Suitability of histopathology as an additional endpoint to the isolated chicken eye test for classification of non-extreme ph detergent and cleaning products

Cazelle, Elodie; Eskes, Chantra; Hermann, Martina; Jones, Penelope; Maiello, Pauline; Prinsen, M.K.; Taylor, Hannah; Wijnands, Marcel V. W.

doi:10.1016/j.toxlet.2014.06.708

Cited by 4 publications

(15 citation statements)

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“…Recently, the use of isolated chicken eye has been validated as an alternative method for the identification of severe irritants and histopathology of the cornea has been shown to be an additional useful tool that can strengthen evidence of eye irritation. 4,11,45,46 In the present study, pig eyes were preferred to chicken eyes due to their larger size, offering a wider surface for cryogens application, and their histological architecture that is more similar to the target species.…”

Section: Discussionmentioning

confidence: 88%

“…Cleft formation is a well-known corneal histological alteration that most of the time is supposed to be a mere consequence of fixation (i.e. processing artifact) 11. However, since clefts were absent or minimal in control eyes, we investigated their possible relation with LN 2 and DMEPI application, hypothesizing that their presence could be related to the freezing temperature, determining the separation of stromal fibers.…”

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confidence: 99%

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The effects of soft cryotherapy on conjunctiva and cornea in isolated pig eyes and comparison with standard liquid nitrogen: A pilot ex vivo study

Barachetti

Giudice

Cescon³

et al. 2020

Veterinary Ophthalmology

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Section: Discussionmentioning

confidence: 88%

mentioning

confidence: 99%

The effects of soft cryotherapy on conjunctiva and cornea in isolated pig eyes and comparison with standard liquid nitrogen: A pilot ex vivo study

Barachetti

Giudice

Cescon³

et al. 2020

Veterinary Ophthalmology

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“…1) as well as those not requiring classification for eye hazard (UN GHS No Category). Furthermore, histopathology has been shown to be a useful additional endpoint to identify UN GHS Category 1 non-extreme pH (2 < pH < 11.5) detergents and surfactants (Cazelle et al, 2014;OECD GD 188, 2018b;OECD GD 160, 2018c…”

Section: Isolated Chicken Eye (Ice) Test Methods (Oecd Tg 438)mentioning

confidence: 99%

Second Edition - Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation

2019

OECD Series on Testing and Assessment

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“…Depth of injury concept: Chicken corneas differ structurally from human corneas; however, their similar morphology makes them a useful fullthickness model to predict human effects. Histopathology can be conducted for additional information about the DOI [45,47,50]. Evaluating histological changes in the endothelial and stromal layers can further support discrimination between moderate and severe irritants (corrosives).…”

Section: Mode Of Actionmentioning

confidence: 99%

“…Reversibility: Per TG 438, histopathology can be conducted to determine the depth and degree of injury to support predictions of reversibility [45,47,50]. Isolated Rabbit Eye (IRE) test [51,52] The test quantitatively measures a substance's ability to induce corneal swelling, and subjectively measures its ability to induce corneal opacity, and injury to the epithelium (measure of fluorescein…”

Section: Mode Of Actionmentioning

confidence: 99%

Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations

Clippinger¹,

Raabe

Allen

et al. 2021

Cutaneous and Ocular Toxicology

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There are multiple in vitro and ex vivo eye irritation and corrosion test methods that are available as internationally harmonized test guidelines for regulatory use. Despite their demonstrated usefulness to a broad range of substances through inter-laboratory validation studies, they have not been widely adopted for testing agrochemical formulations due to a lack of concordance with parallel results from the traditional regulatory test method for this endpoint, the rabbit eye test. The inherent variability of the rabbit test, differences in the anatomy of the rabbit and human eyes, and differences in modelling exposures in rabbit eyes relative to human eyes contribute to this lack of concordance. Ultimately, the regulatory purpose for these tests is protection of human health, and, thus, there is a need for a testing approach based on human biology. This paper reviews the available in vivo, in vitro and ex vivo test methods with respect to their relevance to human ocular anatomy, anticipated exposure scenarios, and the mechanisms of eye irritation/corrosion in humans. Each of the in vitro and ex vivo methods described is generally appropriate for identifying non-irritants. To discriminate among eye irritants, the human three-dimensional epithelial and full thickness corneal models provide the most detailed information about the severity of irritation. Consideration of the mechanisms of eye irritation, and the strengths and limitations of the in vivo, in vitro and ex vivo test methods, show that the in vitro/ex vivo methods are as or more reflective of human biology and less variable than the currently used rabbit approach. Suggestions are made for further optimizing the most promising methods to distinguish between severe (corrosive), moderate, mild and non-irritants and provide information about the reversibility of effects. Also considered is the utility of including additional information (e.g. physical chemical properties), consistent with the Organization for Economic Cooperation and Development's guidance document on an integrated approach to testing and assessment of potential eye irritation. Combining structural and functional information about a test substance with test results from human-relevant methods will ensure the best protection of humans following accidental eye exposure to agrochemicals.

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Suitability of histopathology as an additional endpoint to the isolated chicken eye test for classification of non-extreme ph detergent and cleaning products

Cited by 4 publications

References 0 publications

The effects of soft cryotherapy on conjunctiva and cornea in isolated pig eyes and comparison with standard liquid nitrogen: A pilot ex vivo study

The effects of soft cryotherapy on conjunctiva and cornea in isolated pig eyes and comparison with standard liquid nitrogen: A pilot ex vivo study

Second Edition - Guidance Document on Integrated Approaches to Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation

Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations

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