Showing papers in "Regulatory Toxicology and Pharmacology in 2011"

TL;DR: Experiments were conducted to obtain K(i)'s for 19 approved opioid drugs using a single binding assay in a cell membrane preparation expressing recombinant human MOR, adding to the understanding of the pharmacology of opioid drugs and support the development of a more consistent labeling policies regarding safe disposal.

TL;DR: The remarkable consistency of the quantitative features of the hormetic dose response suggests that hormesis may provide an estimate of biological plasticity that is broadly generalized across plant, microbial and animal (invertebrate and vertebrate) models.

TL;DR: This paper describes work building on that previously published, whose aim was to produce a more robust tool for assessing the safety of consumer products, by expanding the Local Lymph Node Assay dataset used to define the original DST and classifying chemicals in the dataset according to their mechanistic chemistry domains.

TL;DR: A framework for the risk assessment of combined exposure to multiple chemicals based on and developed subsequent to the World Health Organization/International Programme on Chemical Safety Workshop on Aggregate/Cumulative Risk Assessment (Combined Exposures to Multiple Chemicals) held in 2007 is described.

TL;DR: In conclusion, the use of magic mushrooms is relatively safe as only few and relatively mild adverse effects have been reported and the low prevalent but unpredictable provocation of panic attacks and flash-backs remain a point of concern.

TL;DR: The evidence provides scant support for any major adverse health effect of snus, and although some claims that snus reduces initiation or encourages quitting are unsoundly based, snus seems not to increase initiation.

TL;DR: The goal of this research was to develop a physiologically-based pharmacokinetic (PBPK) model for PFOA and PFOS for monkeys and then scale this model to humans in order to describe available human drinking water data, and to help in understanding of human pharmacokinetics.

TL;DR: (therapeutic) experience obtained so far with these different classes of 'complex drugs' and their specifics are discussed to provide scientific arguments and criteria for consideration for a regulatory framework for the market authorization for these type of drugs.

TL;DR: The toxicity profile for ADONA is acceptable for its intended use and is superior to that of APFO.

TL;DR: The objective of this paper is to identify opportunities for consensus in the methods of applying bioinformatics and to outline differences that impact a consistent and reliable allergy safety assessment.

TL;DR: Chlorella derived peptide inhibits UVB-induced MMP-1 expression in skin fibroblasts by suppressing expression of AP-1 and CYR61 and MCP-1 production.

TL;DR: There are several advantages to using the marmoset as a model in nonclinical development of pharmaceutical products, including their relatively small size, reduced material requirements, and ability to be used in both pharmacology and toxicology studies.

TL;DR: Data required for drug approval and post marketing adverse reaction reporting was summarized and the use of these data as a means of arriving at concentrations in water where adverse health effects are minimal or non-existent was explored.

TL;DR: The weight of evidence indicates that, with one exception, they are non-sensitizing skin irritants, confirming that the LLNA tends to overestimate the sensitization potential of surfactants.

TL;DR: Due to the high number of rodent tumour findings with unlikely relevance for humans, the value of the currently used testing strategy for carcinogenicity appears questionable and a revision of the carcinogenic testing paradigm is warranted.

TL;DR: The data suggest that A. blazei could act as a functional food capable of promoting immunomodulation which can account for the destruction of cells with DNA alterations that correlate with the development of cancer, since this mushroom was demonstrated to have a preventive effect against pre-neoplastic colorectal lesions evaluated by the aberrant crypt foci assay.

TL;DR: This work describes a hypothesis-driven WoE approach for hormonally active agents and illustrates the approach by constructing hypotheses for testing the premise that a substance interacts as an agonist or antagonist with components of estrogen, androgen, or thyroid pathways or with component of the aromatase or steroidogenic enzyme systems for evaluating data within the US EPA's Endocrine Disruptor Screening Program.

TL;DR: This analysis provides further evidence for the existence of GC hepatotoxicity as a distinct form of herb induced liver injury, but due to poor data quality the causal association between GC use and liver injury is less strong than hitherto assumed.

TL;DR: A structured, systematic weight of evidence framework is promptly developed, subjected to peer review and adopted to ensure an objective analysis of the results of the required EDSP screening, consistent integration of results across the EDSP ESB assays, and consistent decision making as to whether subsequent testing for adverse effects is needed.

TL;DR: Findings showed that one product of MWCNTs was a very weak acute irritant to the skin and eyes, which is a major route of exposure during the manufacturing, use, and disposal of nanomaterials.

TL;DR: The study indicates that HET-CAM results are useful as part of weight-of-evidence assessments or in tiered approaches to assess eye irritation potentials rather than as stand-alone classification method.

TL;DR: A review of current study designs found that variation in study designs was primarily due to the number of animals used in the main study groups, and the use of animals in toxicokinetic satellite groups and off-treatment recovery groups.

TL;DR: No evidence of a consistent pattern of positive associations indicating a causal relationship between any disease and exposure to glyphosate is found, and it is recommended that pesticide-specific exposure algorithms be developed and validated.

TL;DR: The aim of this review was to identify the excipients most frequently contained in oral medicinal products marketed in Italy for gastrointestinal indications, and to evaluate the main safety concerns, considering both intrinsic toxicity and patient-related risk factors.

TL;DR: The results of blinded case studies designed to test the updated framework for evaluating analogs for use in SAR assessments support the conclusion that the process outlined by Wu et al. (2010) can be successfully applied to develop surrogate values for risk assessment.

TL;DR: The BE values derived here can be used as a screening tools for evaluation of population biomonitoring data for DDT and related compounds in the context of the existing risk assessment and can assist in prioritization of the potential need for additional risk assessment efforts forDDT relative to other chemicals.

TL;DR: Results show that melamine has no mutagenic function in prokaryotes and eukaryotes in vitro and in vivo, and does not induce malignant cell transformation after long-term exposure, however, it has ability to increase sperm abnormality rate and DNA damage.

TL;DR: The results support the notion that this approach might help to prioritise among in use drugs to identify compounds where follow up evidence should be considered, and dissociation of drugs was shown to be important in determining the output and model robustness.

TL;DR: The results of these studies show that the high purity and well-dispersed sample of SWCNTs are not genotoxic under the conditions of the in vitro bacterial reverse mutation assay, chromosomal aberration assay, or in vivo bone marrow micronucleus test, and thus appear not to pose a genotoxicity risk to human health in vivo.

TL;DR: Results indicate that none of the known or novel endogenous IgE-binding proteins detected in this study appear to be altered by genetic modification.