title: The reconstructed skin micronucleus assay (RSMN) in EpiDerm™: detailed protocol and harmonized scoring atlas.
abstract: The European Cosmetic Toiletry and Perfumery Association (COLIPA), along with contributions from the European Centre for the Validation of Alternative Methods (ECVAM), initiated a multi-lab international prevalidation project on the reconstructed skin micronucleus (RSMN) assay in EpiDerm™ for the assessment of the genotoxicity of dermally applied chemicals. The first step of this project was to standardize the protocol and transfer it to laboratories that had not performed the assay before. Here we describe in detail the protocol for the RSMN assay in EpiDerm™ and the harmonized guidelines for scoring, with an atlas of cell images. We also describe factors that can influence the performance of the assay. Use of these methods will help new laboratories to conduct the assay, thereby further increasing the database for this promising new in vitro genotoxicity test.
authors.affiliation: Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA. edahl@iivs.org
authors.forename: Erica L
authors.initials: EL
authors.lastname: Dahl
authors.forename: Rodger
authors.initials: R
authors.lastname: Curren
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
authors.forename: Brigitte
authors.initials: B
authors.lastname: Faquet
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Ginestet
authors.forename: Greg
authors.initials: G
authors.lastname: Mun
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: Greg
authors.initials: G
authors.lastname: Carr
authors.forename: Stefan
authors.initials: S
authors.lastname: Pfuhler
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Aardema
mesh_terms: D017408:Guidelines as Topic; D006801:Humans; D015162:Micronucleus Tests / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D009153:Mutagens / Q000633:toxicity; D012867:Skin; D023422:Skin Irritancy Tests / Q000379:methods* / Q000592:standards*; D023822:Tissue Engineering / Q000379:methods; D054928:Validation Studies as Topic
chemical_list: D009153:Mutagens