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|Title:||International prevalidation studies of the EpiDermTM 3D human reconstructed skin micronucleus (RSMN) assay: Transferability and reproducibility|
|Authors:||AARDEMA M; BARNETT B; KHAMBATTA Z; REISINGER K; OUEDRAOGO G; FAQUET B; GINESTET Ac; MUN G; DAHL E; HEWITT N; CORVI Raffaella; CURREN R|
|Citation:||MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS vol. 701 no. 2 p. 123-131|
|Publisher:||ELSEVIER SCIENCE BV|
|Type:||Articles in periodicals and books|
|Abstract:||Recently, the EpiDerm¿ 3D human skin model has been incorporated into a novel in vitro human reconstructed skin micronucleus (RSMN) assay (Curran et al., Mutat. Res. 607 (2006) 192-204; Mun et al., 673 (2009) 92-99) and shown to have comparable data from three different laboratories in the United States (Hu et al., Mutat. Res. 673 (2009) 100-108). As part of a project sponsored by COLIPA, the European cosmetics companies trade association, and the European Center for Validation of Alternative Methods, international pre-validation studies of the RSMN assay have been conducted. The RSMN assay was transferred and optimized in two laboratories in Europe where dose dependent, reproducible 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 as either positive or negative. These results confirm the international inter-laboratory and inter-experimental reproducibility of the assay and support the conclusion that the RSMN assay in the EpiDermTM 3D human skin model is a valuable in vitro method for genotoxicity assessment of dermally applied chemicals.|
|JRC Institute:||Institute for Health and Consumer Protection|
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