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ABSTRACT: BACKGROUND: Medical devices such as perfusion materials in polyvinyl chloride may contain di(2-ethylhexyl)phthalate (DEHP). Several studies have questioned the harmlessness of phthalates, which have been shown to have toxic effects on the reproductive system and general development. This study was designed to assess DEHP exposure in infants and children benefitting from cyclic parenteral nutrition (PN). The results are compared with those obtained from children used as controls and receiving no PN, to estimate the potential risk to this pediatric population, taking into account exposure levels and already published data. METHODS: Plasmatic concentrations of DEHP were assessed by high-performance liquid chromatography from blood samples taken from 22 children at the start and finish of a 12-hour cyclic PN period and compared with those obtained from 20 control children of comparable age and gender. RESULTS: After a 12-hour cyclic PN period, DEHP migration varied widely among the patients. The concentrations were not quantifiable in 4 children at the start of PN. In 1 child, they were quantifiable neither at the start nor at the end of PN. However, for 17 children, DEHP concentrations were quantifiable at the start of PN and were very variable from one child to another. At the end, DEHP concentrations had significantly but variably increased in these children. No trace of DEHP was found in the blood samples from 20 healthy controls. Conclusion: Considering published data on phthalate toxicity, it would appear advisable to encourage the use of medical devices that are either phthalate or DEHP free. (JPEN J Parenter Enteral Nutr. XXXX;xx:xx-xx).
Journal of Parenteral and Enteral Nutrition 06/2012; · 3.29 Impact Factor
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ABSTRACT: The use of medical devices containing highly criticized phthalates including di(2-ethylhexyl) phthalate (DEHP) has been challenged by European directive 2007/47/CE, put into effect in March 2010. New plasticizers are now being used to soften PVC in medical devices: trioctyltrimellitate (TOTM), di-isononyl-cyclohexan-1,2-dicarboxilate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT). To quantify DEHP in nine DEHP-free medical devices made of PVC softened by alternative plasticizers, high performance liquid chromatography analysis with ultraviolet detection at 220 nm wavelength was achieved. An NMR spectroscopy was performed to confirm DEHP presence. Only two medical devices out of the nine tested were truly without DEHP. One of them showed traces of DEHP exceeding the threshold contamination of 0.1% in plastic mass set by REACH regulations. TOTM plasticizer is still incriminated when polyvinyl-chloride (PVC) is contaminated with DEHP. Manufacturers must verify the purity of their raw material, not only on PVC, but also on other soft plastics entering into the composition of medical infusion devices. The clinical consequences of exposure to certain levels of DEHP have not been evaluated. A solution could be to use alternative PVC-free materials.
International journal of pharmaceutics 06/2011; 412(1-2):47-51. · 2.96 Impact Factor
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ABSTRACT: Plasticizers such as di(2-ethylhexyl) phthalate (DEHP) are added to polyvinyl chloride (PVC) to confer flexibility. However, DEHP is associated with reproductive disorders in humans. Because of its noncovalent bond to the PVC matrix, this plasticizer tends to leach easily. Infants and children undergoing cyclic, long-term parenteral nutrition (PN) could be particularly at risk of potential toxicity from DEHP due to regular exposure. Malondialdehyde (MDA) is one of the most commonly used markers of free radical activity. The purpose of this study was to investigate how long-term exposure to phthalate affects the plasmatic rate of MDA.
Studies were performed on 7 randomized infants and children on regular cyclic, long-term PN, and the results were compared with those of 5 nontreated infants. The circulating concentrations of DEHP in children and infants during the PN therapy were measured by high-performance liquid chromatography. The concentrations were assessed before and after the PN session. In the same way, plasma MDA concentrations were measured.
The circulating concentrations of DEHP before and after a 10- to 11-hour cyclic PN treatment in 7 infants and children under regular perfusion ranged widely, showing a significant increase after the treatment among all the patients. The same phenomenon observed with the rate of MDA showed that the 2 events are closely dependent. Therefore, long-term exposure to DEHP during cyclic PN raised plasma MDA levels, indicating increased oxidative stress.
Long-term exposure to DEHP during PN increased free radical activity in vivo.
Journal of Parenteral and Enteral Nutrition 05/2011; 35(3):395-401. · 3.29 Impact Factor
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ABSTRACT: Di(2-ethylhexyl) phthalate (DEHP) is the most widely plasticizer for polyvinyl chloride (PVC) that is used in plastic tubes, in medical and paramedical devices as well as in food storage packaging. The toxicological profile of DEHP has been evaluated in a number of experimental animal models and has been extensively documented. Its toxicity is in part linked to the activation of the peroxisome proliferator-activated receptor alpha (PPAR(alpha)). As a response, an intensive research for a new, biologically inert plasticizer has been initiated. Among the alternative studied, tri(2-ethylhexyl) trimellitate (TEHTM) or trioctyl trimellitate (TOTM) has attracted increasing interest. However, very little information is available on their biological effects. We proceeded to dock TOTM, DEHP and its metabolites in order to identify compounds that are likely to interact with PPAR(alpha) and PPAR(gamma) binding sites. The results obtained hint that TOTM is not able to bind to PPARs and should therefore be safer than DEHP.
Journal of Enzyme Inhibition and Medicinal Chemistry 11/2008; 23(5):611-6. · 1.62 Impact Factor
