[ 09 June 2005 ]

Study on neonates provides no new information and rings no alarm bells

Statement by the European Council for Plasticisers and Intermediates (ECPI)

Use of di(2-ethylhexyl) phthalate containing medical products and urinary levels of mono(2-ethylhexyl) phthalate in neonatal intensive care unit infants
Ronald Green, Russ Hauser, Antonia M. Calafat, Jennifer Weuve, Ted Schettler, Steven Ringer, Kenneth Huttner, and Howard Hu

Published online by Environmental Health Perspectives - June 8, 2005

This study contains no significant new information and certainly nothing which rings alarm bells. It agrees with earlier studies and states the obvious -- newborns who receive intensive care, perhaps to save their lives, have measured phthalate levels above the average while undergoing these critical medical procedures.

The reported levels in this study are actually reassuring -- even in the most highly exposed group of children studied, the reported phthalate levels in all the children in that group are below the levels that show no effect in laboratory animals. And it takes a whole lifetime of doses far higher than seen here to cause the negative health effects in some rodents.

It should be noted that a recent small study of teenagers who were critically ill at birth and who received intensive care for a longer period than the children in this study showed none of the health effects seen in rodents (please see press release of October 22, 2004)

"This lastest study by Green et al adds nothing to the one by Calafat et al published in Pediatrics in May last year¹", said ECPI Director, Dr David Cadogan.

"Ms Calafat concluded at the time that her study provided the first quantitative evidence confirming that newborns who undergo intensive therapeutic medical interventions are exposed to higher concentrations of DEHP than the general population," he said.

The authors of the earlier study conclude that although the overall benefits of medical procedures using PVC devices outweigh the risks associated with exposure to DEHP, more research was 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.

"The study on teenagers who had been highly exposed as infants² goes a long way towards providing that evidence," said Dr Cadogan.

1. Exposure to Di(2-Ethylhexyl) Phthalate Amiong Premature Neonates in a Neonatal Intensive Care Unit - Antonia M Calafat, Larry L Needham, Manori J Silva, and George Lambert. Pediatrics 2004; 113: e429-e434.

2. Follow-Up Study of Adolescents Exposed to Di(2-Ethylhexyl) Phthalate (DEHP) as Neonates on Extracorporeal Membrane Oxygenation (ECMO) Support - Khodayar Rais-Bahrami,  Susan Nunez, Mary E. Revenis, Naomi L. C. Luban, and Billie L. Short. Environmental Health Perspectives; 112:1339-1340 (2004). doi: 10.1289/ehp. 6901

Please also read the article on this study on the TCS website

For further information please contact:

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

Telephone: +32 2 676 7363
Mobile: +32 475 37 66 93