DOI QR코드

DOI QR Code

Grading criteria of histopathological evaluation in BCOP assay by various staining methods

  • Received : 2021.02.17
  • Accepted : 2021.05.15
  • Published : 2022.01.15

Abstract

This study was performed to provide information on classifying eye irritating chemicals using the BCOP assay. After the BCOP assay, bovine corneas were classifed by IVIS presented in OECD test guideline 437, and three special staining methods (H&E, MT, and PAS) were performed for histopathological evaluation. Non-irritant chemicals (IVIS≤3), showed intact structures. In the 355) showed large increases edema and nuclear condensation by H&E staining. Loose collagen bundles and vacuoles around keratocytes were also observed by MT staining. Bleaching of the epithelial layer, reduction in visibility, and thickness of the basement membrane were confrmed by PAS staining. Based on the stepwise histopathological analysis, we set the criteria and grades for histopathological evaluation and found that eye irritation was increased following the irritation degree of test chemicals. Further histopathological study will support and lead to improvements in the BCOP assay.

Keywords

References

  1. Lee HK, Noh KJ, Seok SH, Baek MW, Lee HY, Kim DJ, Na YR, Park SH, Kim BH, Park KR, Lee JK (2007) Detection of ocular irritant chemicals with bovine corneal opacity assay. J Altern Anim Exp 1:53-56
  2. EU (2003) Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Of J Eur Union 66:11
  3. Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique. Methuen, London. https://doi.org/10.5694/j.1326-5377.1960.tb73127.x
  4. Sina JF (1994) Validation of the bovine corneal opacity-permeability assay as a predictor of oculas irritation potential. Toxicol Vitro 7:283-289
  5. Gautheron P, Dukic M, Alix D, Sina JF (1992) Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449. https://doi.org/10.1093/toxsci/18.3.442
  6. Gautheron P, Giroux J, Cotton M, Audgeground L, Morilla A, Mayrdomo-Blanco L, Tortajada A, Haynes G, Vericat JA, Pirovano R, Gillio TE, Hagemann C, Vanparys P, Deknudt G, Jacobs G, Prinsen M, Kalweit S, Speilmann H (1994) Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicol Vitro 8:381-392. https://doi.org/10.1016/0887-2333(94)90159-7
  7. ICCVAM (2006) Test Method Evaluation Report - In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). NIH Publ 7:4517
  8. ICCVAM (2010) ICCVAM test method evaluation report: current validation status of in vitro test methods proposed for identifying eye injury hazard potential of chemicals and products. NIH Publ 10:7553
  9. Cooper KJ, Earl LK, Harbell J, Raabe H (2001) Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay. Toxicol Vitro 15:95-103. https://doi.org/10.1016/S0887-2333(00)00060-6
  10. Van den Berghe C, Guillet MC, Compan D (2005) Performance of porcine corneal opacity and permeability assay to predict eye irritation for water-soluble cosmetic ingredients. Toxicol Vitro 19:823-830. https://doi.org/10.1016/j.tiv.2005.04.006
  11. OECD (2018) OECD guideline for the testing of chemicals, NO. 438: isolated chicken eye test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classifcation for eye irritation or serious eye damage. https://doi.org/10.1787/20745788
  12. OECD (2020) OECD guideline for the testing of chemicals, NO. 437: Bovine corneal opacity and permeability test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classifcation for eye irritation or serious eye damage. https://doi.org/10.1787/20745788
  13. Furukawa M, Sakakibara T, Itoh K, Kawamura K, Sasaki S, Matsuura M (2015) Histopathological evaluation of the ocular-irritation potential of shampoos, make-up removers and cleansing foams in the bovine corneal opacity and permeability assay. J Toxicol Pathol 4:243-248. https://doi.org/10.1293/tox.2015-0022
  14. Furukawa M, Sakakibara T, Itoh K, Kawamura K, Matsuura M, Kojima H (2017) Suggestion of the updated IVIS cut-of values for identifying non-ocular irritants in the bovine corneal opacity and permeability (BCOP) assay. Toxicol Vitro 45:19-24. https://doi.org/10.1016/j.tiv.2017.07.026
  15. Ok YS, Kim BH (2016) The condition setting study for domestic establishment of Bovine Corneal Opacity and Permeability (BCOP) assay as an alternative eye irritation method. J Prev Vet Med 40:59-67 https://doi.org/10.13041/jpvm.2016.40.2.59
  16. OECD (2018) OECD guidance document on the collection of eye tissues for histopathological evaluation and collection of data NO. 160.
  17. Goldner J (1938) A modifcation of the Masson trichrome technique for routine laboratory purposes. Am J Pathol 14:237-243
  18. Federal Register Notice (2007) Availability of the ICCVAM test method evaluation report on in vitro ocular toxicity test methods for identifying severe irritants and corrosives and fnal in vitro ocular test method background review documents; notice of transmittal of ICCVAM test method recommendations to federal agencies 72:65964-65965
  19. Noh KJ, Seok SH, Baek MW, Lee HY, Kim DJ, Na YR, Park SH, Lee HK, Kim BH, Park KR, Lee JK, Park JH (2007) Establishment of bovine corneal opacity assay as an alternative to eye irritation. J Altern Anim Exp 1:53-56
  20. Maurer JK, Parker RD, Jester JV (2002) Extent of initial corneal injury as the mechanistic basis for ocular irritation: key fndings and recommendations for the development of alternative assays. Regul Toxicol Pharmacol 36:106-117. https://doi.org/10.1006/rtph.2002.1551
  21. Curren RD, Nash JR, Sizemore A, Harbell J (2008) Background review document of an In vitro approach for EPA toxicity labeling of anti-microbial cleaning products
  22. Institute For In Vitro Sciences, Inc. (2016) Guidelines for histopathological evaluation of bovine corneas as an endpoint of the Bovine Corneal Opacity and Permeability (BCOP) assay
  23. Cardif RD, Miller CH, Munn RJ (2014) Manual hematoxylin and eosin staining of mouse tissue sections. Cold Spring Harb Protoc 6:pdb-prot073411. https://doi.org/10.1101/pdb.prot073411
  24. Fischer AH, Jacobson KA, Rose J, Zeller R (2008) Hematoxylin and eosin staining of tissue and cell sections. Cold Spring Harb Protoc 5:pdb-prot4986. https://doi.org/10.1101/pdb.prot4986
  25. Peng H, Katsnelson J, Yang W, Brown MA, Lavker RM (2013) FIH-1/c-kit signaling: a novel contributor to corneal epithelial glycogen metabolism. Invest Ophthalmol Vis Sci 54:2781-2786. https://doi.org/10.1167/iovs.12-11512
  26. Oliveira GAR, do Nascimento Ducas R, Teixeira GC, Batista AC, Oliveira DP, Valadares MC (2015) 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 classifcation of textile dyes. Toxicol Vitro 29:1283-1288. https://doi.org/10.1016/j.tiv.2015.05.007
  27. Casterton PL, Potts LF, Klein BD (1996) A novel approach to assessing eye irritation potential using the bovine corneal opacity and permeability assay. J Toxicol Cutan Ocul Toxicol 15:147-163. https://doi.org/10.3109/15569529609048870
  28. Hanna C, Bicknell DS, O'Brien JE (1961) Cell turnover in the adult human eye. Arch Ophthalmol 65:695-698. https://doi.org/10.1001/archopht.1961.01840020697016