title: International prevalidation studies of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay: transferability and reproducibility.
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 3D human skin model is a valuable in vitro method for assessment of genotoxicity of dermally applied chemicals.
authors.affiliation: Procter & Gamble, Miami Valley Laboratories, 11810 East Miami River Road, Cincinnati, OH 45253, USA.
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Aardema
authors.forename: Brenda C
authors.initials: BC
authors.lastname: Barnett
authors.forename: Zubin
authors.initials: Z
authors.lastname: Khambatta
authors.forename: Kerstin
authors.initials: K
authors.lastname: Reisinger
authors.forename: Gladys
authors.initials: G
authors.lastname: Ouedraogo-Arras
authors.forename: Brigitte
authors.initials: B
authors.lastname: Faquet
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Ginestet
authors.forename: Greg C
authors.initials: GC
authors.lastname: Mun
authors.forename: Erica L
authors.initials: EL
authors.lastname: Dahl
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: Raffallea
authors.initials: R
authors.lastname: Corvi
authors.forename: Rodger D
authors.initials: RD
authors.lastname: Curren
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D006801:Humans; D015162:Micronucleus Tests / Q000379:methods; D009153:Mutagens / Q000633:toxicity; D015203:Reproducibility of Results; D012867:Skin; D023422:Skin Irritancy Tests / Q000379:methods*; D023822:Tissue Engineering
chemical_list: D009153:Mutagens