The Partnership for the Assessment of Risks from Chemicals (PARC) represents a joint effort among risk assessors, regulatory authorities, and the scientific community to advance the implementation of the Next Generation Risk Assessment (NGRA) in line with the objectives of the EU Chemicals Strategy for Sustainability. Addressing the challenges faced...

Research findings suggest that advanced paternal age is associated with an increased risk of autism spectrum disorder (ASD) in children. The biological process behind this father-to-child inheritance of a disease may be driven by sperm epigenetic marks. This has been suggested earlier, but the identification of epigenomic regions responsible for...

The acoustic startle response (ASR) is a conserved sensorimotor reflex widely used to investigate neural plasticity, sensorimotor gating, and neurotoxicity. While zebrafish is an established vertebrate model for ASR analysis, most existing platforms were originally optimized for 6 dpf larvae, which constrains applications requiring reliable assessment of earlier developmental stages...

New Approach Methodologies (NAMs) are gaining significant momentum globally to reduce animal testing and enhance the efficiency and human relevance of chemical safety assessment. Even with substantial EU commitment from regulatory agencies and the academic community, the full regulatory adoption of NAMs remains a distant prospect. This challenge is further...

The European Commission’s Safe and Sustainable by Design (EC SSbD) Framework aims to put together safety and sustainability considerations throughout the entire chemical and material innovation processes. Being a voluntary (pre-market) approach, the framework fosters the development of safe and sustainable chemicals, materials, processes, and products while drawing on existing...

As part of its response to the European Citizens’ Initiative “Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing”, the European Commission committed to developing a roadmap to eliminate the use of animals for the safety testing of chemicals. Five animal protection non-govern­mental organizations arranged a roundtable in...

Chemical pollution of aquatic environments involves diverse substance combinations that can provoke combined biological and toxicological effects even when individual concentrations remain below effect thresholds. Multiple efforts are ongoing to better consider mixture effects in chemical safety regulation, but debate continues over whether a few substances drive aquatic mixture risks...

The strong appeal to reduce animal testing calls for the development and validation of in vitro, in chemico and in silico models that would replace the need for in vivo testing and ex vivo materials. A category that requires such new approach methods is the assessment of immunosuppression that can...

As a complex system governing and interconnecting numerous functions within the human body, the immune system is unsurprisingly susceptible to the impact of toxic chemicals. Toxicants can influence the immune system through a multitude of mechanisms, resulting in immunosuppression, hypersensitivity, increased risk of autoimmune diseases and cancer development. At present...

With global restrictions on Bisphenol A (BPA), various BPA alternatives are increasingly found in ecosystems, raising concerns. This study focuses on the genotoxic potential of three emerging BPA alternatives — Bisphenol AF (BPAF), Bisphenol AP (BPAP), and Bisphenol PH (BPPH) — using an advanced in vitro 3D model system, spheroids...

There is a clear need to develop new approach methodologies (NAMs) that combine in vitro and in silico testing to reduce and replace animal use in chemical risk assessment. Physiologically based kinetic (PBK) models are gaining popularity as NAMs in toxico/pharmacokinetics, but their coverage of complex metabolic pathways occurring in...

Existing approaches for human health risk assessment of chemicals have overall provided a high level of protection for EU citizens. However, the established assessment schemes face numerous challenges. Ethical and scientific concerns about using animals for safety testing have triggered awareness of the need for a paradigm shift, requiring new...

Background and Aims: Drug-induced liver injury (DILI) is one of the most frequentreasons for failure of drugs in clinical trials or market withdrawal. Early assessmentof DILI risk remains a major challenge during drug development. Here, we presenta mechanism-based weight-of-evidence approach able to identify certain candidatecompounds with DILI liabilities due to...

Nephrotoxicity caused by drug or chemical exposure involves complex mechanisms as well as a temporal integration of injury and repair responses in different nephron segments. Distinct cellular transcriptional programs regulate the time-dependent tissue injury and regeneration responses. Whole kidney transcriptome analysis cannot dissect the complex spatio-temporal injury and regeneration responses...

Context In vitro toxicity studies are increasingly being included as evidence in systematic reviews and chemical risk assessments. INVITES-IN, a tool for assessing the internal validity of in vitro studies, is under development in a process consisting of four consecutive studies. Study One in the creation of INVITES-IN was the...

Bisphenol A (BPA) is a well-known endocrine disruptor linked to numerous adverse health outcomes and was, therefore, banned in food-contact materials in the European Union. Numerous alternatives are now in commerce, but their health hazards are often inadequately addressed. This study compared BPA and 26 alternatives in six in vitro...

This article reviews the application of multicriteria decision analysis (MCDA) in chemical alternatives assessment (CAA) and presents an overview of how the methodology has been applied within CAA. The study aimed to identify research that uses MCDA to identify the most harmful or least problematic chemicals and evaluate its current...

Bisphenol A (BPA) is an endocrine-disrupting chemical with estrogen-like activity, known to impair immune function. BPA may act as a pro-inflammatory agent, reducing immune response efficacy, increasing bacterial load in E. coli infections, and altering immune responses in parasitic infections (Leishmania major, Nippostrongylus brasiliensis, Toxocara canis) through cytokine and regulatory...

Human activities severely impact biodiversity, particularly in freshwater lakes. These habitats provide critical ecosystem services and, at the same time, suffer from river inflow, agricultural runoff, and urban discharge. DNA-based techniques are preferred for monitoring biodiversity due to their effectiveness. However, pinpointing the causes of biodiversity decline across landscapes poses...

Human biomonitoring of persistent organic pollutants (POPs) remains essential for tracking long-term exposure, evaluating health risks, and assessing the effectiveness of regulatory bans. For this purpose, an experimental and analytical methodology has been optimized allowing the determination of 47 POPs, encompassing chlorinated cyclodienes, chlorobenzenes, cyclohexanes, polychlorodiphenyl derivatives, several congeners of...