Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Dec 2013
ReviewCharacterisation and toxicological assessment of Neutral Methacrylate Copolymer for GRAS evaluation.
Neutral Methacrylate Copolymer is a fully polymerised copolymer used in the pharmaceutical industry to permit pH-independent delayed release of active ingredients from oral dosage forms. This function has potential use with food supplements and this article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats resulted in the detection of chemically unchanged copolymer in the faeces, with negligible absorption. ⋯ Daily exposure from use in dietary supplements is estimated as up to 10.0 mg/kg bw in adults and 13.3 mg/kg bw in children. There would therefore appear to be no safety concerns under the intended conditions of use. The information provided is intended to support an evaluation that the substance may be "generally recognized as safe" (GRAS).
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Regul. Toxicol. Pharmacol. · Jun 2013
Review Meta Analysis Comparative StudyThe effect on health of switching from cigarettes to snus - a review.
Interest in snus (Swedish type moist snuff) as an alternative to smoking is increasing, but the evidence on the health effects of switching from cigarettes to snus has not previously been reviewed. We identified six epidemiological cohort or case-control studies, all from Sweden, which allowed comparison of cancer or cardiovascular disease risk in current snus users who formerly smoked ("switchers") with that of never snus users who continued to smoke ("continuers") or of never snus users who quit smoking ("quitters"). ⋯ Based on estimates from four studies for ischaemic/coronary heart disease or acute myocardial infarction, meta-analyses gave combined relative risk estimates of 0.55 (95% confidence interval 0.45-0.68) for switchers vs. continuers and 1.02 (95% confidence interval 0.83-1.26) for switchers vs. quitters. Though based on limited evidence with some weaknesses, these results are consistent with a recent review which found no increased risk of cancer or heart disease from snus use.
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Regul. Toxicol. Pharmacol. · Nov 2009
ReviewComments on serious anaphylaxis caused by nine Chinese herbal injections used to treat common colds and upper respiratory tract infections.
Reports describing severe allergic shock and fatality following treatment of a common cold or upper respiratory tract infection (URTI) with a Chinese herbal injection were collected. Our analysis of the risks associated with this treatment suggested that the potential risk of serious, or even lethal, anaphylaxis should preclude its use in treating common colds and URTIs. In light of our findings herein, we propose the following five suggestions for improving the clinical safety of delivering Chinese herbal injections as medical treatments. ⋯ Third, Chinese herbal injections should be used only in cases involving severe disease or to rescue patients in critical condition; they should not be used to treat mild, relatively innocuous diseases, such as common colds and upper respiratory tract infections, given the risk of doing harm. Fourth, Chinese herbal injection formulas should include materials from only a single or a small number of plant sources in known quantities. Fifth, more studies examining the toxicology and allergenic potential of Chinese herbal injections are needed.
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Regul. Toxicol. Pharmacol. · Feb 2009
ReviewEvaluation of potential human carcinogenicity of the synthetic monomer ethyl acrylate.
Ethyl acrylate (EA) is an acrylic monomer used in the manufacture of a variety of polymers and copolymers as components of many commercially important products. Human exposure to EA occurs primarily in the workplace via inhalation or dermal contact. In F344 rat and B6C3F(1) mouse studies of EA carcinogenicity conducted by the National Toxicology Program [National Toxicology Program, NTP, 1986. ⋯ This again supports a non-genotoxic MOA. In addition, the route and rate of EA exposure in rodents for forestomach neoplasia are irrelevant to potential human exposure, since humans do not have forestomach and are not exposed to EA by oral bolus. Thus, the weight of evidence indicates that the tumors produced in the rodent carcinogenicity studies arise from conditions that are irrelevant for human risk assessment.
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Regul. Toxicol. Pharmacol. · Oct 2008
ReviewAn evaluation of the risks of lung cancer and mesothelioma from exposure to amphibole cleavage fragments.
Amphiboles are hydrated mineral silicates five of which occur in asbestiform habits as asbestos grunerite (amosite) asbestos, riebeckite (crocidolite) asbestos, anthophyllite asbestos, tremolite asbestos and actinolite asbestos] and non-asbestiform habits (grunerite, riebeckite, anthophyllite, tremolite and actinolite). The asbestiform varieties are characterized by long, thin fibers while non-asbestiform varieties such as cleavage fragments form short fibers with larger widths. The U. ⋯ St. Lawrence, NY talc does not produce mesotheliomas in animals while amphibole asbestos does. In sum, the weight of evidence fully supports a conclusion that non-asbestiform amphiboles do not increase the risk of lung cancer or mesothelioma.