Posters & Presentations
Building Confidence and Transparency Into a New Validation Paradigm
November 26, 2024For 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).
Approaches to Evaluation of Solvents for use in Photosafety Testing
March 20, 2024New 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. (more…)
Refinement and Optimization of the Photo-KeratinoSens™ Assay to Evaluate Photoallergy Potential
March 20, 2024Identification 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 skin sensitization potential. More recently, there has been an increased interest in ability to identify photoallergens. To this end, an innovative photo-KeratinoSens™ assay was established with addition of an irradiation exposure (5 J/cm2 of UVA) to the KeratinoSens™ Skin Sensitization Test (OECD TG 442D), as described in Tsujita-Inoue, et al. (2015). Twelve reference compounds were previously evaluated at IIVS under a protocol adapted from Tsujita-Inoue, et al. (2015), resulting in an accuracy of 58.3% (7/12 correctly predicted), with low sensitivity (50%, 5/10 positives correctly predicted) (Hilberer, et al., 2023).
Toxicity and Inflammatory Response to Common Magic Mouthwashes in a 3D Oral Reconstructed Tissue Model
November 8, 2023Magic Mouthwash is a general term describing oral rinses prescribed by a doctor for the treatment of pain, inflammation, or infection, commonly as a result of chemotherapy and radiation induced oral sores (oral mucositis). There is no set combination of ingredients for the preparation of a magic mouthwash, rather they are formulated for the individual needs of each patient, selecting from an array of various active ingredients. Although the ingredients most commonly used to formulate Magic Mouthwashes are considered safe as prescribed, the final formulations lack toxicity and inflammatory response data. (more…)
Safety Assessment of Monographed OTC Cold/Cough Medicine Using an In Vitro Testing Platform Based on Human Reconstructed Oral Tissues
November 8, 2023Over-the-counter (OTC) products are available to alleviate concurrent symptoms of colds and flu. They are primarily based on a combination of decongestants, antitussive and alpha adrenergic agonists, which are well-established pharmaceutical agents covered by U.S. monographs. Many of the active components of the OTC cough/cold drugs are bitter and must be masked using flavoring agents. Bayer internally employed a stringent safety testing program for OTC cough/cold medicine line extensions that require the products to be held in the mouth for a short period using an innovative testing platform based on reconstructed oral tissues. (more…)
A Laboratory Method to Measure Skin Surface Staining by Cigarette Smoke
October 20, 2023Exhaled or side-stream cigarette smoke (CS) may visually stain a consumer’s skin over time. Tobacco heating prod- ucts (THPs) and e-cigarettes (ECs) have reduced staining potential because they do not produce side-stream aerosols and their exhaled aerosols have significantly reduced levels of toxicants, particles and odour. Here we assess discolour- ation of porcine skin in vitro after exposure to particulate matter (PM) or aerosols from CS (3R4F), two THPs (glo and glo sens) and an EC (iSwitch Maxx). (more…)
Ensuring the quality of a test system using the principles of Good In Vitro Method Practices (GIVIMP): A case study of cryopreserved human precision-cut lung slices
October 10, 2023Human precision-cut lung slices (hPCLS) are a highly relevant 3-dimensional model of the lung. They offer native architecture and cells of the lung tissue including respiratory parenchyma, small airways, and immune competent cells involved in inflammatory and sensitization processes. The scarcity of human lung tissue available for research and the inability to conduct larger scale testing has limited the use of hPCLS as a test system for routine, high-throughput testing. To overcome this barrier, IIVS has refined the methodology behind the cryopreservation, storage, thaw and post-thaw maintenance of human lung slices. As primary tissues have varied quality and responsiveness, a standardized performance characterization (PC) is conducted on all donor batches. (more…)
Key Recommendations from GIVIMP for Test System Suppliers
October 10, 2023The Organization for Economic Cooperation and Development (OECD) guidance document on Good In Vitro Method Practices (GIVIMP) details a set of quality standards to improve both the quality of and confidence in newly developed, and routinely executed in vitro methods. An important part of (and a source of potential high variability in) any method is the test system. Microphysiological Systems (MPS), including organ-on-a-chip platforms have been used in novel methods for many years. Despite their potential benefits, there are several quality concerns associated with MPS. Two of these concerns are reproducibility and well defined and understood biological relevance, both of which are covered in the GIVIMP guidance. (more…)
Incorporating GIVIMP Recommendations into Method Development, Use, and Transfer
August 30, 2023The demand for toxicology data from human-relevant, New Approach Methodologies (NAMs) continues to increase. Fortunately, the scientific community has responded with new tools based on human tissues and cells. The creators of these systems and test methods utilizing them have invested in their development and also in studies designed to demonstrate their relevance, reproducibility, and transferability. Despite these efforts, scientific confidence in these methods at the regulatory level remains comparatively low. (more…)
IIVS Posters – SOT 2023 Annual Meeting
March 31, 2023IIVS presented several posters at SOT 2023. This post includes links to the full PDF versions of each poster presented. (more…)