PMID- 20621637
OWN - NLM
STAT- MEDLINE
DCOM- 20101020
LR  - 20191210
IS  - 0027-5107 (Print)
IS  - 0027-5107 (Linking)
VI  - 701
IP  - 2
DP  - 2010 Aug 30
TI  - International prevalidation studies of the EpiDerm 3D human reconstructed skin 
      micronucleus (RSMN) assay: transferability and reproducibility.
PG  - 123-31
LID - 10.1016/j.mrgentox.2010.05.017 [doi]
AB  - Recently, a novel in vitro reconstructed skin micronucleus (RSMN) assay 
      incorporating the EpiDerm 3D human skin model (Curren et al., Mutat. Res. 607 
      (2006) 192-204; Mun et al., Mutat. Res. 673 (2009) 92-99) has been shown to 
      produce comparable data when utilized in three different laboratories in the 
      United States (Hu et al., Mutat. Res. 673 (2009) 100-108). As part of a project 
      sponsored by the European cosmetics companies trade association (COLIPA), with a 
      contribution from the European Center for the Validation of Alternative Methods 
      (ECVAM), international prevalidation studies of the RSMN assay have been 
      initiated. The assay was transferred and optimized in two laboratories in Europe, 
      where dose-dependent, reproducibly positive results for mitomycin C and 
      vinblastine sulfate were obtained. Further intra- and inter-laboratory 
      reproducibility of the RSMN assay was established by testing three coded 
      chemicals, N-ethyl-N-nitrosourea, cyclohexanone, and mitomycin C. All chemicals 
      were correctly identified by all laboratories as either positive or negative. 
      These results support the international inter-laboratory and inter-experimental 
      reproducibility of the assay and reinforce the conclusion that the RSMN assay in 
      the EpiDerm 3D human skin model is a valuable in vitro method for assessment of 
      genotoxicity of dermally applied chemicals.
CI  - 2010 Elsevier B.V. All rights reserved.
FAU - Aardema, Marilyn J
AU  - Aardema MJ
AD  - Procter & Gamble, Miami Valley Laboratories, 11810 East Miami River Road, 
      Cincinnati, OH 45253, USA.
FAU - Barnett, Brenda C
AU  - Barnett BC
FAU - Khambatta, Zubin
AU  - Khambatta Z
FAU - Reisinger, Kerstin
AU  - Reisinger K
FAU - Ouedraogo-Arras, Gladys
AU  - Ouedraogo-Arras G
FAU - Faquet, Brigitte
AU  - Faquet B
FAU - Ginestet, Anne-Claire
AU  - Ginestet AC
FAU - Mun, Greg C
AU  - Mun GC
FAU - Dahl, Erica L
AU  - Dahl EL
FAU - Hewitt, Nicola J
AU  - Hewitt NJ
FAU - Corvi, Raffallea
AU  - Corvi R
FAU - Curren, Rodger D
AU  - Curren RD
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100601
PL  - Netherlands
TA  - Mutat Res
JT  - Mutation research
JID - 0400763
RN  - 0 (Mutagens)
SB  - IM
MH  - Animal Testing Alternatives/*methods
MH  - Humans
MH  - Micronucleus Tests/methods
MH  - Mutagens/toxicity
MH  - Reproducibility of Results
MH  - *Skin
MH  - Skin Irritancy Tests/*methods
MH  - *Tissue Engineering
EDAT- 2010/07/14 06:00
MHDA- 2010/10/21 06:00
CRDT- 2010/07/13 06:00
PHST- 2009/11/16 00:00 [received]
PHST- 2010/05/12 00:00 [revised]
PHST- 2010/05/17 00:00 [accepted]
PHST- 2010/07/13 06:00 [entrez]
PHST- 2010/07/14 06:00 [pubmed]
PHST- 2010/10/21 06:00 [medline]
AID - S1383-5718(10)00200-7 [pii]
AID - 10.1016/j.mrgentox.2010.05.017 [doi]
PST - ppublish
SO  - Mutat Res. 2010 Aug 30;701(2):123-31. doi: 10.1016/j.mrgentox.2010.05.017. Epub 
      2010 Jun 1.