Methods and Protocols

    Overview of in vitro assays used in the standard toxicological assessment of Reduced-Risk Products

    PMI

    Published on
    Dec 11, 2014
    Topic
    Summary

    In vitro toxicology involves the analysis of the effects of toxic substances on either cultured bacteria or mammalian cells. We use two main types of in vitro toxicology tests: cytotoxicity assays and genotoxicity assays.

    Cytotoxicity assays

    The method we use to compare the cytotoxicity induced by cigarette smoke and Reduced-Risk Product (RRP) aerosols is based on the assessment of cell membrane integrity.

    Probably the most widely used assay for the assessment of cytotoxicity within the chemical and pharmaceutical industries is the Neutral Red Assay, and it is this method that we use to assess our RRPs.

    Genotoxicity assays

    Genotoxicity assays assess the ability of a substance to damage the genetic information within a cell and cause mutations (which in turn can, but does not necessarily give rise to a number of pathologies, including cancers). In vitro genotoxicity assays are used as a screening method for a potential mutagenic effect in more complex biological systems such as animals and humans. In the assessment of our RRPs, we employ two commonly used genotoxicity assays: the Ames Assay (also known as the Bacterial Reverse Mutation Assay) and the Mouse Lymphoma Assay (also known as the Mammalian Cell Gene Mutation Assay).  

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    Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.