*extrusions* eNewsletter article - DEHP – What's the Worry
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Issue Number 34 NOVEMBER 2014
DEHP — What's the Worry?

DEHP FreeDEHP, or Di(2-ethylhexyl) phthalate, is a chemical agent used as a plasticizer. It's added to PVC resin to increase workability during processing and impart flexibility to the finished product. The substance is leachable, meaning that it may come out of, or leach from, a finished product such as tubing and then mix with whatever fluid is flowing through the tubing.

Leaching is often undesirable, but in a lot of applications it doesn't matter. When the fluid being transferred within the tubing is one that will not be ingested, has no effect on parts or processes farther down the line, or is a waste product, concerns can be limited. However, when the tubing is used in a medical device, unease about its usage arises.

There are varying opinions regarding DEHP's dangers. One viewpoint notes that DEHP and other plasticizers (BBP, DBP, DnHP, and DIDP) are included on lists of carcinogens from the federal government and the state of California (known as California Proposition 65). DEHP has, in fact, been included on the Prop 65 list for over 25 years. The chemicals' use in medical devices has caused so much concern that products containing the substances over a certain concentration must display a warning label.

Other agencies consider DEHP a chemical to be avoided. Their recommendations are based on studies conducted on rodents that show problems with the development of testicles and the production of normal sperm. To date there is no evidence suggesting harm has come to humans because of DEHP exposure, but many assessments regarding chemicals, medical devices and humans are based on the potential for harm. Common practice is to learn whether a device may be harmful before it goes into use and actually causes injury.

Other parties say that the amount of DEHP that can be transferred from a device's tubing to a human is so small that the chemical agent's potential for harm is negligible except for a few specific cases. Concerns involving cumulative exposure to DEHP have been expressed, but currently there is no evidence that DEHP exposure has harmed a human.

If your application calls for PVC tubing that's free of DEHP, take a look at NewAge's Nylobrade® reinforced PVC hose. It's certified by the National Sanitation Foundation for food equipment materials (NSF-51) and potable water (NSF-61) and contains non-toxic ingredients that conform to USP Class VI and FDA standards.

Questions about DEHP or any of our products? Give one of our Fluid Transfer Specialists® a call at 215-526-2300 or 1-800-506-3924.

Article references:

http://www.fda.gov/medicaldevices/resourcesforyou/consumers/choosingamedicaldevice/ucm142643.htm#
http://oehha.ca.gov/prop65/background/p65plain.html
https://noharm-uscanada.org/issues/us-canada/phthalates-and-dehp


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