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WHO Toxic Equivalency Factors (TEFs) for dioxin like compounds, including studies supporting novel methodology for derivation of TEFs Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-12 Lesa L. Aylward
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Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-11 Tsung-Jen Liao, Lynn Crosby, Kevin Cross, Minjun Chen, Rosalie Elespuru
Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting
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GARDskin dose-response assay and its application in conducting Quantitative Risk Assessment (QRA) for fragrance materials using a Next Generation Risk Assessment (NGRA) framework Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-08 Shashikiran Donthamsetty, Andy Forreryd, Paul Sterchele, Xiao Huang, Robin Gradin, Henrik Johansson, Ulrika Mattson, Isabelle Lee, Anne Marie Api, Gregory Ladics
Development of New Approach Methodologies (NAMs) capable of providing a No Expected Sensitization Induction Level (NESIL) value remains a high priority for the fragrance industry for conducting a Quantitative Risk Assesment (QRA) to evaluate dermal sensitization. The tro GARDskin assay was recently adopted by the OECD (TG 442 E) for the hazard identification of skin sensitizers. Continuous potency
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Taring the scales: Weight-of-Evidence Framework for biocompatibility evaluations Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-08 Stephanie M. Street, Whitney V. Christian
ISO 10993–1:2018 describes evaluating the biocompatibility profile of a medical device from a risk-based approach. This standard details the battery of information that should be considered within the assessment of a device, including raw material composition data, manufacturing processes, and endpoint testing. The ISO 10993/18,562 series requires worst-case assumptions and exposure scenarios to be
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GARD™skin and GARD™potency: A proof-of-concept study investigating applicability domain for agrochemical formulations Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-05 Marco Corvaro, Joseph Henriquez, Raja Settivari, Ulrika Mattson, Andy Forreryd, Robin Gradin, Henrik Johansson, Sean Gehen
Several New Approach Methodologies (NAMs) for hazard assessment of skin sensitisers have been formally validated. However, data regarding their applicability on certain product classes are limited. The purpose of this project was to provide initial evidence on the applicability domain of GARD™skin and GARD™potency for the product class of agrochemical formulations.
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Evaluating scientific confidence in the concordance of in vitro and in vivo protective points of departure Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-03-04 En-Hsuan Lu, Lucie C. Ford, Zunwei Chen, Sarah D. Burnett, Ivan Rusyn, Weihsueh A. Chiu
To fulfil the promise of reducing reliance on mammalian laboratory animal studies, new approach methods (NAMs) need to provide a confident basis for regulatory decision-making. However, previous attempts to develop NAMs-based points of departure (PODs) have yielded mixed results, with PODs from U.S. EPA's ToxCast, for instance, appearing more conservative (protective) but poorly correlated with traditional
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Safety assessment for nail cosmetics: Framework for the estimation of systemic exposure through the nail plate Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-28 Xuejun J. Yin, Nicola J. Hewitt, Steffen Erler, Paul Bryson, Brunhilde Blömeke, Anthony A. Gaspari, Carsten Goebel
All cosmetics products, including nail care products, must be evaluated for their safety. The assessment of systemic exposure is a key component of the safety assessment. However, data on the exposure, especially via ungual route (nail plate) are limited. Based on the physicochemical properties of human nails and permeability data of topical onychomycosis drugs, the nail plate is considered a good
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Considerations for the development of guidance on dose level selection for developmental and reproductive toxicity studies Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-24 R.W. Lewis, A.K. Andrus, J. Arroyo, S. Brescia, P.A. Botham, M. Corvaro, G.P. Daston, T. Hofmann, C. Rodriguez, F. Sewell, B. van Ravenzwaay, K. Wiench, S. Marty
In 2022, the European Chemicals Agency issued advice on the selection of high dose levels for developmental and reproductive toxicity (DART) studies indicating that the highest dose tested should aim to induce clear evidence of reproductive toxicity without excessive toxicity and severe suffering in parental animals. In addition, a recent publication advocated that a 10% decrease in body weight gain
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The role of trust in the use of artificial intelligence for chemical risk assessment Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-23 Pim N.H. Wassenaar, Jordi Minnema, Jelle Vriend, Willie J.G.M. Peijnenburg, Jeroen L.A. Pennings, Anne Kienhuis
Risk assessment of chemicals is a time-consuming process and needs to be optimized to ensure all chemicals are timely evaluated and regulated. This transition could be stimulated by valuable applications of Artificial Intelligence (AI)/Machine Learning (ML) models. However, implementation of AI/ML models in risk assessment is lagging behind. Most AI/ML models are considered ‘black boxes’ that lack
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In vivo alkaline comet assay: Statistical considerations on historical negative and positive control data Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-22 Timur Tug, Julia C. Duda, Max Menssen, Shannon Wilson Bruce, Frank Bringezu, Martina Dammann, Roland Frötschl, Volker Harm, Katja Ickstadt, Bernd-Wolfgang Igl, Marco Jarzombek, Rupert Kellner, Jasmin Lott, Stefan Pfuhler, Ulla Plappert-Helbig, Jörg Rahnenführer, Markus Schulz, Lea Vaas, Marie Vasquez, Verena Ziegler, Christina Ziemann
The alkaline comet assay is frequently used as follow-up test within different regulatory environments to characterize the DNA-damaging potential of different test items. The corresponding OECD Test guideline 489 highlights the importance of statistical analyses and historical control data (HCD) but does not provide detailed procedures. Therefore, the working group “Statistics” of the German-speaking
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Replacing concurrent controls with virtual control groups in rat toxicity studies Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-22 Alexander Gurjanov, Carlos Vieira-Vieira, Julia Vienenkoetter, Lea A.I. Vaas, Thomas Steger-Hartmann
Virtual control groups (VCGs) in nonclinical toxicity represent the concept of using appropriate historical control data for replacing concurrent control group animals. Historical control data collected from standardized studies can serve as base for constructing VCGs and legacy study reports can be used as a benchmark to evaluate the VCG performance. Replacing concurrent controls of legacy studies
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Sensory irritation and use of the best available science in setting exposure limits: Issues raised by a scientific panel review of formaldehyde human research studies Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-22 Katy Goyak, Stewart Holm
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Genotoxicity evaluation of food additive titanium dioxide using a battery of standard in vivo tests Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-19 Xiaopeng Zhang, Jin Fang, Nana Sun, Haibo Liu, Yongquan Feng, Huali Wang, Zhou Yu, Xudong Jia
The increasing use of titanium dioxide (TiO) nanoparticles (NPs) has raised concern about the safety of food additive TiO. TiO has been considered no longer safe by EFSA due to concerns over genotoxicity, however, there are conflicting opinions upon the safety of TiO as a food additive, and the number of genotoxicity studies conducted on food additive TiO was limited. In order to investigate the the
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Repeat dose and reproductive toxicity of thrombopoietin mimic peptide in Sprague-Dawley rats Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-09 Shidong Qiu, Yuji Liang, Xiaobo Wang, Xiue Li, Guoyue Wei, Peng Xiao, Suling Teng, Peilu Sun, Lei Song, Zenglin Zhao, Yanling Mu
Thrombopoietin mimic peptide (TMP) is a novel thrombopoietin receptor agonist. In this report, we evaluated the potential toxicity of TMP in repeat-dose toxicity and reproductive/developmental toxicity studies (segment Ⅰ, Ⅱ, Ⅲ). TMP was administered subcutaneously to Sprague-Dawley (SD) rats at 5, 15 or 50 mcg/kg. In repeat-dose toxicity study, the rats were administrated three times a week for 26
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Chronic aquatic toxicity assessment of diverse chemicals on Daphnia magna using QSAR and chemical read-across Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-05 Ankur Kumar, Vinay Kumar, Probir Kumar Ojha, Kunal Roy
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Pre-clinical safety assessment of biotechnologically produced lacto-N-tetraose (LNT) Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-03 Hester van der Woude, Sylvia M.J.G. Pelgrom, Carin Buskens, Roy Hoffmans, Nora Krajcs, Dianne J. Delsing
Lacto--tetraose (LNT) is a human milk oligosaccharide with average concentrations ranging from 0.74-1.07 g/L in breastmilk, depending on the lactation stage. In this study, the preclinical safety of LNT produced by the K-12 E2083 production strain was assessed. LNT was negative in both the bacterial reverse mutation assay and the micronucleus assay, demonstrating the absence of genotoxic potential
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Adverse effects in traditional and alternative toxicity tests Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-02-02 Patience Browne, Katie Paul Friedman, Kim Boekelheide, Russell S. Thomas
Chemical safety assessment begins with defining the lowest level of chemical that alters one or more measured endpoints. This critical effect level, along with factors to account for uncertainty, is used to derive limits for human exposure. In the absence of data regarding the specific mechanisms or biological pathways affected, non-specific endpoints such as body weight and non-target organ weight
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Detailed aggregate exposure analysis shows that exposure to fragrance ingredients in consumer products is low: Many orders of magnitude below thresholds of concern Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-28 Isabelle Lee, Cesar Scrochi, Olive Chon, Mary Ann Cancellieri, Ambarnil Ghosh, John O'Brien, Brendan Ring, Cronan McNamara, Anne Marie Api
The Research Institute for Fragrance Materials (RIFM) and Creme Global Cremeglobal.com partnered to develop an aggregate exposure model for fragrance ingredients. The model provides a realistic estimate of the total exposure of fragrance ingredients to individuals across a population. The Threshold of Toxicological Concern (TTC) and Dermal Sensitization Threshold (DST) were used to demonstrate the
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Is schedule IV suvorexant an appropriate reference drug of abuse to use in preclinical abuse liability testing in the rat? Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-27 Greet B.A. Teuns, Michela Tessari
The abuse potential of novel CNS-active drug candidates with low specificity for known receptors involved in abuse might be complex to test preclinically relative to an appropriate reference drug of abuse. Suvorexant, a Schedule IV dual orexin receptor antagonist was investigated for its potential use as a reference drug in Drug Discrimination Learning (DDL) studies. Firstly, toxicokinetic properties
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In Memoriam: Michael "Mike" Steven Denison 1954–2022 Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-25 Martin van den Berg
Abstract not available
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Derivation of no significant risk levels for three lower acrylates: Conclusions and recommendations from an expert panel Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-26 C.R. Kirman, P.J. Boogaard, J.S. Bus, V.L. Dellarco, K. Shao, B.R. Stern, S.M. Hays
A panel of toxicology, mode of action (MOA), and cancer risk assessment experts was engaged to derive no-significant-risk-levels (NSRLs) for three lower acrylates: methyl acrylate (MA), ethyl acrylate (EA), and 2-ethylhexyl acrylate (2EHA) using the best available science, data, and methods. The review was structured as a five-round, modified Delphi format, a systematic process for collecting independent
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Can “Hazard-Cost-Effectiveness Analysis” improve the risk management of chemicals under REACH? Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-19 Jean-Marc Brignon, Jean-Christophe Vergnaud, Sandrine Andres, Enrico Mombelli, Tsarafara Rambolarimanana
Cost-Effectiveness Analysis (CEA) is a decision-making framework to prioritize policy decisions for chemicals. Differences in hazard profiles among chemicals are not integrated in CEA under the EU REACH Regulation, which could limit its relevance. Another concern is that two different economic decision support methods (CEA for chemicals considered as PBTs or vPvBs from a regulatory perspective and
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Systematic update to the mammalian relative potency estimate database and development of best estimate toxic equivalency factors for dioxin-like compounds Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-18 S. Fitch, A. Blanchette, L.C. Haws, K. Franke, C. Ring, M. DeVito, M. Wheeler, N. Walker, L. Birnbaum, K.I. Van Ede, E.C. Antunes Fernandes, D.S. Wikoff
The World Health Organization (WHO) assesses potential health risks of dioxin-like compounds using Toxic Equivalency Factors (TEFs). This study systematically updated the relative potency (REP) database underlying the 2005 WHO TEFs and applied advanced methods for quantitative integration of study quality and dose-response. Data obtained from fifty-one publications more than doubled the size of the
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Identification of true chemical respiratory allergens: Current status, limitations and recommendations Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-14 Mark A. Pemberton, Josje HE. Arts, Ian Kimber
Asthma in the workplace is an important occupational health issue. It comprises various subtypes: occupational asthma (OA; both allergic asthma and irritant-induced asthma) and work-exacerbated asthma (WEA). Current regulatory paradigms for the management of OA are not fit for purpose. There is therefore an important unmet need, for the purposes of both effective human health protection and appropriate
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Prioritization of chemicals in personal care products based on persistent, bioaccumulative and toxic (PBT) potential: An Indian perspective Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-10 Abirami Balakrishnan, Varshini Senthilkumar, Sowmiya Rajan Jeyakumaran, Jabez John, Kevin Vinodh, Uthradevi Kannan, Balakrishnan Paramasivam
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Biomonitoring and risk assessment of human exposure to triazole fungicides Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-05 Luiz P.A. Marciano, Luiz F. Costa, Naiane S. Cardoso, Josiane Freire, Fernando Feltrim, Geovana S. Oliveira, Fernanda B.A. Paula, Alessandra C.P. Silvério, Isarita Martins
Risk assessment and biomarkers were evaluated in volunteers exposed to triazole fungicides in southern Minas Gerais, Brazil. Volunteers were divided into two groups: occupationally and environmentally exposed to pesticides (n = 140) and those unexposed (n = 50) from urban areas. Urine samples were analyzed by GC-MS for triazoles, and samples from men and women in the exposed group were quantified.
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Examining animal testing for risk assessment: A WC-12 workshop report Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-04 Yadvinder Bhuller, Agnes Karmaus, Nicole Kleinstreuer, Troy Seidle, Harald Schlatter, Michael Wade, P. Charukeshi Chandrasekera
In toxicology and regulatory testing, the use of animal methods has been both a cornerstone and a subject of intense debate. To continue this discourse a panel and audience representing scientists from various sectors and countries convened at a workshop held during the 12th World Congress on Alternatives and Animal Use in the Life Sciences (WC-12). The ensuing discussion focused on the scientific
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Comprehensive safety assessment of serendipity berry sweet protein produced from Komagataella phaffii Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-06 Elaine L. Freeman, Rachel Ward, Mary M. Murphy, Tina Wang, Jason Ryder
Serendipity berry plant (Dioscoreophyllum cumminsii (Stapf) Diels) is the source of a naturally sweet protein referred to as monellin. The safety of serendipity berry sweet protein (SBSP) containing single polypeptide monellin (MON) expressed in Komagataella phaffii (formerly Pichia pastoris) and produced via precision fermentation was examined comprehensively through assessments of in vitro and in
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Corrigendum to “Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products” [Regul. Toxicol. Pharmacol. 72 3 (2015) 673-68] Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-03 B. Safford, A.M. Api, C. Barratt, D. Comiskey, E.J. Daly, G. Ellis, C. McNamara, C. O'Mahony, S. Robison, B. Smith, R. Thomas, S. Tozer
Abstract not available
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Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2024-01-04 LeeAnn Racz, Alison Gauthier, Jennifer Bare, Melissa Heintz, David Feifarek, Stephanie Kennedy, Julie Panko
High density polyethylene (HDPE) containers are fluorinated to impart barrier properties that prevent permeation of liquid products filled in the container. The process of fluorination may result in the unintentional formation of certain per- and polyfluoroalkyl substances (PFAS), specifically perfluoroalkyl carboxylic acids (PFCAs), as impurities. This study measured the amounts of PFCAs that may
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Ninety-day toxicity and genotoxic effects of synthetically derived fully saturated forms of anacardic acid in mice Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-25 S. Sriram, M. Sai Kumar, G.K. Shourie, A. Palukurthi, S. Kadam, T.M. Srikanth
Organically synthesized fully saturated form of Anacardic acid (AA) has previously shown to be effective in the treatment of inflammatory autoimmune disease. In this study, organically synthesized fully saturated form of AA was orally administered to male and female Swiss albino mice for 90 consecutive days at doses of 25, 50 and 100 mg/kg BW (n = 20 per sex/group). Administration of AA was well tolerated
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Are current regulatory log Kow cut-off values fit-for-purpose as a screening tool for bioaccumulation potential in aquatic organisms? Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-28 Sylvia Gimeno, Dawn Allan, Paul Kai, Pauline Remuzat, Marie Collard
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Safety considerations for dietary supplement manufacturers in the United States Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-27 Jay Sirois, Sudheer Reddy, Tony Nguyen, Heather Walker, Jessica Rendall, Georges Bergen, Mark Reimers, Erica Cermak, Asheesh Tiwary, Emily Helmes, Jennifer Palmer, Steve Teo, Tami Mackle, Mimi Park, Charlene Wang
Due to significant dietary supplement use in the US, product manufacturers must understand the importance of implementing a robust approach to establishing safety for all ingredients, including dietary ingredients, components, and finished dietary supplement products. Different regulatory pathways exist by which the safety of dietary ingredients can be established, and thus allowed to be marketed in
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A (not) new Rx: Quality improvement for NAM Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-23 Syril D. Pettit
New Approach Methodologies (NAMs) are a rapidly growing set of tools/methods for use food, drug, consumer product, or chemical safety assessment paradigms. The massive growth in NAMs tech development, publication, and legislation has been paralleled by a growing sense of frustration. The challenge of realizing the systems-level changes needed to catalyze the broad-scale adoption and use of NAMs is
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Non-mutagenic impurities – Recent industry experience of using dose durational limits in drug development Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-23 Andreanne Lortie, Elizabeth A. Martin, Kate Arnot
Absence of clear guidance on the qualification threshold for non-mutagenic impurities during clinical development is a source of inconsistency in both sponsor qualification approaches and health authority requests. A survey was conducted in March 2020 with 6 member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Thirteen examples were gathered of where non-International
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The last resort requirement under REACH: From principle to practice Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-23 Donna S. Macmillan, Anders Bergqvist, Eleanor Burgess-Allen, Ian Callan, James Dawick, Benjamin Carrick, Graham Ellis, Roberto Ferro, Katy Goyak, Chantal Smulders, Ricky A. Stackhouse, Espe Troyano, Carl Westmoreland, Blanca Serrano Ramón, Vanessa Rocha, Xiaoling Zhang
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Apparent Khat chewers exposure to DDT in Ethiopia and its potential toxic effects: A scoping review Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-22 Shimels Ayalew Ali, Addisu Getachew Destaye
Dichlorodiphenyltrichloroethane (DDT) is an insecticide, a member of dirty dozen persistent organic pollutants, used widely in the world until it was banned in the 1970s.The banning of DDT was strengthened by the Stockholm Convention in 2001. DDT is allowed only for malaria control in Ethiopia. However, farmers are misusing DDT and applying it to Khat (Catha edulis) farming. So, this review analyzes
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Acute and chronic toxicity in Sprague–Dawley rats of orally-administered total lignans from Arctii Fructus, a potential therapeutic drug for diabetes Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-08 Jinwang Mei, Xiaobo Li, Zhiyong Xu, Haiyang Zhao, Jingyun Zhang, Qin Xu, Zhaohui Xu
Arctii Fructus is the dried ripe fruit of Arctium lappa L. (family Asteraceae) and is in the Chinese pharmacopoeia. Previous research showed that the total lignans from Arctii Fructus (TLAF) have pharmacological activities related to diabetes. This study evaluated the acute and chronic (26 weeks) toxicities associated with oral daily administration of TLAF in Sprague–Dawley (SD) rats. An acute-toxicity
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Risk assessment of nutrients: There must be a threshold for their effects Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-10 Michiel RH. Löwik, Arne Astrup, Alan R. Boobis, Philip C. Calder, Hannelore Daniel, Ivonne MCM. Rietjens, John L. Sievenpiper, Hans Verhagen
Nutrients serve physiological functions in a dose-dependent manner and that needs to be recognized in risk assessment. An example of the consequences of not properly considering this can be seen in a recent assessment by the European Food Safety Authority (EFSA). EFSA concluded in 2022 that the intake of added and free sugars should be “as low as possible in the context of a nutritionally adequate
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Retrospective evaluation of the eye irritation potential of agrochemical formulations Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-09 Neepa Choksi, Andreia Latorre, Shadia Catalano, Arthur Grivel, James Baldassari, Janaina Pires, Marco Corvaro, Mariana Silva, Maryanne Ogasawara, Monique Inforzato, Priscila Habe, Rosana Murata, Stefan Stinchcombe, Susanne N. Kolle, W. Masinja, Gisele Perjessy, Amber Daniel, David Allen
Multiple in vitro eye irritation methods have been developed and adopted as OECD health effects test guidelines. However, for predicting the ocular irritation/damage potential of agrochemical formulations there is an applicability domain knowledge gap for most of the methods. To overcome this gap, a retrospective evaluation of 192 agrochemical formulations with in vivo (OECD TG 405) and in vitro (OECD
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Uncertainty in the results from oral repeated dose toxicity tests: Impact on regulatory classifications Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-07 Atanas Chapkanov, Terry W. Schultz, Ovanes G. Mekenyan
The Lowest Observed (Adverse) Effect Level (LO(A)EL) values are point-of-departure (PoD) values that quantify repeat dose toxicity (RDT). Here, the uncertainty in the regulatory classification of these PoDs is investigated. In the application stage, the dose-response was approximated for a large set of series, giving an account of the possible presence of a hormesis zone. The minimal effect dose (MED)
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Opinion of the Scientific Committee on health, environmental and emerging risks on the safety of titanium dioxide in toys Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-04 , Theo G. Vermeire, Peter Hoet, Rodica-Mariana Ion, Renate Krätke, Ana Proykova, Marian Scott, Wim H. de Jong,
The Opinion of the Scientific Committee on Health, Environmental and Emerging Risks advises the European Commission on whether the uses of titanium dioxide in toys and toy materials can be considered to be safe in light of the identified exposure, and the classification of titanium dioxide as carcinogenic category 2 after inhalation. Four toy products including casting kits, chalk, powder paints and
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Protein extracted from Moringa oleifera Lam. Leaves: Bio-evaluation and characterization as suitable plant-based meat-protein alternative Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-04 Muhammad Sameem Javed, Smara Qaiser Alvi, Adnan Amjad, Hasan Sardar, Muhammad Junaid Anwar, Asma Javid, Sami Abou Fayssal, Pankaj Kumar, Tracy Abou Fayssal, Saikh M. Wabaidur, Mohammad K. Okla, Ibrahim A. Saleh, Hamada AbdElgawad
This study aimed to isolate and characterize moringa leaf protein (MLP) via HPLC and evaluate its consumption's effects through rat model. Four groups of Albino Wistar rats (n = 25 each) along with a control group (n = 25) were acclimatized. The isolated MLP was added to the basal diet (casein; control) in various percentages (25, 50, 75, 100%) for a 21-day experimental period. On three intervals (1st
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Zinc deficiency induced by the chelating agent DTPA and its regulatory interpretation for developmental toxicity classification Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-08 Josje H.E. Arts, Steffen Bade, Stuart Hindle
Aminocarboxylic acid (ethylenediamine-based) chelating agents such as DTPA are widely used in a variety of products and processes. Recently, DTPA was classified in the European Union as a developmental toxicant CLP Category 1B. However, according to the CLP regulation (CLP, 2008) classification as a developmental toxicant requires a chemical to possess an intrinsic, specific property to do so. This
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Letter to the Editor: Modeling the changing face of Phosphatidylethanol's window of detection Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-12-03 Van Long Nguyen, Ted W. Simon
Abstract not available
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Evaluating the efficiency of the 2020 ban of BPA and BPS in thermal papers in Switzerland. Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-11-21 Anne-Laure Demierre,Hans Reinhard,Silvia Zeltner,Sabine Frey
Thermal printing technology requires a color developer to activate the dye under the action of heat. Bisphenol A (BPA) has traditionally been used for this purpose, although it has increasingly been replaced by bisphenol S (BPS) in recent years. Due to concerns regarding their toxicity, the Swiss authorities have banned both BPA and BPS from thermal papers since 2020. The impact of this regulatory
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The 2022 world health organization reevaluation of human and mammalian toxic equivalency factors for polychlorinated dioxins, dibenzofurans and biphenyls Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-11-14 Michael DeVito, Bas Bokkers, M.B.M. van Duursen, Karin van Ede, Mark Feeley, Elsa Antunes Fernandes Gáspár, 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
In October 2022, the World Health Organization (WHO) convened an expert panel in Lisbon, Portugal in which the 2005 WHO TEFs for chlorinated dioxin-like compounds were reevaluated. In contrast to earlier panels that employed expert judgement and consensus-based assignment of TEF values, the present effort employed an update to the 2006 REP database, a consensus-based weighting scheme, a Bayesian dose
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Retrospective analysis of dog study data from food and color additive petitions Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-11-11 Brenna M. Flannery, Alexandra E. Turley, Njwen Anyangwe, Antonia Mattia, Catherine Whiteside, Steven Hermansky, Heather R. Schaefer, Tina Tyler, Suzanne C. Fitzpatrick
As part of the US FDA CFSAN's efforts to explore alternatives to animal testing, we retrospectively analyzed a sample of food additive (FAP) and color additive petitions (CAP) submitted to the FDA for the utility of dog study data in safety assessment. FAPs and CAPs containing dog studies (161 petitions) were classified as decisive (38%), supportive (27%), supplemental (29%) or undermined (6%) based
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Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-29 Lyle D. Burgoon, Harvey J. Clewell, Tony Cox, Wolfgang Dekant, Linda D. Dell, James A. Deyo, Michael L. Dourson, Bernard K. Gadagbui, Philip Goodrum, Laura C. Green, K. Vijayavel, Travis R. Kline, Tamara House-Knight, Michael I. Luster, Therese Manning, Paul Nathanail, Frank Pagone, Katie Richardson, Tiago Severo-Peixe, Anurag Sharma, Jackie Wright
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A new paradigm for regulatory sciences Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-11-02 Gina M. Hilton, Yadvinder Bhuller, John E. Doe, Douglas C. Wolf, Richard A. Currie
Regulatory science, rooted in legal requirements, provides a mechanism for identifying, assessing, and managing harm to humans and the environment from exposure to hazardous substances. A challenge for regulatory authorities is that many governing laws reflect the scientific paradigm of the mid-20th century. By the nature of legislative processes, most laws are not able to readily adapt to incorporate
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Subchronic feeding study of glyphosate-tolerant maize GG2 with the gr79-epsps and gat genes in Wistar Han RCC rats Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-25 Qinghong Zhou, Shufei Li, Miao Zhao, Yinghua Liu, Ning He, Xiaoli Zhou, Dianming Zhou, Zhiyong Qian
The genetically modified (GM) maize GG2 contains gr79-epsps and gat genes, conferring glyphosate tolerance. The present study aimed to investigate potential effects of maize GG2 in a 90-day subchronic feeding study on Wistar Han RCC rats. Maize grains from GG2 or non-GM maize were incorporated into diets at concentrations of 25% and 50% and administered to Wistar Han RCC rats (n = 10/sex/group) for
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Margin of exposure to free formaldehyde in personal care products containing formaldehyde-donor preservatives: Evidence for consumer safety Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-20 Sang-Tae Kim, Kan Shao, Christine Oleschkewitz, Ryan Hamilton
Formaldehyde has been classified as carcinogenic to humans by International Agency for Research on Cancer and found in personal care (PC) products containing formaldehyde-donor (FD) preservatives. However, the cancer risk associated with the use of FD-containing PC products has not been well established. Our study provides the quantitative cancer risk assessment of formaldehyde in FD-containing PC
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Carcinogenicity testing in drug development: Getting it right Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-23 Paul Baldrick, Sanjay Jain
For a pharmaceutical drug, carcinogenicity testing occurs in rodents to identify its tumorigenic potential to allow assessment of the risk from its use in humans. Testing takes the form of 2-year studies in mice and rats and/or more recently, a 6-month study in transgenic mice. This paper examines the process of regulatory interaction regarding carcinogenicity testing, notably through the United States
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Derivation of oral cancer slope factors for hexavalent chromium informed by pharmacokinetic models and in vivo genotoxicity data Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-19 Chad M. Thompson, Christopher Kirman, Mark A. Harris
Hexavalent chromium [Cr(VI)] is present in drinking water from natural and anthropogenic sources at approximately 1 ppb. Several regulatory bodies have recently developed threshold-based safety criteria for Cr(VI) of 30–100 ppb based on evidence that small intestine tumors in mice following exposure to ≥20,000 ppb are the result of a non-mutagenic mode of action (MOA). In contrast, U.S. EPA has recently
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Development and application of a systematic and quantitative weighting framework to evaluate the quality and relevance of relative potency estimates for dioxin-like compounds (DLCs) for human health risk assessment Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-21 Daniele Wikoff, Caroline Ring, Michael DeVito, Nigel Walker, Linda Birnbaum, Laurie Haws
The toxic equivalency factors (TEFs) approach for dioxin-like chemicals (DLCs) is currently based on a qualitative assessment of a heterogeneous data set of relative estimates of potency (REPs) spanning several orders of magnitude with highly variable study quality and relevance. An effort was undertaken to develop a weighting framework to systematically evaluate and quantitatively integrate the quality
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Use of physiologically based pharmacokinetic modeling to support development of an acute (24-hour) health-based inhalation guideline for manganese Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-19 Camarie S. Perry, Alexander D. Blanchette, Stephanie N. Vivanco, Ann H. Verwiel, Deborah M. Proctor
The toxicokinetics of manganese (Mn) are controlled through homeostasis because Mn is an essential element. However, at elevated doses, Mn is also neurotoxic and has been associated with respiratory, reproductive, and developmental effects. While health-based criteria have been developed for chronic inhalation exposure to ambient Mn, guidelines for short-term (24-h) environmental exposure are also
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New supporting data to guide the use of evident toxicity in acute oral toxicity studies (OECD TG 420) Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-12 Fiona Sewell, Ian Ragan, Graham Horgan, David Andrew, Thomas Holmes, Irene Manou, Boris P. Müller, Tim Rowan, Barbara G. Schmitt, Marco Corvaro
Currently there are three test guidelines (TG) for acute oral toxicity studies of substances or mixtures from the Organisation for Economic Co-operation and Development (OECD). TG 423 and TG 425 use lethality as an endpoint, while TG 420 replaces death with ‘evident toxicity’, defined as clear signs that exposure to a higher dose would result in death. However, the perceived subjectivity of ‘evident
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Biomonitoring Equivalents for N,N-Diethyl-meta-toluamide (DEET) Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-13 Sean M. Hays, Christopher R. Kirman
N,N-Diethyl-meta-toluamide (DEET) is widely used as an effective mosquito and tick repellent. DEET is absorbed systemically after applications to skin. Once absorbed, DEET is rapidly metabolized with the predominant metabolite being m-dimethylaminocarbonyl benzoic acid (DBA). DEET and metabolites are predominantly excreted in urine after being absorbed systemically. Exposures to DEET are typically
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Quantitative Structure Use Relationships: Highlights from a technical summit meeting Regul. Toxicol. Pharmacol. (IF 3.4) Pub Date : 2023-10-12 Rosemary T. Zaleski, Andreas Ahrens, Jon A. Arnot, Richard A. Becker, Mark Bonnell, Sean Collins, Paul DeLeo, Peter Egeghy, Michelle Embry, Todd Gouin, Kristin Isaacs, Elke Jensen
The Quantitative Structure Use Relationship (QSUR) Summit, held on November 2–4, 2022, focused on advancing the development, refinement, and use of QSURs to support chemical substance prioritization and risk assessment and mitigation. QSURs utilize chemical structures to predict the function of a chemical within a formulated product or an industrial process. This presumed function can then be used