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Genotoxicity and cytotoxicity

Micronucleus assay

In vitro tests for genotoxicity have been developed and standardised for many years.  They are widely used in different sectors, and have an important regulatory role in risk assessments, especially in detecting potential carcinogens.

Authoritative international guidelines recommend in vitro genotoxicity tests for chemicals and pharmaceuticals.  These include the Ames test, the micronucleus test and the mouse lymphoma assay [1]. British American Tobacco Group Research & Development has worked with in vitro genotoxicity tests for more than thirty years.  Today, we perform these three tests, recommended for chemicals and pharmaceuticals, at an independent GLP Contract Research Organisation.

The results are used to characterise the genotoxicities of particulate matter, collected from tobacco smoke or of urine samples collected from smokers and non-smokers.  While in vitro tests alone cannot measure human risk, they can contribute to a Weight of Evidence paradigm for the risk assessment of Reduced Toxicant Prototype tobacco products.  Together with smoke composition, in vitro disease models, bio-markers of exposure and effect, and smoking behaviour data, in vitro genotoxicity studies can help to test the hypothesis that the biological significance of exposure to tobacco and/or tobacco smoke toxicants has been reduced, without introducing new genotoxic hazards.

British American Tobacco has a method development programme, to increase the value of in vitro genotoxicity data.  For example, we have measured the stability of stored particulate matter and assessed the statistical power of the assays.  We have recently established a new genotoxicity facility in the Contract Research Organisation.  It can expose cultured cells to tobacco smoke aerosol and its volatile constituents.

British American Tobacco is also part of CORESTA’s In Vitro Task Force, which seeks to measure and reduce the inter-laboratory variability of these methods.

These activities have benefitted from independent expert advice and are presented at scientific conferences.  Click here to see assay details.

  1. OECD Guidelines 470, 476 and 481; ICH Harmonised Tripartite Guidelines (1995 and 1997); EEC Annex V Tests B 13/14 (2000).
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Genotoxicity and cytotoxicity assays