Biomolecules & Therapeutics

  • 제23권4호
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  • Pages.379-385
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  • 2015
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  • 1976-9148(pISSN)
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  • 2005-4483(eISSN)
한국응용약물학회 (The Korean Society of Applied Pharmacology)
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Evaluation of Eye Irritation Potential of Solid Substance with New 3D Reconstructed Human Cornea Model, MCTT HCETM

  • 투고 : 2015.01.06
  • 심사 : 2015.03.30
  • 발행 : 2015.07.01
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초록

The eye irritation potential of drug candidates or pharmaceutical ingredients should be evaluated if there is a possibility of ocular exposure. Traditionally, the ocular irritation has been evaluated by the rabbit Draize test. However, rabbit eyes are more sensitive to irritants than human eyes, therefore substantial level of false positives are unavoidable. To resolve this species difference, several three-dimensional human corneal epithelial (HCE) models have been developed as alternative eye irritation test methods. Recently, we introduced a new HCE model, MCTT HCE$^{TM}$ which is reconstructed with non-transformed human corneal cells from limbal tissues. Here, we examined if MCTT HCE$^{TM}$ can be employed to evaluate eye irritation potential of solid substances. Through optimization of washing method and exposure time, treatment time was established as 10 min and washing procedure was set up as 4 times of washing with 10 mL of PBS and shaking in 30 mL of PBS in a beaker. With the established eye irritation test protocol, 11 solid substances (5 non-irritants, 6 irritants) were evaluated which demonstrated an excellent predictive capacity (100% accuracy, 100% specificity and 100% sensitivity). We also compared the performance of our test method with rabbit Draize test results and in vitro cytotoxicity test with 2D human corneal epithelial cell lines.

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참고문헌

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  2. Prevalidation trial for a novel in vitro eye irritation test using the reconstructed human cornea-like epithelial model, MCTT HCE™ vol.39, 2017, https://doi.org/10.1016/j.tiv.2016.11.010
  3. Evaluation of radioisotopic and non-radioisotopic versions of local lymph node assays for subcategorization of skin sensitizers compliant to UN GHS rev 4 vol.85, 2017, https://doi.org/10.1016/j.yrtph.2017.02.003
  4. Evaluation of ocular irritancy of coal-tar dyes used in cosmetics employing reconstructed human cornea-like epithelium and short time exposure tests vol.108, 2017, https://doi.org/10.1016/j.fct.2017.08.001
  5. PAL-12, a new anti-aging hexa-peptoid, inhibits UVB-induced photoaging in human dermal fibroblasts and 3D reconstructed human full skin model, Keraskin-FT™ 2017, https://doi.org/10.1007/s00403-017-1768-6
  6. Assessment of the Ocular Irritation Potential of Pesticides using Reconstructed Human Cornea-like Epithelium (RhCE) Model as Alternatives to Animal Testing vol.22, pp.3, 2018, https://doi.org/10.7585/kjps.2018.22.3.216
  7. Ezrin as a complementary marker in ocular toxicity assessment using a three-dimensional reconstructed human corneal-like epithelium model, EpiOcular™ vol.92, pp.None, 2018, https://doi.org/10.1016/j.vascn.2018.02.007
  8. Implementation of an in vitro exposure system for 28 GHz vol.42, pp.6, 2015, https://doi.org/10.4218/etrij.2020-0169
  9. Egr1 Gene Expression as a Potential Biomarker for In Vitro Prediction of Ocular Toxicity vol.13, pp.10, 2015, https://doi.org/10.3390/pharmaceutics13101584