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

• TR Number: 636
• Authors: Curren, R.D.  Institute for In Vitro Sciences, Gaithersburg, MD, USA.
• Materials Tested: 1.2 Epoxydodecane, 2-ethyl-1.3-hexanediol, 2-PP, 4-Nitrophenol, BBL, Cyclophosphamide, DCC, ENNG, ENU, MMC, MMS, MNNG, MNU, Trichloroethylene, VB

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)