PMID- 29964119
OWN - NLM
STAT- MEDLINE
DCOM- 20181029
LR  - 20181029
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 97
DP  - 2018 Aug
TI  - Interspecies assessment factors and skin sensitization risk assessment.
PG  - 186-188
LID - S0273-2300(18)30174-0 [pii]
LID - 10.1016/j.yrtph.2018.06.018 [doi]
AB  - For many endpoints in toxicology, an interspecies safety factor remains a 
      standard requirement. However, for skin sensitization, the hazard and potency 
      predictions, notably from the local lymph node assay (LLNA) have been shown to 
      correlate well with human data. Despite this, there are always exceptions, both 
      over and under predictions. For this reason it has been suggested that an 
      interspecies factor of 15 would accommodate potential "errors". An alternative 
      approach is suggested in which an evidence-based strategy is taken: the large 
      majority of the information indicates a human:LLNA ratio of 1, therefore a 
      corrective factor would best be applied where our knowledge of the underlying 
      chemistry of sensitization indicates that it is necessary.
CI  - Copyright (c) 2018. Published by Elsevier Inc.
FAU - Basketter, D A
AU  - Basketter DA
AD  - DABMEB Consultancy Ltd, Sharnbrook, Bedfordshire, UK. Electronic address: 
      dabmebconsultancyltd@me.com.
FAU - Natsch, A
AU  - Natsch A
AD  - Fragrances S&T, Ingredients Research, Givaudan Schweiz AG, Duebendorf, CH-8600, 
      Switzerland.
FAU - Ellis, G
AU  - Ellis G
AD  - Regulatory Affairs and Product Safety, Givaudan International SA, Vernier, 
      CH-1214, Switzerland.
FAU - Api, A M
AU  - Api AM
AD  - Research Institute for Fragrance Materials Inc., 50 Tice Boulevard, Woodcliff 
      Lake, NJ, USA.
FAU - Irizar, A
AU  - Irizar A
AD  - The International Fragrance Association, Avenue des Arts 6, Brussels, 1210, 
      Belgium.
FAU - Safford, B
AU  - Safford B
AD  - B-Safe Toxicology Consulting, Rushden, Northamptonshire, UK.
FAU - Ryan, C
AU  - Ryan C
AD  - The Procter & Gamble Company, Mason Business Center, 8700 Mason Montgomery Rd., 
      Mason, OH, 45040, USA.
FAU - Kern, P
AU  - Kern P
AD  - Procter & Gamble Services Company NV, Temselaan 100, Strombeek-Bever, B-1853, 
      Belgium.
LA  - eng
PT  - Journal Article
DEP - 20180628
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
SB  - IM
MH  - Animals
MH  - Humans
MH  - Local Lymph Node Assay
MH  - Lymph Nodes/drug effects/*pathology
MH  - Mice
MH  - Risk Assessment
MH  - Skin/drug effects/*pathology
EDAT- 2018/07/03 06:00
MHDA- 2018/10/30 06:00
CRDT- 2018/07/03 06:00
PHST- 2018/02/13 00:00 [received]
PHST- 2018/06/22 00:00 [revised]
PHST- 2018/06/28 00:00 [accepted]
PHST- 2018/07/03 06:00 [pubmed]
PHST- 2018/10/30 06:00 [medline]
PHST- 2018/07/03 06:00 [entrez]
AID - S0273-2300(18)30174-0 [pii]
AID - 10.1016/j.yrtph.2018.06.018 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2018 Aug;97:186-188. doi: 10.1016/j.yrtph.2018.06.018. 
      Epub 2018 Jun 28.