Ocular irritation reversibility assessment of a laundry detergent using the Porcine Corneal Opacity Reversibility Assay (PorCORA): a focused study

References

• Herber RF, Duffus JH, Christensen JM, et al. Risk assessment for occupational exposure to chemicals. A review of current methodology (IUPAC technical report). Pure Appl Chem. 2001;73(6):993–1031. doi:10.1351/pac200173060993.
   Web of Science ®Google Scholar
• Scazzola R, Boeije G, Bøtker Pedersen E, et al. Eye hazard classification according to UN GHS/EU CLP and the severity of eye symptoms caused by accidental exposures to detergents and cleaning products. Regul Toxicol Pharmacol. 2019;105:69–76. doi:10.1016/j.yrtph.2019.04.004.
   PubMed Web of Science ®Google Scholar
• Parish ST, Aschner M, Casey W, et al. An evaluation framework for new approach methodologies (NAMs) for human health safety assessment. Regul Toxicol Pharmacol. 2020;112:104592. doi:10.1016/j.yrtph.2020.104592.
   PubMed Web of Science ®Google Scholar
• Wang Q, Li X, Yang H, et al. In silico prediction of serious eye irritation or corrosion potential of chemicals. RSC Adv. 2017;7(11):6697–6703. doi:10.1039/C6RA25267B.
   Web of Science ®Google Scholar
• 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(2):123–134.
   PubMedGoogle Scholar
• Fischer I, Milton C, Wallace H. Toxicity testing is evolving!. Toxicol Res. 2020;9(2):67–80. doi:10.1093/toxres/tfaa011.
   Web of Science ®Google Scholar
• Vij P, Donahue DA, Burke KP, et al. Lack of skin sensitization hazard potential for alpha-glycosyl isoquercitrin (AGIQ) utilizing the local lymph node assay. Toxicol Rep. 2022;9:1291–1296. doi:10.1016/j.toxrep.2022.05.021.
   PubMedGoogle Scholar
• OECD 2022. Test no. 492B: Reconstructed human cornea-like epithelium (RHCE) Test method for eye hazard identification, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• Guhad F. Introduction to the 3Rs (refinement, reduction, and replacement). Contemp Top Lab Anim Sci. 2005;44(2):58–59.
   PubMedGoogle Scholar
• OECD 2019. 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, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• OECD 2020. 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, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• OECD 2019. Test no. 496: in vitro macromolecular test method for identifying chemicals inducing serious eye damage and chemicals not requiring classification for eye irritation or serious eye damage, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• OECD 2020. 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, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• OECD 2021. Guideline no. 497: Defined approaches on skin sensitisation, OECD guidelines for the testing of chemicals. Section 4. Paris: OECD Publishing.
   Google Scholar
• Barile FA. Validating and troubleshooting ocular in vitro toxicology tests. J Pharmacol Toxicol Methods. 2010;61(2):136–145. doi:10.1016/j.vascn.2010.01.001.
   PubMed Web of Science ®Google Scholar
• Wilson SL, Ahearne M, Hopkinson A. An overview of current techniques for ocular toxicity testing. Toxicology. 2015;327:32–46. doi:10.1016/j.tox.2014.11.003.
   PubMed Web of Science ®Google Scholar
• 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(2):521–547. doi:10.1007/s00204-016-1679-x.
   PubMed Web of Science ®Google Scholar
• 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(3):295–304. doi:10.1016/s0887-2333(97)00016-7.
   PubMed Web of Science ®Google Scholar
• Spector J, Fernandez WG. Chemical, thermal, and biological ocular exposures. Emerg Med Clin North Am. 2008;26(1):125–136, vii. doi:10.1016/j.emc.2007.11.002.
   PubMed Web of Science ®Google Scholar
• Willmann D, Fu L, Melanson SW. Corneal injury. StatPearls; 2017.
   Google Scholar
• Huhtala A, Salminen L, Tähti H, et al. Corneal models for the toxicity testing of drugs and drug releasing materials. Topics Multifunct Biomater Dev. 2008;1(2):1–23.
   Google Scholar
• Carathers MR, Vij P, Delacruz E, et al. The porcine corneal opacity and reversibility assay (PorCORA) and assessment of the drivers of classification with regards to ocular damage. Toxicol Suppl Toxicol Sci. 2018;162(1):119. doi:10.13140/RG.2.2.11147.57127.
   Google Scholar
• Piehl M, Gilotti A, Donovan A, et al. Novel cultured porcine corneal irritancy assay with reversibility endpoint. Toxicol in Vitro. 2010;24(1):231–239. doi:10.1016/j.tiv.2009.08.033.
   PubMed Web of Science ®Google Scholar
• Foreman DM, Pancholi S, Jarvis-Evans J, et al. A simple organ culture model for assessing the effects of growth factors on corneal re-epithelialization. Exp Eye Res. 1996;62(5):555–564. doi:10.1006/exer.1996.0065.
   PubMed Web of Science ®Google Scholar
• Richard NR, Anderson JA, Weiss JL, et al. Air/liquid corneal organ culture: a light microscopic study. Curr Eye Res. 1991;10(8):739–749. doi:10.3109/02713689109013868.
   PubMed Web of Science ®Google Scholar
• Tanelian DL, Bisla K. A new in vitro corneal preparation to study epithelial wound healing. Invest Ophthalmol Vis Sci. 1992;33(11):3024–3028.
   PubMed Web of Science ®Google Scholar
• Elsheikh A, Alhasso D, Rama P. Biomechanical properties of human and porcine corneas. Exp Eye Res. 2008;86(5):783–790. doi:10.1016/j.exer.2008.02.006.
   PubMed Web of Science ®Google Scholar
• Obata H, Tsuru T. Corneal wound healing from the perspective of keratoplasty specimens with special reference to the function of the bowman layer and descemet membrane. Cornea. 2007;26(9 Suppl 1):S82–S9. doi:10.1097/ICO.0b013e31812f6f1b.
   PubMed Web of Science ®Google Scholar
• Van den Berghe C, Guillet MC, Compan D. Performance of porcine corneal opacity and permeability assay to predict eye irritation for water-soluble cosmetic ingredients. Toxicol in Vitro. 2005;19(6):823–830. doi:10.1016/j.tiv.2005.04.006.
   PubMed Web of Science ®Google Scholar
• Wilson SE, Hong JW. Bowman’s layer structure and function: critical or dispensable to corneal function? A hypothesis. Cornea. 2000;19(4):417–420. doi:10.1097/00003226-200007000-00001.
   PubMed Web of Science ®Google Scholar
• U.N. Globally. Harmonized system of classification and labelling of chemicals (GHS). New York, Geneva: U.N. Globally; 2021. https://unece.org/sites/default/files/2021-09/GHS_Rev9E_0.pdf
   Google Scholar
• OECD 2016. Guidelines for histopathological evaluation of bovine corneas as an endpoint of the bovine corneal opacity and permeability (BCOP) assay. Institute for in vitro sciences, Inc.
   Google Scholar
• Vij P, Carathers M, Yasso B, et al. Resolving corrosive/severe irritant ocular classifications using an alternative dual ex vivo assay system. Toxicolog Suppl Toxicol Sci. 2017;156(1):414. doi:10.13140/RG.2.2.17334.16966.
   Google Scholar
• Varsho BJ, Vij P, Sergeyev D, et al. Identifying eye irritants (GHS category 2) using validated, nonanimal tests. Int. J. Toxicol. 2020;39(1):59. doi:10.13140/RG.2.2.15341.87520.
   Web of Science ®Google Scholar
• Donahue DA, Avalos J, Kaufman LE, et al. Ocular irritation reversibility assessment for personal care products using a porcine corneal culture assay. Toxicol in Vitro. 2011;25(3):708–714. doi:10.1016/j.tiv.2010.12.008.
   PubMed Web of Science ®Google Scholar
• Ditzel E, Vij P, Sergeyev D, et al. Use of porcine corneal opacity reversibility assay (PorCORA) to determine the GHS classification for an irritating mixture (cleaner emulsifier and degreaser). Toxicolog Suppl Toxicol Sci. 2019;168(1):438. doi:10.13140/RG.2.2.33125.06880.
   Google Scholar
• ECETOC. 1998. Eye irritation – reference chemicals data bank. Technical Report No. 48 (2), European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels.
   Google Scholar
• Draize JH. 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.
   Web of Science ®Google Scholar