Robert Leverette¹, Thomas Shutsky¹, John Wertman¹, Katarina Aleksa², Dhatri Lakshmanan², Rebecca Payne³, Kristen Jordan^1
1Scientific & Regulatory Affairs, RAI Services Company, Winston-Salem, NC, USA; 
²Labstat International Inc. Kitchener, ON, Canada;
³Labcorp Early Development Laboratories Ltd., Harrogate, UK

This poster shows whole aerosol exposures of combustible and next generation tobacco products, including Electronic Nicotine Delivery Systems. A Vitrocell® VC10® robot generated and delivered aerosols to the Mammalian 6/48 aerosol dilution and exposure system, with up to 7 concurrent doses plus a clean air control. Dosimetry module allowed the capture and quantification of deposited aerosol constituents (nicotine, glycerol and carbonyls). The study utilized the Neutral Red Uptake (NRU) assay in which mammalian cells were exposed to either combined TPM + GVP (submerged culture) or Whole Aerosol (ALI).

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Now Heated Tobacco Products (HTP) can be continuously smoked with automatic button actuation. The heat-and-turn feature for heat-not-burn devices enables automatic smoking at all 10 ports of the VC 10 S-TYPE Robot. Selective guidance of the aerosol to max. 6 exhaust lines is possible as well.

VITROCELL Application Note

Watch the video on Youtube

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Regular leak tests are mandatory in aerosol research. A leak caused by a forgotten connection or defective o-ring may have a significant influence on the aerosol exposure process. We recommend to carry out a leak test prior to the experiment and as part of cleaning or service routine.

VITROCELL Application Note

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https://doi.org/10.1007/s11626-020-00517-7

Xuefei Cao¹, Jayme P. Coyle², Rui Xiong¹, Yiying Wang¹, Robert H. Heflich¹, Baiping Ren¹, William M. Gwinn³, Patrick Hayden⁴, Liying Rojanasakul²

¹ Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd., AR Jefferson, USA
² Allergy and Clinical Immunology Branch, Health Effects Laboratory Division, National Institute for Occupational Safety and Health, Centers forDisease Control and Prevention,Morgantown,WV, USA
³ Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Durham, NC, USA
⁴ BioSurfaces Inc., Ashland, MA, USA

One important element for validating any new assay for making regulatory decisions is determining its performance relative to an accepted standard. Conducting in vivo inhalation toxicity studies using whole-body or nose-only exposure systems is expensive and time-consuming and typically requires a large number of animals. The goal of using alternative methods, like human in vitro ALI airway cultures, ultimately is to replace inhalation toxicity testing in animals with in vitro approaches. Transition from animal- to human-based models is ultimately expected to lead to faster and better predictive toxicity assessments and therapeutic development at lower cost.  This study shows the development and validation of alternative in vitro methods for acute toxicity testing, including acute inhalation toxicity testing.
 

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DOI: https://doi.org/10.1016/j.mrgentox.2020.503230 

Authors
Thorne D¹, Hollings M², Kilford J², Clements J², Payne R², Ballantyne M², Dalrymple, A¹, Dillon, D¹, Meredith, C¹, Gaҫa, M^{1  
 
1} British American Tobacco, R&D, Southampton, Hampshire SO15 8TL, UK. 
² Covance Laboratories Ltd, Otely Road, Harrogate, HG1 PY, UK

Highlights

• An experimental concept of exposing L5178Y cells at the air-agar-interface
• Cells were lightly seeded on an agar surface to achieve exposure
• Flowing air, plating and recovery efficiencies from the agar-surface were investigated
• Positive controls were responsive, suggesting a clear cellular interaction with the agar-matrix 
• Cigarette smoke aerosol showed a dose-response relationship with increasing mutant frequencies

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