[ 13 March 2003 ]

Health Effects of DEHP in Rodents Unlikely to be Relevant to Humans Shows New Research

High Doses Show No Testicular Effects in Developing Primates

The safe use of the plasticiser Di(2-ethylhexyl) phthalate (DEHP) has been further confirmed by a major new scientific research study which shows that reproductive effects seen in rodents are unlikely to be relevant to humans.

The new study, presented at the 42nd Annual Society of Toxicology Meeting (SOT) in the United States (March 9 - 13, 2003), was conducted on Marmosets, scientifically considered to be among the closest primate species to humans in terms of reproductive development. The young male marmosets, studied from weaning to sexual maturity, were shown to have developed normally without the testicular effects of DEHP that have been seen in rodents.

“This was the closest to conducting a realistic human study without testing on humans themselves,” said Dr David Cadogan, Director of the European Council for Plasticisers and Intermediates (ECPI). “It is very important because it clearly shows that reproductive effects seen in rodents are species-specific and do not appear to affect primates”.

Two years ago DEHP was removed from the World Health Organisation’s list of possible human carcinogens after it had been similarly determined that effects seen on rodents were not relevant to primates.

The new study, conducted over 65 weeks and at a cost of more than $1 million, was carried out by a Japanese research institute using the very latest and most technically advanced scientific equipment. It closely follows the recent publication of two other scientific reports⁽¹⁾ which similarly support the growing evidence that DEHP can continue to be used safely and without concern for human health.

Although the animals were treated with exceptionally large doses of DEHP in order to ascertain whether it would affect them even at very high levels, it was tolerated well by the marmosets and they were all treated humanely. The study was also conducted according to strict international ethical standards.

DEHP is widely used today to make polyvinyl chloride (PVC) flexible in a broad range of everyday applications from flooring to life-saving medical devices.

• Study Abstract
• DEHP Information Centre

(1) Schilling, K., Gembardt, C., and Hellwig, J. (2001). Di-2-ethylhexyl phthalate - Two-generation reproduction toxicity study in Wistar rats. Continous dietary administration. Experimental Toxicology and Ecology, BASF Aktiengesellschaft, D-67056 Ludwigshafen, FRG. Laboratory project identification 70R0491/97139. 1183 pages.

(2) Wolfe G, Layton K, Nehrebeckyj L, Wang Y, Chapin R, Rousselle S and Bishop J,  Reproductive effects of DEHP in Sprague - Dawley rats when assessed by the continuous breeding protocol. Presented at the US Society of Toxicology meeting, 20 March 2002
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For further information please contact:

Tim Edgar
Deputy Director
European Council for Plasticisers and Intermediates (ECPI)
Brussels, Belgium

Tel: 0032 2 676 7363 / 0032 475 37 66 93
Fax: 0032 2 676 7392
e-mail: ted@cefic.be