Showing papers in "Regulatory Toxicology and Pharmacology in 1999"

TL;DR: The hepatocarcinogenic response of rodents to DEHP is not relevant to human cancer risk at any anticipated exposure level, and DEHP should be classified an unlikely human carcinogen with a margin of exposure (MOE) approach to risk assessment.

TL;DR: No statistically significant effects on prostate weight or sperm efficiency were recorded for offspring of animals exposed to either DES or BPA in utero, despite earlier reported effects for DES and BPA at these low doses.

TL;DR: As foods marketed in the United States bear labels stating both the quantity per serving size and the corresponding percentage of the daily value (% DV) of fiber, consumers can make appropriate choices and decisions about daily consumption without exceeding individual tolerance.

TL;DR: Results do not confirm the previous findings of Sharpe et al. (1996) and show that low doses of BPA had no effects on male sexual development in the rat.

TL;DR: The scientific evidence supports the continued use of DINP as a plasticizer in children's products and its effects on rodent liver through a known threshold-based mechanism of little, if any, relevance to humans, using a NOAEL uncertainty factor approach.

TL;DR: It is very important that the basis for the tolerable intake is fully described so that informed judgments can be made about the health consequences of exceeding it, within the framework of the IPCS project on harmonization of approaches to the assessment of risk from exposure to chemicals.

TL;DR: The different in vivo and in vitro experimental test systems and approaches used by animal health industries, contract laboratories, and regulatory authorities to assess the safety of veterinary drug residues in foods for human consumption are reviewed.

TL;DR: In this paper, a comprehensive approach to risk assessment demands that default assumptions be replaced with an integrated understanding of the rate-limiting steps in the induction of toxicity or cancer along with quantitative measures of the shapes of those dose-response curves.

TL;DR: This study supports the increasing evidence that screening assays for estrogenic activity or studies with limited numbers of animals and/or unrealistic dose regimens are inappropriate for use in the assessment of human health and environmental risk.

TL;DR: The expert panel concludes that the best scientific information available indicates that elevated levels of TSH and the consequent thyroid tumors would not be produced under approved use conditions of SMZ.

TL;DR: It is concluded that the minimum detection level of NP as a weakly estrogenic material in the rat should be set at approximately 40 mg/kg/day and that use of subcutaneously implanted minipumps/pellets is inappropriate for risk/hazard assessment studies of chemicals already established as estrogenic in vitro and in vivo.

TL;DR: Data are presented showing that inhibition of acetylcholinesterase (AChE) associated with red blood cells (RBC), an enzyme similar to or identical with that in the nervous system, is a more appropriate endpoint on which to base the RfD.

TL;DR: A generic risk assessment model was developed for five different use scenarios: child-care centers, kitchen gardens, ornamental gardens, parks, and sports grounds, and the results for benzo[a]pyrene and lead are presented.

TL;DR: It is asserted that the toxicological information generally available does not warrant numerical estimates of risk at low levels of human exposure and support a unified approach for all adverse health effects of dividing a benchmark dose by appropriate uncertainty factors to establish guidelines for human exposures to toxic substances.

TL;DR: Dietary concentrations of up to 4.38% plant stanol esters (equivalent to 2.5% total stanols in the diet) are not associated with adverse effects on reproduction, pup mortality, pupBody weight, or pup body weight change in Wistar rats.

TL;DR: Probabilistic modeling was identified as a suitable way to produce multifactorial submodels and address some of the problems of combining distributions of consumption and residues and the output was used as an aid to decision making in terms of necessary regulatory action.

TL;DR: D-tagatose holds promise as a sweetener with no adverse clinical effects observed in these studies, and is associated with a slight decrease of plasma phosphorus and a slight increase of magnesium.

TL;DR: It can be shown that breast feeding will lead to higher body burdens in early life than would have been reached by ingestion of the TDI daily from birth, however, these peak body burdens will still be below the steady-state body burden achieved by ingesting 10 pg TCDD/kg body wt/day from birth.

TL;DR: The current model is expected to provide insight into the behavior of in organic arsenic and its methylated metabolites within the body and may help increase the understanding of risk assessment issues associated with inorganic arsenic in drinking water.

TL;DR: It is concluded that Isofrax and Insulfrax have low biodurability, would not be expected to produce either pulmonary fibrosis or lung tumors in a well-designed animal inhalation bioassay, have weighted half-lives beneath the threshold established by the European Union for classification as a carcinogen, and based on epidemiological data for SVFs would not been expected to result in incremental cancer in human cohorts.

TL;DR: The addition of 29 g D-tagatose added as a sweetener to a continental breakfast was tested for the appearance of gastrointestinal side effects in a double-blind randomized cross-over study with 29 g sucrose as a control treatment.

TL;DR: These initial studies suggest that a biologically based mathematical model can be constructed and tested to extrapolate the outcome of toxicity from a given dose of individual compounds as well as their mixtures, where the responses measured are injury on the one hand and compensatory tissue repair on the other.

TL;DR: There is no convincing human evidence that such doses can cause reproductive or developmental effects, but since such effects have been reported in animals, it may be advisable not to exceed a daily intake of 1 microgram/kg body wt for such potentially sensitive subsections of the population as children and women who are pregnant or lactating.

TL;DR: The results suggest that 30 g taken at one time may be above the dose which should be recommended for ordinary use, and flatulence after D-tagatose was frequently reported in all the studies and the flatulence did not decline during a 15-day period with intake of 30 g in one dose daily.

TL;DR: The history and scientific basis for the intraspecies uncertainty factor is examined, showing that the preponderance of evidence in the areas of pharmacodynamics and pharmacokinetics supports the routine use of an intraspes uncertainty factor in the range of 1-10 as being protective of greater than 99% of the human population.

TL;DR: Livers of the treated rats had increased glycogen and the absence of alterations of endoplasmatic reticulum, mitochondria, and Golgi apparatus, and liver weights were significantly increased in linear relation to the D-tagatose intake.

TL;DR: It is demonstrated that a 20-g dose of D-tagatose is tolerated well in comparison to lactitol, and is associated with a significant increase in the frequency of passing feces, or in the number of subjects passing watery feces, in a double-blind, controlled crossover study.

TL;DR: Two stanol fatty acid ester preparations were fed to groups of 20 male and 20 female Wistar rats for 13 weeks and were found to be well tolerated, with the absence of clinical changes or major abnormalities in growth, food and water consumption, ophthalmoscopic findings, routine hematological and clinical chemistry values, renal concentrating ability, and histopathological findings.

TL;DR: It is concluded that a finding of increased MNCL in F-344 rats exposed for a lifetime to a nongenotoxic chemical is not toxicologically relevant to humans, even when MNCL is observed at an increased incidence that is statistically significant.

TL;DR: Categorical regression is suggested to be a useful screening tool to analyze risks above the RfD for specific chemicals and suggest its application in evaluating comparative risks where multiple chemical exposures exist.