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Evaluation of radioisotopic and non-radioisotopic versions of local lymph node assays for subcategorization of skin sensitizers compliant to UN GHS rev 4

Title
Evaluation of radioisotopic and non-radioisotopic versions of local lymph node assays for subcategorization of skin sensitizers compliant to UN GHS rev 4
Authors
Ha, SoojinAhn, Il YoungKim, Da-eunLee, Jong KwonSohn, SoojungJung, Mi-SookHeo, YongOmori, TakashiBae, SeungJinLim, Kyung-Min
Ewha Authors
배승진임경민
SCOPUS Author ID
배승진scopus; 임경민scopus
Issue Date
2017
Journal Title
REGULATORY TOXICOLOGY AND PHARMACOLOGY
ISSN
0273-2300JCR Link1096-0295JCR Link
Citation
vol. 85, pp. 124 - 131
Keywords
Local lymph node assayNon-radioisotopic LLNAsUN Global Harmonization SystemGHSSkin sensitizationAlternative to animal test
Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
Recently UN GHS has introduced the sub-categorization of skin sensitizers for which ECt (concentration estimated to induce stimulation index above threshold) of the murine local lymph node assay (LLNA) is used as criteria. Non-radioisotopic variants of LLNA, LLNA: DA, LLNA: BrdU-ELISA, LNCC and LLNA: BrdU-FCM were developed yet their utilities for potency sub-categorization are not established. Here we assessed the agreement of LLNA variants with LLNA or human data in potency sub-categorization for 22 reference substances of OECD TG429. Concordance of sub-categorization with LLNA was highest for LLNA: BrdU-FCM(91%, K = 0.833, weighted kappa) followed by LLNA: BrdU-ELISA (82%, K = 0.744) and LLNA: DA (73%, K = 0.656) whereas LNCC only showed a modest association (64%, K= 0.441). With human data, LLNA agreed best (77%) followed by LLNA: DA and LLNA: BrdU-FCM(73%), LLNA: BrdU-ELISA (68%) and LNCC(55%). Bland-Altman plot revealed that ECt's of LLNA variants largely agreed with LLNA where most values fell within 95% limit of agreement. Correlation between ECt's of LLNA and LLNA variants were high except for LNCC(pair-wise with LLNA, LLNA: DA, r = 0.848, LLNA: BrdU-ELISA, r = 0.744, LLNA: BrdU-FCM, r=0.786, and LNCC, r = 0.561 by Pearson). Collectively, these results demonstrated that LLNA variants exhibit performance comparable to LLNA in the potency sub categorization although additional substances shall be analyzed in the future. (C) 2017 Elsevier Inc. All rights reserved.
DOI
10.1016/j.yrtph.2017.02.003
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약학대학 > 약학과 > Journal papers
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