Showing papers in "Regulatory Toxicology and Pharmacology in 2001"

TL;DR: A conceptual framework was developed, based on the general principles involved in considering the chemical induction of a specific tumor in animals, based partly on the Bradford Hill criteria for causality as modified by Faustman et al. (1997) for developmental toxicity.

TL;DR: It is unlikely that changes which improve upon desired enzyme function will result in the creation of a toxic protein, so it is prudent to assess such very small theoretical risks by conducting limited toxicological tests on engineered enzymes.

TL;DR: Several lines of evidence indicate that the proliferative effects of kojic acid on thyroid are not related to a genotoxic pathway and the risk of functional inhibition of iodine uptake and its metabolism (organification) and thyroid tumor induction by k Mojic acid in humans appears to be extremely low.

TL;DR: Present data do not support a causative role for aluminum in Alzheimer's disease (AD), and safety evaluation and approval of these ingredients by the Food and Drug Administration indicate that these aluminum-containing compounds are safe for use in foods.

TL;DR: The weight of evidence demonstrated that no association with DBP exposure exists for over a dozen outcomes including low and very low birth weight, preterm delivery, some specific congenital anomalies, and neonatal death.

TL;DR: The most important aspect in the development of a new UV filter is its safety as discussed by the authors, and the safety of new UV filters is assessed by an initial in vitro screen including photostability, cytotoxicity, photocytotoxicity and genotoxicity tests.

TL;DR: The Panel concluded that the assay performed as well as currently accepted guinea pig methods for the hazard identification of strong to moderate chemical sensitizing agents, but that it might not correctly identify all weak sensitizers or metals or all strong irritants.

TL;DR: Information from experimental studies and studies of metabolism indicate reproductive impacts are unlikely at formaldehyde exposures levels observed in the epidemiology studies, and it is difficult to draw conclusions from the epidemiological data alone.

TL;DR: To evaluate the reliability of the murine local lymph node assay (LLNA), a test for allergic contact dermatitis activity, the inter- and intralaboratory consistency statistics were calculated for validation studies testing multiple chemicals and supported the use of an SI of 3 as the decision criteria.

TL;DR: The validation and acceptance criteria and process used for the first test method evaluated by ICCVAM, the murine local lymph node assay (LLNA), have been described and it is confirmed that the LLNA has been accepted by U.S. regulatory agencies as a stand-alone assay for allergic contact dermatitis.

TL;DR: A clear dose response to the combined positive GI effects and to nausea alone was demonstrated and an acute NOAEL and lowest-observed-adverse-effect level of 4 and 6 mg Cu/L were determined in drinking water for a combined international human population.

TL;DR: DRM treatment had no effect on estrus cycles or reproductive performance including mating performance, fertility, gestation length, parturition, or gestation index, and litter size, sex ratio, and offspring viability indices were similarly unaffected and there were no effects of DRM treatment on the physical development of F1 animals.

TL;DR: This final report of a series in the development of a transparent science base for a revised FDA regulatory policy in the area of filth and extraneous materials in food includes a comprehensive list of the references that form the science base.

TL;DR: No adult-children differences in the parent chemical concentrations of the VOCs are likely to be observed during inhalation exposures and can replace the currently used empirical default approaches to provide chemical-specific UF(HH-PK) in future risk assessments.

TL;DR: A biologically based kinetic model to predict the long-term retention of particles in the lungs of coal miners and indicates that rodent models extrapolated to humans, without adjustment for the kinetic differences in particle clearance and retention, would be inadequate for predicting lung dust burdens in humans.

TL;DR: Evaluation of the anecdotal reports of adverse health effects revealed that the reported effects were generally mild and also common in the general population and that there was no consistent or unique pattern of symptoms that could be causally linked to consumption of aspartame.

TL;DR: This review examines the epidemiological evidence for adverse reproductive outcomes from those occupational studies that present toluene-specific findings and concludes that spontaneous abortion has generally not been observed as a major problem among highly exposed women who abuse toLUene during pregnancy.

TL;DR: An application of Hill's causation criteria to epidemiologic data of malignant mesothelioma among auto mechanics clearly demonstrates that auto mechanics do not have an increased risk of mal cancers as a result of exposure to asbestos fibers from brake linings and clutch facings.

TL;DR: It is concluded that after consumption of copper in purified water, the NOEL is 2 mg Cu/L and the LOAEL 4 mgCu/L for nausea, while tolerable intake is between 2 and 4 mg Cu-L in water depending on whether apparent or confirmed nausea is used as the criterion to define critical effects.

TL;DR: The data sets utilized by the trichloroethylene risk assessors are surprisingly incomplete and it is concluded that biased data selection may have influenced some of the risk assessor's conclusions.

TL;DR: It is concluded that podophyllin preparations have no place in the modern treatment portfolio for anogenital warts because of overwhelming safety and efficacy data in favor of Podophyllotoxin-derived products.

TL;DR: The results of this series of mutagenicity assays support the conclusion that DRM does not have any genotoxic potential, further supporting its lack of any chromosomal effects.

TL;DR: Within the constraints of the experimental design employed here, the HFA mice model proved to be acceptable for studying dose-related effects of tetracycline on human intestinal microflora and the potential sensitivity of this endpoint for evaluating the microbiological risk of t PetracyCline residues is indicated.

TL;DR: Maternal exposure to DRM during organogenesis did not adversely affect the frequency of postimplantation loss, mean fetal body weight/litter, or external, visceral, or skeletal malformations in either the rat or the rabbit and developmental toxicity was not observed at any DRM dose level.

TL;DR: There is no reason to conclude that humans are more sensitive to fibers than rats with respect to the development of lung cancer, and the available evidence suggests that the rat is preferable as a model for the human.

TL;DR: This paper proposes a formal statistical procedure to estimate the cumulative risk by fitting the dose-response model of the mixture under dose addition, and suggests that the relative potency between two chemicals is estimated directly from the joint dose response model of a mixture.

TL;DR: This report compares cancer classification systems, health risk assessment approaches, and procedures used for establishing occupational exposure limits (OELs), in various European countries and scientific organizations to highlight and compare key aspects of these processes.

TL;DR: None of the publications reviewed provide clinical evidence that PCBs (polychlorinated biphenyls) and related chemicals adversely affect weight, immune, or thyroid function in infants or children born to healthy mothers.

TL;DR: It is concluded that the direct use and interpretation of human data, in conjunction with data gathered from experimental animals, are public health protective policies that should be encouraged.

TL;DR: The animal data demonstrates that long-term exposure to EE and NA formulations pose very little health risks to humans, and these agents are not teratogenic when given in combination.