[HTML][HTML] New approach methodologies in human regulatory toxicology–Not if, but how and when!

S Schmeisser, A Miccoli, M von Bergen… - Environment …, 2023 - Elsevier
The predominantly animal-centric approach of chemical safety assessment has increasingly
come under pressure. Society is questioning overall performance, sustainability, continued …

[HTML][HTML] A walk in the PARC: developing and implementing 21st century chemical risk assessment in Europe

P Marx-Stoelting, G Rivière, M Luijten… - Archives of …, 2023 - Springer
Current approaches for the assessment of environmental and human health risks due to
exposure to chemical substances have served their purpose reasonably well. Nevertheless …

[HTML][HTML] Alternative test methods for (nano) materials hazards assessment: Challenges and recommendations for regulatory preparedness

SIL Gomes, JJ Scott-Fordsmand, MJB Amorim - Nano Today, 2021 - Elsevier
The outstanding work performed by standardization organizations for guidelines to assess
hazards, eg, OECD (Organisation for Economic Co-operation and Development), is clearly …

[HTML][HTML] A framework for chemical safety assessment incorporating new approach methodologies within REACH

N Ball, R Bars, PA Botham, A Cuciureanu… - Archives of …, 2022 - Springer
The long-term investment in new approach methodologies (NAMs) within the EU and other
parts of the world is beginning to result in an emerging consensus of how to use information …

Development of a roadmap for action on new approach methodologies in risk assessment

SE Escher, F Partosch, S Konzok… - EFSA Supporting …, 2022 - Wiley Online Library
While whole animal studies have their place in risk assessment of food and feed
components, it is thought that more modern approaches such as human focused new …

Next-generation risk assessment of chemicals-rolling out a human-centric testing strategy to drive 3R implementation: the RISK-HUNT3R project perspective

G Pallocca, MJ Moné, H Kamp, M Luijten… - 2022 - kops.uni-konstanz.de
In many industrial sectors, there is a need for reliable ways to evaluate the safety of
chemicals with methods anchored to human biology and pathology. For this purpose, many …

REACH out-numbered! The future of REACH and animal numbers

C Rovida, F Busquet, M Leist, T Hartung - ALTEX-Alternatives to animal …, 2023 - altex.org
Abstract The EU's REACH (Registration, Evaluation, Authorisation and Restriction of
Chemicals) Regulation requires animal testing only as a last resort. However, our study …

[HTML][HTML] G× E interactions as a basis for toxicological uncertainty

I Suciu, D Pamies, R Peruzzo, PH Wirtz… - Archives of …, 2023 - Springer
To transfer toxicological findings from model systems, eg animals, to humans, standardized
safety factors are applied to account for intra-species and inter-species variabilities. An …

[HTML][HTML] Modernizing persistence–bioaccumulation–toxicity (PBT) assessment with high throughput animal-free methods

BI Escher, R Altenburger, M Blüher, JK Colbourne… - Archives of …, 2023 - Springer
The assessment of persistence (P), bioaccumulation (B), and toxicity (T) of a chemical is a
crucial first step at ensuring chemical safety and is a cornerstone of the European Union's …

[HTML][HTML] Capturing time-dependent activation of genes and stress-response pathways using transcriptomics in iPSC-derived renal proximal tubule cells

P Jennings, G Carta, P Singh… - Cell biology and …, 2023 - Springer
Transcriptomic analysis is a powerful method in the utilization of New Approach Methods
(NAMs) for identifying mechanisms of toxicity and application to hazard characterization …