[ 22 October 2004 ]

Neonate exposure to DEHP doesn't harm physical or sexual growth

New study confirms no long-term effects from life-saving medical devices

A study of a group of teenagers, highly exposed to di(2-ethylhexyl) phthalate (DEHP) as babies, has shown no adverse effects on their physical growth or sexual development.

The study, on 19 children aged between 14 and 16 years old, was conducted to investigate whether exposure to high levels of DEHP by neonates might cause adverse health effects. However, it showed that pubertal maturity, liver, renal and male and female reproductive functions were normal.

DEHP is used to make polyvinyl chloride (PVC) plastic tubing soft and flexible, and is widely used in disposable medical devices. However, it is known that small amounts can seep out of flexible medical devices and ultimately enter the patient. Individuals undergoing medical treatment such as dialysis, exchange transfusion, extracorporeal membrane oxygenation (ECMO), and cardiovascular surgery can be exposed to higher than normal levels.

The findings of the study, published in the September issue of the peer-reviewed journal Environmental Health Perspectives (EHP), are based on the analysis of adolescents who had been treated as neonates with ECMO. During ECMO, which is used for patients who are too sick to be supported with a ventilator, blood is circulated outside the body and oxygenated before being returned again. During ECMO treatment, infants can be exposed to DEHP at levels similar to those shown to cause adverse reproductive effects in animals.

“Our study did not show long-term adverse outcome related to physical growth and pubertal development in adolescents previously exposed to DEHP in the neonatal period,” the study authors write. “This is in contrast to the animal data in multiple species, which show a variety of reproductive and developmental toxicities when this plasticiser is administered.”

“The results are very reassuring,” said Dr David Cadogan, Director of the European Council for Plasticisers and Intermediates (ECPI). “Medical devices, made flexible with DEHP, have been used for more than 40 years without a single known case of anyone having been harmed as a result. To the contrary, they have saved many lives and continue to be vital to modern health care.”

“Consumer groups have expressed concern that adverse reproductive and developmental effects seen in rodents when exposed to very high levels of DEHP might put highly exposed people at risk. However, these studies are very encouraging,” he said.

In a published Opinion on the use of di(2-ethylhexyl) phthalate (DEHP) in medical devices the European Union’s Scientific Committee on Medicinal Products and Medical Devices said that it could make no recommendations to limit its use, even for the most highly exposed patients.

Although the scientific committee report proposed that additional research be conducted to monitor the situation, it said "there are no reports concerning any adverse effects in humans following exposure to DEHP-PVC, even in neonates or other groups of relatively high exposure."

The team of researchers who carried out this study are from two leading medical institutions in the United States and were led by Dr Khodayar Rais-Bahrami of the Children’s National Medical Center and the George Washington University School of Medicine.

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Notes for Editors:

The full article “Follow-Up Study of Adolescents Exposed to Di(2-Ethylhexyl) Phthalate (DEHP) as Neonates on Extracorporeal Membrane Oxygenation (ECMO) Support” is available online from Environmental Health Perspectives (EHP): http://ehp.niehs.nih.gov/docs/2004/6901/abstract.html

EHP is published by the National Institute of Environmental Health Sciences, part of the U. S. Department of Health and Human Services.

For further information please contact:

Tim Edgar
European Council for Plasticisers and Intermediates
Avenue E Van Nieuwenhuyse 4,
B-1160 Brussels, Belgium

ted@cefic.be

Telephone: 0032 2 676 7363
Mobile: 0032 475 37 66 93