October 17, 2019The Family Smoking Prevention and Tobacco Control Act gave the FDA regulatory authority over next generation tobacco products (NGTP) such as E-vapor products. E-vapor product liquids contain a variety of ingredient combinations that should be assessed for human risk. One human lung-relevant testing platform with reasonable throughput, is human precision-cut lung slices (HuPCLS). HuPCLS are arguably the most complex non-animal model of the lung, retaining native architecture and immune-competent cells over multi-week culture periods. HuPCLS were exposed to three concentrations...
Precision Cut Lung Slices (PCLS) | Respiratory Toxicology | Tobacco | Hans Raabe | Holger Behrsing | HuPCLS | New Generation Tobacco Products | NGTP
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...
kDPRA | Agro/Petrochemical | Cleaning Products | Fragrance & Flavors | Household & Consumer Products | Andreas Natsch | Barbara Birk | Britta Wareing | Cindy Ryan | Erin Hill
March 18, 2019The selection of reference and proficiency chemicals is an important component of method validation and proficiency evaluations. Reference chemicals are a set of test substances used by a method developer to evaluate there liability and relevance of a new method, in comparison to reference data (usually to a validated reference method). Proficiency chemicals, as defined in OECD Guidance Document on Good In Vitro Method Practices, are defined post validation as a subset of the reference chemicals, or other chemicals with...
BCOP | Corrositex | BASF SE | Erin Hill | GIVIMP | Good In Vitro Method Practices | Hans Raabe | Robert Landsiedel | SOT 2019 | Susanne Kolle