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The release of plasticizer from polyvinyl chloride haemodialysis tubing.

The extent of migration of plasticizer from haemodialysis lines into saline and plasma has been examined and a number of different types of tubing have been compared. A model system designed to simulate in vivo haemodialysis was evolved. The method uses a continuous cyclohexane extraction in order to mimic uptake of plasticizer by body tissues. Although not an ideal system, the results obtained are indicative of the extent to which the plasticizers are leached.

Adipates↗

Extraction of diethylhexylphthalate from total nutrient solution-containing polyvinyl chloride bags.

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.

Diethylhexyl Phthalate↗

[Experimental substantiation of the maximum permissible concentration (MAC) of polyvinyl chloride resin].

The acute and chronic oral, dermal and inhalatory toxicity of PVH resin is studied in white rats. It is established that in acute treatment, irrespective of the route of PVC resin penetration into the organism, its effect proves weakly toxic. During chronic oral and inhalatory experiments, a slight affection of peripheral blood elements only is noted. In the lungs of the animals inhalating 2 and 6 mg/m3 concentrations for a duration of four months, no changes are detected which might be interpreted as being PVH specific. Cumulative effect, and skin stimulating and sensibilizing action of the polymer are neither established. Against the background of the obtained results, a provisional normal MAC value is proposed, namely 2 mg/m3 of PVH dust in the air of the working environment.

Administration, Oral↗