PMID- 38417477
OWN - NLM
STAT- MEDLINE
DCOM- 20240322
LR  - 20240322
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 148
DP  - 2024 Mar
TI  - Use of guinea pig data to obtain starting points for skin sensitisation risk 
      assessment - A commentary.
PG  - 105584
LID - S0273-2300(24)00025-4 [pii]
LID - 10.1016/j.yrtph.2024.105584 [doi]
AB  - The increasing drive to understand the likelihood of skin sensitisation from 
      plant protection products (PPPs) in workers and the general public has resulted 
      in recent initiatives to establish a quantitative risk assessment (QRA) 
      methodology applicable to these products and their exposure scenarios. The 
      effective evaluation of skin sensitising substances requires not only the 
      identification of that toxicological hazard, but also determination of relative 
      sensitising potency. Typically, this has been achieved by interpretation of local 
      lymph node assay (LLNA) dose response data, delivering what is known as the EC3 
      value. This permitted regulatory division of skin sensitisers into defined 
      potency sub-categories, but more importantly enabled derivation of a no expected 
      sensitisation induction level (NESIL) as the point of departure for QRA. However, 
      for many existing substances there is no LLNA data, only older guinea pig results 
      exist. To avoid additional (in vivo) testing, an approach has been outlined to 
      employ guinea pig data and existing regulatory guidelines on the determination of 
      potency sub-categorisation to provide a guinea pig based NESIL. The approach 
      adopts a conservative extrapolation from LLNA NESIL benchmarks to deliver points 
      of departure as the basis for the type of QRA process already in successful use 
      by other industries.
CI  - Copyright (c) 2024 Elsevier Inc. All rights reserved.
FAU - Basketter, David
AU  - Basketter D
AD  - DABMEB Consultancy Ltd, Kingswood, Gloucestershire, GL12 8RN, UK. Electronic 
      address: dabmebconsultancyltd@me.com.
FAU - Corea, Namali
AU  - Corea N
AD  - Syngenta, Jealott's Hill International Research Centre, Bracknell, UK.
FAU - Corvaro, Marco
AU  - Corvaro M
AD  - Corteva Agriscience, Rome, Italy.
FAU - Grivel, Arthur
AU  - Grivel A
AD  - Bayer SAS Crop Science, Sophia Antipolis, France.
FAU - Kluxen, Felix M
AU  - Kluxen FM
AD  - ADAMA Deutschland GmbH, Edmund-Rumpler-Str. 6, 51149, Cologne, Germany.
FAU - Morgan, Neil
AU  - Morgan N
AD  - Syngenta, Jealott's Hill International Research Centre, Bracknell, UK.
FAU - Wiemann, Christiane
AU  - Wiemann C
AD  - BASF Oesterreich GmbH, 1200, Vienna, Austria.
LA  - eng
PT  - Journal Article
DEP - 20240228
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
SB  - IM
MH  - Guinea Pigs
MH  - Animals
MH  - *Dermatitis, Allergic Contact/prevention & control
MH  - Allergens/toxicity
MH  - Skin
MH  - Local Lymph Node Assay
MH  - Risk Assessment/methods
OTO - NOTNLM
OT  - Buehler test
OT  - Guinea pig maximisation test
OT  - Pesticides
OT  - Plant protection
OT  - Potency assessment
OT  - Regulatory guidelines
OT  - Risk assessment
OT  - Skin sensitisation
COIS- Declaration of competing interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests:The authors and/or reviewers listed immediately below are members of 
      CropLife Europe expert groups and are employed as toxicologists and risk 
      assessors who put plant protection products on the market that may become subject 
      to quantitative risk assessment for skin sensitisation: Namali Corea, Marco 
      Corvaro, Felix M. Kluxen, Arthur Grivel, Neil Morgan, Christiane Wiemann. David 
      Basketter was compensated by CropLife Europe for time spent in the preparation of 
      the manuscript.
EDAT- 2024/02/29 00:42
MHDA- 2024/03/22 06:45
CRDT- 2024/02/28 19:13
PHST- 2023/12/15 00:00 [received]
PHST- 2024/02/11 00:00 [revised]
PHST- 2024/02/18 00:00 [accepted]
PHST- 2024/03/22 06:45 [medline]
PHST- 2024/02/29 00:42 [pubmed]
PHST- 2024/02/28 19:13 [entrez]
AID - S0273-2300(24)00025-4 [pii]
AID - 10.1016/j.yrtph.2024.105584 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2024 Mar;148:105584. doi: 10.1016/j.yrtph.2024.105584. 
      Epub 2024 Feb 28.