Genotoxicity assessment: opportunities, challenges and perspectives for quantitative evaluations of dose–response data

J Menz, ME Götz, U Gündel, R Gürtler, K Herrmann… - Archives of …, 2023 - Springer
Genotoxicity data are mainly interpreted in a qualitative way, which typically results in a
binary classification of chemical entities. For more than a decade, there has been a …

Food-borne chemical carcinogens and the evidence for human cancer risk

T Kobets, BPC Smith, GM Williams - Foods, 2022 - mdpi.com
Commonly consumed foods and beverages can contain chemicals with reported
carcinogenic activity in rodent models. Moreover, exposures to some of these substances …

A pragmatic framework for the application of new approach methodologies in one health toxicological risk assessment

KA Magurany, X Chang, R Clewell… - Toxicological …, 2023 - academic.oup.com
Globally, industries and regulatory authorities are faced with an urgent need to assess the
potential adverse effects of chemicals more efficiently by embracing new approach …

[HTML][HTML] Traditional and novel approaches to derive health-based guidance values for pesticides

L Niemann, J Choi, C Kneuer, T Tralau - Current Opinion in Food Science, 2023 - Elsevier
Highlights•Pesticides•Toxicological data requirements and evaluation•Reference
values•NOAEL vs. Benchmark dose approach•New approach methodologies (NAMs)Due to …

Application of a new approach methodology (NAM)-based strategy for genotoxicity assessment of data-poor compounds

AMV Fortin, AS Long, A Williams, MJ Meier… - Frontiers in …, 2023 - frontiersin.org
The conventional battery for genotoxicity testing is not well suited to assessing the large
number of chemicals needing evaluation. Traditional in vitro tests lack throughput, provide …

[HTML][HTML] A new paradigm for regulatory sciences

GM Hilton, Y Bhuller, JE Doe, DC Wolf… - Regulatory Toxicology …, 2023 - Elsevier
Regulatory science, rooted in legal requirements, provides a mechanism for identifying,
assessing, and managing harm to humans and the environment from exposure to …

[HTML][HTML] Development of a framework for risk assessment of dietary carcinogens

CA Bates, LT Haber, MM Moore, R Schoeny… - Food and Chemical …, 2023 - Elsevier
Although there are a number of guidance documents and frameworks for evaluation of
carcinogenicity, none of the current methods fully reflects the state of the science. Common …

[HTML][HTML] A Cautionary tale for using read-across for cancer hazard classification: Case study of isoeugenol and methyl eugenol

X Zhang, SP Felter, AM Api, K Joshi… - Regulatory Toxicology …, 2022 - Elsevier
Chemical grouping and read-across are frequently used non-animal alternatives for filling
toxicological data gaps. When grouping chemicals, it is critical to define the applicability …

[HTML][HTML] An integrated assessment of the 1, 4-dioxane cancer mode of action and threshold response in rodents

M Lafranconi, J Anderson, R Budinsky, L Corey… - Regulatory Toxicology …, 2023 - Elsevier
Dioxane is an environmental contaminant that has been shown to cause cancer in rodents
after chronic high dose exposures. We reviewed and integrated information from recently …

Primer on human and environmental risk assessment

DJ Paustenbach, BT Langenbach… - Human and ecological …, 2024 - Wiley Online Library
The field of risk assessment, which was pioneered by Arnold Lehmann when at the FDA in
1954, was formally adopted by all agencies as an important way to assess chemical and …