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).  

      Related Publications

      Tobacco Heating System 2.4 has less harmful impact on 2D bone co-culture system than cigarette smoke

      Pre-clinical Toxicology

      Characterizing the Genotoxic Potential of E-Cigarette Components In Vitro

      Pre-clinical Toxicology

      Evaluation of Chronic Toxicity and Carcinogenicity of Flavored E-Vapor Aerosols in an 18-Month Inhalation Study in A/J Mice

      Pre-clinical Toxicology

      Toxicological Assessment of Highly Mentholated Reduced-Risk Tobacco Products in Sprague Dawley Rats Following Sub-Chronic Inhalation Exposure

      Pre-clinical Toxicology

      Exposure to a Heated Tobacco Product Aerosol Is Associated with Lower Activity of Hepatic Cytochrome P450 Enzymes and Reduced Alteration in Clozapine Metabolism Than Exposure to Cigarette Smoke

      Pre-clinical Toxicology

      Evaluation of Chronic Inhalation Toxicity of E-Vapor Aerosols in an 18-Month Study in AJ Mice

      Pre-clinical Toxicology

      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
      ​
      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.