International prevalidation studies of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay: transferability and reproducibility

Mutation Research
Marilyn J AardemaRodger D Curren

Abstract

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 3...Continue Reading

References

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Citations

Mar 30, 2013·Toxicological Sciences : an Official Journal of the Society of Toxicology·Nicola J HewittStefan Pfuhler
May 3, 2011·Archives of Toxicology·Sarah AdlerJosé-Manuel Zaldivar
Jul 22, 2014·Environmental and Molecular Mutagenesis·Luoping ZhangSundaresan Venkatactahalam
Jul 3, 2013·Toxicology in Vitro : an International Journal Published in Association with BIBRA·S PfuhlerJ Barroso
Aug 31, 2013·Mutation Research. Genetic Toxicology and Environmental Mutagenesis·Katsuyuki YukiToshio Kasamatsu
Jul 13, 2016·Mutation Research. Genetic Toxicology and Environmental Mutagenesis·Shambhu RoyMarilyn J Aardema
Aug 25, 2016·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Raffaella Corvi, Federica Madia
Sep 11, 2016·Particle and Fibre Toxicology·John W WillsShareen H Doak
Oct 16, 2016·Archives of Toxicology·Andrea Haase, Andreas Luch
Jan 21, 2017·International Journal of Pharmaceutics·Andreia AlmeidaFrancisca Rodrigues
Mar 27, 2018·Experimental Dermatology·Christian RiebelingTewes Tralau
Apr 28, 2018·Toxicological Sciences : an Official Journal of the Society of Toxicology·Rosalie ElespuruJennifer Y Tanir
Dec 20, 2011·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Christine GötzEllen Fritsche
Feb 19, 2020·Mutagenesis·Lizao ChenGladys Ouedraogo
Jul 23, 2011·Alternatives to Laboratory Animals : ATLA·Damien BrehenyStephen P Faux
Jan 23, 2021·Toxicological Sciences : an Official Journal of the Society of Toxicology·Maik SchulerBrett Hollingshead
Apr 19, 2021·Mutation Research. Genetic Toxicology and Environmental Mutagenesis·Ashley AllemangStefan Pfuhler

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