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SKINETHIC™ HCE EYE IRRITATION TEST (EIT): AN OECD ADOPTED METHOD TEST FOR IDENTIFYING CHEMICALS NOT REQUIRING CLASSIFICATION AND LABELLING FOR EYE IRRITATION OR SERIOUS EYE DAMAGE (OECD TG492)
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CONTEXT
Serious eye damage refers to the production of tissue damage in the eye, or serious physical decay of vision, which is not fully reversible, occurring after exposure of the eye to a test chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). Test chemicals inducing serious eye damage are classified as UN GHS Category 1, while those inducing eye irritation are classified as UN GHS Category 2. Test chemicals not classified for eye irritation or serious eye damage are referred to as UN GHS No Category (No Cat).
The SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (SkinEthic HCE EIT) describes an in vitro procedure allowing the identification on its own of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS ocular hazard categories. Note that this test method is not intended to differentiate between UN GHS Category 1 and 2.
The SkinEthic™ HCE Eye Irritation Test in vitro test method on Liquids (SkinEthic™ HCE EITL) and on Solids (SkinEthic™ HCE EITS) has been developed and established within L’Oréal by evaluating 200 chemicals (Alépée et al, 2016a; Alépée et al., 2016b).
On the basis of the data currently available, the SkinEthic™ HCE EIT method was shown to be applicable to a wide range of liquid/viscous/solids chemicals, covering a large variety of chemical types, chemical classes, functional groups, direct MTT reducers. The test method allows the hazard identification of mono and multi-component test liquid/viscous/solids (neat or in dilution) chemicals.
A multicentric study demonstrated the relevance (predictive capacity) and reliability (reproducibility within and between laboratories) of the test method by testing 120 coded chemicals within three naïve laboratories and therefore was referred as a Validated Reference Method to address the human health ocular endpoint (EURL ECVAM, 2016),
The SkinEthic™ HCE EIT test method has adopted as OECD Test Guidelines (TG) 492 in 2017.
Therefore in the context of Integrated Approach on Testing and Assessment (IATA) published as GD 263 by the OECD (2017), a proposed Defined Approach focuses on a combination of the SkinEthic HCE EIT and BCOP test methods has been developed by Cosmetics Europe for neat liquids (Alépée et al, 2019). This defined approach has shown to successfully distinguish between the three UN GHS categories for each hazard identification and is under currently OECD acceptance.
MODELS
SkinEthicTM HCE - Epitélio da Córnea Humana
PROTOCOL PRINCIPLE
Identification on its own of chemicals not requiring classification and labelling
This test method is applicable to substances and mixtures, to solids, liquids, semi-solids and waxes. The liquids may be aqueous or non-aqueous, fully water miscible or not fully water miscible; solids may be soluble or insoluble in water.
DETAILED ASSAY PROCEDURE
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REFERENCES
Multi- laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals.
Alépée, N., Leblanc, V., Adriaens, E., Grandidier, M.H., Lelièvre, D, Meloni, M., Nardelli, L., Roper, C.S, Santirocco, E., Toner, F., Van Rompay, A., Vinall, J., Cotovio, J. (2016).
Toxicol. In Vitro 31, 43-53. 12.
Multilaboratory evaluation of SkinEthic HCE test method for testing serious eye damage/eye irritation using solid chemicals and overall performance of the test method with regard to solid and liquid chemicals testing.
Alépée, N., Adriaens, E., Grandidier, M.H., Meloni, M., Nardelli, L., Vinall, C.J., Toner, F., Roper, C.S, Van Rompay, A.R., Leblanc, V., Cotovio, J. (2016).
Toxicol. In Vitro 34, 55- 70. 13.
EURL ECVAM Science Advisory Committee. (2016). ESAC Opinion on the SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT). ESAC Opinion No. 2016-02 of 24 June 2016;EUR 28175 EN; doi : 10.2787/390390. Available at: [http://publications.jrc.ec.europa.eu/repository/handle/JRC103704].
Development of a defined approach for eye irritation or serious eye damage for neat liquids based on Cosmetics Europe Analysis of in vitro RhCE and BCOP test methods.
Alépée N, Adriaens E, Abo T, Bagley D, Desprez B, Hibatallah J, Mewes KR, Pfannenbecker U, Sala A, Van Rompay AR, Verstraelen S, McNamee P. (2019).
Toxicology In Vitro (2019) 59: 100-114. doi: 10.1016/j.tiv.2019.04.011.