PMID- 37207870
OWN - NLM
STAT- MEDLINE
DCOM- 20230710
LR  - 20230710
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 141
DP  - 2023 Jun
TI  - Assessing the risk of induction of skin sensitization to plant protection 
      products: A quantitative approach.
PG  - 105408
LID - S0273-2300(23)00076-4 [pii]
LID - 10.1016/j.yrtph.2023.105408 [doi]
AB  - Exposure to skin sensitizers is common and regulated in many industry sectors. 
      For cosmetics, a risk-based approach has been implemented, focused on preventing 
      the induction of sensitization. First, a No Expected Sensitization Induction 
      Level (NESIL) is derived, then modified by Sensitization Assessment Factors 
      (SAFs) to derive an Acceptable Exposure Level (AEL). The AEL is used in risk 
      assessment, being compared with an estimated exposure dose, specific to the 
      exposure scenario. Since in Europe there is increased concern regarding exposure 
      towards potentially sensitizing pesticides via spray drift, we explore how 
      existing practice can be modified to allow Quantitative Risk Assessment (QRA) of 
      pesticides for bystanders and residents. NESIL derivation by the Local Lymph Node 
      Assay (LLNA), the globally required in vivo assay for this endpoint, is reviewed 
      alongside consideration of appropriate SAFs. Using a case study, the principle 
      that the NESIL in mug/cm(2) can be derived by multiplying LLNA EC3% figure by a 
      factor of 250 is adopted. The NESIL is then reduced by an overall SAF of 25 to 
      establish an exposure level below which there is minimal bystander and resident 
      risk. Whilst this paper focuses on European risk assessment and management, the 
      approach is generic and universally applicable.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved.
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 - Kluxen, Felix M
AU  - Kluxen FM
AD  - ADAMA Deutschland GmbH, Edmund-Rumpler-Str. 6, 51149, Cologne, Germany.
FAU - Grivel, Arthur
AU  - Grivel A
AD  - Bayer SAS Crop Science, Sophia Antipolis, France.
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.
FAU - Basketter, David
AU  - Basketter D
AD  - DABMEB Consultancy Ltd, Kingswood, Gloucestershire, GL12 8RN, UK. Electronic 
      address: dabmebconsultancyltd@me.com.
LA  - eng
PT  - Journal Article
DEP - 20230518
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
RN  - 0 (Pesticides)
SB  - IM
MH  - Humans
MH  - Allergens/toxicity
MH  - *Dermatitis, Allergic Contact/etiology/prevention & control
MH  - Local Lymph Node Assay
MH  - *Pesticides/toxicity
MH  - Risk Assessment
MH  - Skin
MH  - Skin Tests
OTO - NOTNLM
OT  - Bystanders
OT  - Plant protection products
OT  - Quantitative risk assessment
OT  - Residents
OT  - Skin sensitization
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 sensitization: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- 2023/05/20 09:42
MHDA- 2023/06/05 06:42
CRDT- 2023/05/19 19:25
PHST- 2023/02/26 00:00 [received]
PHST- 2023/04/26 00:00 [revised]
PHST- 2023/05/01 00:00 [accepted]
PHST- 2023/06/05 06:42 [medline]
PHST- 2023/05/20 09:42 [pubmed]
PHST- 2023/05/19 19:25 [entrez]
AID - S0273-2300(23)00076-4 [pii]
AID - 10.1016/j.yrtph.2023.105408 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2023 Jun;141:105408. doi: 10.1016/j.yrtph.2023.105408. 
      Epub 2023 May 18.