Migration of a Phthalate Ester Plasticizer from Polyvinyl Chloride Blood Bags into Stored Human Blood and Its Localization in Human Tissues

Jaeger, Rudolph J.; Rubin, Robert J.

doi:10.1056/nejm197211302872203

Cited by 382 publications

(65 citation statements)

References 19 publications

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“…As was demonstrated and stated above, the maximum nonteratogenic (both gross and skeletal) dose and median fetolethal dose (fetal LD50) in mice are approximately the same, around 600 mg/kg, while the maximum nonfetolethal dose in mice is about 64 mg/kg. In humans, approximately 4 mg/kg would be a possible maximum intake of DEHP by blood transfusion or hemodialysis (18). The level (unconditional) of the acceptable daily intake for humans (ADI) is about 1 mg/kg/day (19).…”

Section: Resultsmentioning

confidence: 99%

Teratogenicity/fetotoxicity of DEHP in mice.

Tomita¹,

Nakamura²,

Yagi³

et al. 1982

Environ Health Perspect

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The embryonic/fetotoxic effects of DEHP on pregnant mice (ddY-Slc Y x CBA Cd) were studied. DEHP was administered orally in dosages of 0.05 ml/kg to 30.0 mg/kg on day 6, 7, 8, 9 or 10 of gestation. A single administration of DEHP over 0.1 ml/kg (1/300 of LD50) on day 7 of gestation decreased the numbers and the body weight of living fetuses, whereas no significant changes in the numbers of living fetuses (with no gross and skeletal abnormalities) were observed compared with those of the control group, when 0.05 ml/kg (1/600 of LD50) of DEHP was administered. The fetotoxicity (fetal death) was dose dependent. The LD50 and the nonfetolethal maximum dosage of DEHP in its single, oral administration was 592 mg/kg and 64 mg/kg, respectively. The latter value is much higher than an estimated DEHP intake from commercial foodstuffs in men, which is approximately 0.03 mg/kg/day.

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Section: Resultsmentioning

confidence: 99%

Teratogenicity/fetotoxicity of DEHP in mice.

Tomita¹,

Nakamura²,

Yagi³

et al. 1982

Environ Health Perspect

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“…Their PVC plastic-rich environment includes a high percentage (up to 40% by weight) of di-(2-ethylhexyl) phthalate (DEHP), which is the only plasticizer approved by the US Food and Drug Administration for medical uses. 1 DEHP, which is not covalently bound to the plastic, is released from PVC medical devices [2][3][4][5] at a rate that depends on several factors, including storage and use temperatures, storage time, flow rate of solutions through the tubing, percentage of DEHP in the PVC product, and the lipophilic nature of the solution in contact with the PVC plastic. 6,7 Therefore, patients who undergo medical procedures that involve the use of medical devices that contain PVC may be potentially exposed to much higher levels of DEHP than the general population because these procedures may deliver to the patient via ingestion, intravenous, and dermal absorption considerable doses of DEHP.…”

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confidence: 99%

Exposure to Di-(2-Ethylhexyl) Phthalate Among Premature Neonates in a Neonatal Intensive Care Unit

et al. 2004

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ABSTRACT. Objective. Premature neonates who spend time in a neonatal intensive care unit may be at increased risk of adverse health effects from exposure to di-(2-ethylhexyl) phthalate (DEHP) because of their increased risk of high exposure, their small body size, and their physical condition. DEHP, a reproductive toxicant in animals, is a major component in polyvinyl chloride (PVC) plastics, which are frequently used in medical tubing and blood storage bags. DEHP is not covalently bound to PVC, and it may be easily released from the PVC medical devices. The objective of this study was to determine whether premature infants who undergo medical procedures, such as blood transfusions, intravenous therapy, enteral and parenteral nutrition support, and dialysis, are at increased risk of exposure to DEHP than the general population. Because of their smaller size, children and especially premature and small infants may receive a larger dose of DEHP on a milligram per kilogram basis than adults when the same-size medical device is used for all ages.Methods. Premature neonates who seemed to have the potential to be on intravenous infusion for >2 weeks and were expected to survive were eligible for enrollment in the study. We assessed exposure to DEHP in 6 premature newborns by measuring in 41 urine samples the levels of 3 DEHP metabolites: mono-(2-ethylhexyl) phthalate (mEHP), mono-(2-ethyl-5-hydroxyhexyl) phthalate (mEHHP), and mono-(2-ethyl-5-oxohexyl) phthalate (mEOHP).Results. mEHHP and mEOHP were detected in all 41 urine samples, and mEHP was detected in 33. Because only 33 of the samples had detectable amounts for all 3 metabolites, statistical analyses were limited to those 33. The levels of all 3 DEHP metabolites varied widely, and the urinary mean and median concentrations of mEOHP and mEHHP were 1 order of magnitude higher than those for mEHP. Furthermore, the geometric mean urinary concentrations of mEOHP (1617 ng/mL), mEHHP (2003 ng/mL), and mEHP (100 ng/mL) in these 6 premature infants who underwent intensive therapeutic interventions were found to be severalfold higher than in the US general population (for mEHP, geometric mean in those 6 years and older was 3.43 ng/mL).Conclusions. This study provides the first quantitative evidence confirming that newborns who undergo intensive therapeutic medical interventions are exposed to higher concentrations of DEHP than the general population. Although the overall benefits of medical procedures using PVC devices outweigh the risks associated with exposure to DEHP, more research is needed to determine whether infants and children who undergo intensive therapeutic interventions using DEHP-containing devices are at higher risk for altered health outcomes than infants and children who undergo similar treatments but are not potentially exposed to DEHP. Pediatrics 2004;113:e429 -e434. URL: http://www.pediatrics.org/ cgi/content/full/113/5/e429; DEHP, phthalate, plasticizer, urine, biomarker.ABBREVIATIONS. PVC, polyvinyl chloride; DEHP, di-(2-ethylhexyl) phthalate; mEHP,...

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“…In 1970 DEHP was detected in the tissues and organs of two deceased patients who had previously received transfusions (9). The potential for DEHP accumulation in blood (10) and red cell concentrates (20) was found to be high during the storage of these materials in bags made of polyvinyl chloride.…”

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confidence: 99%