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Esters of 1,2-benzene dicarboxylic acid (or phthalates) are general purpose plasticizers used in multiple polyvinyl chloride (PVC) consumer applications. Some of these plasticizers are permitted for safe use in a narrow subset of food packaging applications by global regulatory agencies, including the US FDA. Several US studies have reported the presence of trace concentrations of phthalates (parts per billion) in the diet. These findings have prompted calls for regulatory action based on the potential for adverse impacts on public health. These claims are misguided. Global food safety regulatory frameworks are designed with the expectation that low concentrations of food contact materials may be present in food. These frameworks include guardrails (in the form of content limits and/or migration limits) to minimize the potential for dietary risk. This concept of exposure and risk is often missing in many studies identifying low concentrations of phthalates in food. Dietary risk assessments, based on total diet studies, have been published by food safety agencies in the EU, Australia, New Zealand, UK, and Canada. Without exception, all risk assessments confirm that concentrations of phthalates in food are low and do not pose a public health concern. In this review, we calculate dietary risk estimates for concentrations of high molecular weight phthalates reported in some US food articles. The results confirm that dietary exposures, even in the most conservative scenarios, are below levels of concern. [ABSTRACT FROM AUTHOR]

Results from a 13-week inhalation study in rats on a C10-C12 isoparaffinic solvent are compared to the results of repeated inhalation and oral toxicity studies of four other isoparaffinic hydrocarbon solvents. Statistically significant findings which were consistent across all studies included: nephropathy and small but significant changes in hematological parameters in male rats and liver enlargement in both male and female rats. The male rat kidney changes were due to an alpha 2u globulin process and not relevant for human health or risk assessment. The liver enlargement without pathologic changes or elevations in liver enzyme markers was considered to be an adaptive response. The reason for the reductions in hematological parameters that were observed in males only is not clear, but it is suggested that these were either due to normal variation or a secondary consequence of the nephropathy. The overall No Observed Adverse Effect Concentration (NOAEC) was the highest concentration tested in the study, >10,000 mg/m(3). Because of the overall pattern of response, this solvent is considered to be representative of low aromatic C9-C14 aliphatic solvents in general. The data are useful for risk assessment and other purposes including the development of occupational exposure recommendations., (Copyright © 2013 Elsevier Inc. All rights reserved.)