Documents & Resources
Evaluating the Use of Predictive Models in Combination with In Vitro Assays
April 11, 2022IIVS 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…)
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials
January 3, 2022Happy 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.
How a GIVIMP Certification Program Can Increase Confidence in In Vitro Methods
April 20, 2021Regulatory 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 .
Acute Electronic Vapour Product Whole Aerosol Exposure of 3D Human Bronchial Tissue
March 2, 2021IIVS 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.
Webinar : Use of Non-animal Skin Sensitization Methods
June 3, 2020A 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 ...
Phototox and BCOP Russian Translations
February 25, 2020IIVS, 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...
IIVS Workshop Series: Identification, Discussion and Recommendations for the Optimal Generation and Use of In Vitro Genotoxicity Assay Data for Tobacco and Nicotine Products
October 18, 2019The 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.
Use of Ex Vivo Precision-Cut Lung SLices as a Screening Tool for Potential Respiratory Toxicity of E-Liquids
October 17, 2019The 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.
Evaluation of TRPV1 Activity to Assess the Eye Stinging Potential of Cosmetic Formulations
October 17, 2019The Transient Receptor Potential Vanilloid type 1 (TRPV1) receptor is one of the most well characterized pain-inducing receptors and has been recently identified as a valuable tool to predict eye stinging potential of surfactant based formulations. In this study we sought to predict eye stinging of nonsurfactant based cosmetic formulations by studying TRPV1 activity using the NociOcular assay. In the NociOcular assay, TRPV1 expressing neuroblastoma cells are exposed to test substance and TRPV1 activity is measured by acute increases in intracellular calcium. Three of the formulations induced stinging in the human test and were also positive in the NociOcular assay. The other four formulations evaluated were classified as stinging in the human test, but a conclusive determination could not be made in the NociOcular assay as the formulations were not fully soluble in assay buffers. The formulations were also evaluated in the EpiOcularTM assay, an established in vitro model for eye irritation utilized by the cosmetics industry. The Epiocular™ assay results did not correlate with the human sting data. Our data support that the NociOcular assay may be a valuable in vitro tool to predict human eye stinging sensation for cosmetic formulations. Future efforts seeks to further expand the applicability of the assay to product types other than surfactant based formulations.
Promoting the Uptake of Alternatives to Animal Testing Through the Development of eLearning Tools
September 13, 2019In order to further promote the implementation of Directive 2010/63/EU, the European Commission issued calls for a number of related projects last year. One of these projects is aimed at facilitating the uptake of non-animal alternatives by developing two e-learning modules. The contract for this project was awarded to a consortium consisting of SYRCLE, the Swiss 3R Competence Centre, lnstitute for ln Vitro Sciences, Pharma Launcher and Ecorys UK. This consortium will develop two modules, i.e., one eLearning module focused on searching for existing non-animal alternatives (including systematic reviews) and one module targeted at researchers who want to develop reliable and relevant non-animal alternatives for regulatory use taking into account Good In Vitro Method Practices (GIVIMP). The quality of the developed modules will be assessed by external review groups. The learning outcomes will be presented to the commission along with the design of the assignments through which these outcomes will be realised.