Comparison of two in vitro and two in vivo methods for the measurement of irritancy

Sterzel, W.; Bartnik, F.G.; Matthies, W.; Kästner, Wolfgang; Künstler, K.

doi:10.1016/0887-2333(90)90146-k

Cited by 24 publications

(8 citation statements)

References 9 publications

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“…Most protocols observe the time in seconds whereby a substance causes hemorrhage, vasoconstriction and/or coagulation that is measured, scored and then categorized (Vinardell and Mitjans, 2008). Other endpoints include injection (mild hemorrhage), vasoconstriction, dilation and lysis (disintegration of vessels) (Gettings et al, 1996;Luepke, 1985;Luepke and Kemper, 1986;Macian et al, 1996;Spielmann, 1995;Sterzel et al, 1990). The irritation scoring varies dependent upon the classification system being used.…”

Section: Non-ocular Organotypic Modelsmentioning

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: Non-ocular Organotypic Modelsmentioning

confidence: 99%

An overview of current techniques for ocular toxicity testing

2015

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“…In our present study, oleic acid which is well tolerated by the eye was chosen as the liquid lipid (Vandamme, 2002;Alany et al, 2006). Sterzel et al showed that oleic acid as well as fatty acid esters with carbon chain length of 18 atoms, to be non-irritant on the eye (Sterzel et al, 1990).…”

Section: Preparation Of Ofx Loaded Nlcsmentioning

confidence: 99%

Preparation and in vitro–in vivo evaluation of ofloxacin loaded ophthalmic nano structured lipid carriers modified with chitosan oligosaccharide lactate for the treatment of bacterial keratitis

Okur

Gökçe

Bozbıyık

et al. 2014

European Journal of Pharmaceutical Sciences

150

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“…At 0.5, 2, and 5 minutes after rinsing, visual inspection is used for evaluating development of irritant endpoints, including hyperemia, hemorrhage, and coagulation. The development of hemorrhage and coagulation is evaluated in combination with other endpoints including injection (mild hemorrhage), vasoconstriction, dilation, and lysis (Budai and Várnagy 2000; CEC 1991; Gettings et al 1996; Luepke and Kemper 1986; Macián et al 1996; Sterzel et al 1990). …”

Section: Hen's Egg Test-chorioallantoic Membrane (Het-cam) Testmentioning

confidence: 99%

“…These advantages have also been noted as shortcomings–that is, the elimination of other biological factors in the cell culture system does not allow the method to mimic interactions occurring in the whole organism, particularly with a specialized organ such as the eye. Yet, many in vitro methods have been developed since the early 1980s; widespread regulatory acceptance, however, especially in the U.S., was limited (Barile and Cardona 1998; Casterton et al 1996; Gautherton et al 1992; Harbell and Curren 1998; Kalweit et al 1987; Luepke 1985; Leupke and Kemper 1986; Sterzel et al 1990). Besides the lack of scientific comparability between the in vitro and in vivo systems, the problems also centered on the time and cost necessary to develop the tests and the arduous validation process (Balls, et al , 2006; Ekwall and Barile, 1994; Hartung et al , 2004)—a process that establishes a specific purpose of an assay by measuring its reliability and relevance.…”

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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Comparison of two in vitro and two in vivo methods for the measurement of irritancy

Cited by 24 publications

References 9 publications

An overview of current techniques for ocular toxicity testing

An overview of current techniques for ocular toxicity testing

Preparation and in vitro–in vivo evaluation of ofloxacin loaded ophthalmic nano structured lipid carriers modified with chitosan oligosaccharide lactate for the treatment of bacterial keratitis

Validating and troubleshooting ocular in vitro toxicology tests

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