Article
Medicine, Legal
Eric A. J. Bleeker, Elmer Swart, Hedwig Braakhuis, Maria Luisa Fernandez Cruz, Steffi Friedrichs, Ilse Gosens, Frank Herzberg, Keld Alstrup Jensen, Frank von der Kammer, Jolinde A. B. Kettelarij, Jose Maria Navas, Kirsten Rasmussen, Kathrin Schwirn, Maaike Visser
Summary: This paper provides an overview of the development and adaptation of EU chemicals legislation, guidance, and test guidelines for nanomaterials to promote their safe use. Eleven action needs were identified by a group of experts, covering twenty-two specific information requirements relevant to multiple regulatory areas. These needs focused on resolving issues related to dispersion stability and dosing in toxicity testing, degradation and transformation of organic nanomaterials, and cellular reactivity of nanomaterials. Addressing these issues will lead to better test methods for regulatory compliance and ensure the validity of hazard and risk assessments of nanomaterials. The study emphasizes the importance of a structured process for identifying information needs and generating knowledge, preferably as part of risk governance and connected to technological innovation policy.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2023)
Article
Mathematics
Sirao Wang, Jiajuan Liang, Min Zhou, Huajun Ye
Summary: The study explores testing methods for multivariate normality, proposes an improvement based on representative points, and validates the method through Monte Carlo simulations and real data analysis.
Editorial Material
Agriculture, Dairy & Animal Science
Yong Hyun Chung, Mary Gulumian, Richard C. C. Pleus, Il Je Yu
Summary: The OECD test guidelines for animal experiments are important in evaluating chemical hazards, especially when the good laboratory practice principle is applied, to reduce duplication of toxicity testing and ensure mutual acceptance of data. The OECD inhalation toxicity test guidelines have been revised to include nanomaterials and reflect recent scientific and technological developments. These guidelines aim to evaluate the toxicity of nanomaterials objectively by assessing bronchoalveolar lavage fluid.
Review
Biotechnology & Applied Microbiology
Uwe Strotmann, Gerald Thouand, Udo Pagga, Stefan Gartiser, Hermann J. Heipieper
Summary: In the past decades, a complex standardized system has been developed by the industrial and scientific communities to evaluate the biodegradability of chemical substances. Although this system has been widely adopted and integrated into European legislation, there are still deficiencies in the different tests and their accuracy in reflecting the real environment. This review focuses on the technical advantages and weaknesses of current tests, the properties of microbial inocula, and the prediction models for biodegradation.
APPLIED MICROBIOLOGY AND BIOTECHNOLOGY
(2023)
Review
Nanoscience & Nanotechnology
Robert Landsiedel, Naveed Honarvar, Svenja Berit Seiffert, Barbara Oesch, Franz Oesch
Summary: Nanomaterials have unique advantages but may also have adverse effects on humans. However, traditional genotoxicity tests may not be suitable for nanomaterials and modifications are needed. This review critically examines available genotoxicity tests for nanomaterials and discusses their relative usefulness, as well as the open questions and further needs in adapting these tests.
WILEY INTERDISCIPLINARY REVIEWS-NANOMEDICINE AND NANOBIOTECHNOLOGY
(2022)
Article
Environmental Sciences
Prasit Shrestha, Christopher B. Hughes, Louise Camenzuli, Delina Lyon, Boris Meisterjahn, Thomas Hennecke, Megan Griffiths, Dieter Hennecke
Summary: Standardized biodegradation testing methods play a crucial role in assessing the environmental risks of chemicals. However, there are challenges in testing hydrophobic volatile chemicals. This study aimed to improve a closed testing setup to maintain aerobic conditions in the water phase. By optimizing the system geometry, agitation technique, and co-solvent application strategy, it was possible to achieve this goal.
Article
Environmental Sciences
Silvia Berkner, Julia Margaretha Anke, Rolf-Alexander Duering, Silke Fiebig, Thomas Junker, Dieter Hennecke, Monika Herrchen, Maria Meinerling, Joerg Roembke, Soren Thiele-Bruhn, Edward Topp, Wolfgang Voelkel, Susanne Walter-Rohde
Summary: This article describes the validation of a method for studying the anaerobic transformation of chemicals in pig and cattle liquid manure. The method was adopted as OECD Test Guideline (TG) 320 after undergoing validation tests and the process of the Organisation for Economic Cooperation and Development.
Review
Public, Environmental & Occupational Health
Eleonora Scarcello, Adriana Sofranko, Tina Wahle, Roel P. F. Schins
Summary: Testing of engineered nanomaterials in neurotoxicology faces challenges due to their complex physicochemical properties and lack of toxicokinetic data, which may induce indirect neurotoxic effects.
FRONTIERS IN PUBLIC HEALTH
(2022)
Article
Mathematics, Applied
Jiajuan Liang, Ping He, Jun Yang
Summary: This paper proposes a representative-point-based test for multivariate normality, which shows a considerable improvement in power compared to traditional methods according to a limited Monte Carlo study. An illustrative example demonstrates the complementary function of the new test when used together with existing methods in the literature.
Article
Pharmacology & Pharmacy
Kyu Sang Sim, Song Park, Huiwon Seo, Seok-Hee Lee, Hee-Seok Lee, Yooheon Park, Jun Ho Kim
Summary: This study compared the estrogenic properties of fifteen known phytoestrogens using various standardized methods. The results showed that eight test compounds exhibited positive responses in the estrogen receptor-alpha dimerization assay, while seven compounds showed negative responses. Further analysis revealed that three test compounds, biochanin A, 8-prenylnaringenin, and coumestrol, had relatively higher in vitro estrogenic activities and their effects were ER-dependent in the uterus. Additionally, these phytoestrogens regulated uterine gene expressions differently compared to estrogens. The results demonstrated the effectiveness of the test methods used in this study, which could be used for screening phytoestrogens and studying their interactions with ER-alpha.
TOXICOLOGY AND APPLIED PHARMACOLOGY
(2022)
Article
Medicine, Legal
Jacqueline Allan, Susanne Belz, Arnd Hoeveler, Marta Hugas, Haruhiro Okuda, Anil Patri, Hubert Rauscher, Primal Silva, William Slikker, Birgit Sokull-Kluettgen, Weida Tong, Elke Anklam
Summary: Nanotechnology offers novel solutions to societal challenges, but regulatory frameworks struggle to keep pace with its rapid development. Global collaboration and consensus are needed, particularly in emerging fields like micro- and nanoplastics.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2021)
Review
Biology
Vinita Chauhan, Nobuyuki Hamada, Ruth Wilkins, Jacqueline Garnier-Laplace, Dominique Laurier, Danielle Beaton, Knut Erik Tollefsen
Summary: This paper provides an overview of the OECD AOP Development Programme, including its application in the field of chemical toxicology and its work towards regulatory implementation. While the drivers for developing AOPs differ between the chemical and radiation fields, the principles of the approach can benefit both scientific disciplines.
INTERNATIONAL JOURNAL OF RADIATION BIOLOGY
(2022)
Article
Multidisciplinary Sciences
Miriam P. van der Meulen, Esther Toes-Zoutendijk, Manon C. W. Spaander, Evelien Dekker, Johannes M. G. Bonfrer, Anneke J. van Vuuren, Ernst J. Kuipers, Folkert J. van Kemenade, M. F. van Velthuysen, Maarten G. J. Thomeer, Harriet van Veldhuizen, Harry J. de Koning, Iris Lansdorp-Vogelaar, Monique E. van Leerdam
Summary: The participation rate in FIT screening is lower for individuals with a lower socioeconomic status (SES), but they have a higher detection rate for advanced neoplasia. Screening has the potential to reduce health inequalities in CRC mortality.
Article
Environmental Sciences
David Patch, Iris Koch, Derek Peloquin, Denis O'Carroll, Kela Weber
Summary: The study aimed to develop a method to simulate human weathering of silver-containing textiles. It found that non-weathered textiles released a certain amount of silver into wash water effluent, with a portion being ionic silver and the rest as metallic nanomaterials, nanosheets, and particulates. Real and simulated human weathered textiles released similar amounts of total silver, consisting of ionic and a mixture of metallic and chlorinated nanomaterials, nano-sheets, and particulates. The method effectively detached environmentally representative silver materials from textiles for future studies on their fate, transport, and toxicity.
Article
Economics
Jamel Saadaoui, Chi Keung Marco Lau, Yifei Cai
Summary: This study examines the stationarity and sustainability of public finance for six industrial countries using three complementary approaches. The results show that longer-run debt sustainability is not rejected for the UK, Sweden, and the US, while the evidence is somewhat equivocal for Canada, Italy and Portugal.
APPLIED ECONOMICS LETTERS
(2022)
Review
Environmental Sciences
Nanna B. Hartmann, Keld Alstrup Jensen, Anders Baun, Kirsten Rasmussen, Hubert Rauscher, Ratna Tantra, Denisa Cupi, Douglas Gilliland, Francesca Pianella, Juan M. Riego Sintes
JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH-PART B-CRITICAL REVIEWS
(2015)
Article
Toxicology
Luisana Di Cristo, Dania Movia, Massimiliano G. Bianchi, Manfredi Allegri, Bashir M. Mohamed, Alan P. Bell, Caroline Moore, Silvana Pinelli, Kirsten Rasmussen, Juan Riego-Sintes, Adriele Prina-Mello, Ovidio Bussolati, Enrico Bergamaschi
TOXICOLOGICAL SCIENCES
(2016)
Article
Environmental Sciences
Agnes G. Oomen, Eric A. J. Bleeker, Peter M. J. Bos, Fleur van Broekhuizen, Stefania Gottardo, Monique Groenewold, Danail Hristozov, Kerstin Hund-Rinke, Muhammad-Adeel Irfan, Antonio Marcomini, Willie J. G. M. Peijnenburg, Kirsten Rasmussen, Araceli Sanchez Jimenez, Janeck J. Scott-Fordsmand, Martie van Tongeren, Karin Wiench, Wendel Wohlleben, Robert Landsiedel
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
(2015)
Review
Medicine, Legal
Kirsten Rasmussen, Mar Gonzalez, Peter Kearns, Juan Riego Sintes, Francois Rossi, Phil Sayre
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2016)
Article
Medicine, Legal
Kirsten Rasmussen, Hubert Rauscher, Agnieszka Mech, Juan Riego Sintes, Douglas Gilliland, Mar Gonzalez, Peter Kearns, Kenneth Moss, Maaike Visser, Monique Groenewold, Eric A. J. Bleeker
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2018)
Review
Nanoscience & Nanotechnology
A. Mech, K. Rasmussen, P. Jantunen, L. Aicher, M. Alessandrelli, U. Bernauer, E. A. J. Bleeker, J. Bouillard, P. Di Prospero Fanghella, R. Draisci, M. Dusinska, G. Encheva, G. Flament, A. Haase, Y. Handzhiyski, F. Herzberg, J. Huwyler, N. R. Jacobsen, V. Jeliazkov, N. Jeliazkova, P. Nymark, R. Grafstroem, A. G. Oomen, M. L. Polci, C. Riebeling, J. Sandstroem, B. Shivachev, S. Stateva, S. Tanasescu, R. Tsekovska, H. Wallin, M. F. Wilks, S. Zellmer, M. D. Apostolova
Article
Medicine, Legal
Kirsten Rasmussen, Hubert Rauscher, Peter Kearns, Mar Gonzalez, Juan Riego Sintes
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2019)
Article
Chemistry, Multidisciplinary
Agnieszka Mech, Wendel Wohlleben, Antoine Ghanem, Vasile-Dan Hodoroaba, Stefan Weigel, Frank Babick, Raphael Bruengel, Christoph M. Friedrich, Kirsten Rasmussen, Hubert Rauscher
Article
Environmental Sciences
Frederic Loosli, Kirsten Rasmussen, Hubert Rauscher, Richard K. Cross, Nathan Bossa, Willie Peijnenburg, Josje Arts, Marianne Matzke, Claus Svendsen, David Spurgeon, Per Axel Clausen, Emmanuel Ruggiero, Wendel Wohlleben, Frank von der Kammer
Summary: Before introducing a new nanoform on the market, it is important to evaluate its potential adverse effects through hazard and risk assessment. Grouping and read-across of nanoforms can help reduce resource consumption and maximize the use of existing data for assessment. The impact of nanoforms on human health and the environment depends greatly on their concentration and physicochemical properties, making knowledge of these properties essential for assessing similarity.
Article
Environmental Sciences
Gianpietro Basei, Alex Zabeo, Kirsten Rasmussen, Georgia Tsiliki, Danail Hristozov
Summary: The study proposes a quantitative Weight of Evidence (WoE) approach for hazard classification of nanomaterials, integrating and evaluating results from heterogeneous studies based on data quality and completeness criteria, with the ability to highlight uncertainty through probabilistic integration. The use of Monte Carlo resampling allows for the quantitative integration of weighted evidence, leading to coherent and justifiable hazard classification of nanomaterials.
Article
Chemistry, Multidisciplinary
Harald Bresch, Vasile-Dan Hodoroaba, Alexandra Schmidt, Kirsten Rasmussen, Hubert Rauscher
Summary: This paper investigates the precise rules for counting particles in electron microscopy and compares four commonly used methods in case studies. The impact of counting rules on particle size distribution is highlighted, aiming to support the use of specific counting approaches to meet regulatory requirements and achieve reliable and reproducible results.
Article
Environmental Sciences
Lya G. Soeteman-Hernandez, Cindy Bekker, Monique Groenewold, Paula A. Jantunen, Agnieszka Mech, Kirsten Rasmussen, Juan Riego Sintes, Adrienne J. A. M. Sips, Cornelle W. Noorlander
Article
Engineering, Chemical
Hubert Rauscher, Kirsten Rasmussen, Birgit Sokull-Kluttgen
CHEMIE INGENIEUR TECHNIK
(2017)
Article
Environmental Sciences
A. Paula K. Jantunen, Stefania Gottardo, Kirsten Rasmussen, Hugues P. Crutzen
Article
Medicine, Legal
Fiona Sewell, Ian Ragan, Graham Horgan, David Andrew, Thomas Holmes, Irene Manou, Boris P. Mueller, Tim Rowan, Barbara G. Schmitt, Marco Corvaro
Summary: There are currently three test guidelines for acute oral toxicity studies, but the subjectivity of one guideline may be hindering its wider use. In order to address this, the NC3Rs and EPAA collaborated to analyze historical data and provide recommendations on the recognition of 'evident toxicity'.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2024)
Article
Medicine, Legal
Michael DeVito, Bas Bokkers, Majorie B. M. van Duursen, Karin van Ede, Mark Feeley, Elsa Antunes Fernandes Gaspar, Laurie Haws, Sean Kennedy, Richard E. Peterson, Ron Hoogenboom, Keiko Nohara, Kim Petersen, Cynthia Rider, Martin Rose, Stephen Safe, Dieter Schrenk, Matthew W. Wheeler, Daniele S. Wikoff, Bin Zhao, Martin van den Berg
Summary: In October 2022, the World Health Organization reevaluated the toxic equivalency factors (TEFs) for chlorinated dioxin-like compounds in a panel convened in Lisbon. This effort utilized an updated database, Bayesian dose response modeling, and meta-analysis to derive Best-Estimate TEFs. Applying these new TEFs may result in lower total toxic equivalents for dioxin-like chemicals.
REGULATORY TOXICOLOGY AND PHARMACOLOGY
(2024)