Publications

Optimizations of the Reconstructed Human Epidermis-Based Phototoxicity Testing to Evaluate the Safety of Long-Lasting Cosmetic Products

The safety of cosmetic products coming in contact with consumers’ skin is often assessed using New Approach Methodologies, which include Reconstructed human Epidermis (RhE) tissue models that have demonstrated utility as reliable test systems. In our manuscript, we evaluated the phototoxicity potential of long-lasting cosmetic products, such as lipsticks and foundations containing UV-absorbing ingredients. given their design to persist on application areas of skin, technical challenges were encountered in the experiments using RhE tissues as the products could not be entirely removed at the end of the exposure period. (more…)

A Proof-of-Concept for Safety Evaluation of Inhalation Exposure to Known Respiratory Irritants Using In Vitro and In Silico Methods

There is increased interest in developing non-animal test systems for inhalation exposure safety assessments. However, defined methodologies are absent for predicting local respiratory effects from inhalation exposure to irritants. The current study introduces a concept for applying in vitro and in silico methods for inhalation exposure safety assess- ment. (more…)

Human relevance of in vivo and in vitro skin irritation tests for hazard classification of pesticides

Test methods to inform hazard characterization and labeling of pesticides to protect human health are typically conducted using laboratory animals, and for skin irritation/corrosion the rabbit Draize test is currently required by many regulatory agencies. Although the Draize test is generally regarded to provide protective classifications for human health, new approach methodologies (NAMs) have been developed that offer more human relevant models that circumvent the uncertainty associated with species differences that exist between rabbits and humans. (more…)

The Fibrotic Phenotype of Human Precision-Cut Lung Slices Is Maintained after Cryopreservation

Human precision-cut lung slices (hPCLS) prepared from fibrotic lungs recapitulate the pathophysiological hallmarks of fibrosis. These hallmark features can also be induced by treating non-fibrotic hPCLS with a fibrotic cocktail (FC). As a result, the fibrotic and fibrosis-induced hPCLS are rapidly emerging as preferred models for disease modeling and drug discovery. However, current hPCLS models are limited by tissue viability in culture, as they are usually only viable for one week after harvesting. (more…)

Deriving a point of departure for assessing the skin sensitization risk of wearable device constituents with in vitro methods

Wearable devices are in contact with the skin for extended periods. As such, the device constituents should be evaluated for their skin sensitization potential, and a Point of Departure (PoD) should be derived to conduct a proper risk assessment. Without historical in vivo data, the PoD must be derived with New Approach Methods (NAMs). To accomplish this, regression models trained on LLNA data that use data inputs from OECD-validated in vitro tests were used to derive a predicted EC3 value, the LLNA value used to classify skin sensitization potency, for three adhesive monomers (Isobornyl acrylate (IBOA), N, N- Dimethylacrylamide (NNDMA), and Acryloylmorpholine (ACMO) and one dye (Solvent Orange 60 (SO60)). (more…)

The Importance of Supplier Qualification for Vendors of Materials Used in In Vitro Assays

Pre-clinical assays, including in vitro assays, rely heavily on suppliers who provide essential products or services. In the current regulatory environment, the burden is placed on the users of these products or services to ensure that the methods employed at the suppliers' facilities meet a sufficient level of quality. Variable results for the same assay controls over time could indicate high lot-to-lot variability of the test system or of critical assay components. (more…)

Cryopreserved human precision-cut lung slices provide an immune competent pulmonary test system for “on-demand” use and long-term cultures

Human precision-cut lung slices (hPCLS), considered a highly relevant ex vivo model of the lung, offer native architecture and cells of the lung tissue including respiratory parenchyma, small airways, and immune competent cells. However, the irregular availability of donor lungs has limited the accessibility of this system. As described here, thousands of hPCLS can be created from 1 lung, cryopreserved, and used “on demand” by applying slicing and cryopreservation methodology improvements. (more…)

Multiscale Stiffness of Human Emphysematous Precision-Cut Lung Slices

IIVS is excited to announce a new publication in Science with co-authors at Boston University and Mechanobiologix (Newton, MA, USA)! Abstract: Emphysema is a debilitating disease that remodels the lung leading to reduced tissue stiffness. Thus, understanding emphysema progression requires assessing lung stiffness at both the tissue and alveolar scales. (more…)

IIVS Financial Conflict of Interest in Research Policy

Key Challenges and Recommendations for In Vitro Testing of Tobacco Products for Regulatory Applications: Consideration of Test Materials and Exposure Parameters

The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to identify, discuss and develop recommendations for optimal scientific and technical approaches for conducting in vitro assays, to assess potential toxicity within and across tobacco and various next generation nicotine and tobacco products (NGPs), including heated tobacco products (HTPs) and electronic nicotine delivery systems (ENDS). (more…)