title: Evaluation and analysis of exposure levels of di(2-ethylhexyl) phthalate from blood bags.
abstract: BACKGROUND
  The US FDA and The Ministry of Health, Labor and Welfare of Japan have indicated that the risk assessment of di(2-ethylhexyl) phthalate (DEHP) released from polyvinyl chloride (PVC) medical devices requires immediate attention. In particular, the analysis of the exposure to DEHP from blood bags is very important for medical treatment. However, human exposure to DEHP via blood transfusion remains poorly understood. We evaluated DEHP and mono(2-ethylhexyl) phthalate (MEHP) levels, migration patterns, and metabolism in blood products for the detailed assessment of exposure to DEHP.
  
  
  METHODS
  A method that is based on column-switching liquid chromatography-electrospray mass spectrometry (LC-MS) coupled with on-line extraction was used for the direct analysis of DEHP and MEHP in the blood products. From the Japanese Red Cross Society, 78 blood products (red blood cell concentrate: n=18, irradiated red blood cell concentrate: n=18, whole blood: n=18, blood platelet: n=18, and frozen plasma: n=6) were sampled in January 2003 for use in this study.
  
  
  RESULTS
  The detection levels of DEHP and MEHP ranged from 1.8 to 83.2 microg/ml and from 0.1 to 9.7 microg/ml, respectively. The levels of MEHP and DEHP in the blood products were increased with increasing storage time. In addition, whole blood products in PVC bags had the highest DEHP levels compared to the other blood products. Our results indicate that the maximum level of human exposure to DEHP released from blood bags is 0.7 mg/kg weight/time.
  
  
  CONCLUSIONS
  This first quantitative evidence may be useful for the risk assessment of DEHP released from blood bags.
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Tokyo 142-8501, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Inoue
authors.forename: Migaku
authors.initials: M
authors.lastname: Kawaguchi
authors.forename: Retsuji
authors.initials: R
authors.lastname: Yamanaka
authors.forename: Tae
authors.initials: T
authors.lastname: Higuchi
authors.forename: Rie
authors.initials: R
authors.lastname: Ito
authors.forename: Koichi
authors.initials: K
authors.lastname: Saito
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakazawa
mesh_terms: D001792:Blood Platelets / Q000737:chemistry; D001793:Blood Preservation / Q000295:instrumentation* / Q000379:methods; D001803:Blood Transfusion / Q000295:instrumentation* / Q000379:methods; D002853:Chromatography, Liquid / Q000379:methods; D004051:Diethylhexyl Phthalate / Q000031:analogs & derivatives / Q000032:analysis*; D004912:Erythrocytes / Q000737:chemistry; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods; D010949:Plasma / Q000737:chemistry; D019064:Product Packaging / Q000295:instrumentation / Q000706:statistics & numerical data*; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D004051:Diethylhexyl Phthalate; C016599:mono-(2-ethylhexyl)phthalate