Validating and Troubleshooting Ocular in Vitro Toxicology Tests

Overview

Journal J Pharmacol Toxicol Methods

Publisher Elsevier

Specialties Pharmacology
Toxicology

Date 2010 Jan 26

PMID 20096797

Citations 21

Authors

Frank A Barile

Affiliations

Soon will be listed here.

Abstract

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 functions 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, improving 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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References

Burton A, York M, Lawrence R . The in vitro assessment of severe eye irritants. Food Cosmet Toxicol. 1981; 19(4):471-80. DOI: 10.1016/0015-6264(81)90452-1. View

Gettings S, Lordo R, Hintze K, Bagley D, Casterton P, Chudkowski M . The CTFA Evaluation of Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations. Food Chem Toxicol. 1996; 34(1):79-117. DOI: 10.1016/0278-6915(96)89525-1. View

Eskes C, Cole T, Hoffmann S, Worth A, Cockshott A, Gerner I . The ECVAM international validation study on in vitro tests for acute skin irritation: selection of test chemicals. Altern Lab Anim. 2008; 35(6):603-19. DOI: 10.1177/026119290703500608. View

Muir C . Opacity of bovine cornea in vitro induced by surfactants and industrial chemicals compared with ocular irritancy in vivo. Toxicol Lett. 1985; 24(2-3):157-62. DOI: 10.1016/0378-4274(85)90052-9. View

Demirci F, Paper D, Franz G, Baser K . Investigation of the Origanum onites L. essential oil using the chorioallantoic membrane (CAM) assay. J Agric Food Chem. 2004; 52(2):251-4. DOI: 10.1021/jf034850k. View

WEIL C, Scala R . Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol Appl Pharmacol. 1971; 19(2):276-360. DOI: 10.1016/0041-008x(71)90112-8. View

Scott L, Eskes C, Hoffmann S, Adriaens E, Alepee N, Bufo M . A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In Vitro. 2009; 24(1):1-9. DOI: 10.1016/j.tiv.2009.05.019. View

Kalweit S, Gerner I, Spielmann H . Validation project of alternatives for the Draize eye test. Mol Toxicol. 1987; 1(4):597-603. View

Ohno Y, Kaneko T, Inoue T, Morikawa Y, Yoshida T, Fujii A . Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) Overview of the validation study and Draize scores for the evaluation of the tests. Toxicol In Vitro. 2010; 13(1):73-98. DOI: 10.1016/s0887-2333(98)00064-2. View

10.

Ubels J, Paauw J, Casterton P, Kool D . A redesigned corneal holder for the bovine cornea opacity and permeability assay that maintains normal corneal morphology. Toxicol In Vitro. 2002; 16(5):621-8. DOI: 10.1016/s0887-2333(02)00046-2. View

11.

Calabro A, Konsoula R, Barile F . Evaluation of in vitro cytotoxicity and paracellular permeability of intact monolayers with mouse embryonic stem cells. Toxicol In Vitro. 2008; 22(5):1273-84. PMC: 2516403. DOI: 10.1016/j.tiv.2008.02.023. View

12.

Sterzel W, Bartnik F, Matthies W, Kastner W, Kunstler K . Comparison of two in vitro and two in vivo methods for the measurement of irritancy. Toxicol In Vitro. 2010; 4(4-5):698-701. DOI: 10.1016/0887-2333(90)90146-k. View

13.

Demirci B, Dadandi M, Paper D, Franz G, Baser K . Chemical composition of the essential oil of Phlomis linearis Boiss. & Bal., and biological effects on the CAM-assay: a safety evaluation. Z Naturforsch C J Biosci. 2004; 58(11-12):826-9. DOI: 10.1515/znc-2003-11-1214. View

14.

Balls M, Amcoff P, Bremer S, Casati S, Coecke S, Clothier R . The principles of weight of evidence validation of test methods and testing strategies. The report and recommendations of ECVAM workshop 58. Altern Lab Anim. 2007; 34(6):603-20. PMC: 2709979. DOI: 10.1177/026119290603400604. View

15.

Budai P, Varnagy L . In vitro ocular irritation toxicity study of some pesticides. Acta Vet Hung. 2001; 48(2):221-8. View

16.

Macian M, Seguer J, Infante M, Selve C, Vinardell M . Preliminary studies of the toxic effects of non-ionic surfactants derived from lysine. Toxicology. 1996; 106(1-3):1-9. DOI: 10.1016/0300-483x(95)03131-x. View

17.

Tufan A, Lale Satiroglu-Tufan N . The chick embryo chorioallantoic membrane as a model system for the study of tumor angiogenesis, invasion and development of anti-angiogenic agents. Curr Cancer Drug Targets. 2005; 5(4):249-66. DOI: 10.2174/1568009054064624. View

18.

Sina J, Galer D, Sussman R, Gautheron P, Sargent E, Leong B . A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundam Appl Toxicol. 1995; 26(1):20-31. DOI: 10.1006/faat.1995.1071. View

19.

Burton A . A method for the objective assessment of eye irritation. Food Cosmet Toxicol. 1972; 10(2):209-17. DOI: 10.1016/s0015-6264(72)80198-6. View

20.

Lordo R, Feder P, Gettings S . Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score. Toxicol In Vitro. 2010; 13(1):45-72. DOI: 10.1016/s0887-2333(98)00062-9. View