Effect of sterilization process on the formation of mono(2-ethylhexyl)phthalate from di(2-ethylhexyl)phthalate

J Pharm Biomed Anal. 2006 May 3;41(2):455-60. doi: 10.1016/j.jpba.2005.12.021. Epub 2006 Mar 23.

Abstract

The risk assessment of di(2-ethylhexyl)phthalate (DEHP) migrating from polyvinyl chloride (PVC) medical devices is an important issue. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags is hydrolyzed by esterase into mono(2-ethylhexyl)phthalate (MEHP). However, MEHP is thought to be even more toxic than the parent compound. Therefore, a method for the simultaneous determination of DEHP and MEHP was developed. The limits of quantification (LOQs) of DEHP and MEHP were 2.5 and 0.75 ng/ml, respectively. In this study, the effect of sterilization process on the levels of DEHP and MEHP migration was investigated. The level of migration of DEHP from gamma(gamma)-ray sterilized PVC sheet was low compared with that of the unsterilized control. By contrast, the level of MEHP migration from the gamma-ray sterilized PVC sheet was high compared with that of the unsterilized control. In addition, a high content of MEHP was found in the gamma-ray sterilized PVC sheet.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chromatography, Liquid / methods
  • Diethylhexyl Phthalate / analogs & derivatives*
  • Diethylhexyl Phthalate / analysis*
  • Diethylhexyl Phthalate / chemical synthesis
  • Diethylhexyl Phthalate / chemistry
  • Diethylhexyl Phthalate / toxicity
  • Equipment and Supplies
  • Gamma Rays
  • Polyvinyl Chloride / chemistry*
  • Polyvinyl Chloride / radiation effects
  • Reproducibility of Results
  • Risk Assessment
  • Spectrometry, Mass, Electrospray Ionization
  • Sterilization*

Substances

  • Polyvinyl Chloride
  • Diethylhexyl Phthalate
  • mono-(2-ethylhexyl)phthalate