PMID- 27085510
OWN - NLM
STAT- MEDLINE
DCOM- 20170323
LR  - 20220311
IS  - 1879-3177 (Electronic)
IS  - 0887-2333 (Linking)
VI  - 34
DP  - 2016 Aug
TI  - Analysis of the Local Lymph Node Assay (LLNA) variability for assessing the 
      prediction of skin sensitisation potential and potency of chemicals with 
      non-animal approaches.
PG  - 220-228
LID - S0887-2333(16)30075-3 [pii]
LID - 10.1016/j.tiv.2016.04.008 [doi]
AB  - The knowledge of the biological mechanisms leading to the induction of skin 
      sensitisation has favoured in recent years the development of alternative 
      non-animal methods. During the formal validation process, results from the Local 
      Lymph Node Assay (LLNA) are generally used as reference data to assess the 
      predictive capacity of the non-animal tests. This study reports an analysis of 
      the variability of the LLNA for a set of chemicals for which multiple studies are 
      available and considers three hazard classification schemes: POS/NEG, GHS/CLP and 
      ECETOC. As the type of vehicle used in a LLNA study is known to influence to some 
      extent the results, two analyses were performed: considering the solvent used to 
      test the chemicals and without considering the solvent. The results show that the 
      number of discordant classifications increases when a chemical is tested in more 
      than one solvent. Moreover, it can be concluded that study results leading to 
      classification in the strongest classes (1A and EXT) seem to be more reliable 
      than those in the weakest classes. This study highlights the importance of 
      considering the variability of the reference data when evaluating non-animal 
      tests.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Dumont, Coralie
AU  - Dumont C
AD  - Joint Research Centre, European Commission, Ispra, Italy.
FAU - Barroso, Joao
AU  - Barroso J
AD  - Joint Research Centre, European Commission, Ispra, Italy.
FAU - Matys, Izabela
AU  - Matys I
AD  - Joint Research Centre, European Commission, Ispra, Italy.
FAU - Worth, Andrew
AU  - Worth A
AD  - Joint Research Centre, European Commission, Ispra, Italy.
FAU - Casati, Silvia
AU  - Casati S
AD  - Joint Research Centre, European Commission, Ispra, Italy. Electronic address: 
      silvia.casati@ec.europa.eu.
LA  - eng
PT  - Journal Article
DEP - 20160413
PL  - England
TA  - Toxicol In Vitro
JT  - Toxicology in vitro : an international journal published in association with 
      BIBRA
JID - 8712158
RN  - 0 (Haptens)
SB  - IM
MH  - Animal Testing Alternatives
MH  - Animals
MH  - Dermatitis, Allergic Contact
MH  - Haptens/classification/*toxicity
MH  - *Local Lymph Node Assay
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
OTO - NOTNLM
OT  - Alternative methods
OT  - ECETOC
OT  - GHS/CLP
OT  - LLNA variability
OT  - Validation
EDAT- 2016/04/18 06:00
MHDA- 2017/03/24 06:00
CRDT- 2016/04/18 06:00
PHST- 2015/12/21 00:00 [received]
PHST- 2016/03/22 00:00 [revised]
PHST- 2016/04/12 00:00 [accepted]
PHST- 2016/04/18 06:00 [entrez]
PHST- 2016/04/18 06:00 [pubmed]
PHST- 2017/03/24 06:00 [medline]
AID - S0887-2333(16)30075-3 [pii]
AID - 10.1016/j.tiv.2016.04.008 [doi]
PST - ppublish
SO  - Toxicol In Vitro. 2016 Aug;34:220-228. doi: 10.1016/j.tiv.2016.04.008. Epub 2016 
      Apr 13.