PMID- 20599457
OWN - NLM
STAT- MEDLINE
DCOM- 20110119
LR  - 20191210
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 58
IP  - 2
DP  - 2010 Nov
TI  - Comparative testing for the identification of skin-sensitizing potentials of 
      nonionic sugar lipid surfactants.
PG  - 301-7
LID - 10.1016/j.yrtph.2010.06.016 [doi]
AB  - The Local Lymph Node Assay (LLNA) is the preferred test for the identification of 
      skin-sensitizing potentials of chemicals in Europe and is also the first choice 
      method within REACH. In the formal validation, only a very few surfactant 
      chemicals were evaluated and SDS was identified as a false positive. In this 
      study, 10 nonionic sugar lipid surfactants were tested in an LLNA, guinea pig 
      maximization test (GPMT) and human repeated insult patch test. Of the 10 
      surfactants tested in the LLNA, 5 showed stimulation indices above 3.0. Three of 
      five positive reactions were concomitant with signs of skin irritation indicated 
      by an increase in ear thickness. In the GPMT, all test products were classified 
      as nonsensitizers. In human volunteers, no skin reactions suggestive of 
      sensitization were reported. In conclusion, these results are indicative of the 
      LLNA overestimating sensitization potentials for this category of chemicals. This 
      may in part be due to irritant effects generated by these surfactants. Until 
      suitable nonanimal alternative tests obtain regulatory acceptance, use of other 
      tests, e.g. GPMTs, may in cases be justified. Results such as these need be taken 
      into account when developing nonanimal alternative methods to ensure reliable 
      data sets for method validation purposes.
CI  - Copyright (c) 2010 Elsevier Inc. All rights reserved.
FAU - Garcia, Christine
AU  - Garcia C
AD  - SEPPIC, Paris, France.
FAU - Ball, Nicholas
AU  - Ball N
FAU - Cagen, Stuart
AU  - Cagen S
FAU - Carrillo, Juan-Carlos
AU  - Carrillo JC
FAU - Certa, Hans
AU  - Certa H
FAU - Eigler, Dorothea
AU  - Eigler D
FAU - Esch, Harald
AU  - Esch H
FAU - Graham, Cynthia
AU  - Graham C
FAU - Haux, Carl
AU  - Haux C
FAU - Kreiling, Reinhard
AU  - Kreiling R
FAU - Mehling, Annette
AU  - Mehling A
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Validation Study
DEP - 20100703
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Surface-Active Agents)
SB  - IM
MH  - Animals
MH  - Guinea Pigs
MH  - Humans
MH  - *Local Lymph Node Assay
MH  - Mice
MH  - Mice, Inbred CBA
MH  - Patch Tests/methods
MH  - Skin Irritancy Tests/*methods
MH  - Skin Tests/methods
MH  - Species Specificity
MH  - Surface-Active Agents/chemistry/*toxicity
EDAT- 2010/07/06 06:00
MHDA- 2011/01/20 06:00
CRDT- 2010/07/06 06:00
PHST- 2010/05/12 00:00 [received]
PHST- 2010/06/21 00:00 [revised]
PHST- 2010/06/23 00:00 [accepted]
PHST- 2010/07/06 06:00 [entrez]
PHST- 2010/07/06 06:00 [pubmed]
PHST- 2011/01/20 06:00 [medline]
AID - S0273-2300(10)00108-X [pii]
AID - 10.1016/j.yrtph.2010.06.016 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2010 Nov;58(2):301-7. doi: 10.1016/j.yrtph.2010.06.016. 
      Epub 2010 Jul 3.