If you missed the webinar: Establishing Scientific Confidence in New Approach Methodologies (NAMs): Eye Irritation Testing and Beyond, co-sponsored by the Risk Assessment and In Vitro and Alternative Methods Specialty Sections of SOT, a recording is now posted. Speakers included Hans Raabe (IIVS) and Dr. Amy Clippinger...
Thank you to all who visited our booth or poster sessions at the 2022 Society of Toxicology annual meeting. If you would like copies of any of the poster presented we now have them available to view online (more…)
IIVS is excited to announce the publication of 2 papers evaluating the use of predictive models in combination with in vitro assays to provide a quantitative assessment of skin sensitization potential. This work is presented Drs. Frank Gerberick (GF3 Consultancy, Chief Scientific Advisor to IIVS) and Andreas Natsch (Senior Research Fellow at Givaudan ) (more…)
Happy New Year! IIVS is pleased to greet 2022 with the announcement of a joint publication with the Research Institute for Fragrance Materials (RIFM) involving the evaluation of photoirritation potential of over 100 compounds. This effort, spanning the course of 7 years, involved a tiered testing approach with the application of 3 OECD test guidelines: TG 101, 432 and the recently accepted 498, which codifies the acceptance of Reconstructed human Epidermis as a model for assessing this endpoint. Read the full article here.
Regulatory bodies, validation authorities, method developers, and industry toxicologists realize the need to increase confidence in the scientific validity of novel in vitro methods – especially those being proposed for regulatory application .
IIVS is excited to have taken part in a new publication highlighting the use of non-animal methods to compare cellular and molecular responses of tobacco smoke and Electronic Vapor Product aerosols. Read and Download the open access article here.
A recorded webinar on the "Use of Non-animal Skin Sensitization Methods" by IIVS’s Hans Raabe and US EPA's Gino Scarano and James Cox is now available for viewing at https://www.piscltd.org.uk/nam-webinars/. The webinar reviews the status of Non-Animal methods acceptance of skin sensitization testing ...
IIVS, in collaboration with EPAA, is pleased to announce that our training videos for eye irritation and phototoxicity are now available with Russian subtitles. To view subtitled versions in different languages including Chinese, Portuguese and Spanish, please visit our YouTube channel. https://youtu.be/DISE5yNYZck...
The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to identify, discuss and develop recommendations for optimal scientific/technical approaches for utilizing in vitro assay data within and across tobacco and nicotine product categories. Workshops provide a unique opportunity for invited expert stakeholders to share experiences and to develop recommendations that may serve as a resource for developing optimal approaches and data to evaluate the toxicity of tobacco and nicotine products. It is envisioned that some of these recommendations would form the basis for the generation of guidance documents and/or serve as authoritative reference publications for optimal methodologies and data interpretation and to support regulatory submissions. Invited experts for the IIVS workshops include scientists from tobacco companies, contract research organizations, US regulatory agencies, and other in vitro assay experts with tobacco product and/or genetic toxicology experience. The format for this workshop series is primarily discussion among participants which provides an environment to tackle issues in detail. Participants are expected to actively participate by collecting relevant published and unpublished non-proprietary research information, to offer experiences and expert opinions, and to actively share with other workgroup members. While the focus will be on the widely used regulatory in vitro genetic toxicology assays, it is important to note that much of the discussion will be applicable to all in vitro assays. As a part of the workshop discussion, data gaps will be identified. Thus, in addition to recommendations based on current information, this workshop series will provide key research questions that need to be addressed by the scientific community. This will provide a useful roadmap for research that can have direct impact on the regulation of tobacco products and on protecting human health related to consumer use of tobacco products. The product of these workshops will be a series of scientific publications and meeting presentations that can be utilized by all stakeholders. Prior to the first workshop (November 27-28, 2018) important issues for using in vitro genotoxicity assays for evaluating tobacco and nicotine products were identified. During the first workshop issues were triaged into three priority categories based on the amount of available information.
The Family Smoking Prevention and Tobacco Control Act gave the FDA regulatory authority over next generation tobacco products (NGTP) such as E-vapor products. 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 assessment of H&E stained slides). Positive control treatments consisted of 10μM Phortress and 13μM bleomycin. HuPCLS were fed every day with fresh medium ± treatment and harvested at days 4, 8, and 16. Untreated control UC) HuPCLS viability was confirmed using protein and a denylate kinase assays. Over 16 days in culture, UC lost 30% viability while WST-8 results indicated no loss over 16 days in culture. Phortress caused severe damage by day 4 and bleomycin by day 8 (histologically & WST-8 viability). Prolonged 1.2% PG exposure diminished WST-8 viability by ~30% at day 16 which agreed with histological results. High osmolality is the suspected mechanism of toxicity. There was no effect histologically or via WST-8 viability for prolonged exposure to 0.1% and 0.5% PG. In summary, PG, a common E-vapor product ingredient, at 1.2% had adverse effects in a human pulmonary model in an exaggerated exposure regimen(prolonged exposures with changes in osmolarity). The HuPCLS platform has huge potential to serve as a screening tool for e-liquid(and other materials of concern) by elucidating potentially relevant, long-term events following NGTP ingredient exposure.