al, 2013;Cotovio et al, 2010). Upon arrival, tissues were transferred to 24 well plates containing 37 • C pre-warmed maintenance media (1 mL/well) and incubated 24 h at 37 • C, 5% CO2 and 95% relative humidity.…”

Section: Chemicalsmentioning

confidence: 99%

“…For both models, if the percentage of viability was >50%, the substance was predicted as Non-Irritant (EU classification: no label; GHS classification: No category); if the percentage of viability was ≤50%, the substance was predicted as Irritant (EU classification: R38, R41 or R36, depending on the model; GSH classification: Cat-egory 1 or Category 2) (Cotovio et al, 2010).…”

Section: Mtt Assaymentioning

confidence: 99%

“…The assessment of ocular irritation is part of the early testing procedure for the evaluation of new cosmetic ingredients (Cotovio et al, 2010). The use of cosmetic products can produce adverse effects on the ocular surface, ranging from mild discomfort to visionthreatening conditions (Coroneo et al, 2006).…”

Section: Ocular Irritability Testsmentioning

confidence: 99%

“…The assessment of irritation is one of the primary procedures to evaluate and hazard classify a substance, particularly, in cosmet-ics or pharmaceuticals (Cotovio et al, 2010). In line with the 7th amendment deadlines, European Union bans the in vivo skin irriDeionised water was obtained using Mili-Q water purification sys-tem (TGI Pure Water Systems, USA).…”

Section: Introductionmentioning

confidence: 99%

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Are coffee silverskin extracts safe for topical use? An in vitro and in vivo approach

Rodrigues

Pereira

Pimentel

et al. 2015

Industrial Crops and Products

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Recent changes in regulatory requirements and social views on animal testing have incremented the development of reliable alternative tests for predicting skin and ocular irritation potential of products based on new raw materials. In this regard, botanical ingredients used in cosmetic products are among those materials, and should be carefully reviewed concerning the potential presence of irritant con-stituents. In particular, cosmetic products used on the face, in vicinity of the eyes or that may come in contact with mucous membranes, should avoid botanical ingredients that contain, or are suspected to contain, such ingredients. In this study, we aimed to evaluate the effect of a new cosmetic ingredi-ent, namely, coffee silverskin (CS), with an in vitro skin and ocular irritation assay using reconstructed human epidermis, EpiSkin TM , and human corneal epithelial model, SkinEthics TM HCE, and an in vivo assay. Three different extracts of CS were evaluated. The histology of the models after extracts applica-tions was analysed. The in vitro results demonstrated that extracts were not classified as irritant and the histological analyses proved that extracts did not affect both models structure. The content of caffeine, 5-hydroxymethyl furfural and chlorogenic acid was quantified after the epidermal assay. The in vivo test carried out with the most promising extract (hydroalcoholic) showed that, with respect to irritant effects, these extracts can be regarded as safe for topical application.

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Section: Tm Tory For Alternatives To Animal Testing (Ecvam) As Replacmentioning

confidence: 99%

Section: Chemicalsmentioning

confidence: 99%

Section: Mtt Assaymentioning

confidence: 99%

Section: Ocular Irritability Testsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Are coffee silverskin extracts safe for topical use? An in vitro and in vivo approach

Rodrigues

Pereira

Pimentel

et al. 2015

Industrial Crops and Products

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Predictive performance of the Vitrigel‐eye irritancy test method using 118 chemicals

Yamaguchi

Kojima²,

Takezawa

2015

J of Applied Toxicology

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We recently developed a novel Vitrigel‐eye irritancy test (EIT) method. The Vitrigel‐EIT method is composed of two parts, i.e., the construction of a human corneal epithelium (HCE) model in a collagen vitrigel membrane chamber and the prediction of eye irritancy by analyzing the time‐dependent profile of transepithelial electrical resistance values for 3 min after exposing a chemical to the HCE model. In this study, we estimated the predictive performance of Vitrigel‐EIT method by testing a total of 118 chemicals. The category determined by the Vitrigel‐EIT method in comparison to the globally harmonized system classification revealed that the sensitivity, specificity and accuracy were 90.1%, 65.9% and 80.5%, respectively. Here, five of seven false‐negative chemicals were acidic chemicals inducing the irregular rising of transepithelial electrical resistance values. In case of eliminating the test chemical solutions showing pH 5 or lower, the sensitivity, specificity and accuracy were improved to 96.8%, 67.4% and 84.4%, respectively. Meanwhile, nine of 16 false‐positive chemicals were classified irritant by the US Environmental Protection Agency. In addition, the disappearance of ZO‐1, a tight junction‐associated protein and MUC1, a cell membrane‐spanning mucin was immunohistologically confirmed in the HCE models after exposing not only eye irritant chemicals but also false‐positive chemicals, suggesting that such false‐positive chemicals have an eye irritant potential. These data demonstrated that the Vitrigel‐EIT method could provide excellent predictive performance to judge the widespread eye irritancy, including very mild irritant chemicals. We hope that the Vitrigel‐EIT method contributes to the development of safe commodity chemicals. Copyright © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd.

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Comparison of Biodegradability, and Toxicity Effect of Biosurfactants with Synthetic Surfactants

Fernandes

Simões

Dias

2023

Advancements in Biosurfactants Research

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In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic™ HCE model: Application to 435 substances from consumer products industry

Cited by 42 publications

References 22 publications

Are coffee silverskin extracts safe for topical use? An in vitro and in vivo approach

Are coffee silverskin extracts safe for topical use? An in vitro and in vivo approach

Predictive performance of the Vitrigel‐eye irritancy test method using 118 chemicals

Comparison of Biodegradability, and Toxicity Effect of Biosurfactants with Synthetic Surfactants

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