This document describes the state of knowledge of the adverse outcome pathway (AOP) for skin sensitisation initiated by covalent binding to proteins, assesses the weight-of-evidence supporting the AOP, identifies the key events, and identifies databases containing test results related to key events.

Social pressure to minimize the use of animal testing, the ever-increasing concern on animal welfare, and the need for more human-relevant and more predictive toxicity tests are some of the drivers for new approaches to chemical screening. This book focuses on The Adverse Outcome Pathway, an analytical construct that describes a sequential chain of causally linked events at different levels of biological organization that lead to an adverse health or ecotoxicological effect. While past efforts have focused on toxicological pathway-based vision for human and ecological health assessment relying on in vitro systems and predictive models, The Adverse Outcome Pathway framework provides a simplified and structured way to organize toxicological information. Within the book, a systems biology approach supplies the tools to infer, link, and quantify the molecular initiating events and the key events and key event relationships leading to adverse outcomes. The advancement of these tools is crucial for the successful implementation of AOPs for regulatory purposes.

This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.

Efforts are being made by research organizations and cosmetic industries worldwide to develop more precise and targeted 3D models that mimic humans for testing cosmetic and personal health care product ingredients, following a complete ban on animal testing. This book includes several subtopics dedicated to the progress made, challenges faced, roadblocks encountered, and future prospects in the development and validation of 3D models for testing these products. The book consist of an editorial and 14 themed chapters that will showcase the significant progress made so far, challenges encountered, and future prospects in the development of 3D reconstruct models.

Skin Allergy, An Issue of Immunology and Allergy Clinics of North America, E-Book

With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of ...

With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides guidance on the reporting of defined approaches to testing and assessment in the area of skin ...

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.

This Test Guideline (TG) provides an in vitro procedure (the ARE-Nrf2 luciferase test method) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS.

This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.