Showing papers in "Regulatory Toxicology and Pharmacology in 2000"

TL;DR: The survey results support the value of in vivo toxicology studies to predict for many significant HTs associated with pharmaceuticals and have helped to identify HT categories that may benefit from improved methods.

TL;DR: It was concluded that the use of Roundup herbicide does not result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals, and glyphosate is noncarcinogenic.

TL;DR: Plants modified to express insecticidal proteins from Bacillus thuringiensis (referred to as Bt-protected plants) provide a safe and highly effective method of insect control and reduce reliance on conventional chemical pesticides.

TL;DR: This approach, specifically considering the dermal route of exposure as the most relevant one for fragrance ingredients, has been developed and is designed to be conservative but not so much so as to require excessive effort when not justified.

TL;DR: Specific guidance to assist companies in the development of their excipients is urgently needed and an excipient testing strategy would be an excellent topic for inclusion for International Conference on Harmonisation consideration.

TL;DR: The serious difficulties associated with defining "common mechanism of toxicity" and "concurrent exposure" combined with the current paucity of data and methodology required to conduct cumulative risk assessment suggest that the procedure is not yet ready for use in pesticide regulation.

TL;DR: The overall data suggest a nonlinear dose-response relationship for carcinogenicity, but the data are insufficient to determine the doses at which such nonlinearities occur.

TL;DR: It was concluded by the NAS committee that immaturity does not necessarily entail greater sensitivity to chemical toxicity; age-dependent toxicity is chemical-dependent; and the existing 10-fold interspecies uncertainty factor provides adequate protection of infants and children, based on current knowledge.

TL;DR: A variety of types of DNA oxidation occur endogenously and mediated by xenobiotics, and certain forms are mutagenic and carcinogenic and may lead to other pathologies.

TL;DR: Based on a review and meta-analyses of cohort studies of more than 350,000 petroleum workers in the United States, the United Kingdom, Canada, Australia, Finland, Sweden, and Italy, it is concluded that there was no increased mortality from digestive cancers, lung cancer, bladder cancer, kidney cancer, or brain cancer.

TL;DR: The proposal to introduce an additional 10-fold factor for pesticides when exposure of infants and children is anticipated implies either age-related differences between species or differences within humans which exceed those present in adults.

TL;DR: Some mechanisms for nongenotoxic tumorigenicity are described and which type of testing should be done to substantiate why in those cases such a mechanism is not relevant to humans are indicated.

TL;DR: Data describing the expression and distribution of CYP450 forms in human microsomes can be used to extrapolate in vitro derived metabolic rates for toxicologically important reactions, when form selectivity and specific activity are known.

TL;DR: The quantitative adduct techniques will enable comparisons of endogenous and exogenous adduct levels and will give important clues to the etiology of human cancer, and adducts will provide an intermediary tool for genotyping studies, both for metabolic enzyme and for DNA repair system genotypes.

TL;DR: This paper incorporates data uncertainties with confidence limits and model uncertainties with a weighted average of an estimate from each of various models with a numerical tool to compute the maximum likelihood estimates and confidence limits.

TL;DR: All food additives approved in the European Union and allocated numerical acceptable daily intake values were studied and joint actions or interactions between additives do not represent a significant health concern.

TL;DR: The data suggest that both the Long-Evans and the Wistar rats are comparably sensitive to the antiandrogenic effects of vinclozolin and at dose levels below the NOAEL, there were no indications of any test-substance-related effects.

TL;DR: It is concluded that BPA may be weakly uterotrophic to the mouse under specific conditions of test, and in the complete absence of a dose-response relationship to this activity, which is broadly consistent with those reported earlier by Coldham et al.

TL;DR: A database of 100 chemicals was created from a random selection of chemicals in commerce, providing a more accurate estimate of the proportions of mutagens among chemicals in Commerce than can be derived from published mutagenicity databases.

TL;DR: The safety and pharmacokinetics of HFC 134a and HFC 227 were assessed in two separate double-blind studies as discussed by the authors, where each HFC (hydrofluorocarbon) was administered via whole-body exposure as a vapor to eight (four male and four female) healthy volunteers.

TL;DR: Evidence exists that estrogens are metabolically activated to 4-hydroxylated metabolites by a specific cytochrome P450 in tissues prone to estrogen-induced cancer.

TL;DR: The authors conclude that the most effective approach for dealing with the problem is to generate the most appropriate data possible, which means producing human rather than laboratory animal dermal absorption data, conducting full-day exposure monitoring studies, and whenever feasible generating dermal rather than oral toxicology data.

TL;DR: Overall, subjects categorized stool as "diarrhea" when stool decreased from their perceived "normal," but the vast majority of these reports were not associated with clinically significant diarrhea.

TL;DR: This metabolic conversion could not be detected in 33 fresh human nasal tissue samples, supporting the earlier view that the acetochlor-induced rat nasal tumors do not represent a hazard for humans.

TL;DR: Considerable animal toxicity data on styrene support the conclusion that styrene is neither an endocrine-active substance nor anendocrine disrupter, and human studies also support this conclusion.

TL;DR: The use of PBPK modeling may add to help inform and improve toxicological aspects of a regulatory process by informing on issues relating to extrapolation between and within species.

TL;DR: The Hershberger assay appears to be a sensitive and practical test system for the detection of androgens, antiandrogens, and inhibitors of male sex hormone anabolism, however, continued attention will need to be given to the derivation of a standard protocol for the routine deployment of the assay.

TL;DR: The results show that the use of Endod berries for snail control in schistosomiasis-infested water bodies is environmentally acceptable and ready degradability in aquatic environments under aerobic conditions.