Comparative study on the migration of di-2-ethylhexyl phthalate (DEHP) and tri-2-ethylhexyl trimellitate (TOTM) into blood from PVC tubing material of a heart-lung machine

Chemosphere

Volumn 145, Issue , 2016, Pages 10-16

  Eckert, Elisabeth ^b   Münch, Frank ^a   Göen, Thomas ^b   Purbojo, Ariawan ^a   Müller, Johannes ^b   Cesnjevar, Robert ^a  

^a UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^b UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

Author keywords

Blood tubing; Leaching; Medical devices; Plasticizers; PVC; Silicone

Indexed keywords

ARTIFICIAL ORGANS; BIOLOGICAL ORGANS; BLOOD; DEGRADATION; ESTERS; FUNCTIONAL POLYMERS; LEACHING; PLASTICIZERS; POLYVINYL CHLORIDES; REINFORCED PLASTICS; SILICONES; SOLVENTS;

CARDIOPULMONARY BYPASS; COMPARATIVE STUDIES; CONTROL MATERIALS; DEGRADATION PRODUCTS; DI-2-ETHYLHEXYL PHTHALATE; MEDICAL DEVICES; MEDICAL PROCEDURES; PLASTICIZER MIGRATION;

TUBING;

PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER; PLASTICIZER; POLYVINYLCHLORIDE; SILICONE; TRI 2 ETHYLHEXYL TRIMELLITATE; TRICHLOROETHYLENE; UNCLASSIFIED DRUG; BENZOIC ACID DERIVATIVE; TRI-(2-ETHYLHEXYL)TRIMELLITATE;

BLOOD; COMPARATIVE STUDY; DEGRADATION; DISPERSANT; LEACHING; MACHINERY; PHTHALATE; POLYMER; PUBLIC HEALTH; SILICON;

ARTICLE; CONTROLLED STUDY; DEGRADATION; DEVICE MATERIAL BLOOD MIGRATION; HEART LUNG MACHINE; IN VITRO STUDY; MASS; MEDICAL DEVICE COMPLICATION; PERFUSION; STORAGE; TIME; TUBE; WEIGHT; ANIMAL; BLOOD; CHEMISTRY; DISPOSABLE EQUIPMENT; SHEEP;

ANIMALS; BENZOATES; DIETHYLHEXYL PHTHALATE; DISPOSABLE EQUIPMENT; HEART-LUNG MACHINE; PLASTICIZERS; POLYVINYL CHLORIDE; SHEEP;

EID: 84960155944     PISSN: 00456535     EISSN: 18791298     Source Type: Journal    
DOI: 10.1016/j.chemosphere.2015.11.067     Document Type: Article

References (31)

1. Bernard L., Cueff R., Breysse C., Décaudin B., Sautou V. Migrability of PVC plasticizers from medical devices into a simulant of infused solutions. Int. J. Pharm. 2015, 485:341-347.
2. Bui T.T., Giovanoulis G., Cousins A.P., Magnér J., Cousins I.T., de Wit C.A. Human exposure, hazard and risk of alternative plasticizers to phthalate esters. Sci. Total Environ. 2016, 541:451-467.
3. Chiellini F., Ferri M., Morelli A., Dipaola L., Latini G. Perspectives on alternatives to phthalate plasticized poly(vinyl chloride) in medical devices applications. Prog. Polym. Sci. 2013, 38:1067-1088.
4. Council of Europe, European pharmacopoeia Monographs No. 3.1.1.1, 3.1.1.2, 3.2.3, 3.2.6 2014, Council of Europe, Strasbourg. eighth ed.
5. Directive, 2005 Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005, L344/40-43.
6. ECHA (European Chemicals Agency) Tris(2-ethylhexyl) Benzene-1,2,4-tricarboxylate (CAS: 3319-31-1) 29 Jul 2013, first published 17 Mar 2011, last modified, URL:. http://echa.europa.eu/de/information-on-chemicals/registered-substances.
7. Eckert E., Müller J., Göen T. Simultaneous determination of polyvinylchloride plasticizers di(2-ethylhexyl) phthalate and tri(2-ethylhexyl) trimellitate and its degradation products in blood by liquid chromatography-tandem mass spectrometry. J. Chromatogr. A 2015, 1410:173-180.
8. EFSA (European Food Safety Authority) Opinion of the scientific panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the commission related to bis(2-ethylhexyl)phthalate (DEHP) for use in food contact materials. EFSA J. 2005, 243:1-20.
9. Genay S., Luciani C., Decaudin B., Kambia N., Dine T., Azaroual N., Di Martino P., Barthelemy C., Odou P. Experimental study on infusion devices containing polyvinyl chloride: to which extent are they di(2-ethylhexyl)phthalate-free?. Int. J. Pharm. 2011, 412:47-51.
10. Gimeno P., Thomas S., Bousquet C., Maggio A.F., Civade C., Brenier C., Bonnet P.A. Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS. J. Chromatogr. B 2014, 949-950:99-108.
11. Helling R., Mieth A., Altmann S., Simat T.J. Determination of the overall migration from silicone baking moulds into simulants and food using 1H-NMR techniques. Food Add. Contam. Part A 2009, 26:395-407.
12. Heudorf U., Mersch-Sundermann V., Angerer J. Phthalates: toxicology and exposure. Int. J. Hyg. Environ. Health 2007, 210:623-634.
13. Högberg J., Hanberg A., Berglund M., Skerfving S., Remberger M., Calafat A.M., Filipsson A.F., Jansson B., Johansson N., Appelgren M., Håkansson H. Phthalate diesters and their metabolites in human breast milk, blood or serum, and urine as biomarkers of exposure in vulnerable populations. Environ. Health Perspec 2008, 116:334-339.
14. Hornung R.W., Reed L.D. Estimation of average concentration in the presence of nondetectable values. Appl. Occup. Environ. Hyg. 1990, 46-51.
15. IARC (International Agency for Research on Cancer) Surgical implants and other foreign bodys. IARC Monogr. Eval. Carcinog. Risks Humans 1999, 74.
16. IARC (International Agency for Research on Cancer) Some Chemicals present in industrial and Consumer products, food and drinking water. IARC Monogr. Eval. Carcinog. Risks Humans 2012, 101:149-284. Di(2-ethylhexyl) phthalate.
17. Inoue K., Kawaguchi M., Yamanaka R., Higuchi T., Ito R., Saito K., Nakazawa H. Evaluation and analysis of exposure levels of di(2-ethylhexyl) phthalate from blood bags. Clin. Chim. Acta 2005, 358:159-166.
18. Ito R., Seshimo F., Miura N., Kawaguchi M., Saito K., Nakazawa H. High-throughput determination of mono- and di(2-ethylhexyl)phthalate migration from PVC tubing to drugs using liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal. 2005, 39:1036-1041.
19. Ito R., Miura N., Iguchi H., Nakamura H., Ushiro M., Wakui N., Nakahashi K., Iwasaki Y., Saito K., Suzuki T., Nakazawa H. Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS/MS. Int. J. Pharm. 2008, 360:91-95.
20. Kambia K., Dine T., Azar R., Gressier B., Luyckx M., Brunet C. Comparative study of the leachability of di(2-ethylhexyl) phthalate and tri(2-ethylhexyl) trimellitate from haemodialysis tubing. Int. J. Pharm. 2001, 229:139-146.
21. Kambia K., Dine T., Gressier B., Dupin-Spriet T., Luyckx M., Brunet C. Evaluation of the direct toxicity of trioctyltrimellitate (TOTM), di(2-ethylhexyl) phthalate (DEHP) and their hydrolysis products on isolated rat hepatocytes. Int. J. Artif. Organs 2004, 27:971-978.
22. Ohashi A., Kotera H., Hori H., Hibiya M., Watanabe K., Murakami K., Hasegawa M., Tomita M., Hiki Y., Sugiyama S. Evaluation of endocrine disrupting activity of plasticizers in polyvinyl chloride tubes by estrogen receptor alpha binding assay. J. Artif. Organs 2005, 8:252-256.
23. Pollack G.M., Buchanan J.F., Slaughter R.L., Kohli R.K., Shen D.D. Circulating concentrations of di(2-ethylhexyl) phthalate and its de-esterified phthalic acid products following plasticizer exposure in patients receiving hemodialysis. Toxicol. Appl. Pharmacol. 1985, 79:257-267.
24. Rock G., Secours V.E., Franklin C.A., Chu I., Villeneuve D.C. The accumulation of mono-2-ethylhexylphthalate (MEHP) during storage of whole blood and plasma. Transfusion 1978, 18:553-558.
25. Rücker C., Kümmerer K. Environmental Chemistry of organosiloxanes. Chem. Rev. 2015, 115:466-524.
26. Silva M.J., Samandar E., Preau J.L., Needham L.L., Calafat A.M. Urinary oxidative metabolites of di(2-ethylhexyl) phthalate in humans. Toxicol 2006, 219:22-32.
27. Simmchen J., Ventura R., Segura J. Progress in the removal of Di-(2-ethylhexyl)phthalate as plasticizer in blood bags. Transfus. Med. Rev. 2012, 26:27-37.
28. Takatori S., Okamoto Y., Kitagawa Y., Hori S., Izumi S.-I., Makino T., Nakazawa H. Simulated neonatal exposure to DEHP and MEHP from PVC enteral nutrition products. Int. J. Pharm. 2008, 352:139-145.
29. Tickner J.A., Schettler T., Guidotti T., McCally M., Rossi M. Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review. Am. J. Ind. Med. 2001, 39:100-111.
30. Van Vliet E.D.S., Reitano E.M., Chhabra J.S., Bergen G.P., Whyatt R.M. A review of alternatives to di (2-ethylhexyl) phthalate-containing medical devices in the neonatal intensive care unit. J. Perinatol. 2011, 31:551-560.
31. Zhang K., Wong J.W., Begley T.H., Hayward D.G., Limm W. Determination of siloxanes in silicone products and potential migration to milk, formula and liquid simulants. Food Add. Contam. Part A 2012, 29:1311-1321.