Showing papers in "Regulatory Toxicology and Pharmacology in 2002"

TL;DR: Estimates of exposure through different routes and leading to different potential endpoints indicate that deposition on the surface of the skin following use of cosmetics represents the major route of exposure to fragrance ingredients when conservative estimates for evaporation, rinsing, and other forms of product removal are employed.

TL;DR: Current understanding of the rates of maturation of metabolic capability and evidence from case examples indicate that human infants up to approximately 6 months of age are typically--but not always--more sensitive to chemical toxicity than adults.

TL;DR: The safety of aspartame and its metabolic components was established through extensive toxicology studies in laboratory animals, using much greater doses than people could possibly consume as discussed by the authors, and its safety was further confirmed through studies in several human sub-populations, including healthy infants, children, adolescents, and adults, obese individuals, diabetics; lactating women; and individuals heterozygous (PKUH) for the genetic disease phenylketonuria (PKU) who have a decreased ability to metabolize the essential amino acid, phenylalanine.

TL;DR: Whereas there is general agreement that high doses of nonsteroidal chemicals can evoke endocrine disruptive effects, there is no consensus that such substances produce low-dose effects or that humans are at risk of endocrine disruption due to exposure to environmentally relevant levels of such chemicals.

TL;DR: The limitations of the epidemiological data available and the state of the science on the mode-of-action of arsenic toxicity are inadequate to support the conclusion that there are adverse health effects in the United States from arsenic in drinking water at or below the limit of 50 microg/L.

TL;DR: The results of these surveys provide evidence that constituent yields are, in general, proportional to "tar" yield and that the relationships between constituent yields and " tar" have remained constant during this time span.

TL;DR: Repeat-dose toxicity studies in the rat and dog showed expected immunostimulatory effects and/or signs of toxicity associated with overstimulation of the immune system, and MPL was shown to have no adverse effects on cardiovascular/respiratory function, reproduction, and genotoxicity.

TL;DR: Drawing conclusions about the adequacy of UF(H), the uncertainty factor used to account for intrahuman variability, in terms of its ability to protect children on the basis of the modest data available is challenging.

TL;DR: The findings indicate that a mechanistically based alternative to in vivo ocular irritation tests would be the microscopic or biochemical measurement of initial injury using either ex vivo or in vitro corneal equivalent systems composed ofCorneal epithelial, stromal keratocyte, and cornean endothelial cell layers.

TL;DR: It is concluded that styrene respiratory tract toxicity in mice and rats, including mouse lung tumors, are mediated by CYP2F-generated metabolites, and the PBPK model predicts that humans do not generate sufficient levels of these metabolites in the terminal bronchioles to reach a toxic level.

TL;DR: The cytotoxic potential of selected strains of Bacillus licheniformis, Bacillus amyloliquefaciens, and Bacillus subtilis, used in the production of industrial enzyme products, has been assessed and it was demonstrated that these industrial strains did not react with antibodies against B. cereus enterotoxins.

TL;DR: The results support the conclusion that the pituitary/hypothalamic axis in peripubertal femaleSD rats is less sensitive than that in adult female SD rats, as indicated by delayed sexual maturation.

TL;DR: It was concluded that BPA is not likely to be carcinogenic to humans, and exposure assessment reveals that current use of BPA would result in only a trivial human exposure.

TL;DR: Under real-world conditions, human exposures to resorcinol are not expected to cause adverse effects on thyroid function, and a risk assessment comparing potential worst-case exposures through its use in dermatological preparations supports the conclusion.

TL;DR: An interspecies physiologically based pharmacokinetic (PBPK) model describing isopropanol and its major metabolite, acetone, was applied to perform route-to-route and cross-species dosimetry to derive reference dose and reference concentration values for IPA, providing a more conservative estimate than those based on AUCs for IPA or acetone.

TL;DR: Evaluated the interaction of three pyrethroids with androgen receptor (AR)- and estrogen receptor (ER)-mediated mechanisms using in vivo short-term assays and concluded that none of esfenvalerate, fenavalerate, or permethrin exhibit any potential to cause adverse (anti-) androgenic or estrogenic effects at dose levels below that of those causing excessive systemic toxicity.

TL;DR: This effort sets the stage for the acquisition of critical data and further integration of polymorphism data with PBPK modeling as a means to quantitate population variability.

TL;DR: In vitro methods accurately predicted human in vivo percutaneous absorption of OPP on the basis of the potential absorbed dose, and with respect to the other parameters studied, considerable differences were observed between the various in vitro models.

TL;DR: There was little variability among species, particularly at the median, and the LOAEL-to-NOAEL UF values were not associated with the size of the experimental group, reflecting only of mild acute inhalation toxicity.

TL;DR: The capacity to display hormetic effects is one of a variety of factors affecting differential susceptibility to xenobiotics and needs to be addressed within the hazard assessment process.

TL;DR: The results indicate that in utero and lactational exposure to deltamethrin may induce subtle changes in reproductive behavior and physiology of male offspring rats at dose levels that do not cause maternal toxicity.

TL;DR: It is suggested that the dissolution mechanism for these fibers relates to the density of the surface silica layer on dissolving fibers and that the fraction of Si-O-Si linkages influences this.

TL;DR: In this article, two international ring studies were performed to develop appropriate parameters within standard toxicology study for screening of immunotoxicological potential of unknown substances, including CSA and HCB.

TL;DR: The benchmark dose (BMD) method was evaluated using the USEPA BMD software and a conservative model selection approach was applied, and Akaike's information criterion (AIC) was considered for comparison between models.

TL;DR: Risks can be substantially lower for smaller values of interindividual variability, and the estimate of risk can be improved for a specific case by replacing an overall estimate of the standard deviation for inter individual variability by an estimate of a particular class of chemicals and/or biological endpoint, if available.

TL;DR: Follow-up mortality data in this retrospective cohort study demonstrate that treatment with risedronate has no effect on overall mortality rates, and a trend toward lower cardiovascular mortality was observed in the risingronate groups compared with placebo.

TL;DR: The results of theSubcutaneous toxicity studies support the development of rhuIL-10 for present and future clinical indications by the subcutaneous route of administration.

TL;DR: NaFeEDTA and carbonyl Fe were compared with FeSO(4), the most common form of iron for dietary supplements, to obtain information relevant to the acute toxicological profile in young rats, and total liver nonheme iron increased with increasing dose, but the response was approximately 50% lower with NaFeEDta compared withFeSO( 4.

TL;DR: Administration of DRM did not produce any treatment-related adverse effects in Sprague-Dawley rats of relevance to humans at dosages up to 4000 mg/kg/day for 13 weeks and a slight increase in the incidence, but not severity, of cardiomyopathy was observed.