Showing papers in "Regulatory Toxicology and Pharmacology in 2004"

TL;DR: Cardiovascular, gastrointestinal, antiviral, anxiolytic sedatives hypnotics and antipsychotics, corticosteroid, and thyroid pharmaceuticals were the predicted most hazardous therapeutic classes.

TL;DR: Overall, assay pH did not influence the time to disappearance of the full-length protein or protein fragments, however, results across laboratories were more consistent at pH 1.2 than pH 2.0, demonstrating that this common protocol for evaluating the in vitro digestibility of proteins is reproducible and yields consistent results when performed using the same proteins at different laboratories.

TL;DR: The results of this study indicate that the in vitro methodology for assessing skin absorption is relatively robust and may be largely attributed to human variability in dermal absorption and the skin source.

TL;DR: The extent of mycotoxin tests in food enzyme preparations should be judged on a case-by-case basis, through a careful evaluation based on knowledge of taxonomy, biochemistry, and genetics.

TL;DR: Biological evidence suggests that there is no delivery of inhaled formaldehyde to distant sites, and that multiple inhalation bioassays have not induced leukemia in animals, and the negative findings provide convincing evidence that formaldehyde is not leukemogenic.

TL;DR: MOE values based on the upper bound 95th percentile population serum PFOA concentration were large, ranging from 1600 (liver-weight increase) to 8900 (Leydig cell adenoma).

TL;DR: Dose-response studies using intratracheal administration of a range of PAHs singly and in combination to assess additivity are required to develop a PEF system for inhalation PEFs derived from DNA adduct measurements.

TL;DR: The results of monitoring campaigns on the River Po, in Northern Italy, were used to assess the accuracy of predictive models with measured environmental concentrations and indicated that in some cases a refined PEC value can provide a good approximation of the MEC.

TL;DR: Results for ISO smoke yields support the validity of benchmarking when brands, for which yields are to be predicted, have design characteristics within boundaries established by the exploratory brands, and estimation methods proposed relate to machine-smoking conditions.

TL;DR: Gamma-cyclodextrin (gamma-CD) is a cyclic alpha-1,4-linked oligosaccharide consisting of eight glucose molecules as mentioned in this paper.

TL;DR: The quantitative correlation between results from the LLNA and two human sensitization tests--specifically, human repeat insult patch tests (HRIPTs) and human maximization tests (HMTs) is investigated, and theLLNA can be considered a reliable basis for relative potency assessments for skin sensitizers.

TL;DR: The evaluated data make it possible to describe uncertainty associated with the process of interspecies extrapolation by allometric rules, and caloric demand scaling is proposed as a generic inter species extrapolation method in the absence of substance-specific data.

TL;DR: This paper describes a systematic methodology to derive quality standards for organic (anthropogenic) contaminants in sewage sludge added to agricultural land, in the context of revision of EU Sludge Directive 86/278/EEC and the broader Soil Thematic Strategy.

TL;DR: Data do not provide consistent support for a relationship between formaldehyde exposure and leukemia risk and are evaluated to determine if publication or reporting biases may be affecting the estimates.

TL;DR: MDL QSAR predictive modeling of the human MRDD may provide a better, simpler and more relevant estimation of the MRSD for pharmaceuticals and the toxic dose threshold of chemicals in humans than current animal extrapolation based risk assessment models and may be a useful addition to current methods.

TL;DR: In this article, a chimeric mouse/rat anti-mouse CD11a monoclonal antibody (muM17) was evaluated as a potential surrogate for efalizumab, a humanized anti-CD11a antibody in development for psoriasis.

TL;DR: Oral exposure to DINP from mouthing soft plastic toys is not likely to present a health hazard to children, according to a risk assessment by the U.S. Consumer Product Safety Commission staff.

TL;DR: Results suggest that strategies to reduce MeHg exposure by reducing the amount of fish consumed are more effective at eliminating the high end of the exposure distribution than are strategies intended to change the types ofFish consumed.

TL;DR: It is concluded that most dramatic age-related physiological changes that may affect biokinetics occur in the first 6-12 months of age and risk assessment in children could be improved by application of pediatric PBPK-models in order to gain insight into internal exposure.

TL;DR: At low doses, children do not appear to be more sensitive than adults on a dose-per-body-weight basis, although data for acute exposures are limited and uncertainties exist for quantifying potential neurological or vascular effects at low-level subchronic exposures.

TL;DR: Research on biochemical and physiological mechanisms suggests that EPA's assessment overstates the potency of ACM, and therefore, the risk from foods and other sources of exposure may be lower than previously anticipated.

TL;DR: The finding that NCI's suggestion of a causal association is not robust with respect to alternative categorizations of formaldehyde exposure and methods of data analysis casts considerable additional uncertainty regarding the validity of this suggested association.

TL;DR: In this article, the importance of calcium in the myriad regulation of cellular processes in the health and well being throughout one's lifetime has focused on the need to ensure a sufficiency of its intake for nutritional, physiological, and medical reasons.

TL;DR: The use of BMDL as a component (at not more than 2% by weight) of an antimicrobial spray was determined Generally Recognized As Safe (GRAS) for three proposed uses (i.e., beef carcasses, subprimals, and finished cuts), provided that the ingredient statement of food products that contain milk-derived lactoferrin identifies the source of the protein.

TL;DR: The results raise the question of whether annual CBC surveillance for benzene-exposed workers has adequate sensitivity to detect meaningful hematological changes due to low-level exposures.

TL;DR: The increased interest and/or need to perform pediatric clinical trials to allow the marketing and safe use of a wider range of medicines in children has raised the profile of the need to conduct juvenile animal studies and it is argued that such studies may identify "unique" toxicities not seen from available adult animal and clinical data.

TL;DR: Use of the risk-based BMD results in identification of more valid and meaningful POD estimates for non-cancer effects compared to the use of the relative ED approach, and demonstrates the potential impact of alternative choices in benchmark dose methodology.

TL;DR: It is concluded that, even at fecal levels below those reached during therapy, ciprofloxacin may impact the human gut flora sufficiently to facilitate colonization by S. kedougou.

TL;DR: For high-level consumers and individuals eating fish from relatively contaminated sites, PCB TEQ exposure from fish consumption alone may exceed the 1 pg TEQ/kg/day average adult daily intake estimated by EPA, which itself carries an upper bound cancer risk of 1 in 1000.

TL;DR: Simulations show that the impact of the existing standards on cereals and the currently proposed standards on wine generally do not significantly reduce the risk to be overexposed to OTA and shows that a non-parametric probabilistic approach is well adapted for the purpose of exposure assessment.