PMID- 28193562
OWN - NLM
STAT- MEDLINE
DCOM- 20170327
LR  - 20170327
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 85
DP  - 2017 Apr
TI  - Evaluation of radioisotopic and non-radioisotopic versions of local lymph node 
      assays for subcategorization of skin sensitizers compliant to UN GHS rev 4.
PG  - 124-131
LID - S0273-2300(17)30024-7 [pii]
LID - 10.1016/j.yrtph.2017.02.003 [doi]
AB  - 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%, kappa = 0.833, weighted kappa) followed by LLNA: BrdU-ELISA (82%, 
      kappa = 0.744) and LLNA: DA (73%, kappa = 0.656) whereas LNCC only showed a modest 
      association (64%, kappa = 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.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Ha, Soojin
AU  - Ha S
AD  - College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea.
FAU - Ahn, Il Young
AU  - Ahn IY
AD  - National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug 
      Safety, Osong, Republic of Korea.
FAU - Kim, Da-Eun
AU  - Kim DE
AD  - College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea.
FAU - Lee, Jong Kwon
AU  - Lee JK
AD  - National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug 
      Safety, Osong, Republic of Korea.
FAU - Sohn, Soojung
AU  - Sohn S
AD  - National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug 
      Safety, Osong, Republic of Korea.
FAU - Jung, Mi-Sook
AU  - Jung MS
AD  - Pharmacology Efficacy Team, Biotoxtech Co., Ltd, O-Chang, Republic of Korea.
FAU - Heo, Yong
AU  - Heo Y
AD  - Department of Occupational Health, College of Natural Sciences, Catholic 
      University of Daegu, Republic of Korea.
FAU - Omori, Takashi
AU  - Omori T
AD  - Division of Biostatistics, Department of Social/Community Medicine and Health 
      Science, Kobe University School of Medicine, Kobe, Japan.
FAU - Bae, SeungJin
AU  - Bae S
AD  - College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea. Electronic 
      address: sjbae@ewha.ac.kr.
FAU - Lim, Kyung-Min
AU  - Lim KM
AD  - College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea. Electronic 
      address: kmlim@ewha.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20170210
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
RN  - 0 (Haptens)
RN  - 0 (Radioisotopes)
SB  - IM
CIN - Regul Toxicol Pharmacol. 2018 Apr;94:325-329. PMID: 29355661
MH  - Allergens/classification/toxicity
MH  - Animals
MH  - *Dermatitis, Allergic Contact
MH  - Haptens/classification/toxicity
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Radioisotopes
MH  - Reproducibility of Results
MH  - United Nations
OTO - NOTNLM
OT  - Alternative to animal test
OT  - GHS
OT  - Local lymph node assay
OT  - Non-radioisotopic LLNAs
OT  - Skin sensitization
OT  - UN Global Harmonization System
EDAT- 2017/02/15 06:00
MHDA- 2017/03/28 06:00
CRDT- 2017/02/15 06:00
PHST- 2016/10/20 00:00 [received]
PHST- 2017/02/04 00:00 [revised]
PHST- 2017/02/05 00:00 [accepted]
PHST- 2017/02/15 06:00 [pubmed]
PHST- 2017/03/28 06:00 [medline]
PHST- 2017/02/15 06:00 [entrez]
AID - S0273-2300(17)30024-7 [pii]
AID - 10.1016/j.yrtph.2017.02.003 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2017 Apr;85:124-131. doi: 10.1016/j.yrtph.2017.02.003. 
      Epub 2017 Feb 10.