Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Assays Mucosal
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Archive

Human In Vitro Models for Respiratory Toxicology: Evaluation of Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays

March 28, 2018
Robust 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...

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...

Collaborative Effort Aims to Replace Rabbit Test for Personal Lubricant Products

August 21, 2017
Study in Response to Consumer Demands for Humane Testing Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices. The work of the lubricant industry, the Institute for In Vitro Sciences...

Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology

October 18, 2016
This one-hour webinar, led by IIVS Director of Quality and Compliance, introduces some of the concepts of Good Laboratory Practices (GLPs) designed to promote study and data integrity within an in vitro toxicology framework. Applying these concepts within your own laboratory should aid in production of robust, repeatable studies. View Slides...

Pulmonary Models

August 24, 2016
The Respiratory Toxicology Program utilizes state-of-the-art in vitro and ex-vivo models of pulmonary (and related) tissue. Models available offer a range of testing types, including screening and high content analysis for complex events. The choice of cell line (including reporter cells), primary cells, or 3-dimensional tissues depends on the throughput desired and level of assessment needed. Consider our oral cavity tissues to also model ingestion exposures. Let IIVS guide you to the model best for you! Pulmonary cell lines are readily...

Vaginal Irritation

August 24, 2016
The irritation potential of pharmaceutical, cosmetic and personal care products that are specifically formulated for application onto human mucosal tissues is evaluated using reconstructed tissue models such as EpiVaginal™ (MatTek Corporation, Ashland, MA, USA) or the Human Vaginal Epithelium (HVE) (EpiSkin, Lyon, France). The toxicity is determined by measuring the relative viability of the tissues treated with the test materials and compared to the negative/solvent control-treated tissues. The safety of the pharmaceutical, cosmetic and personal care products that are specifically formulated...

Oral – Gingival Screening

August 24, 2016
The safety assessment of raw ingredients or finished products intended for human oral use or that can accidentally come in contact with humans’ oral tissues can be performed using in vitro testing platforms based on reconstructed tissue models. The oral irritation potential of oral care, pharmaceutical or tobacco products can be investigated using the tissue viability (%) as main endpoint in the evaluation of cytotoxicity. The potential oral/buccal irritation of raw ingredients or finished products can be assessed using commercially available...

Next Generation Tobacco Products

August 24, 2016
IIVS has a long-standing history of working with various industries to help establish or utilize in vitro models for the prediction of risk and the assessment of products under development. With the Food and Drug Administration extending its authority to all tobacco products (including e-cigarettes, cigars, and hookah) the tobacco industry is faced with the task of assessing product safety for product development and regulatory submission. Further, the manufacture of tobacco products may entail risk to workers that come in...