Documents & Resources

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

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 articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures. Full article available to full and paid subscribers of ATLA.  

Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology

Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in chemico or in vitro, of which some are validated for regulatory purposes. The manuscript also addresses emerging technologies in the form of “organ/body-on-a-chip” platforms which announce to be instrumental in allowing alternative systems to in vivo models to assess systemic toxic effects induced by chemicals. Read the full article.

Webinar: Skin Tone Modulation: In Vitro Pre-clinical and Clinical Efficacy Testing Strategies and Innovative Solutions in Cosmetics

Addressing uneven skin tone often associated with photo-aging is a key area of interest in the cosmetic industry. The design of novel, safe, and efficacious actives and ingredients capable of inducing subtle changes in skin tone can be accomplished using modern, relevant and reliable pre-clinical testing strategies prior to clinical assessment. During this one-hour webinar, IIVS Study Director...

Navigating the Claim Substantiation Maze in Cosmetics Industry

Read this article by IIVS study director Dr. Gertrude-Emilia Costin and biologist Asha Shravanthi Pidathala in the June 2017 issue of Eurocosmetics.  The article examines modern, relevant, and reliable in vitro testing strategies using pigmented tissue models that assess the capacity of ingredients and formulations that impact skin tone.    

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

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

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, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling.

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Multiparametric Image Analysis of Rat Dorsal Root Ganglion Cultures to Evaluate Peripheral Neuropathy-Inducing Chemotherapeutics

Chemotherapy-induced peripheral neuropathy (CIPN) is a major, dose-limiting adverse effect experienced by cancer patients. Advancements in mechanism-based risk mitigation and effective treatments for CIPN can be aided by suitable in vitro assays.  To this end, we developed a multiparametric morphology-centered rat dorsal root ganglion (DRG) assay.

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Precision Digital Dispensing of Patterned Picoliter Quantities of Test Material onto Apical Surfaces of Human 3D-Reconstructed Airway Tissues

There is an increasing need for researchers to understand the dynamic aspects of inhaled tobacco product exposure. Available 3D human reconstructed airway tissues (RHuA) provide researchers with a more physiological platform that offers apical and basal compartments for flexibility in modelling relevant exposures. We have tested the Tecan D300 digital dispenser as potential technical solution to deliver precise amounts of very small vehicle droplets to coat the apical surface of an available RHuA.

Addressing the Assignment of US EPA Hazard Categories for Dermal Safety by a Revised Prediction Model of the Validated In Vitro Skin Irritation Test (OECD TG 439)

One of the current goals of the United States Environmental Protection Agency Office of Pesticide Programs (US EPA OPP) is to replace by non-animal testing methods as many of the endpoints of the battery of acute toxicity tests known as the “6-pack” as possible. One of the “6-pack” tests is the Draize rabbit test for dermal irritation. We investigated whether the validated in vitro Skin Irritation Test (SIT, OECD TG 439) can be used to determine US EPA OPP dermal hazard category assignment.

The 3D Human Reconstructed Skin Micronucleus Assay (RSMN) Using the EpiDerm Tissue: Validation and Application to the Safety Assessment of Cosmetics Ingredients

Regulatory restrictions on animal use have increased the reliance of risk assessors and regulators on in vitro test systems. Ideally, tissue-based assays could replace the animal studies as follow-up tools to verify results from standard in vitro assays. The RSMN assay combines the EpiDerm™ 3D reconstructed skin (RS) model with the micronucleus (MN) assay to provide a more realistic model for evaluating the genotoxic potential of dermally applied chemicals or products, such as cosmetics.