PMID- 32866543
OWN - NLM
STAT- MEDLINE
DCOM- 20210708
LR  - 20210708
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 117
DP  - 2020 Nov
TI  - Building confidence in skin sensitisation potency assessment using new approach 
      methodologies: report of the 3rd EPAA Partners Forum, Brussels, 28th October 
      2019.
PG  - 104767
LID - S0273-2300(20)30193-8 [pii]
LID - 10.1016/j.yrtph.2020.104767 [doi]
AB  - Skin sensitising substances that induce contact allergy and consequently risk 
      elicitation of allergic contact dermatitis (ACD) remain an important focus 
      regarding the replacement of animal experimentation. Current in vivo methods, 
      notably the local lymph node assay (LLNA) refined and reduced animal usage and 
      led to a marked improvement in hazard identification, characterisation and risk 
      assessment. Since validation, regulatory confidence in the LLNA approach has 
      evolved until it became the first choice assay in most regulated sectors. 
      Currently, hazard identification using the LLNA is being actively replaced by a 
      toolbox of non-animal approaches. However, there remains a need to increase 
      confidence in the use of new approach methodologies (NAMs) as replacements for 
      LLNA sensitiser potency estimation. The EPAA Partners Forum exchanged the current 
      state of knowledge on use of NAMs in various industry sectors and regulatory 
      environments. They then debated current challenges in this area and noted several 
      ongoing needs. These included a requirement for reference standards for potency, 
      better characterisation of applicability domains/technical limitations of NAMs, 
      development of a framework for weight of evidence assessments, and an increased 
      confidence in the characterisation of non-sensitisers. Finally, exploration of an 
      industry/regulator cross-sector user-forum on skin sensitisation was recommended.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Basketter, D
AU  - Basketter D
AD  - DABMEB Consultancy Ltd, Sharnbrook, UK. Electronic address: 
      dabmebconsultancyltd@me.com.
FAU - Beken, S
AU  - Beken S
AD  - European Medicines Agency, Amsterdam, the Netherlands.
FAU - Bender, H
AU  - Bender H
AD  - hjb Consulting, Bonn, Germany.
FAU - Bridges, J
AU  - Bridges J
AD  - University of Surrey, Guildford, UK.
FAU - Casati, S
AU  - Casati S
AD  - European Commission, Joint Research Centre (JRC), Ispra, Italy.
FAU - Corvaro, M
AU  - Corvaro M
AD  - Corteva Agrisciences, Rome, Italy.
FAU - Cuvellier, S
AU  - Cuvellier S
AD  - COSMED, Aix-en-Provence, France.
FAU - Hubesch, B
AU  - Hubesch B
AD  - Hubesch Consult BVBA, Sint-Pieters-Leeuw, Belgium; European Chemical Industry 
      Council (Cefic), Brussels, Belgium.
FAU - Irizar, A
AU  - Irizar A
AD  - The International Fragrance Association (IFRA), Geneva, Switzerland.
FAU - Jacobs, M N
AU  - Jacobs MN
AD  - Public Health England, Chilton, UK.
FAU - Kern, P
AU  - Kern P
AD  - Procter and Gamble Services Company NV/SA, Strombeek-Bever, Belgium.
FAU - Lamplmair, F
AU  - Lamplmair F
AD  - European Commission, Brussels, Belgium.
FAU - Manou, I
AU  - Manou I
AD  - European Partnership for Alternative Approaches to Animal Testing (EPAA), 
      Brussels, Belgium.
FAU - Muller, B P
AU  - Muller BP
AD  - Symrise AG, Holzminden, Germany.
FAU - Roggeband, R
AU  - Roggeband R
AD  - Procter and Gamble Services Company NV/SA, Strombeek-Bever, Belgium.
FAU - Rossi, L H
AU  - Rossi LH
AD  - European Chemicals Agency, Helsinki, Finland.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20200828
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
SB  - IM
MH  - Allergens/*toxicity
MH  - Animal Testing Alternatives/methods/*standards
MH  - Animals
MH  - Belgium/epidemiology
MH  - Congresses as Topic/*standards
MH  - Dermatitis, Allergic Contact/diagnosis/epidemiology
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Research Report/*standards
MH  - Risk Assessment/methods/standards
MH  - Skin/*drug effects
OTO - NOTNLM
OT  - Hazard assessment
OT  - In vitro alternatives
OT  - Potency measurement
OT  - Skin sensitisation
EDAT- 2020/09/01 06:00
MHDA- 2021/07/09 06:00
CRDT- 2020/09/01 06:00
PHST- 2020/04/07 00:00 [received]
PHST- 2020/08/17 00:00 [revised]
PHST- 2020/08/24 00:00 [accepted]
PHST- 2020/09/01 06:00 [pubmed]
PHST- 2021/07/09 06:00 [medline]
PHST- 2020/09/01 06:00 [entrez]
AID - S0273-2300(20)30193-8 [pii]
AID - 10.1016/j.yrtph.2020.104767 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2020 Nov;117:104767. doi: 10.1016/j.yrtph.2020.104767. 
      Epub 2020 Aug 28.