OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins
Author: OECD
Publisher: OECD Publishing
Total Pages: 63
Release: 2015-02-05
Genre:
ISBN: 9264229701

This Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. It provides an in chemico procedure (Direct Peptide Reactivity Assay – DPRA) used for supporting the discrimination between skin sensitisers and non-sensitisers.

OECD Guidelines for the Testing of Chemicals, Section 4 Guideline No. 497: Defined Approaches on Skin Sensitisation

OECD Guidelines for the Testing of Chemicals, Section 4 Guideline No. 497: Defined Approaches on Skin Sensitisation
Author: OECD
Publisher: OECD Publishing
Total Pages: 53
Release: 2023-07-04
Genre:
ISBN: 9264903003

A Defined Approach (DA) consists of a selection of information sources (e.g in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical, rule-based model). DAs use methods in combination and are intended to overcome some limitations of the individual, stand-alone methods.

European Partnership on the Assessment of Risks from Chemicals (PARC): Focus on New Approach Methodologies (NAMs) in Risk Assessment

European Partnership on the Assessment of Risks from Chemicals (PARC): Focus on New Approach Methodologies (NAMs) in Risk Assessment
Author: Terje Svingen
Publisher: Frontiers Media SA
Total Pages: 125
Release: 2024-08-21
Genre: Medical
ISBN: 2832553389

The European Partnership on the Assessment of Risks from Chemicals (PARC) project was launched in 2022. The overarching aim of this partnership is to enhance our knowledge about chemical substances to better safeguard human health and the environment against harmful effects. The project will run for seven years under Horizon Europe. PARC is subdivided into several work packages (WPs). WP5 is focused on hazard assessment for human and environmental health and includes more than 80 partners across Europe. WP5 aims to fill data gaps for specified chemical substances of concern (e.g, bisphenol alternatives) and to develop or improve new approach methodologies (NAMs) for chemical hazard assessment. This is in order to progress towards a risk assessment paradigm relying less on animal toxicity data, both with respect to human health and environmental safety. As the PARC initiative will evolve over time with respect to both projects and activities, presenting early initiatives will foster an increased awareness of ongoing activities and potential incorporation of new activities going forward.

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
Total Pages: 592
Release: 2019-11-21
Genre: Technology & Engineering
ISBN: 0081026447

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

Environmental Toxicology

Environmental Toxicology
Author: Luis M. Botana
Publisher: Walter de Gruyter GmbH & Co KG
Total Pages: 364
Release: 2024-03-18
Genre: Technology & Engineering
ISBN: 3111014444

The book about Non-bacterial toxins will cover those toxins that affect food safety and are produced by fungi (mycotoxins), cyanobacteria (cyanotoxins) and marine microalgae (phycotoxins). These three group of toxins affect food safety and drinking water quality at a global scale, and they pose three main challenges for scientists: 1) Climate change is causing a slow but steady change on the chemical profile of each of these groups, causing intoxications in areas that are geographically new to the intoxications map. For this reason, emerging toxins are a new topic that requires an important reallocation of resources to understand the new toxins trends, their toxicology, their analytical control and how to deal with them from a regulatory standpoint. 2) Toxicological science needs to be updated to determine the impact of the toxins in all kind of vectors (more and more are being discovered) and how they disseminate on the food chain. Also, the mode of action of many of this toxins is not understood or even known, and this affects also to the impact of the coexistence of several toxins in the same matrix. 3) Detection and regulation, as this requires the use of advance technology (mass spectrometry, biosensors, multitask screening etc) that is in many cases underdevelopped or not available, especially for many of the new toxins. Climate change, toxicology and detection affect so many areas of science that this book will try to keep the readers updated about the current state of the art.