Showing papers in "Regulatory Toxicology and Pharmacology in 2003"

TL;DR: Analysis of risk assessments carried out by several U.S. governmental and private organizations for eight essential trace elements shows that increased coordination has resulted in values that are more compatible than revealed in past evaluations.

TL;DR: Scientific data indicate that the consumption of fish or fish oil containing omega-3 PUFAs reduces the risk of coronary heart disease, decreases mild hypertension, and prevents certain cardiac arrhythmias and sudden death.

TL;DR: E-Polylysine was practically non-toxic in an acute oral toxicity study in rats, with no mortality up to 5 g/kg and was not mutagenic in bacterial reversion assays, and the proposed use of e-polylysine as a preservative in foods is considered to be safe.

TL;DR: The long-term accumulation of negative, weak, and inconsistent findings suggests that TCDD eventually will be recognized as not carcinogenic for humans, and the use of a linear dose-response model by the USEPA is scientifically unjustified.

TL;DR: There is a several-fold reduction in exposures and body burdens in the general population over the three decades from 1970 to 2000, and further efforts to reduce exposures through attempts to control emissions or food levels should be carefully evaluated to understand the likely efficacy of the efforts and the relative costs and benefits.

TL;DR: Animal data and mechanistic theory suggest that the apparent absence of risk in workers with low nickel exposures is due to threshold-like responses in lung tumor incidence, tumor promotion, and genetic damage, and the predicted risks at occupational exposures are remarkably similar to those observed in nickel-exposed workers.

TL;DR: A comparison of LLNA EC3 values with HRIPT and HMT LOEL, and NOEL values revealed that the EC3 can be used as a surrogate value for the human NOEL in risk assessment, and the uncertainty/extrapolation factor approach was used to derive an 'acceptable non-sensitizing area dose' (ANSAD) to protect non-allergic individuals against skin sensitization.

TL;DR: Details are provided of the approach used by the RIFM Expert Panel (REXPAN), to examine the dermal effects, systemic toxicity and environmental consequences of the use of and exposure to fragrance materials, which allow a reliable determination of safe use under intended conditions.

TL;DR: The application of the NAS paradigm to characterize risks from human exposure to skin sensitizers can also be used to establish an exposure level for skin allergens that does not present an appreciable risk of sensitization.

TL;DR: A critical review of the scientific literature indicates that a formal reevaluation of the carcinogenic potency of 1,4-dioxane is warranted and a comparison of cancer risk estimates from linear and nonlinear models in the presence or absence of PBPK modeling suggests that USEPAs current cancer slope factor significantly overestimates the potential cancer risk from 1, 4- dioxane.

TL;DR: There is a large margin of safety based on the repeated dose safety and reproductive/teratology studies in rodents, and in humans, there is a very long history of use with respect to dietary exposure, and even in the case of very high exposures from dietary sources, there are no indication of any significant adverse effects.

TL;DR: Of the endpoints investigated, the most sensitive proved to be histopathology of the testes, which showed a higher sensitivity than fertility parameters, and in most cases, not only one but several endpoints were affected.

TL;DR: Electrotopological E-state descriptors and QSAR IS (MDLQSAR) software are promising new in silico approaches for modeling and predicting rodent carcinogenicity and may have application for other toxicological endpoints.

TL;DR: For new enzyme products produced with strains from this lineage using the design and build technology no new sub-acute/chronic oral toxicity studies are needed, which has the benefit that no longer test animals are needed to demonstrate the safety of products produced by these strains.

TL;DR: The most important factor appears to be the potential for decreased clearance of toxic chemicals in the perinatal period due to immature metabolic enzyme systems, although this same factor can also reduce the risk from reactive metabolites during the same period.

TL;DR: The results from this study do not provide any evidence of toxicity of lycopene at dietary levels up to 1.0% as demonstrated by the findings of clinical observations, neurobehavioral observations, motor activity assessment, body weight and food consumption measurements, ophthalmoscopic examinations, hematology, clinical chemistry, urinalysis, organ weights, gross pathology, or histopathology.

TL;DR: This report postulates that oral absorption of non-anti cholinergic, pre-hydrolyzed OPs, sources of APs other than pesticides, and the conservative result of summing exposure from each AP at the geometric mean contribute to non-quantified overestimates of absorbed dosage from the CDC biomonitoring data reported in March 2001.

TL;DR: This study demonstrates that administration of DRM (at up to five times the anticipated commercial dose) did not produce any treatment-related adverse effects in commercial strains of swine.

TL;DR: Reversing the burden of proof will speed up the regulatory process but the examples demonstrate that applying the PP appropriately, and balancing the countervailing risks and the socio-economic benefits, will continue to be a difficult task for the regulator.

TL;DR: The results of this assessment generally support the use of scaling factors recommended in the published literature, but a dose-dependency in the results suggests that the scaling factors appropriate at high exposures may differ from those at low exposures, primarily due to the impact of saturable metabolism.

TL;DR: The expectation that lives will be saved by reducing ambient PM(2.5) in the U.S. is not supported by the weight of scientific evidence, although other bases for regulating PM may be justifiable.

TL;DR: A previously determined human acute NOAEL for Cu added to distilled water, and additional, controlled human data for determining safe concentrations of Cu in drinking water, are provided.

TL;DR: Biological and epidemiological data for brake workers exposed to chrysotile asbestos should be viewed in context with the conditions of service to which the product was subjected over a lower range of temperatures than previously considered important.

TL;DR: The ILSI Risk Science Institute asked a select working group to characterize the pertinent non-tumor data available for 1,3-butadiene, benzene, and vinyl chloride and to comment on the utility of these data in characterizing cancer risks, and concludes with 15 simple principles for the use of non-Tumors data in cancer risk assessment.

TL;DR: In this paper, the authors discuss sources of uncertainty and possibilities for quantification of uncertainty associated with different steps in the risk assessment of non-carcinogenic health effects, and provide information about the extent of uncertainty introduced by these factors.

TL;DR: BD5088 alpha-amylase derived from archaeal sources has characteristics of pH and temperature tolerance that are well suited to hydrolysis of starch in food processing applications and may be considered safe for use in food production such as corn wet milling.

TL;DR: Analysis of data from long-term studies in Sprague-Dawley rats support the conclusion that changes in FC alone can cause the observed changes in BWG in neotame studies when changes are scaled allometrically.

TL;DR: It is shown that the extremely limited data available do not support either of the two common interpretations of LRB results, which means some known human carcinogens are not positive in the LRB, potentially allowing widespread human exposure to misidentified chemicals.

TL;DR: The data suggest that the estrogen-like effects observed in toxicity studies with female rats at oral NP doses of approximately 50 mg/kg/d and greater are a result of the increased bioavailability of NP which occurs following metabolic saturation.

TL;DR: Beside exposure of babies via human milk, the intake by direct licking off salves from the breast of their nursing mothers may be much higher and calls for a toxicological re-evaluation of the mineral paraffins or for measures ensuring that Exposure of babies is reduced.