The CFTA evaluation of alternatives program: An evaluation of in vitro alternatives to the draize primary eye irritation test. (Phase III) surfactant-based formulations

Gettings, S.D.; Lordo, Robert A.; Hintze, K. L.; Bagley, Daniel M.; Casterton, Phillip L.; Chudkowski, M.; Curren, Rodger; Demetrulias, J.; DiPasquale, Louis C.; Earl, L.K.; Feder, Paul I.; Galli, C. L.; Glaza, S. M.; Gordon, Virginia C.; Janus, Jeffrey; Kurtz, P. J.; Marenus, K.; Moral, José F. Quı́lez del; Pape, Wolfgang; Renskers, Kevin J.; Rheins, Lawrence A.; Roddy, M.; Rozen, M. G.; Tedeschi, J. P.; Zyracki, J.

doi:10.1016/0278-6915(96)89525-1

Cited by 78 publications

(42 citation statements)

References 30 publications

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“…Our Wnding that classiWcation schemes bias the underlying experiment adds to the problem of the imperfect reference standard which in vitro toxicology faces regularly (Gettings et al, 1996;Worth and Cronin, 2001). The animal test is imperfect, since assessment of its predictive capacity for human health eVects is limited by absence of relevant comparative human data.…”

Section: Resultsmentioning

confidence: 99%

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

Hoffmann

Cole

Hartung

2005

Regulatory Toxicology and Pharmacology

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Section: Resultsmentioning

confidence: 99%

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

Hoffmann

Cole

Hartung

2005

Regulatory Toxicology and Pharmacology

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“…In comparison with other cytotoxicity tests, RBC hemolysis test is clear and simple and mammalian RBC is easy to get. But so far, this test has not been validated other than for surfactants (60). …”

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

2017

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Human eyes and skin are frequently exposed to chemicals accidentally or on purpose due to their external location. Therefore, chemicals are required to undergo the evaluation of the ocular and dermal irritancy for their safe handling and use before release into the market. Draize rabbit eye and skin irritation test developed in 1944, has been a gold standard test which was enlisted as OECD TG 404 and OECD TG 405 but it has been criticized with respect to animal welfare due to invasive and cruel procedure. To replace it, diverse alternatives have been developed: (i) For Draize eye irritation test, organotypic assay, in vitro cytotoxicity-based method, in chemico tests, in silico prediction model, and 3D reconstructed human cornea-like epithelium (RhCE); (ii) For Draize skin irritation test, in vitro cytotoxicity-based cell model, and 3D reconstructed human epidermis models (RhE). Of these, RhCE and RhE models are getting spotlight as a promising alternative with a wide applicability domain covering cosmetics and personal care products. In this review, we overviewed the current alternatives to Draize test with a focus on 3D human epithelium models to provide an insight into advancing and widening their utility.

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“…More recently, organotypic models have warranted sufficient interest as methods that maintain short-term normal physiological and biochemical function of the mammalian cornea in an isolated system (Barile 2007; Cooper et al 2001; Gettings et al 1996; Muir 1985). In these test methods, damage by the test substance is assessed by quantitative measurements of changes in corneal opacity and permeability using opacitometry and spectrophotometry, respectively.…”

Section: Introductionmentioning

confidence: 99%

Validating and troubleshooting ocular in vitro toxicology tests

Barile

2010

Journal of Pharmacological and Toxicological Methods

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In vitro organotypic models for testing ocular irritants have warranted sufficient interest as methods to replace in vivo ocular testing. The in vitro organotypic models claim to maintain short-term normal physiological and biochemical function of the mammalian cornea in an isolated system. In these test methods, damage by the test substance is assessed by quantitative measurements of changes in corneal opacity and permeability using opacitometry and spectrophotometry, respectively. Both measurements are used quantitatively for irritancy classification for prediction of the in vivo ocular irritation potential of a test substance. Examples of organotypic models that incorporate these criteria include: the bovine corneal opacity and permeability (BCOP) assay, the isolated chicken eye (ICE) test method and the isolated rabbit eye (IRE) assay. A fourth method, the hen's egg test-chorioallantoic membrane (HET-CAM) assay, differs in the evaluation criteria but is also normally included among this class of in vitro protocols. Each of these protocols is discussed in detail as representative candidate in vitro methods for assessing ocular irritation and corrosion. The methodologies, protocol details, applications, and their validation status are discussed. A brief historical perspective of the development of original in vitro ocular testing models is also mentioned. More importantly, improvement and troubleshooting the current techniques, in order to present the models as stand-alone in vitro tools for ocular toxicity assessment, is emphasized.

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The CFTA evaluation of alternatives program: An evaluation of in vitro alternatives to the draize primary eye irritation test. (Phase III) surfactant-based formulations

Cited by 78 publications

References 30 publications

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

Validating and troubleshooting ocular in vitro toxicology tests

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