Journal of Clinical Toxicology
Open Access

Genotoxicity: Basic aspects and most commonly worldwide employed and validated in vitro assays

4^th Global Summit on Toxicology

August 24-26, 2015 Philadelphia, USA

Leon F Stankowski

Scientific Tracks Abstracts: J Clin Toxicol

Abstract :

In vitro genotoxicity assays that are commonly used for regulatory purposes can be categorized into two main groups based
upon the endpoints analyzed: Gene mutation and chromosome aberration. The single most commonly performed test is
the bacterial reverse mutation assay generally referred to as the Ames assay which is often used as the first go/no go decision
point in product development. Gene mutation can also be evaluated in mammalian cell test systems such as the mouse
lymphoma or CHO/HPRT assays, where the cells become resistant to metabolic poisons after loss of specific gene function.
The other main group of assays is based upon cytogenetic analyses that examine changes in chromosome structure or number.
Clastogens induce structural changes that can be detected microscopically and may manifest as breaks or rearrangements
involving one or both chromatids of one chromosome or multiple chromosomes. While chromosome aberration assays may
detect limited types of numerical aberrations (polyploidy and endoreduplication), the micronucleus assay is better suited for
that purpose since it can detect aneugens (spindle poisons) that cause more limited changes in chromosome number (i.e., gain
or loss of single chromosomes). The basic principles underlying these assays and their basic design will be presented as well as
a discussion of the pros and cons of each.

Biography :

Leon F Stankowski, Jr., PhD received BS degrees from The Pennsylvania State University in pre-medicine and biophysics; studied toward a MS in biochemistry at
the University of Scranton; and received a PhD in biomedical sciences, specializing in genetics, from the University of Tennessee – Oak Ridge Graduate School
of Biomedical Sciences. Since then, he has held various scientific and management positions in contract research organizations and the pharmaceutical industry.
He has served a study director for a variety of in vitro and in vivo genetic toxicology assays, and as a program manager or consultant. He has directed thousands
of assays in multiple in vivo and in vitro test systems; has had a lead role in developing and validating novel mutagenesis, in vitro toxicity and biochemistry
methods and services; and has published original research results in multiple journals and presented at numerous meetings. He is a member of the Environmental
Mutagenesis and Genomics Society and the Genetic Toxicology Association (GTA), and served on the GTA Board of Directors from 2000 to 2003, as the GTA
Assistant Treasurer from 2003 to 2006, and as the GTA Treasurer from 2006 to present. He has been a reviewer for several journals in the field, served on
numerous industrial workgroups involving in vitro and in vivo mammalian mutagenesis assays, including ASTM, IWGT, US EPA, and ILSI-HESI, and is a US
Delegate to the Expert Working Group for the review of most of the OECD Test Guidelines on Genotoxicity.