Toxicological Research

  • 제38권4호
  • /
  • Pages.531-544
  • /
  • 2022
  • /
  • 1976-8257(pISSN)
  • /
  • 2234-2753(eISSN)
한국독성학회 (Korean Society of Toxicology & Korea Environmental Mutagen Society)
권호 표지
DOI QR코드

DOI QR Code

Pre-validation study of spectrophotometric direct peptide reactivity assay (Spectro-DPRA) as a modified in chemico skin sensitization test method

  • Seo, Jung-Ah (Department of Public Health, Keimyung University) ;
  • Cho, Sun-A (Safety and Microbiology Lab, Amorepacific Corporation R&D Center) ;
  • Park, Chang Eon (Korea Testing and Research Institute) ;
  • Seo, Dong Hyuk (Korea Conformity Laboratories) ;
  • Choi, Myungsuk (Department of Public Health Science, Korea University) ;
  • An, Susun (Safety and Microbiology Lab, Amorepacific Corporation R&D Center) ;
  • Kim, Bae-Hwan (Department of Public Health, Keimyung University)
  • 투고 : 2021.12.29
  • 심사 : 2022.03.14
  • 발행 : 2022.10.15
⟨ 이전 논문 다음 논문 ⟩

초록

Skin sensitization is induced when certain chemicals bind to skin proteins. Direct peptide reactivity assay (DPRA) has been adopted by the OECD as an alternative method to evaluate skin sensitization by assessing a substance's reaction to two model peptides. A modified spectrophotometric method, Spectro-DPRA, can evaluate skin sensitization, in a high throughput fashion, to obviate some limitations of DPRA. Pre-validation studies for Spectro-DPRA were conducted to determine transferability and proficiency, within- and between-laboratory reproducibility, and predictive ability based on GLP principles at three laboratories (AP, KTR, and KCL). All laboratories confirmed high (>90%) concordance for evaluating the sensitivity induced by ten chemical substances. The concordance among the three tests performed by each laboratory was 90% for AP, 100% for KTR, and 100% for KCL. The mean accuracy of the laboratories was 93.3% [compared to the standard operating procedure (SOP)]. The reproducibility among the three laboratories was as high as 86.7%; the accuracy was 86.7% for AP, 100% for KTR, and 86.7% for KCL (compared to the SOP). An additional 54 substances were assessed in 3 separate labs to verify the prediction rate. Based on the result, 29 out of 33 substances were classified as sensitizers, and 19 out of 21 identified as non-sensitizers; the corresponding sensitivity, specificity, and accuracy values were 87.9%, 90.5%, and 88.9%, respectively. These findings indicate that the Spectro-DPRA can address the molecular initiating event with improved predictability and reproducibility, while saving time and cost compared to DPRA or ADRA.

키워드

과제정보

This research was supported by grants (19182MFDS495 and 21182MFDS339) from the Ministry of Food and Drug Safety, Republic of Korea.

참고문헌

  1. Adam J, Pichler WJ, Yerly D (2011) Delayed drug hypersensitivity: models of T-cell stimulation. Br J Clin Pharmacol 71:701-707. https://doi.org/10.1111/j.1365-2125.2010.03764.x
  2. Kimber I, Basketter DA, Gerberick GF, Ryan CA, Dearman RJ (2011) Chemical allergy: translating biology into hazard characterization. Toxicol Sci 120(suppl_1):S238-S268. https://doi. org/10. 1093/toxsci/kfq346 https://doi.org/10.1093/toxsci/kfq346
  3. Adler S, Basketter D, Creton S et al (2011) Alternative (nonanimal) methods for cosmetics testing: current status and future prospects-2010. Arch Toxicol 85:367-485. https://doi.org/10.1007/s00204-011-0693-2
  4. EU Commission (2013) Communication from the Commission to the European Parliament and the Council. Brussels. https://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013DC0135&from=fr
  5. Vogel R (2009) Alternatives to the use of animals in safety testing as required by the EU-Cosmetics Directive 2009. Altex 26:223-226. https://doi.org/10.14573/altex.2009.3.223
  6. Yamamoto Y, Tahara H, Usami R et al (2015) A novel in chemico method to detect skin sensitizers in highly diluted reaction conditions. J Appl Toxicol 35:1348-1360. https://doi.org/10.1002/jat.3139
  7. Gerberick F, Aleksic M, Basketter D et al (2008) Chemical reactivity measurement and the predicitve identification of skin sensitisers. The report and recommendations of ECVAM Workshop 64. Altern Lab Anim 36:215-242. https://doi.org/10.1177/026119290803600210
  8. Fujita M, Yamamoto Y, Tahara H, Kasahara T, Jimbo Y, Hioki T (2014) Development of a prediction method for skin sensitization using novel cysteine and lysine derivatives. J Pharmacol Toxicol Methods 70:94-105. https://doi.org/10.1016/j.vascn.2014.06.001
  9. Maxwell G, MacKay C, Cubberley R et al (2014) Applying the skin sensitisation adverse outcome pathway (AOP) to quantitative risk assessment. Toxicol Vitro 28:8-12. https://doi.org/10.1016/j.tiv.2013.10.013
  10. Landesmann B, Mennecozzi M, Berggren E, Whelan M (2013) Adverse outcome pathway-based screening strategies for an animal-free safety assessment of chemicals. Lab Anim 41:461-471. https://doi.org/10.1177/026119291304100609
  11. OECD. OECD Guidelines for the Testing of Chemicals (2021) Key event-based test guideline for in chemico skin senditisation assays addressing the adverse outcome pathway key event on covalent binding to proteins. Organization for Economic Co-Operation and Development, Paris. https://doi.org/10.1787/97892 64229709-en
  12. Ahlfors SR, Sterner O, Hansson C (2013) Reactivity of contact allergenic haptens to amino acid residues in a model carrier peptide, and characterization of formed peptide-hapten adducts. Skin Pharmacol Appl Skin Physiol 16:59-68. https://doi.org/10.1159/000068288
  13. Lalko JF, Kimber I, Gerberick GF, Foertsch LM, Api AM, Dearman RJ (2012) The direct peptide reactivity assay: selectivity of chemical respiratory allergens. Toxicol Sci 129:421-431. https://doi.org/10.1093/toxsci/kfs205
  14. Cho SA, Jeong YH, Kim JH et al (2014) Method for detecting the reactivity of chemicals towards peptides as an alternative test method for assessing skin sensitization potential. Toxicol Lett 225:185-191. https://doi.org/10.1016/j. toxlet. 2013. 12. 007
  15. Cho SA, An S, Park JH (2019) High-throughput screening (HTS)-based spectrophotometric direct peptide reactivity assay (Spectro-DPRA) to predict human skin sensitization potential. Toxicol Lett 314:27-36. https://doi.org/10.1016/j.toxlet.2019.07.014
  16. Jeong YH, An S, Shin K, Lee TR (2013) Peptide reactivity assay using spectrophotometric method for high-throughput screening of skin sensitization potential of chemical haptens. Toxicol Vitro 27:264-271. https://doi.org/10.1016/j.tiv.2012.08.032
  17. Udenfriend S, Stein S, Bohlen P, Dairman W, Leimgruber W, Weigele M (1972) Fluorescamine: a reagent for assay of amino acids, peptides, proteins, and primary amines in the picomole range. Science 178:871-872. https://doi.org/10.1126/science.178.4063.871
  18. Gerberick GF, Vassallo JD, Bailey RE, Chaney JG, Morrall SW, Lepoittevin JP (2004) Development of a peptide reactivity assay for screening contact allergens. Toxicol Sci 81:332-343. https://doi.org/10.1093/toxsci/kfh213
  19. OECD (2010) OECD guidelines for the testing of chemicals, section 4. No. 429. Skin sensitization: local lymph node assay. Organization for Economic Co-Operation and Development, Paris. https://doi.org/10.1787/97892 64071100-en
  20. Gerberick GF, Vassallo JD, Foertsch LM, Price BB, Chaney JG, Lepoittevin JP (2007) Quantification of chemical peptide reactivity for screening contact allergens: a classification tree model approach. Toxicol Sci 97:417-427. https://doi.org/10.1093/toxsci/kfm064
  21. Wanibuchi S, Yamamoto Y, Sato A, Kasahara T, Fujita M (2019) The amino acid derivative reactivity assay with fluorescence detection and its application to multi-constituent substances. J Toxicol Sci 44:821-832. https://doi.org/10.2131/jts.44.821
  22. Hirota M, Ashikaga T, Kouzuki H (2018) Development of an artificial neural network model for risk assessment of skin sensitization using human cell line activation test, direct peptide reactivity assay, KeratinoSens™ and in silico structure alert parameter and in silico structure alert parameter. J Appl Toxicol 38:514-526. https://doi.org/10.1002/jat. 3558
  23. Lambrechts N, Vanheel H, Nelissen I et al (2010) Assessment of chemical skin-sensitizing potency by an in vitro assay based on human dendritic cells. Toxicol Sci 116:122-129. https://doi.org/10.1093/toxsci/kfq108
  24. Gerberick GF, Ryan CA, Kern PS et al (2005) Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods. Dermatitis 16:157-202. https://doi.org/10.1097/01206501-200512000-00002
  25. Loveless SE, Api AM, Crevel RW et al (2010) Potency values from the local lymph node assay: application to classification, labelling and risk assessment. Regul Toxicol Pharmacol 56:54-66. https://doi.org/10.1016/j.yrtph.2009.08.016
  26. Cho SA, Choi M, Park SR, An S, Park JH (2020) Application of Spectro-DPRA, KeratinoSens™ and h-CLAT to estimation of the skin sensitization potential of cosmetics ingredients. J Appl Toxicol 40:300-312. https://doi.org/10.1002/jat. 3904
  27. Fleiss JL (1971) Measuring nominal scale agreement among many raters. Psychol Bull 76:378-382. https://doi.org/10.1037/h0031619
  28. Fleiss JL, Levin B, Paik MC (2003) Statistical methods for rates and proportions, 3rd edn. Wiley, Hoboken. https://doi.org/10.1002/0471445428.ch6
  29. Landis JR, Koch GG (1977) The measurement of observer agreement for categorical data. Biometrics 33:159-174. https://doi.org/10.2307/2529310
  30. Daniel AB, Strickland J, Allen D et al (2018) International regulatory requirements for skin sensitization testing. Regul Toxicol Pharmaco 95:52-65. https://doi.org/10.1016/j.yrtph.2018.03.003
  31. Buehler EV (1965) Delayed contact hypersensitivity in the guinea pig. Arch Dermatol 91:171-177. https://doi.org/10.1001/archderm.1965.01600080079017
  32. Magnusson B (1980) Identification of contact sensitizers by animal assay. Contact Dermat 6:46-50. https://doi.org/10.1111/j.1600-0536.1980.tb03894.x
  33. OECD (2021) OECD guidelines for the testing of chemicals, section 4 No. 406. Skin sensitisatioon Guinea pig maximisation test and buehler test. Organization for Economic Co-Operation and Development, Paris. https://doi.org/10.1787/9789264070660-en
  34. Enoch SJ, Roberts DW (2013) Predicting skin sensitization potency for Michael acceptors in the LLNA using quantum mechanics calculations. Chem Res Toxicol 26:767-774. https://doi.org/10.1021/tx400 0655
  35. Kimber I, Basketter DA, Berthold K et al (2001) Skin sensitization testing in potency and risk assessment. Toxicol Sci 59:198-208. https://doi.org/10.1093/toxsci/59.2.198
  36. OECD (2018) OECD guidelines for the testing of chemicals, section 4 No. 442D. In vitro skin sensitisation: ARE-Nrf2 luciferase test method. Organization for Economic Co-Operation and Development, Paris. https://doi.org/10.1787/9789264229822-en
  37. OECD (2018) OECD guidelines for the testing of chemicals, section 4 No. 442E. In vitro skin sensitisation assay addressing the key event on activation of dendritic cells on the adverse outcome pathway for skin sensitisation. Organization for Economic Co-Operation and Development, Paris. https://doi.org/10.1787/9789264264359-en
  38. Basketter DA, Kimber I (2009) Updating the skin sensitization in vitro data assessment paradigm in 2009. J Appl Toxicol 29:545-550. https://doi.org/10.1002/jat.1443
  39. Emter R, Ellis G, Natsch A (2010) Performance of a novel keratinocyte-based reporter cell line to screen skin sensitizers in vitro. Toxicol Appl Pharmacol 245:281-290. https://doi.org/10.1016/j.taap.2010.03.009
  40. Reisinger K, Hoffmann S, Alepee N et al (2015) Systematic evaluation of non-animal test methods for skin sensitisation safety assessment. Toxicol Vitro 29:259-270. https://doi.org/10.1016/j.tiv.2014.10.018
  41. Roberts DW (2018) Is a combination of assays really needed for non-animal prediction of skin sensitization potential? Performance of the GARD™ (Genomic Allergen Rapid Detection) assay in comparison with OECD guideline assays alone and in combination. Regul Toxicol Pharmacol 98:155-160. https://doi.org/10.1016/j.yrtph.2018.07.014
  42. Zhang F, Erskine T, Klapacz J, Settivari R, Marty S (2018) A highly sensitive and selective high pressure liquid chromatography with tandem mass spectrometry (HPLC/MS-MS) method for the direct peptide reactivity assay (DPRA). J Pharmacol Toxicol Methods 94:1-15. https://doi.org/10.1016/j.vascn.2018.07.004
  43. Gerberick GF, Ryan CA, Kern PS et al (2004) A chemical dataset for evaluation of alternative approaches to skin-sensitization testing. Contact Dermat 50:274-288. https://doi.org/10.1111/j.0105-1873.2004.00290.x
  44. Mitjans M, Galbiati V, Lucchi L et al (2010) Use of IL-8 release and p38 MAPK activation in THP-1 cells to identify allergens and to assess their potency in vitro. Toxicol In vitro 24:1803-1809. https://doi.org/10.1016/j.tiv.2010.06.001
  45. Basketter DA (1992) Skin sensitization to cinnamic alcohol: The role of skin metabolism. Acta Derm Venereol 72:264-265. https://doi.org/10.2340/0001555572264265
  46. Elahi EN, Wright Z, Hinselwood D, Hotchkiss SA, Basketter DA, Pease CK (2004) Protein binding and metabolism influence the relative skin sensitization potential of cinnamic compounds. Chem Res Toxicol 17:301-310. https://doi.org/10.1021/tx034 1456
  47. Strickland J, Zang Q, Kleinstreuer N et al (2016) Integrated decision strategies for skin sensitization hazard. J Appl Toxicol 36:1150-1162. https://doi.org/10.1002/jat.3281
  48. OECD (2021) OECD guidelines for the testing of chemicals, section 4 No. 497. Guideline on defined approaches for skin sensitisation. Organization for Economic Co-Operation and Development OECD (OECD), Paris. https://doi.org/10.1787/b92879a4-en