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PubMed2002

[Migration of di(2-ethylhexyl) phthalate from polyvinyl chloride tubes used in preparation of foods].

Three samples of polyvinyl chloride products for food use were examined for di(2-ethylhexyl) phthalate (DEHP) migration levels under the conditions described in the Japanese Food Sanitation Law. These samples were two kinds of tubes and one stretched film, containing 12 to 41% DEHP by weight. DEHP migration levels from them were very low, all below 0.1 ppm, into 3 kinds of food simulant; water, 4% acetic acid and 20% ethanol. However, high levels of DEHP migrated into n-heptane, 12 ppm from the stretched film sample and more than 800 ppm from the tube samples. Migration from the 2 tubes was higher than 150 ppm, the limit of residues after evaporation in containers and wraps. Though the limit of residues after evaporation is not set for equipment used in the preparation of foods, the tested tubes were considered to be unsuitable for uses in which they come into direct contact with oils, fats or oily foods.

Diethylhexyl Phthalate↗
PubMed1984

Permeability of latex and polyvinyl chloride gloves to 20 antineoplastic drugs.

Permeability of latex and polyvinyl chloride (PVC) gloves to 20 injectable antineoplastic drugs was studied. Four types of gloves were evaluated: latex surgical gloves, latex examination gloves, and PVC gloves in two thicknesses. Each glove material was exposed to each drug for 90 minutes, and permeation was tested using a mutagenicity assay. Individual fingertips of thin PVC gloves and latex surgical gloves were tested for permeability at five time points (2-30 minutes) using a doxorubicin coloration assay. All drugs permeated the thin PVC gloves. Latex surgical gloves were definitely permeable to two drugs (carmustine and thiotepa) and exhibited borderline permeability to mechlorethamine hydrochloride. The thick PVC gloves were definitely permeable to four drugs (carmustine, thiotepa, mechlorethamine hydrochloride, and daunorubicin hydrochloride) and exhibited borderline permeability to two drugs (doxorubicin and mercaptopurine). The latex examination gloves were permeable to carmustine, thiotepa, mechlorethamine hydrochloride, and cyclophosphamide. Doxorubicin permeation of individual fingertips of thin PVC gloves varied in time and amount. Doxorubicin did not permeate the latex surgical glove material, but testing with thiotepa showed that individual fingertips of this material also varied in permeability. Glove thickness was a major determinant of permeability; latex surgical gloves were the least permeable and thin PVC gloves the most permeable to the antineoplastic drugs tested. Within individual gloves and glove types, time and amount of permeation were not uniform.

Antineoplastic Agents↗
PubMed2000

Migration of di-(2-ethylhexylexyl)adipate plasticizer from food-grade polyvinyl chloride film into hard and soft cheeses.

Food-grade polyvinyl chloride (PVC) film containing 28.3% di-(2-ethylhexylexyl)adipate (DEHA) plasticizer was used to wrap three different types of cheese (Kefalotyri, Edam, and Feta). Samples were split into two groups and stored at 5+/-0.5 degrees C. One group was analyzed for DEHA content at intervals between 1 and 240 h of contact (kinetic study), and a second group was cut into slices (1.2 mm thick) after 240 h of cheese/PVC contact and was analyzed for DEHA content (penetration study). The DEHA was determined by indirect gas chromatography. Statistically significant differences in migration of DEHA were observed between the cheese types. Migration of DEHA depended on contact time, fat, and moisture contents, and consistency of cheese samples. Equilibrium conditions were approached after approximately 100 h of contact for Edam and 150 h for Kefalotyri cheese. Equilibrium conditions were not reached for Feta cheese, even after 240 h of contact. After 240 h of contact under refrigeration, the migration of DEHA was approximately 345.4 mg/kg (18.9 mg/dm2) for Kefalotyri, 222.5 mg/kg (12.2 mg/dm2) for Edam, and 133.9 mg/kg (7.3 mg/dm2) for Feta. The loss of DEHA from the PVC film into the three cheese types was 37.8, 24.3, and 14.6%, respectively. These values, with the exception of Feta, were higher than the upper limit for global migration from plastic packaging materials into food and food stimulants set by the European Union (EU) (10 mg/dm2 or 60 mg/kg). After 240 h of cheese/film contact, DEHA was detected in the first three slices beneath the cheese surface (3.6 mm total depth) of Edam cheese and in the first two slices (2.4 mm total depth) of Kefalotryi and Feta cheeses. DEHA was not detected in subsequent layers. The effect of cheese rind on migration of DEHA was studied in Edam and Kefalotyri cheeses. The DEHA migration after 240 h into the first 1 mm beneath the surface of Kefalotyri cheese was 22.4 mg/kg, while DEHA was not detected in Edam cheese.

Adipates↗
PubMed1988

Cuff failure in polyvinyl chloride tracheal tubes sprayed with lignocaine.

The incidence of tracheal tube cuff rupture was noted in 30 polyvinyl chloride tracheal tubes lubricated with three different solutions. All cuffs moistened with water were intact after 2 hours of cuff inflation whereas two of 10 lubricated with 4% lignocaine solution had burst. Both of these had leaked at the site of cuff attachment to the tube. Fifty percent of tubes lubricated with Astra lignocaine spray burst during the study. Four of the five had developed pinholes in the cuffs themselves. The remaining 50% of this group showed marked distortion and thinning of their intact cuff walls. The implications of these findings are discussed in view of the widespread use of PVC tracheal tubes.

Aerosols↗
PubMed1986

Sorption of four drugs to polyvinyl chloride and polybutadiene intravenous administration sets.

Sorption of nitroglycerin, isosorbide dinitrate, diazepam, and clomethiazole edisylate (chlormethiazole) to polyvinyl chloride (PVC) i.v. administration sets with and without cellulose propionate burettes and to polybutadiene (PBD) sets with and without methacrylate butadiene styrene (MBS) burettes was studied. All drugs (except chlormethiazole) were diluted with 0.9% sodium chloride injection (NS) in glass bottles or in the burette chambers. Initial samples of each solution were obtained from the bottle or from the burette, and effluent samples were collected at various times up to 240 minutes from the sets without burettes and up to 90 minutes from the sets with burettes. For nitroglycerin, flow rates of 0.5 and 1.0 mL/min were used without the burette. The effect of priming the tubing before adding drug to the burette was studied for diazepam. Triplicate samples were analyzed for nitroglycerin and isosorbide dinitrate by high-performance liquid chromatography and for diazepam and chlormethiazole by ultraviolet spectrophotometry. Up to 50% potency of chlormethiazole and nitroglycerin, 15-25% of isosorbide dinitrate, and 13-20% of diazepam was lost to PVC sets without burettes, and an additional 10-15% loss of each drug resulted when PVC sets with burettes were used. Less sorption of nitroglycerin to the PVC sets occurred at the higher flow rate, but flow rate through the PBD sets did not affect sorption. Priming the tubing before adding diazepam to the burette did not affect final drug delivery. No loss to PBD sets was observed for nitroglycerin, isosorbide dinitrate, and diazepam; loss of chlormethiazole to PBD was 7-13%. Drug potency in effluent from PBD sets was not affected by presence or absence of a burette.(ABSTRACT TRUNCATED AT 250 WORDS)

Adsorption↗
PubMed1981

Interactions between drugs and polyvinyl chloride infusion bags.

Forty-six injectable drug products, many of which are administered by i.v. infusion, were studied for loss from aqueous solutions stored in polyvinyl chloride infusion bags for various periods of time. The polyvinyl bags were stored in the dark at room temperature for up to three months. Drugs stored in glass vials served as controls. The solutions were assayed spectrophotometrically at regular intervals. The effects of drug concentration and pH on the loss of drug from solution were studied. Octanol-water partition coefficients were used as a gauge of lipid solubility of the drugs. Five of the drug products-clomethiazole edisylate, diazepam, hydralazine hydrochloride, thiopental sodium, and warfarin sodium-were found to be lost to a substantial extent after one week. For all drugs studied, the effects of the initial concentration on drug loss varied. The amount of drug lost over a given time was a function of the pH of the solution. The main physico-chemical determinants controlling drug sorption appeared to be the extent of ionization and the lipid solubility of the drug. For most of the drugs studied, minimal losses from the aqueous solutions were observed over short periods of storage time. Disappearance was slow and time dependent, indicating a diffusion-controlled sorption process. The losses of clomethiazole edisylate, thiopental sodium, and diazepam may be clinically important.

Drug Packaging↗
PubMed1982

Respiratory illness caused by overheating of polyvinyl chloride.

On 9 August 1979, 62 (30.8%) of 201 workers and one of 60 management personnel in a polyvinyl chloride (PVC) fabricating plant developed acute upper and lower respiratory irritation, headache, nausea, and fainting. All were taken to hospital; none died. Sixty of the patients were women. Interviews two weeks later with 57 affected and 14 unaffected workers disclosed that illness had followed exposure to fumes from an overheated (362 degrees C) PVC extruding machine. Fumes were emitted from 1100 until 1150; cases occurred from 1100 until late afternoon. All workers who became ill worked west of the overheated extruder, and the affected manager had visited that area. The earliest cases occurred closest to the machine, and incidence decreased (from 53.3% to 15.4%) with distance westward. This pattern was consistent with plant ventilation. Incidence rates in men and women did not differ (p greater than 0.1). At two and 14 weeks, pulmonary function testing of workers with persistent pulmonary symptoms showed abnormalities in 13 of 16 and in 9 of 11 respectively; the group with persistent symptoms contained an excess of non-smokers and of those with previous respiratory illnesses. One kilogram of PVC heated to 300 degrees C releases an estimated 12.9 g of hydrochloric acid (HCl) and 4.9 g of carbon monoxide (CO). We attributed the outbreak to exposure to toxic HCl and CO and rejected the hypothesis of mass psychogenic illness.

Carbon Monoxide Poisoning↗
PubMedDate not supplied

Polyvinyl chloride--its risk potential in the hospital.

A potential risk management problem for hospitals is the thermal degradation of polyvinyl chloride (PVC). PVC is a synthetic, plastic, polymer wire insulating material which releases hydrogen chloride (HCl) gas when it is thermally degraded. Inhalation of HCl, either as a gas or in combination with water vapor, is irritating to all mucous membranes. Thermal degradation of 25 feet of PVC wire yields 1.4 mg HCl/L, which is 70 times greater than the recommended maximum concentration. Because of the potential risks, ther is an immediate need to develop a safe, economical substitute for PVC.

Electric Wiring↗
PubMed1980

Polyvinyl chloride dermatitis not caused by phthalates.

Seven cases of contact dermatitis in children due to identification bracelets made of polyvinyl chloride plastic are reported. Patch tests with the bracelets were negative in the five cases tested. It is concluded that the reactions were irritant due to some unknown chemical in the bracelets. The most widely used plasticizers in PVC, phthalates, must have very low sensitizing properties, as only one positive patch test was found in 1532 patch tests with phthalate mix, performed as a joint study by the International Contact Dermatitis Research Group.

Child, Preschool↗
PubMed1987

Exposure of patients to phthalates from polyvinyl chloride tubes and bags during dialysis.

The exposure of patients to the plasticizer di-(2-ethylhexyl)phthalate (DEHP) from polyvinyl chloride (PVC) tubes and bags during dialysis has been investigated. In vitro studies of the migration of DEHP from hemodialysis tubes into plasma revealed a migration coefficient of 7.7 micrograms/ml/h. An artificial kidney did not influence the plasma concentration of DEHP. The calculated exposure from a single hemodialysis can be as much as the total annual exposure using continuous ambulatory peritoneal dialysis (CAPD). CAPD fluids in PVC bags contain low concentrations of DEHP and its hydrolysis product mono-(2-ethylhexyl)phthalate (MEHP). These phthalates were analyzed in serum from patients receiving both CAPD and hemodialysis using gas chromatography. A group of patients not yet on dialysis treatment was used as control. In no case could MEHP be detected. The DEHP concentration was 0.8-4.2 micrograms/ml serum in the 17 hemodialysis patients after dialysis and 0.1-0.9 microgram/ml in 4 of the CAPD patients. In 3 of the CAPD and all of the predialysis patients, DEHP could not be detected (less than 0.1 microgram/ml).

Diethylhexyl Phthalate↗
PubMed2002

In vitro toxicity assessment of polyvinyl chloride particles and comparison of six cellular systems.

Occupational exposure to polyvinyl chloride (PVC) dust has been occasionally associated with lung disease. Our aim was to evaluate the in vitro toxicity of various types of PVC particles in relevant cell culture systems. Six samples from the normal industrial suspension process (PVC-S) and eight samples from the emulsion process (PVC-E) were studied. Cytotoxicity was assessed, using the MTT assay, after 20 h of incubation in A549 cells and in primary cultures of alveolar macrophages (AM) and type II pneumocytes (TII) obtained from rats (r-AM, r-TII) or from human surgical specimens (h-AM, h-TII). Hemolysis was assessed after 2 h of incubation with human erythrocytes (h-RBC). A positive control (crystalline SiO(2), Min-U-Sil) and relevant additives of these PVC particles were tested concurrently. No toxicity of PVC-S particles could be established up to 5 mg/ml in the hemolysis test and 2.5 mg/ml in the MTT assay. In contrast, 4 out of 8 PVC-E particles induced significant toxicity, with EC50 values ranging from 0.7 to 3.7 mg/ml in the hemolysis test and from 0.2 to 1.2 mg/ml in primary cells. The most toxic particles were those that contained the additives with the highest in vitro cytotoxicity. There was a good correlation between EC50 values obtained in relevant bioassays. The sensitivity order of the cell systems was A549 < h-RBC approximately h-TII < or = h-AM < r-TII < or = r-AM for the particles. In conclusion, PVC-E particles produced a moderate in vitro toxicity for primary rat and human pulmonary cells, probably because of the residual presence of additives.

Aged↗
PubMed2002

Stability of dacarbazine in amber glass vials and polyvinyl chloride bags.

The stability of dacarbazine in commercial glass vials and polyvinyl chloride (PVC) bags in various storage conditions and the emergence of 2-azahypoxanthine, a major degradation product possibly linked with some adverse effects, were studied. Triplicate samples of reconstituted (11 mg/mL) and diluted (1.40 mg/mL) dacarbazine admixtures were prepared and stored at 4 degrees C or at 25 degrees C in daylight, fluorescent light, or the dark. The effect of several light-protective measures (amber glass vials, aluminum foil wrapping, and opaque tubing) on dacarbazine stability in a simulated i.v. infusion system was also evaluated. Dacarbazine quantification and main degradation product determination were performed by high-performance liquid chromatography. Stability was defined as conservation of 90-105% of initial dacarbazine concentration without major variations in clarity, color, or pH and without precipitate formation. Reconstituted dacarbazine solutions were stable for 24 hours at room temperature and during light exposure and stable for at least 96 hours at 2-6 degrees C when stored in the dark. After dilution in PVC bags, stability time increased from 2 hours in daylight to 24 hours in fluorescent light and to 72 hours when covered with aluminum foil. After two hours of simulated infusion, dacarbazine remained stable. Diluted dacarbazine solutions stored at 2-6 degrees C were stable for at least 168 hours. The only degradation product found was 2-azahypoxanthine, which was detected in every sample. The storage and handling of dacarbazine should take into account both the loss of the drug and the production of its potentially toxic degradation product. Dacarbazine must be carefully protected from light, administered using opaque infusion tubing, and, if necessary, refrigerated before administration to reduce 2-azahypoxanthine formation.

Antineoplastic Agents, Alkylating↗
PubMed1984

Acoustic properties of polyvinyl chloride gelatin for use in ultrasonography.

Visualization of superficial structures with conventional rapid scanners has been difficult. A solid flexible polyvinyl chloride (PVC) gelatin slab used as a stand-off material can provide a constant scan distance and thus overcome the problem of poor near field resolution. PVC gelatin expands the capability of the 3-4 MHz transducer to delineate superficial structures. We report on the acoustic properties of the PCV gelatin, including the values of velocity and attenuation as a function of both frequency and temperature, and the comparison of data with published values of velocity and attenuation for water, soft tissue, and a phantom material.

Gelatin↗
PubMed1984

Two cases of liver angiosarcoma among polyvinyl chloride (PVC) extruders of an Italian factory producing PVC bags and other containers.

Two cases are reported of liver angiosarcoma occurring among polyvinyl chloride (PVC) extruders from a small Italian factory producing PVC bags and other containers. The possibility that PVC extrusion carries a risk of liver angiosarcoma is important because of the very large number of people working with extruding, manufacturing and handling PVC, as compared with the number of people working in PVC polymerization and/or VC production. In the past, the level of vinyl chloride (VC) concentration in PVC extrusion workplaces has been thought to be "safe".

Hemangiosarcoma↗
PubMed1988

Plasticized polyvinyl chloride film as a primary burns dressing: a microbiological study.

Twenty-four patients were studied after the application of plasticized polyvinyl chloride (PVC) film as a temporary burns dressing. The burns were assessed as being partial thickness (nine patients) and full thickness (15 patients) in depth and involving 2 per cent to 35 per cent of the body surface area. Microbiological cultures were performed on the exudate beneath the plasticized PVC film and then at each dressing change until the burn was healed. Bacterial isolates showed no unexpected organisms and there was no predominant organism to suggest contamination from the plasticized PVC film. Indeed, bacteria were only rarely isolated from the initial exudate (three of 37 burn wounds), and subsequent bacterial cultures did not differ from those normally found in burn wounds. In addition, incorporation of the plasticized PVC film into nutrient broth and agar with Staph, aureus and Ps. aeruginosa did not influence the recovery of these organisms, indicating that plasticized PVC film does not exert any antibacterial effect.

Adolescent↗
PubMed1983

[Effect of an electric charge on athrombogenic properties of polyvinyl chloride foil].

The authors present the results of investigation of fresh, human citrate blood after and before the contact with monoelectret of polyvinyl chloride (PVC). The investigations concerned the influence of electric charge of the results of thromboelastographic test and the outcome of microscopic examination. It was proved that blood after the contact with monoelectret contrary to the blood after the contact with sample lacking electret effect, had markedly prolonged thromboelastographic coagulation time and time of clot formation to standard elasticity.

Blood Coagulation↗
PubMed1989

The influence of product factors on the migration in soft polyvinyl chloride infusion fluid bags.

The concentration of epoxidized vegetable oils (EVO) and di(2-ethylhexyl) phthalate (DEHP) in infusion fluids in soft polyvinyl chloride (PVC) bags has been determined by gas-liquid chromatography prior to and after agitation. Normal saline, isotonic glucose and Ringer acetate from four different manufacturers were investigated. Agitation resulted in an increased concentration of EVO and DEHP. Significant differences in contamination level were observed between solutions of different compositions and in synonymous preparations from different manufacturers. The results indicated that the total amount of migrating EVO and DEHP was affected by the pH of the solution and by the age of the plastic material. It is suggested that the migration of EVO and DEHP during agitation is influenced by the concentration of plastic degradation products.

Chemistry, Pharmaceutical↗
PubMed1983

Evaluation of the pulmonary toxicity of plasticized polyvinyl chloride thermal decomposition products in guinea pigs by repeated CO2 challenges.

Male guinea pigs were exposed to thermal decomposition products of plasticized polyvinyl chloride (PVC-A) at different concentrations up to levels inducing acute lethality. Several groups exposed at sublethal levels were then evaluated for pulmonary performance for a period of 57 days following exposure. Pulmonary performance was evaluated by challenging each animal with a mixture containing 10% CO2, 20% O2, and 70% N2. In control animals, this mixture induced an increase in both tidal volume and respiratory frequency. This hyperventilatory response was greatly depressed during the first 3 days following exposure and gradually returned to normal during the following weeks with the exception of the highest exposure group which still showed a diminished response 57 days after exposure. The pulmonary toxicity induced by thermal decomposition products of PVC-A is probably related to the very large amount of HCl released during thermal decomposition. The CO2 response test, a nonintrusive and noninvasive method to evaluate pulmonary performance in guinea pigs, is easily performed and appears to be a very promising type of pulmonary function test for toxicological evaluations.

Animals↗