Showing papers in "Regulatory Toxicology and Pharmacology in 2021"

TL;DR: It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently.

TL;DR: The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCs/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe.

TL;DR: In this paper, the authors report on the ongoing development of the first formal reporting framework describing the processing and analysis of both transcriptomic and metabolomic data for regulatory toxicology, and introduce the modular structure, content, harmonization and strategy for trialling this reporting framework prior to its publication by the OECD.

TL;DR: The toxicity of boric acid, borax and other forms of boron, after inhalation, dermal and oral exposure was assessed in this article, showing that intact skin seems to pose a more effective barrier to borone than compromised skin.

TL;DR: In this article, the hazard assessment for occupational exposure to hexavalent chromium (Cr(VI) and carcinogenic effects by integrating and weighting evidence provided by international agencies complemented with newly published studies was provided.

TL;DR: The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL) as discussed by the authors.

TL;DR: The Next Generation Risk Assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making as discussed by the authors, however, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context.

TL;DR: This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands to improve screening and priority setting.

TL;DR: In this article, the authors evaluated the mechanistic data related to the steps and timing of cellular events following therapeutic recommended (≤4 grams/day) and higher doses of acetaminophen that may cause hepatotoxicity to evaluate whether these changes indicate that the drug is a carcinogenic hazard.

TL;DR: In this article, the authors present a review of non-cancer health effects that could be caused by exposure to hexavalent chromium (Cr(VI) compounds during maintenance activities.

TL;DR: In 2016, the German Human Biomonitoring Commission (HBM-C) published a statement on its decision to develop HBM-I values for Perfluorooctanoic acid (PFOA) and perfluorOOctanesulfonic acid (PFOS).

TL;DR: In this article, the authors discuss adverse outcome pathways through which cytotoxicity can lead to carcinogenicity and the development of integrated approaches for testing and assessment for nongenotoxic carcinogens.

TL;DR: In this paper, the risk parameters and drivers in the current European Union (EU) worker risk assessment for pesticides, for example considering crop maintenance, crop inspection or harvesting activities, were reviewed.

TL;DR: In this article, total arsenic (As), inorganic arsenic (iAs), cadmium (Cd), lead (Pb), mercury (Hg), pesticides, and aflatoxins (B1, B2, G1, G2) in Indian rice (Oryza sativa) and their dietary exposure risks for the general Saudi population were evaluated.

TL;DR: In this article, the authors present a comprehensive assessment of available in vivo preclinical data on the carcinogenic hazard potential of exposure to Co-containing alloys (CoCA) in medical devices by relevant routes.

TL;DR: Antimony mobilization was sufficiently repeatable using either EN 1811 or ISO 105-E04 but the latter is recommended for an assessment of antimony mobilization and potential exposure because its pH is closer to that of human sweat.

TL;DR: In this paper, the reproducibility of the in-vivo rabbit skin irritation test was evaluated using a curated data set of 2624 test records, representing 990 substances, each tested at least twice.

TL;DR: Two pioneering in silico AOT programs are evaluated: the Leadscope Acute Oral Toxicity Suite and the Collaborative Acute Toxicity Modeling Suite and it is found that these models can be effectively utilized to identify PCs which are of low acute oral toxicity, PCs which should not be classified as Dangerous Goods, and can assist in identifying a starting dose for in vivo AOT studies.

TL;DR: In this article, a group of triazole compounds was selected to investigate the confidence that may be associated with read-across of a complex data gap: repeated dose toxicity, and evaluated using Assessment Elements (AEs) from the European Chemicals Agency's (ECHA's) Read-Across Assessment Framework (RAAF), alongside appraisal of associated uncertainties.

TL;DR: In this article, a case study on the model substance caffeine demonstrates the viability of a 10-step read-across (RAX) framework in practice and demonstrates the applicability of RAX in practice.

TL;DR: LegH Prep from this P. pastoris production process is unlikely to pose a risk of food allergenicity and Pichia protein sequences showed very good alignment to homologous proteins from many common yeasts including Saccharomyces sp.

TL;DR: In this article, mechanical ultrasonic methods were used to prepare TTO nanoemulsion (nanoTTO) with a mean droplet diameter of 161.80nm±3.97, polydispersity index of 0.21−±−0.01, and zeta potential of −12.33−±-0.72mV.

TL;DR: The authors provide an overview of some of the events and activities that have had, and continue to have, the greatest impact on animal use in pharmaceutical development, and highlight some ongoing efforts to further meet the challenge of achieving our mission as humanely as possible.

TL;DR: To explore current industry practice, a questionnaire was developed to capture relevant information around process, documentation and tools/factors used for species selection, which could be adapted towards a harmonized approach or best practice for industry consideration.

TL;DR: In this article, the authors have shown that DCM is a threshold carcinogen in mice, initiating carcinogenicity via the low affinity/high capacity GSTT1 pathway; a biotransformation pathway that becomes relevant only at high exposure concentrations.

TL;DR: It is proposed that 1% could be used as a worst-case dermal penetration value for nanoparticles within the boundaries of the properties of those included in the analysis.

TL;DR: Results indicate the potential for reliable and broad application of these models across different industrial sectors, and provide guidance on the use of AOT models to fulfill testing requirements, GHS classification/labelling, and transportation needs.

TL;DR: In this article, the effects of a model irritant, sodium dodecyl sulphate (SDS), on an in vitro model of the airway, MucilAir™, was explored.

TL;DR: In this paper, a new in vivo study (in vivo alkaline comet assay in mice - OECD 489) was conducted to test the potential genotoxicity of aloe-emodin at doses of 250, 500, 1000 and 2000 milligrams/kg/day on preparations of single cells from the kidney and colon of treated male mice.

TL;DR: Adenomas in nasal cavity were observed in 16 females and significantly increased only in female mice, indicating acrolein is carcinogenic in two species, i.e. rats and mice.