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10 results

  1. CORESTA Congress, Online, 2020, Smoke Science/Product Technology Groups, STPOST 16

    Comparison of in vitro cytotoxicity and genotoxicity of condensates derived from electronic-cigarettes and reference combustible cigarette

    DOSHI U.; GARDNER W.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In recent years, electronic nicotine delivery systems (ENDS) including electronic cigarettes (e-cigarettes) have emerged as potential reduced-risk alternatives to conventional cigarettes for adult smokers. The U.S. Food and Drug Administration (FDA),...
  2. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 38

    In vitro cytotoxicity and genotoxicity of representative e-liquid flavor mixtures

    DOSHI U.; ZHANG J.; KUMAR A.; LEE K.M.
    Altria Client Services LLC, Richmond, VA 23219, U.S.A.
    Flavor compounds “generally recognized as safe” for oral consumption are commonly used in inhalable e-vapor products for which insufficient safety data exists. The hazard characterization of each flavor and various flavor mixtures is resource and...
  3. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 067

    Characterization of smokeless tobacco products extracted with different solvents for in vitro testing

    ZHANG JINGJIE (1); DOSHI U.(1); THAIKOOTTATHIL J.(1); LEE K.M.(1); WOLZ R.L.(2)
    (1) Altria Client Services, Richmond, VA, USA; (2) Enthalpy Analytical, Richmond, VA, USA
    Unlike cigarettes, there are no standardized methods available for preparing extracts from smokeless tobacco (SLT) products for in vitro toxicological evaluation. Methods are available for Harmful and Potentially Harmful constituents (HPHCs)...
  4. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 29 (also presented at TSRC 2018)

    Toxicological assessment of e-liquid formulations using in vitro genotoxicity and cytotoxicity assays

    COFFA B.G.; DOSHI U.; ZHANG J.; McKINNEY W.J.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In the electronic nicotine delivery systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the U.S. Food and Drug Administration (FDA) recommends a full assessment of the toxicological profile associated with new tobacco products,...
  5. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 30

    Effects of exposure to e-cigarette aerosols compared with cigarette smoke on 3D human buccal and small airway cultures: a systems toxicology assessment

    ISKANDER A.(1); STEINER S.(1); MAJEED S.(1); KONDYLIS A.(1); XIANG Yang(1); ZANETTI F.(1); FRENTZEL S.(1); MARTIN F.(1); PEITSCH M.C.(1); DOSHI U.(2); McKINNEY W.J.(2); LEE K.M.(2); HOENG J.(1)
    (1) Philip Morris Products S.A. (part of Philip Morris International group of companies), PMI R&D, Neuchâtel, Switzerland; (2) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond VA, U.S.A.
    Considerable attention has been given toward the reduced risk potential of e-cigarettes (e-cigs). Most in vitro studies have focused on testing e-liquid formulations directly on submerged 2D cultures. Here, we examined the effects of exposure to the...
  6. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 32

    Characterization and in vitro testing of whole smoke condensates from combustible cigarettes

    DOSHI U.(1); GARDNER W.P.(1); GILLMAN I.G.(2); LEE K.M.(1)
    (1) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond, VA, U.S.A.; (2) Enthalpy Analytical, Inc., Richmond, VA, U.S.A.
    Health Canada recommends in vitro testing of separately collected gas and particulate phases of cigarette smoke for cytotoxicity and genotoxicity assessment. While these test materials have shown cytotoxicity and genotoxicity in literature, there has...
  7. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 34

    Characterization of an air-liquid-interface (ALI) in vitro exposure system (VITROCELL® VC1/7 and Ames 48) using a prototype e-vapor product

    ZHANG Jingjie(1); DOSHI U.(1); OLDHAM M.J.(1); COFFA B.G.(1); GILLMAN I.G.(2); WOLZ R.L.(2); KOSACHEVSHY P.(2); LEE K.M.(1)
    (1) Altria Client Services LLC, Richmond, VA, U.S.A.; (2) Enthalpy Analytical, Inc., Richmond, VA, U.S.A.
    Direct delivery of aerosol or vapor to the apical surface of cells (ALI) allows more relevant exposure for in vitro toxicological evaluation of inhalable chemicals. In this study, we quantitatively characterized the aerosol delivery in a commercially...
  8. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 43

    In vitro micronucleus (MN) assay using TK6 cells: review of historical positive and negative control data

    STANKOWSKI L.F. Jr(1); HURTADO S.B.(1); WELLS M.M.(1); KWOK V.Y.(1); DOSHI U.(2); COFFA B.G.(2); LEE K.M.(2)
    (1) Charles River Laboratories, Genetic and In Vitro Toxicology, Skokie, IL, U.S.A.; (2) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond, VA, U.S.A.
    TK6 human lymphoblastoid cells are widely used in the in vitro MN assay as a part of regulatory genotoxicity testing for pharmaceuticals, but have seen relatively limited use in testing of other test materials, including tobacco-related products. As...
  9. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 009 (also presented at CORESTA 2018)

    Toxicological assessment of e-liquid formulations using in vitro genotoxicity and cytotoxicity assays

    COFFA B.G.; DOSHI U.; ZHANG Jingjie; McKINNEY W.J.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, USA
    In the Electronic Nicotine Delivery Systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the FDA recommends a full assessment of the toxicological profile associated with new tobacco products, using in vitro toxicology (e.g.,...
  10. TSRC, Tob. Sci. Res. Conf., 2017, 71, abstr. 007

    Neutral red uptake cytotoxicity assay in A549 cells under different culture conditions

    COFFA B.G.(1); DOSHI U.(1); ZHANG Jingjie(1); McKINNEY W.J.(1); LEE K.M.(1); DESAI P.(2)
    (1) Altria Client Services, Richmond, VA, USA; (2) Enthalpy Analytical, Richmond, VA, USA
    The OECD guideline (TG129) recommends mouse fibroblasts (3T3) & normal human epidermal keratinocytes (NHK) for performing in vitro cytotoxicity assays but also mentions limitations of these cells, such as having little to no metabolic capacity or...