Showing papers in "Regulatory Toxicology and Pharmacology in 2015"

TL;DR: A newly developed probabilistic model, the Creme RIFM model, is used to estimate aggregate exposure to fragrance ingredients using the example of 2-phenylethanol (PEA) to demonstrate the utility of the model in determining systemic and dermal exposure to fragrances from individual products, and aggregate exposure.

TL;DR: The data and modelling methods presented show potential as a means of performing ingredient safety assessments for personal care and cosmetics products, and the robustness and ability to estimate aggregate consumer product exposure are presented.

TL;DR: Templates, developed from work to prepare for the application of new toxicological data to read-across assessment, are presented and act as proposals to assist in assessing similarity in the context of chemistry, toxicokinetics and toxicodynamics as well as to guide the systematic characterisation of uncertainty.

TL;DR: The Cramer class of over 1000 fragrance materials across diverse chemical classes were determined by using Toxtree, the OECD QSAR Toolbox, and expert judgment to determine the concordance within various chemical classes.

TL;DR: The aim of this review is to survey current knowledge specifically on the toxicity issues of synthetic food colorants using official reports published by the EFSA and other available studies published since the respective report.

TL;DR: It is concluded that by combining the reactive DST with knowledge of chemistry a threshold can be established below which there is no appreciable risk of sensitisation for protein-reactive chemicals.

TL;DR: A comprehensive comparative assessment of existing nanomaterial definitions put forward by governments found that the size limits used in different definitions were inconsistent, as were considerations of other elements, including agglomerates and aggregates, distributional thresholds, novel properties, and solubility.

TL;DR: The chemical properties and structural features of high potency sensitisers are discussed, and an approach whereby they can be identified and consequently excluded from application of the Dermal Sensitisation Threshold (DST) is derived.

TL;DR: Results of the single test methods for the simple '2 out of 3' ITS for 213 substances have been compiled and qualitatively compared to both animal and human data, and the non-animal test methods exhibited good predictivities when compared to local lymph node assay (LLNA) data and even better predictivitiesWhen compared to human data.

TL;DR: The state of the art of different regulatory measures for nanomaterials in agri/feed/food, including legislation and guidance for safety assessment in EU and non-EU countries are discussed.

TL;DR: A decision tree is suggested to evaluate the potential risk for consumers and workers exposed to NPs to suggest that one main difference should be made between metal and non-metal NPs.

TL;DR: The DF4nanoGrouping is a hazard and risk assessment tool that applies modern toxicology and contributes to the sustainable development of nanotechnological products and saves animals and resources.

TL;DR: A prototype quantitative model for assessing the WoE of an AOP using tools of multi-criteria decision analysis (MCDA) is described and the applicability of the approach is demonstrated using the case example aromatase inhibition leading to reproductive dysfunction in fish.

TL;DR: E-cigs could be a less harmful alternative for tobacco users in comparison with regular smoking, and the combination of glycerin and propylene glycol as the vehicle facilitated delivery of more nicotine than Glycerin alone.

TL;DR: Considering the generally modest use of N2O and its relative safety, it is not necessary to take legal measures, however, (potential) users should be informed about the risk of vitamin B12-deficiency related neurological and hematological effects associated with heavy use.

TL;DR: A substitution of BPA by BPF and BPS should be considered with caution, since they exhibit almost a similar endocrine activity as BPA, however further analyses are needed to better characterize their effects on the hormonal system.

TL;DR: A review of data from investigational new drug applications for ADCs found that selecting a FIH dose that is 1/6th the highest non-severely toxic dose (HNSTD) in cynomolgus monkeys or 1/10th the STD10 in rodents scaled according to body surface area (BSA) generally resulted in the acceptable balance of safety and efficient dose-escalation in a Phase 1 trial.

TL;DR: A scientific confidence framework for evaluating and applying a given AOP for different regulatory purposes ranging from prioritizing chemicals for further evaluation, to hazard prediction, and ultimately, risk assessment is proposed.

TL;DR: Measurement of emissions from commercial cigarettes is associated with considerable variation for low-level toxicants, and this variation would increase if the analyses were conducted in more than one laboratory.

TL;DR: Key scientific principles that should be applied when evaluating in silico predictions with a focus on accuracy and scientific rigour that will support a consistent and practical route to regulatory submission are discussed.

TL;DR: SFSE-G showed median lethal dose more than 4350mg/kg and no-observed adverse effect levels (NOAEL) of 250mg/ kg for both sexes during AOT and sub-acute toxicity study, respectively.

TL;DR: There is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages, as price and quality regulations are both important causes of drug shortages or drug unavailability.

TL;DR: It is concluded that Lamb et al.'s attempt of deconstructing the UNEP/WHO (2013) report is not particularly erudite and that their critique is not intended to be convincing to the scientific community, but to confuse the scientific data.

TL;DR: The present manuscript provides basic information on gene expression profiling, along with guidance on evaluating the quality of genomic experiments and data, and interpretation of results presented in the form of heat maps, pathway analyses and other common approaches.

TL;DR: The deliberations of the Cefic LRI read-across team in characterizing scientific confidence in the development and evaluation of read-ACross are summarized.

TL;DR: There was a significant difference of lead content in the lipsticks of different price categories, but there was no significant non-carcinogenic health risk due to the exposure of these heavy metals through lipstick consumption for the prolonged exposure of 35 years.

TL;DR: Analytical detection limits for measurements of potential reaction and thermal breakdown products in vaping aerosol, should be informed by the contaminant threshold, and 5ng/puff is recommended as an appropriate limit of detection for untargeted aerosol measurements.

TL;DR: The present work is an attempt to provide a model for the use of WHO template for calculating the short term intake of vegetables, especially useful for developing countries where information about consumption rate is rather meager.

TL;DR: Evaluating current legislation on dietary supplements in the United States, the European Union and Brazil, and the profile of adulterated and/or irregular products on these markets found 180 adulterations, 41.1% due to undeclared drugs.

TL;DR: By considering the dietary pattern and use of bioactive substances with prescribed medication, both health professionals and consumers will be increasingly aware of interactions and these interactive adverse effects can be prevented.