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

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.

AARDEMA M;  BARNETT B;  KHAMBATTA Z;  REISINGER K;  OUEDRAOGO G;  FAQUET B;  GINESTET Ac;  MUN G;  DAHL E;  HEWITT N;  CORVI Raffaella;  CURREN R; 

2010-10-21

ELSEVIER SCIENCE BV

JRC55498

1383-5718,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC55498,   

10.1016/j.mrgentox.2010.05.017,