DEVELOPMENT OF A NEW IN VITRO GENETIC TOXICOLOGY MODEL USING RECONSTRUCTED HUMAN SKIN.

Choosing the Approach: • Procter & Gamble, a major cosmetics company, had excellent genetox personnel and expertise….and the idea to use a reconstructed skin model as a target tissue. • IIVS had extensive experience in using 3D skin models and in developing regulatory compliant in vitro assay systems. • IIVS is a non-profit company with a remit to help build the field of in vitro toxicology. • Result – a promising collaboration. Progress to Date: • Traditional monolayer MN methodology transferred to a reconstructed skin model • Known positive and negative genotoxins tested • Negative and positive control statistics developed • Intra- and inter-laboratory reproducibility evaluated • Coded materials tested in multiple laboratories (in progress) • Applicability domain assessed (in progress)

Cytochrome P450, EPI-200-MNA, EpiDerm, False positives, Genetic toxicology, Genotoxins, Hair dyes, In Vitro micronucleus assay, Inter-laboratory reproducibility, Reconstructed skin micronucleus (RSMN) assay, Tissue disruption

1.2 Epoxydodecane, 2-ethyl-1.3-hexanediol, 2-PP, 4-Nitrophenol, BBL, Cyclophosphamide, DCC, ENNG, ENU, MMC, MMS, MNNG, MNU, Trichloroethylene, VB