Skin Sensitizing Predictability on Chemical Substances with False Positivity or Negativity Following the Transfer of Human Cell Line Activation Test (피부감작능 평가 대체시험법간 위양성 및 위음성 화학물질에 대한 인체 세포주 활성화방법의 전수에 따른 예측력 평가)

AhRang Cho (조아랑); KyengUk Yeo (여경욱); MiSook Jung (정미숙); JaeHee Lee (이재희); YANG SU JEONG (양수정); Ravi Gautam; GiYong Lee (이기용); JiHun Jo (조지훈); Manju Acharya; Anju Maharjan; Kim Chang Yul (김창열); Yong Heo (허용)

doi:10.23032/jaae.2020.14.1.002

Skin Sensitizing Predictability on Chemical Substances with False Positivity or Negativity Following the Transfer of Human Cell Line Activation Test

Journal of Alternatives to Animal Experiments
Abbr : J Altern Anim Exp
2020, 14(1), pp.15-21
DOI : 10.23032/jaae.2020.14.1.002
Publisher : Korean Society for Alternatives to Animal Experiments
Research Area : Medicine and Pharmacy > Veterinary > Basic Veterinary Medicine > Laboratory Animal Medicine
Received : August 11, 2020
Accepted : December 8, 2020
Published : December 30, 2020

AhRang Cho ¹, KyengUk Yeo ², MiSook Jung ³, JaeHee Lee ¹, YANG SU JEONG ¹, Ravi Gautam ¹, GiYong Lee ⁴, JiHun Jo ¹, Manju Acharya ⁵, Anju Maharjan ⁵, Kim Chang Yul ¹, Yong Heo ¹

¹대구가톨릭대학교
²한국화학융합시험연구원
³(주)바이오톡스텍 부설연구소
⁴대구가톨릭대학교 GLP센터
⁵대구가톨릭대학교 산업보건학과

Candidate

ABSTRACT

The in vitro alternative assay for evaluating skin sensitizing potentials (SSP) called human Cell Line Activation Test (h-CLAT) has been recently adopted as an international test guideline. The present study was proceeded to pursue the domestic establishment and expansion of h-CLAT. The standard operational procedure was prepared in detail by the lead laboratory (LL) and transferred to one participating laboratory (PL). The LL demonstrated technical proficiency for the 10 substances listed in OECD TG 442E. The PL also demonstrated a certain level of proficiency, in that 4-phenylenediamine and 4-aminobenzoic acid distributed with coded names were correctly classified as positive and negative on SSP, respectively, and other indices including 75% cell viability (CV75) and relative fluorescence intensity (RFI) % for CD54 and CD86 were fell within the reference range. Methyl methacrylate, nickel chloride, and resorcinol, which are inconsistent in predicting SSP through various alternative test methods, were unanimously predicted as negative, positive, and positive on SSP by the two laboratories for the first time through h-CLAT. Both chlorobenzene and sodium lauryl sulfate with the existing h-CLAT report as positive and negative, respectively, were predicted as negative by the PL, which could contribute toward overall categorization into non-skin sensitizer.

KEYWORDS

human-Cell Line Activation Test, Predictability, Transferability, false positive or negative chemicals, skin sensitization

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[other] 식품의약품안전평가원 / 2017 / 화장품 피부감작성 동물대체시험법(인체 세포주 활성화 방법, h-CLAT) 가이드라인(민원인 안내서)

[journal] Ahn IY / 2016 / Performance standard-based validation study for local lymph node assay: 5-bromo-2-deoxyuridineflow cytometry method / Regulatory Toxicology and Pharmacology 80 : 183~194

[journal] Ashikaga T / 2006 / Development of an in vitro skin sensitization test using human cell lines : The human Cell Line Activation Test(h-CLAT)I / Optimization of the h-CLAT protocol. Toxicology In Vitro 20 : 767~773

[journal] Casati S. / 2018 / Integrated approaches to testing and assessment / Basic & Clinical Pharmacology & Toxicology 123 : 51~55

[journal] Clouet E / 2017 / Comparison and validation of an in vitro skin sensitization strategy using a data set of 33 chemical references / Toxicology in Vitro 45 : 374~385

[journal] Coecke S / 2005 / Guidance on good cell culture practice : A report of the second ECVAM task force on good cell culture practice / Alternatives to Laboratory Animals 33 : 261~287

[report] Dean J / 1999 / The murine local lymph node assay: a test method for assessing the allergic contact dermatitis potential of chemicals/compounds: The results of an independent peer review evaluation coordiated by the interagency coordinating committee on the validation of alternative methods (ICCVAM) and the national toxicology program center for the evaluation of alternative toxicological methods (NICEATM) / NIH Publication

[report] EURL-ECVAM / 2016 / Human Cell line Activation Test (h-CLAT) / Joint Research Centre

[journal] Gibbs S / 2018 / Assessment of metal sensitizer potency with the reconstructed human epidermis IL-18 assay / Toxicology 393 : 62~72

[journal] Hartung T / 2002 / Good cell culture practice : ECVAM Good cell culture practice task force report 1 / Alternatives to Laboratory Animals 30 : 407~414

[report] ICCVAM / 2010 / ICCVAM test method evaluation report. nonradioactive local lymph node assay: BrdU-ELISA test method protocol (LLNA: BrdU-ELISA) / National Institute of Environmental Health Sciences

[report] ICCVAM / 2010 / ICCVAM test method evaluation report. nonradioactive local lymph node assay: modified by Daicel Chemical Industries, Ltd., based on ATP content test method protocol (LLNA: DA) / National Institute of Environmental Health Sciences

[journal] Kimber I. / 2019 / The activity of methacrylate esters in skin sensitisation test methods : a review / Regulatory Toxicology and Pharmacology 104 : 14~20

[journal] Kolle SN / 2019 / A review of substances found positive in 1 of 3 in vitro tests for skin sensitization / Regulatory Toxicology and Pharmacology 106 : 352~368

[journal] Lee JH / 2019 / Prediction of the skin sensitization potential of didecyldimethylammonium chloride and 3,7-dimethyl-2,6- octadienal and mixtures of these compounds with the excipient ethylene glycol through the human Cell Line Activation Test and the Direct Peptide Reactivity Assay / Toxicology and Industrial Health 35 : 507~519

[report] OECD / 2010 / OECD guideline for the testing of chemicals. Skin sensitization: Local lymph node assay

[report] OECD / 2016 / OECD guideline for the testing of chemicals. In Vitro Skin sensitisation: human Cell Line Activation Test (h-CLAT)

[report] OECD / 2018 / Key event-based test guideline. In vitro skin sensitisation assays addressing the key event on activation of dendritic cellls on the adverse outcome pathway for skin sensitisation

[journal] Schmidt M / 2010 / Crucial role for human Toll-like receptor 4 in the development of contact allergy to nickel / Nature Immunology 11 : 814~819

[journal] Takenouchia O / 2015 / Test battery with the human cell line activation test, direct peptide reactivity assay and DEREK based on a 139 chemical data set for predicting skin sensitizing potential and potency of chemicals / Journal of Applied Toxicology 35 : 1318~1332

[journal] Urbisch D / 2015 / Assessing skin sensitization hazard in mice and men using non-animal test methods / Regulatory Toxicology and Pharmacology 71 : 337~351

[journal] Urbisch D / 2016 / Assessment of pre-and pro-haptens using nonanimal test methods for skin sensitization / Chemical Research in Toxicology 29 : 901~913

[report] USEPA / 2018 / Strategic plan to promote the development and implementation of alternative test methods with the TSCA program / U.S. Environmental Protection Agency

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Journal of Alternatives to Animal Experiments 2023 KCI Impact Factor : 0.07

Skin Sensitizing Predictability on Chemical Substances with False Positivity or Negativity Following the Transfer of Human Cell Line Activation Test

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* References for papers published after 2023 are currently being built.

Journal of Alternatives to Animal Experiments 2023 KCI Impact Factor : 0.07

Skin Sensitizing Predictability on Chemical Substances with False Positivity or Negativity Following the Transfer of Human Cell Line Activation Test

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