Archive

ToxTracker®

July 31, 2023
ToxTracker® is a unique, stem-cell based assay which takes advantage of a Green Fluorescent Protein (GFP) reporter system to identify hazard and mode-of-action (MOA) of potentially genotoxic materials. ToxTracker has been extensively validated to predict in vivo genotoxic substances with an accuracy of more than 90%. Over 1,500 compounds have been successfully evaluated with the assay. Parent compounds as well as their metabolites are evaluated for genotoxicity with the inclusion induced-S9 mix in the test system prior to test material...

Bhas 42 Cell Transformation Assay

January 31, 2023
Bhas 42 Cell Transformation Assay (Bhas 42 CTA) The Bhas 42 CTA is used to evaluate the carcinogenic potential (tumor-initiating activity and/or -promoting activity) of genotoxic or non-genotoxic test articles. The untransformed Bhas 42 cells grow to confluence forming a density-dependent contact-inhibited monolayer. A carcinogenic stimulus induces morphological alterations and leads to the formation of discrete anchorage-independent altered colonies referred to as transformed foci, atop the confluent monolayer. This measure of transformation frequency, which can be extrapolated to an assessment of...

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

March 30, 2017
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....

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...

Reconstructed Skin Micronucleus (RSMN)

August 24, 2016
Reconstructed Skin Micronucleus (RSMN) Using the EpiDerm™ Reconstructed Human Epidermis Model RSMN is used to evaluate the genotoxicity potential of the test article to the EpiDerm™ Skin Model. Genotoxicity potential is determined by assessing whether the micronucleus frequency in tissues exposed to the test article showed a statistically significant increase relative to the tissues exposed to the solvent (negative) control. Evaluate the genotoxic potential of new ingredients and chemicals at exposure-relevant doses RSMN determines the skin genotoxicity/mutagenicity potential of a test substance...

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...

Specialty Chemical

August 24, 2016
Specialty chemicals are chemical products identified on the basis of their performance or function, rather than their composition. They can be single-chemical entities or formulations and cover a wide range of product categories such as consumer products, cosmetics, food additives, manufacturing, etc. As a result, testing for these chemicals can include a wide range in the irritation spectrum, from materials that are classified as mild irritants to those that are designated as corrosive. The testing needs also cover a wide range...