Archive
Next-Generation Tobacco and Nicotine Products: Substantiating Harm Reduction and Supporting Tobacco Regulatory Science
June 21, 2018A framework for the assessment of novel next-generation tobacco and nicotine products with the potential to reduce health risks compared with cigarettes should integrate scientific studies incorporating nonclinical, clinical, and population studies approaches. These products should have lower emissions and exhibit reduced biological effects compared with those of cigarettes, ideally approaching those of smoking cessation. The products should also be acceptable cigarette alternatives for current smokers, while not appealing to nonsmokers or former smokers. Validating harm reduction and promoting regulatory acceptance...
Characterization of a Vitrocell VC1 Using Nicotine Dosimetry: An Essential Component Toward Standardized In Vitro Aerosol Exposure of Tobacco and Next Generation Nicotine Delivery Products
June 21, 2018The U.S. Food and Drug Administration has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs). There is a desire by the industry, regulators and animal protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment. When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures (such as human reconstructed airways or lung slices) at the air–liquid interface are needed. Using nicotine dosimetry, we report the...
Holger Behrsing, PhD, Participates in Round Table Discussion on Non-Animal Approaches for Inhalation Toxicology
June 14, 2018Holger Behrsing, PhD, was recently invited to participate in an expert round table discussion convened on the development and implementation of 21st century non-animal approaches to assess the toxicity of inhaled substances. The discussion included perspectives from government, industry, nonprofit, and academic sectors on the advantages and challenges of using these approaches, ongoing efforts, and steps needed to gain widespread use and acceptance of these approaches. A transcript of the discussion has just been published in Applied In Vitro Toxicology, Vol....
Human In Vitro Models for Respiratory Toxicology: Evaluation of Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays
March 28, 2018Robust non-animal models and assays for pulmonary toxicology are required to make competent product development and risk assessments for new materials requiring toxicity testing. Three in vitro assays (goblet cell hyperplasia [GCH], ciliary beat frequency [CBF], and MUC5AC quantitation) were evaluated for performance and reproducibility. To assess these assays, 6 laboratories contributed data using a common protocol utilizing IL-13 as an inducer of adverse mucociliary-relevant tissue changes. MatTek EpiAirway™ and Epithelix MucilAir™ 3D tissue models were used to evaluate endpoints...
Use of Ex Vivo Precision-Cut Lung Slices as a Screening Tool for Potential Respiratory Toxicity of E-Liquids
March 28, 2018E-vapor product liquids contain a variety of ingredient combinations that should be assessed for human risk. One human lung-relevant testing platform with reasonable throughput, is human precision-cut lung slices (HuPCLS). HuPCLS are arguably the most complex non-animal model of the lung, retaining native architecture and immune-competent cells over multi-week culture periods. HuPCLS were exposed to three concentrations (0.1%, 0.5%, and 1.2%) of propylene glycol (PG; an E-vapor product constituent) continuously for 16-days. Exposure-effects were evaluated biochemically (WST-8 assay) and histologically (viability...
Nicotine Characterization of an In Vitro Inhalation Exposure System Using Conventional and Next-Generation Tobacco Products: A US/UK Inter-Laboratory Comparison
March 28, 2018The US-FDA has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs). There is a desire by the industry, regulator and animal protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment. When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures at the air-liquid interface are needed....
IIVS at SOT 2018
February 8, 2018IIVS will have several events and posters at the upcoming SOT meeting, March 11-15, in San Antonio, TX. The events and three of our five posters focus on our respiratory toxicology program in support of our new laboratory that opened in 2017. Other posters examine topics in phototoxicity. Be sure to visit our booth at the meeting - Booth #533. View more details on our events and posters at SOT....
In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
August 17, 2017In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities...
Awards of VITROCELL In Vitro Inhalation Exposure Systems
June 30, 2017The PETA International Science Consortium (PISC) awarded four VITROCELL in vitro exposure systems to researchers from institutions in the UK, US, and Belgium who are leading the development of non-animal methods to test the toxicity of airborne substances. IIVS is grateful to PISC for donating the VITROCELL System for use in its new respiratory toxicology laboratory. The new lab provides non-animal testing services for evaluating potential respiratory hazards associated with novel ingredients and chemistries used in fragrances, personal care products, household and institutional cleaning...
Using In Vitro Assays, the Direct Peptide Reactivity Assay (DPRA), KeratinoSens™ Assay (KS), and Human Cell Line Activation Test (h-CLAT) to Assess Skin Sensitization Potential of Electronic Cigarette Liquids
April 4, 2017Three regulatory accepted in vitro assays were evaluated in a proof-of-concept project to determine skin sensitization potential of electronic cigarette liquids (eliquids). These assays measure molecular initiating events and initial cellular responses prescribed in the OECD Integrated Testing Strategy (ITS) describing key events in the adverse outcome pathway (AOP) leading to skin sensitization....