Extraction of Diethylhexylphthalate from Total Nutrient Solution‐Containing Polyvinyl Chloride Bags

Abstract

Total nutrient solution (TNS) is a new method for delivering total parenteral nutrition (TPN) by admixing dextrose, amino acids, and lipids in a single container. Recommendations are to use nonpolyvinyl chloride (PVC) containers for admixture of these solutions. PVC is a hard, brittle, and inflexible substance, and plasticizers, predominantly diethylhexylphthalate (DEHP), are added to impart flexibility. DEHP is a lipid soluble suspected carcinogen, hepatotoxin, and teratogen which has been shown to leach from PVC products containing lipophilic admixtures. The purpose of this study was to quantitate the amount of DEHP which leaches from PVC bags containing TNS. Six study groups, which contained three formulas stored at 25 degrees C +/- 2 degrees C and 4 degrees C +/- 1 degree C, were assayed for DEHP at time 0, 12, 24, 48 and 72 hr, 1 wk, and 3 wk using high-performance liquid chromatography. The control group contained an amino acid source, a carbohydrate source, and standard electrolytes, and the other groups contained a 10% lipid source or a 20% lipid source in addition to the constituents of the control group. Lipid-containing groups demonstrated detectable levels of DEHP at 48 hr, and DEHP content increased in these groups throughout the 21-day study. DEHP concentrations were lower in lipid-containing groups stored at 4 degrees C than comparable groups stored at 25 degrees C.

The effect of temperature on di(2‐ethylhexyl) phthalate leaching from PVC infusion sets exposed to lipid emulsions

“…Di(2‐ethylhexyl) phthalate has limited solubility in aqueous solutions (approximately 3 ng.ml −1 in distilled water at 20 °C [28]), but is non‐covalently bound to PVC, so will leach into an aqueous solution at higher temperatures [29] and during the mechanical stress associated with dynamic flow [30]. The lipophilicity of DEHP explains the greater rate of leaching into lipid‐containing solutions [12], and may also be affected by other factors, including the length and volume of the infusion line, infusate pH, infusion duration, plasticity and agitation of the PVC equipment [31].…”

Effect of partial replacement of di(2‐ethyl hexyl)phthalate, by a polymeric plasticizer, on the permeability and leaching properties of poly(vinyl chloride)

“…Several studies have indicated that as DEHP is not chemically bound to PVC, it leaches out from medical products into the media, which comes in contact with it 6–9. There is mounting concern for the exposure to the phthalate ester through various medical procedures such as intravenous therapy, enteral and parenteral nutrition support, blood transfusion, hemodialysis and peritoneal dialysis, cardiopulmonary bypass, and extracorporeal membrane oxygenation 10–13. Although DEHP is suggested to be of low acute toxicity, long‐term exposure may adversely affect the human being 14.…”

Determination of di(2-ethylhexyl)phthalate and mono(2-ethylhexyl)phthalate in human serum using liquid chromatography-tandem mass spectrometry

“…Patients undergoing medical procedures, such as intravenous therapy, nutritional support, blood transfusion, hemodialysis, cardiopulmonary bypass or extracorporeal membrane oxygenation (EMO) can be exposed to DEHP. Previous studies have shown detectable amounts of DEHP in blood products, in intravenous solutions, and in intravenous fat emulsions stored in PVC bags [1][2][3][4][5]. In animal studies, DEHP and/or MEHP are toxicants to the reproductive and developmental systems [6][7][8][9][10].…”