References
- Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 1944;82:377–390.
- Verstraelen S, Jacobs A, De Wever B, et al. Improvement of the bovine corneal opacity and permeability (BCOP) assay as an in vitro alternative to the Draize rabbit eye irritation test. Toxicol In Vitro 2013;27:1298–1311.
- Oliveira GA, Ducas Rdo N, Teixeira GC, et al. Short time exposure (STE) test in conjunction with bovine corneal opacity and permeability (BCOP) assay including histopathology to evaluate correspondence with the globally harmonized system (GHS) eye irritation classification of textile dyes. Toxicol In Vitro 2015;29:1283–1288.
- European Parliament and Council. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. 2009. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223 [last accessed 10 Apr 2018].
- Organisation for Economic Co-operation and Development. Test no. 437: Bovine corneal opacity and permeability test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2017. Available from: https://www.oecd-ilibrary.org/environment/test-no-437-bovine-corneal-opacity-and-permeability-test-method-for-identifying-i-chemicals-inducing-serious-eye-damage-and-ii-chemicals-not-requiring-classification-for-eye-irritation-or-serious-eye-damage_9789264203846-en [last accessed 21 Sep 2018].
- Organisation for Economic Co-operation and Development. Test no. 438. Isolated chicken eye test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2017. Available from: https://www.oecd-ilibrary.org/environment/test-no-438-isolated-chicken-eye-test-method-for-identifying-i-chemicals-inducing-serious-eye-damage-and-ii-chemicals-not-requiring-classification-for-eye-irritation-or-serious-eye-damage_9789264203860-en [last accessed 21 Sep 2018].
- Organisation for Economic Co-operation and Development. Test no. 492: Reconstructed human cornea-like epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2017. Available from: https://www.oecd-ilibrary.org/environment/test-no-492-reconstructed-human-cornea-like-epithelium-rhce-test-method-for-identifying-chemicals-not-requiring-classification-and-labelling-for-eye-irritation-or-serious-eye-damage_9789264242548-en [last accessed 21 Sep 2018].
- Organisation for Economic Co-operation and Development. Test no. 491: Short time exposure in vitro test method for i) identifying chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2018. Available from: https://www.oecd-ilibrary.org/environment/test-no-491-short-time-exposure-in-vitro-test-method-for-identifying-i-chemicals-inducing-serious-eye-damage-and-ii-chemicals-not-requiring-classification-for-eye-irritation-or-serious-eye-damage_9789264242432-en [last accessed 22 Oct 2018].
- Organisation for Economic Co-operation and Development. Test no. 460: Fluorescein leakage test method for identifying ocular corrosives and severe irritants. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2017. Available from: https://www.oecd-ilibrary.org/environment/test-no-460-fluorescein-leakage-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264185401-en [last accessed 6 Apr 2020].
- Organisation for Economic Co-operation and Development. Test no. 494: Vitrigel-eye irritancy test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. In: OECD guidelines for the testing of chemicals, section 4: health effects. Paris: OECD Publishing; 2019. Available from: https://www.oecd-ilibrary.org/environment/tg-494-vitrigel-eye-irritancy-test-method-for-identifying-chemicals-not-requiring-classification-and-labelling-for-eye-irritation-or-serious-eye-damage_9f20068a-en [last accessed 6 Apr 2020].
- Lotz C, Schmid FF, Rossi A, et al. Alternative methods for the replacement of eye irritation testing. ALTEX 2016;33:55–67.
- United Nations. Globally harmonized system of classification and labelling of chemicals (GHS). Seventh revised edition. ST/SG/AC.10/30/Rev.7. New York (NY): United Nations; 2017. Available from: https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e0.html#c61353 [last accessed 21 Sep 2018].
- U.S. Environmental Protection Agency. Chapter 7: Precautionary statements: EPA; 2014. Available from: https://www.epa.gov/sites/production/files/2015-03/documents/chap-07-jul-2014.pdf [last accessed 10 Apr 2018].
- Eskes C, Hoffmann S, Facchini D, et al. Validation study on the Ocular Irritection assay for eye irritation testing. Toxicol In Vitro 2014;28:1046–1065.
- Organisation for Economic Co-operation and Development. OECD Series on Testing and Assessment Number 34, Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. ENV/JM/MONO(2005)14, 2005. Available from: https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/oecd/oecd-gd34.pdf [last accessed 6 Apr 2020].
- Scott L, Eskes C, Hoffmann S, et al. A proposed eye irritation testing strategy to reduce and replace in vivo studies using bottom-up and top-down approaches. Toxicol In Vitro 2010;24:1–9.
- European Centre for Ecotoxicology and Toxicology of Chemicals. TR 048-Eye irritation: reference chemicals databank. 2nd ed. Brussels: ECETOC; 1998.
- Organisation for Economic Co-operation and Development. OECD principles on good laboratory practice [as revised in 1997]. In: Series on principles of good laboratory practice and compliance monitoring number 1. Paris (FR): OECD Publishing; 1998. Available from: http://www.oecd.org/officialdocuments/displaydocument/?cote=env/mc/chem(98)17&doclanguage=en [last accessed 21 Sep 2018].
- QSAR Toolbox. 4.1. [Internet]. Paris: Organisation for Economic Co-operation and Development; 2012. Available from: https://www.qsartoolbox.org/ [last accessed 4 Dec 2018].
- European Centre for Ecotoxicology and Toxicology of Chemicals. Eye irritation: Reference chemicals data bank. 2nd ed. Brussels, Belgium: ECETOC; 1998. Available from: http://www.ecetoc.org/wp-content/uploads/2014/08/ECETOC-TR-0481.pdf [last accessed 10 Apr 2018].
- Earl LK, Dickens AD, Rowson MJ. A critical analysis of the rabbit eye irritation test variability and its impact on the validation of alternative methods. Toxicol In Vitro 1997;11:295–304.
- Luechtefeld T, Maertens A, Russo DP, et al. Analysis of Draize eye irritation testing and its prediction by mining publicly available 2008–2014 REACH data. ALTEX 2016;33:123–134.
- Adriaens E, Barroso J, Eskes C, et al. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods. Arch Toxicol 2014;88:701–723.
- Barroso J, Pfannenbecker U, Adriaens E, et al. Cosmetics Europe compilation of historical serious eye damage/eye irritation in vivo data analysed by drivers of classification to support the selection of chemicals for development and evaluation of alternative methods/strategies: the Draize eye test Reference Database (DRD). Arch Toxicol 2017;91:521–547.
- Furr KA, ed. CRC handbook of laboratory safety. Boca Raton, FL: CRC Press LLC; 2000. Laboratory Operations.
- XploSens PS [Internet]. Stillwater (OK): XploSafe LLC; 2018. Available from: https://www.xplosafe.com/products/xplosens-ps [last accessed 4 Dec 2018].