Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Industries Tobacco
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Archive

Use of Ex Vivo Precision-Cut Lung Slices as a Screening Tool for Potential Respiratory Toxicity of E-Liquids

March 28, 2018
E-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...

Oral Irritation Assessment of Electronic Liquids Using an In Vitro Oral Testing Model

March 28, 2018
While data are still being collected and analyzed, there were at least 1,300 accidental electronic liquid (e-liquid) exposures reported as of 2013. Deaths have occurred as a result of ingestion of e-liquid with the effects being attributed primarily to nicotine. The Food and Drug Administration (FDA) sought to regulate e-liquid through the Tobacco Control Act passed in 2009. In 2014, the FDA issued its “Deeming” proposals for public comments, which covered e-liquid manufacturing; the Final Rule giving the FDA authority to...

Nicotine Characterization of an In Vitro Inhalation Exposure System Using Conventional and Next-Generation Tobacco Products: A US/UK Inter-Laboratory Comparison

March 28, 2018
The 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....

View our Posters from SOT 2018

March 28, 2018
Thank you to all who visited our booth at the 2018 SOT meeting.  Our scientists presented several posters at the meeting. If you did not have an opportunity to view our posters, or would like to view them again, we now have them available here to view online. ...

IIVS at SOT 2018

February 8, 2018
IIVS 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....

Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond

August 28, 2017
The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative...

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, 2017
In 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, 2017
The 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, 2017
Three 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....

Assessment of In Vitro COPD Models for Tobacco Regulatory Science: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

March 30, 2017
On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current Assessment of In Vitro COPD Models for Tobacco Regulatory Science technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular,...