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Recent progress in safety evaluation studies on plasticizers and plastics and their controlled use in Japan.

Recent experimental studies in Japan on the evaluation of potential health hazards from phthalate esters used in manufacturing poly (vinyl chloride) as well as several plastics for medical devices and for food containers and packages were introduced. Development of pulmonary granuloma formation after intravenous injection of diethylhexyl phthalate was assumed to be dependent on the particle size of the phthalate in vehicle used. Dietary administration of large amount of diethylhexyl phthalate and dibutyl phthalate produced renal cysts in mothers and in descendants in reproduction studies in mice. Cytotoxicity and mutagenicity of the phthalates and several plastics and resins were also examined by in vivo and in vitro studies. Hematological parameters examined in rabbits after repeated intravenous injection of diethylhexyl phthalate and after implantation of plastics in aorta for 3--6 months did not show any significant change. A slow decrease of radioactivity was observed in adipose tissue of rats following oral administration of 14C-labeled diethylhexyl phthalate. tthe administrative action on phthalates by the Japanese Ministry of Health and Welfare is briefly reviewed.

Animals

Attempts to control clothes-borne infection in a burn unit, 3. An open-roofed plastic isolator or plastic aprons to prevent contact transfer of bacteria.

An open-roofed plastic isolator was built in a single patient isolation room in a burn unit. It was designed to prevent contact contamination only, as this had been shown to be the important route of cross-colonization in the unit. To exclude any possible effect on airborne transfer of bacteria, the isolator was first examined by means of an airborne particle tracer of the same size as bacteria-carrying particles. Such experiments indicated that the isolator might prevent some transfer out of but not into the isolator. This was not confirmed in simulated nursing experiments nor in a patient study, where the air counts of bacteria were practically the same inside and outside the isolator wall. Two patients only were nursed in the isolator. Both patients acquired exogenous colonizations from other patients, one with Ps. aeruginosa and the other with S. aureus. Nursing in the isolator was difficult and staff-demanding. In simulated nursing experiments, plastic aprons and gauntlets as the only protective measures against contact contamination gave as much protection to a mock patient as did the isolator. S. aureus were released from nurses' clothes more easily during work with the isolator than in open nursing with aprons and gauntlets. In conclusion, the isolator did not seem to be a realistic alternative to impermeable clothes such as plastic aprons as a means of preventing clothes-borne cross-contamination between burn patients.

Adult

Fate in humans of the plasticizer, di-2-ethylhexyl phthalate, arising from transfusion of platelets stored in vinyl plastic bags.

Platelet concentrates were shown to contain 18 to 38 mg/dl of a phthalate plasticizer (DEHP) which arose by migration from the vinyl plastic packs in which the platelets were prepared and stored. Transfusion of these platelets into six adult patients with leukemia resulted in peak blood plasma levels of DEHP ranging from 0.34 to 0.83 mg/dl (approximately 0.02 mg/dl plasma per mg DEHP administered per square meter of surface area). The blood levels fell monoexponentially with a mean rate of 2.83 per cent per minute and a half-life of 28.0 minutes. Urine was assayed by a method that would measure unchanged DEHP as well as all phthalic acid-containing metabolites. In two patients, at most 60 and 90 per cent of the infused dose, respectively, was excreted in the urine collected for 24 hours posttransfusion. These estimates, however, could be high due to the simultaneous excretion of DEHP remaining from previous transfusions or arising from uncontrolled environmental exposures.

Blood Platelets