Uncategorized

22 Sep A Decision Tree For Acute Oral Toxicity: Implementing The Last Resort Requirement In Practice

Acute oral toxicity (AOT) testing is widely used for hazard identification in chemical safety assessment, but traditional animal methods are still implemented despite their scientific limitations and ethical implications. Despite the availability of non-animal methods, regulatory uptake has been inconsistent, also due to a lack of structured guidance. To address this, the Animal-Free Safety Assessment Collaboration has developed a science-based Decision Tree (DT) aligned with the Organisation for Economic Co-operation and Development (OECD) Integrated Approaches to Testing and Assessment (IATA) framework. IATA integrate existing information in a Weight of Evidence (WoE) assessment with the possible generation of new data appropriate to the decision context. The DT is built as a specific IATA to provide a transparent, modular workflow integrating in silico tools, in vitro assays, and WoE strategies to support AOT hazard identification for regulatory decision-making, such as European Union's Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation, ensuring that animal testing is used only as a last resort. The DT aims to inform regulatory guidance updates and promote acceptance of non-animal approaches by formalising decision-making to bridge the gap between legal mandates to reduce animal testing and current regulatory practice, still heavily reliant on animals, supporting the transition toward improved chemical safety evaluations.

22 Sep A Proposed Evaluation Of New Approach Methodologies For Dermal Toxicity Assessment Of Botanicals

Botanicals are widely used in topical formulations for cosmetics, hair care, and personal care products, reflecting consumer interest in plant-derived materials. Their complex and variable composition, presents challenges for traditional toxicological approaches developed for single chemicals. Although many botanicals are well tolerated, reports of skin irritation, sensitization, and phototoxicity highlight the need for reliable approaches to identify dermal hazards and evaluate risk. Established in silico, in chemico, and in vitro test methods, often referred to as New Approach Methodologies (NAMs), may offer efficient and mechanistically informed tools.

22 Sep Lost In Nams-Lation: A Review Of Animal-Free Science Definitions

The use of terminology related to animal-free science has grown rapidly over the past two decades; however, definitions and interpretations of key terms remain inconsistent across global regulatory, scientific, and policy contexts. The term “new approach methodology(ies)” (NAM(s)) exemplifies this issue: though rarely used prior to 2019, its uptake in scientific literature has increased substantially in recent years. Despite this growth, the term, and its acronym, “NAM”, is used with varied meanings, leading to misunderstanding regarding the types of methods described. Similarly, the term “animal” is defined differently across common language, scientific discourse, and legal frameworks, resulting in further ambiguity in what constitutes “animal-free science”. These variations can hinder productive dialogue and collaboration, particularly in international settings. This manuscript maps the current landscape of definitions of key terms such as “NAM”, “animal”, and “animal-free”, drawing on regulatory, academic, and institutional sources to enhance understanding of the range of existing interpretations. By improving transparency and clarity in terminology, this effort seeks to support more coherent and effective global communication in the field of animal-free science. In addition, the definition of NAM, as agreed by the members of the International Collaboration on Cosmetics Safety, is described. Tabulated definitions and sources are provided as a reference tool.

22 Sep Key Challenges For In Vitro Testing Of Oral Tobacco And Nicotine Products For Regulatory Applications: Recommendations For Using In Vitro Toxicity And Disease Models

The Institute for In Vitro Sciences (IIVS) has sponsored a series of workshops with the aim of developing recommendations for scientific and technical approaches to conducting in vitro assays to assess potential toxicity within and across tobacco and nicotine products. As well as providing a background overview of oral tobacco and nicotine products, this report focuses on the methods used to generate extracts from these products for in vitro testing, the recommended best testing practices, and suggested areas for future research. This publication was developed by a working group of workshop members, in conjunction with the ninth IIVS in vitro workshop entitled ‘In Vitro Models for Testing Oral Tobacco and Nicotine Products and Continued Discussion of In Vitro Models of Toxicity and Disease’, which was held in January 2024.

22 Sep Key Challenges For In Vitro Testing Of Tobacco And Next Generation Products For Regulatory Applications: Recommendations For The Ames Test

The Ames bacterial mutagenesis assay (Ames test) has been used for more than 50 years, to help assess the safety of a variety of single chemicals and complex mixtures in the form of solids, liquids or aerosols. Because of the diverse range of substances that need to be tested, many modifications of this test, as well as modifications of the methods by which the test substances are prepared and applied to the bacterial test system, have been developed. Currently, there is a need for mutagenicity testing of both traditional tobacco products and next generation products (NGPs) such as e-cigarettes, heated tobacco products, tobacco-free nicotine products, oral pouches, etc. There are currently no standardised guidelines that cover the differing, often complex, procedures used by different laboratories to assess NGPs with the Ames test. To address this problem, the Institute for In Vitro Sciences (IIVS) convened a workshop, where representatives of industry, government, academia, contract research organisations (CROs) and non-government organisations (NGOs) could present bespoke experimental techniques and data from their testing platforms. The further aim of the workshop was to help formulate some general guidelines that could be used in the testing of tobacco and nicotine products, to allow better comparisons to be made between laboratories. The workshop discussions also resulted in the identification of some suggested areas for future research activities.