Archive
kDPRA: An in chemico Method to Characterize the Skin Sensitization Potency of Chemicals
September 13, 2019While the skin sensitization hazard of substances can readily be identified using non-animal methods, the classification of potency into UN GHS sub-categories 1A and 1B remains challenging. The kinetic direct peptide reactivity assay (kDPRA) is a modification of the DPRA (OECD TG 442C) wherein the reaction kinetics of a test substance towards a synthetic cysteine-containing peptide is evaluated. For this purpose, several concentrations of the test substance are incubated with the synthetic peptide for several incubation times at 25°C. After...
See You at EUROTOX 2019!
August 15, 2019IIVS is excited about meeting attendees of the 55th EUROTOX conference! Please join us at booth #34 to meet our representatives who are looking forward to discussing trends and New Methodologies in Alternative Approaches (NAMs) to toxicological research, as well providing updates on services offered by our organization! Also, don’t miss our posters: The kinetic Direct Peptide Reactivity Assay (kDPRA): An in chemico method to characterize the skin sensitization potency of chemicals (Poster Viewing 1) Increased Throughput and Cryopreservation of Precision-Cut Lung...
Increased Throughput and Cryopreservation of Precision-cut Lung Slices Extend the Utility of Human-relevant, 3-Dimensional Pulmonary Test Systems
March 18, 2019Human-relevant, in vitro/ex vivo assays are considered an ethical and economically viable manner by which to screen the thousands of chemicals requiring hazard assessment. Of the 3-dimensional models, human precision-cut lung slices (PCLS) are often considered the most physiologically relevant pulmonary test system, but lower throughput and difficulties in cryopreservation have hampered PCLS use. We have modified a tissue slicer to accommodate 3 tissue cores for simultaneous slicing. Increased slice production was quantified using agarose and tissue cores in the slicer....
Register For ICCVAM’s Free Webinar on In Vitro Inhalation Toxicity Testing
January 10, 2019NICEATM will organize a free webinar on behalf of ICCVAM on January 22, 2019 between 1:00-2:30 p.m. Eastern Time. Registration will be required. Topics will include an overview of ongoing collaborative efforts, as well as the presentation of a case study on refining inhalation risk assessment for point of contact toxicity that uses a source-to-outcome approach with both in vitro and in silico methods. The preliminary agenda and additional information about presentations will be posted when available....
ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D)
October 18, 2018KeratinoSensTM is a cell-based reporter gene assay that models the second key event in the Adverse Outcome Pathway for Dermal Sensitization (keratinocyte activation). The assay measures the induction of a stably transfected luciferase gene under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene. Following the methodology described in OECD Test Guideline 497, KeratinoSens is an alternative to animal testing methods necessary for the purpose of hazard identification. In conjunction with other in vitro tests, the results of this assay...
IIVS Hosts Quarterly Meeting for SQA’s Computer Validation and IT Compliance (CVIC) Specialty Section
October 4, 2018The CVIC agenda included a presentation and follow-up discussion on artificial intelligence and computer learning and their use in regulated industry, a panel discussion of cloud computing adoption in “GxP” environments, and open discussion on the use of the “Internet of Things” and data integrity and governance concepts. In addition to the CVIC member, an FDA representative was on site to gather industry input on specific topics. IIVS is pleased to support activities like this through the Society of Quality Assurance. If...
Encouraging Regulatory Acceptance of Non-Animal Testing Methods Discussed at Annual SACATM Meeting
October 2, 2018Among the topics discussed at the annual Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting held in early September was ways to encourage both regulators and regulated industry to use new approach methodologies (NAMs). The meeting brought together experts from academia, industry, and animal welfare organizations and the importance of collaboration among the different groups and geographical regions was a recurring theme. Learn more...
Strategies for Eye Irritation Testing
September 17, 2018Determination of ocular irritation potential is a key toxicological endpoint required to support chemical and raw material characterization and industrial hygiene, to guide product development, and to achieve final product safety standards. IIVS possesses extensive experience with numerous test methods and testing strategies for commercial, industrial and regulatory applications. From standard regulatory hazard assessments to providing information on the degree of ocular irritation, to discriminating among extremely mild eye area products, IIVS’ Study Directors take the time to understand your...
Modernization of EPA “6-Pack” of Acute Toxicity Tests Continues
July 27, 2018The US Environmental Protection Agency (US EPA) continues to drive significant efforts in the United States to modernize the battery of acute toxicity tests classically known as the “6-pack.” Learn More....
Defined Approaches for EPA Testing
July 26, 2018The US Environmental Protection Agency (US EPA) continues to drive significant efforts in the United States to modernize the battery of acute toxicity tests classically known as the “6-pack.” Known for many years as an “all in vivo” testing strategy for products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the 6-pack was revised in 2015 to include non-animal (in vitro/ex vivo) test methods for classification and labeling for Eye Irritation, both for commonly used household cleaning products...