California Proposition 65 currently establishes a no significant risk level of 80 ug/day, low compared to the percent levels used in plastics and our possible exposure. Several research groups believe that DEHP acts as a hormone disruptor.  An NTP panel found that out of several phthalate esters, only DEHP is a significant concern as a reproductive toxin.

Common uses of flexible PVC tubing and DEHP that are currently under attack are in power cords and medical devices (intravenous sets and delivery tubes) .

bis(2-ethylhexl) phthalate, DEHP, or dioctyl phthalate (DOP) is a commonly used plasticizer in vinyl plastics

C&EN March 3, 2003

C&EN Nov 14, 2005

FDA Safety Assessment
 for Medical Devices

Testing for DEHP and other Phthalates

Phthalates can be determined by gas chromatography (GC, EPA Methods 606 and 8060) or gas chromatography -mass spectrometry (GCMS, EPA Methods 525 and 8270). GCMS is the preferred technique due to the added specificity of the mass spectrometer detector and the potential for interferences in complex samples. The detection limit in solution is less than 1 ug/mL. With common extraction and concentration techniques, GC and 

GCMS are capable of detecting ppb levels of phthalates. 

Factors which need to be taken into account when analyzing for DEHP are that (1) it may be one of several phthalate esters used in the plasticizer and (2) phthalate esters hydrolyze in water to phthalic acid (1,2-benzenedicarboxylic acid). Some commercial plasticizers use complex mixtures of phthalate esters of which DEHP is only a minor part and may be difficult to resolve from other esters. 

For a quotation...

Interlaboratory Studies

WCAS has participated in two international interlaboratory studies to measure various phthalates in several types of PVC.  The studies were conducted by the Institute for Interlaboratory Studies (IIS).  The study of February 2007 included 70 laboratories, up from 20 laboratories in the February 2002 study. WCAS was one of two laboratories in the USA to participate.

The GCMS technique described above was used to test for 11 different phthalate esters. 

The results for DEHP are summarized below.  The studies included other phthalate esters as well as total phthalates.  Our results showed no false positives or false negatives, and all results were within one standard deviation of the mean.

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