Author: Mitchell Gaydash
08 Jan September 2024 Newsletter
If you will be at EUROTOX, September 8-11, stop by BOOTH #34 to speak with IIVS President, Amanda Ulrey and meet our new Client Relationship Manager Joseph Hughes. We have some new methods available for GLP use now and several others that are currently in the technology transfer phase. We look forward to catching up with you there.08 Jan 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.26 Nov Building Confidence and Transparency Into a New Validation Paradigm
For the last two decades, validation management organizations have evaluated new test methods according to the OECD’s Guidance Document 34: Guidance Document On The Validation And International Acceptance Of New Or Updated Test Methods For Hazard Assessment (“GD 34”, 2005, https://doi.org/10.1787/20777876; now under revision)....
24 Sep 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.24 Sep 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.24 Sep 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)).20 Mar Approaches to Evaluation of Solvents for use in Photosafety Testing
New Approach Methodologies (NAMs) are routinely used in photosafety testing to evaluate if a test compound has the potential to become more toxic upon exposure and subsequent exposure to light. Three such NAMs to address photosafety are the in chemico UV-Vis Assay, the cell-based 3T3 Neutral Red Uptake (NRU) Phototoxicity Test (PT), and the tissue-based Reconstructed human EpiDermis (RhE) Phototoxicity Test (PT), described under OECD Test Guidelines (TG) 101, 432, and 498, respectively.20 Mar Refinement and Optimization of the Photo-KeratinoSens™ Assay to Evaluate Photoallergy Potential
Identification of test chemicals that have the potential to become more reactive, more toxic, or may become phototoxic upon application and subsequent exposure to sunlight is integral to photosafety testing. Several regulatory-based New Approach Methodologies (NAMs) are widely used in the evaluation of phototoxicity and...
20 Mar IIVS 2023 Impact Report
I am happy to present to you the Institute for In Vitro Sciences' (IIVS) 2023 annual report, marking my first year serving as President. It has been an honor to lead the IIVS team through a period of growth and transformation, and I am excited...