Showing papers in "Regulatory Toxicology and Pharmacology in 2006"

TL;DR: The pharmacokinetics of glycyrrhizin have been described and show that its bioavailability is reduced when consumed as licorice; this has hampered attempts to establish clear dose-effect levels in animals and humans.

TL;DR: This document proposes a staged threshold of toxicological concern (TTC) approach for the intake of genotoxic impurities over various periods of exposure based on knowledge about tumorigenic potency of a wide range ofgenotoxic carcinogens and can be used for genot toxic compounds, for which cancer data are limited or not available.

TL;DR: The safety of microorganisms used as hosts for enzyme-encoding genes, the construction of recombinant production strains, and methods of improving enzyme properties are discussed.

TL;DR: The history and the current legislation in the European Union on probiotics feed additives including the requirements for the safety assessment for the target animal species, consumers, workers, and environment are presented.

TL;DR: The updated epidemiologic 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: From both human and animal studies, it was concluded that at airborne levels for which the prevalence of sensory irritation is minimal both in incidence and degree, risks of respiratory tract cancer are considered to be negligibly low.

TL;DR: Results revealed that carcinogenicity was well correlated with certain tests for gene mutation, in vivo clastogenicity, unscheduled DNA synthesis assay, and reprotox among 63 endpoints.

TL;DR: The applicability of in vitro digestion models as a tool for consumer products in (ad hoc) risk assessment and preliminary validate the model for one case showed good correlation and never underestimated the bioavailability is described.

TL;DR: Nanotoxicological information, currently insufficient, will be vital in aiding academia, industry and regulatory bodies in elucidating the mechanisms of action, balancing its risk and benefit, thus maximizing the utility of these materials in medicine without compromising public health and environmental integrity.

TL;DR: The value of the present and other similar studies is that they show that low exposures to pure chrysotile do not present a detectable risk to health and suggest that the risk of an adverse outcome may be low if even any high exposures experienced were of short duration.

TL;DR: The safety of the antioxidant alpha-lipoic acid (racemic form) (ALA), also called thioctic acid (CAS RN 1077-28-7) was assessed in acute and subchronic toxicity studies as well as in in vitro and in vivo mutagenicity/genotoxicity studies as mentioned in this paper.

TL;DR: These two assessments (safety and chemistry) culminate in identification of genotoxic impurities known or suspected to exceed acceptable levels in API, thereby triggering actions needed to assure appropriate control and measurement methods are in place.

TL;DR: Dermal potency equivalency factor values were identified which may be used with other carcinogenic PAH in the calculation of total B[a]P equivalent dermal cancer risk estimates and an identified area for further investigation is the consideration of scaling in extrapolating the calculated Dermal cancer slope factor from mice to humans.

TL;DR: Development of comprehensive classification schemes for modes/mechanisms of toxic action and mechanisms of interaction is needed to ensure a sound theoretical foundation for mixture-related regulatory activity and provide a firm basis for iterative hypothesis development and experimental testing.

TL;DR: Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized.

TL;DR: Systematic evaluation of the research designs and data provide a basis for risk assessment and the usual tolerable Upper Level of Intake (UL) derived from it if the newer methods described as the Observed Safe Level (OSL) or Highest Observed Intake (HOI) are utilized.

TL;DR: A novel method to identify carcinogens that employed expanded data sets composed of in silico data pooled with actual experimental genetic toxicity and reproductive and developmental toxicity data showed good correlation with carcinogenicity testing results and had correlation indicator values of 75.5-88.7%.

TL;DR: The safety profile of Coenzyme Q10 at high doses for healthy subjects was assessed in a double-blind, randomized, placebo-controlled study and showed that Kaneka Q10 was well-tolerated and safe for healthy adults at intake of up to 900 mg/day.

TL;DR: There was no significant difference between control animals and treated animals at 20 or 60 mg/kg bw/day with respect to body weight gain, food consumption, behavioural effects, haematological and clinical chemistry parameters, and gross and histopathological findings.

TL;DR: A database for repeated dose toxicity data has been developed, which allows analyzing the influence of structural features or PC data on LOELs, target organs and effects and can be used as an expert system.

TL;DR: The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 2000mg/day l-carnitine equivalents for chronic supplementation, and this level is identified as the OSL.

TL;DR: Suggestions for contextualizing biomonitoring results are presented in order to provide the public with the tools to distinguish genuine health risks from trivial ones and to recommend an approach of careful interpretation.

TL;DR: Both durability and biopersistence are correlated with the outcome of chronic inhalation bioassays, and the dose-dimension-durability paradigm is used to explain the key determinants of SVF toxicology.

TL;DR: The results of the toxicity studies presented herein attest to the safety of BD16449 lipase for use in the degumming of edible vegetable oil.

TL;DR: It is evident from this study that treatment with higher concentrations of DEP results in mitochondrial proliferation as well as accumulation of glycogen, cholesterol and triglycerides within the liver, but exposure to lower concentrations for longer periods results in increase in peroxisome numbers leading to severe hepatocellular changes.

TL;DR: Bayesian population analysis of a harmonized physiologically based pharmacokinetic (PBPK) model for trichloroethylene (TCE) and its metabolites provided accurate estimates of TCE, TCA, and TCOH kinetics and provided an important step toward estimating uncertainty of dose-response relationships in noncancer and cancer risk assessment.

TL;DR: A "market map" comparison methodology for cigarette smoke chemistry yields is presented, and a comparison of smoke constituent yields and in vitro smoke cytotoxicity and mutagenicity assay results for the 1R4F Kentucky reference cigarette and its replacement 2F4F were included.

TL;DR: The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 5 g/d for chronic supplementation, and this level is identified as the OSL.

TL;DR: The PBPK model using the calibrated metabolic parameters was used to perform a cancer risk assessment for DCM, using the same tumor incidence and exposure concentration data relied upon in the current IRIS entry.

TL;DR: The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use and the non-significance of p value is used for the proof of safety.