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3230526 
Journal Article 
Migrability of PVC plasticizers from medical devices into a simulant of infused solutions 
Bernard, L; Cueff, R; Breysse, C; Décaudin, B; Sautou, V; Armed Study Group 
2015 
Yes 
International Journal of Pharmaceutics
ISSN: 0378-5173
EISSN: 1873-3476 
Elsevier 
485 
1-2 
341-347 
English 
25796128 
WOS:000353730400037 
Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs. Each PVC tubing sample was immersed in a simulant consisting of a mixture of ethanol/water (50/50v/v) at 40°C and migration tests were carried out after 24h, 72h, and 10 days.DEHP had the highest migration ability, which increased over time. The amount of TOTM released was more than 20 times less than that of DEHP, which makes it an interesting alternative. DEHT is also promising, with a migration level three times smaller than DEHP. However, the migration ability of DINCH was similar to DEHP, with the released amounts equaling 1/8th of the initial amount in the tubing after 24h of contact. Taking into account the available toxicological data, TOTM and DEHT appear to be of particular interest. However, these data should be supplemented and correlated with clinical and toxicological studies on plasticizers and their metabolites. 
di isononyl 1,2 cyclohexane dicarboxylate; phthalic acid bis(2 ethylhexyl) ester; plasticizer; polyvinylchloride; trimellitic acid tris(2 ethylhexyl) ester; unclassified drug; alcohol; benzoic acid derivative; cyclohexanecarboxylic acid derivative; dicarboxylic acid; diisononyl 1,2-cyclohexanedicarboxylic acid; phthalic acid bis(2 ethylhexyl) ester; plasticizer; polyvinylchloride; trioctyl trimellitate; water; Article; controlled study; gas chromatography; immersion; in vitro study; mechanics; medical device; migrability; priority journal; adverse effects; chemistry; comparative study; devices; diffusion; equipment design; human; infusion; materials testing; nutritional support; risk assessment; solubility; time; Benzoates; Cyclohexanecarboxylic Acids; Dicarboxylic Acids; Diethylhexyl Phthalate; Diffusion; Equipment Design; Ethanol; Humans; Infusions, Parenteral; Materials Testing; Nutritional Support; Plasticizers; Polyvinyl Chloride; Risk Assessment; Solubility; Time Factors; Water