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Informative Facts and Information Concerning
Di(2-ethylhexyl)
phthalate DEHP
There is worldwide debate as to the health
hazards and risks associated with the chemical DEHP. The European
community, led by a study conducted in Sweden, and a recent meeting of the
European Union in Italy, states that DEHP at moderate levels does not pose
any serious health problems.
The Agency for Toxic
Substances and Disease Registry here in the United States has published
similar findings. “Exposure to DEHP is generally very low. Increased
exposures may come from intravenous fluids delivered through plastic
tubing, and from ingesting contaminated foods or water. DEHP is not toxic
at low levels. In animals, high levels of DEHP damaged the liver and
kidney and affected the ability to reproduce.”
“The Department of Health and Human Services
(DHHS) has determined that DEHP may reasonably be anticipated to be a
human carcinogen. The EPA has determined that DEHP is a probable human
carcinogen. These determinations were based entirely on liver cancer in
rats and mice. The International Agency for Research on Cancer (IARC) has
stated that DEHP cannot be classified as to its carcinogenicity to
humans.”
“The EPA limits the amount of DEHP that may be
present in drinking water to 6 parts of DEHP per billion parts of water (6
ppb).
The Occupational Safety and Health
Administration (OSHA) sets a maximum average of 5 milligrams of DEHP per
cubic meter of air (5 mg/m³) in the workplace during an 8-hour shift. The
short-term (15-minute) exposure limit is 10 mg/m³.”
FDA Public Health Notification: PVC Devices
Containing the Plasticizer DEHP
Everyone is exposed to small levels of DEHP in
everyday life. However, some individuals can be exposed to high levels of
DEHP through certain medical procedures. DEHP can leach out of plastic
medical devices into solutions that come in contact with the plastic. The
amount of DEHP that will leach out depends on the temperature, the lipid
content of the liquid, and the duration of contact with the plastic.
Seriously ill individuals often require more than one of these procedures,
thus exposing them to even higher levels of DEHP.
Exposure to DEHP has produced a range of
adverse effects in laboratory animals, but of greatest concern are effects
on the development of the male reproductive system and production of
normal sperm in young animals. We have not received reports of these
adverse events in humans, but there have been no studies to rule them out.
However, in view of the available animal data, precautions should be taken
to limit the exposure of the developing male to DEHP.
U.S. Environmental Protection Agency
Bis(2-ethylhexyl) phthalate (DEHP) is used in
the production of polyvinyl chloride (PVC). It exhibits low toxicity from
acute (short-term) and chronic (long-term) exposures. Acute exposure to
large oral doses of DEHP can cause gastrointestinal distress in humans.
No information is available on the chronic, reproductive, developmental,
or carcinogenic effects of DEHP in humans. Animal studies have reported
increased lung weights and increased liver weights from chronic inhalation
exposure to DEHP. Oral exposure has resulted in developmental and
reproductive effects in rats and mice. A study by the National Toxicology
Program (NTP) showed that DEHP administered orally increased the incidence
of liver tumors in rats and mice. EPA has classified DEHP as a Group B2,
probable human carcinogen
Sources and Potential Exposure
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The most probable route of exposure to DEHP is through
food, with an average contribution of DEHP from food of 0.25 milligrams
per day (mg/d). DEHP migrates into food from plastics during processing
and storage.
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Exposure to DEHP can also occur during certain medical
procedures, such as blood transfusions and kidney dialysis and use of
respirators
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In one study, DEHP was found in drinking water, at
levels ranging from 0.04 to 30 parts per billion (ppb).
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The average ambient air concentration of DEHP is very
low, with < 0.002 ppb in urban areas. DEHP levels in indoor air in a
newly painted room or a room with recently installed flooring could be
higher than levels in the outdoor air.
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Occupational
exposure to DEHP may occur for those workers in factories that
manufacture or use the chemical.
References:
Agency for Toxic
Substances and Disease Registry
http://www.atsdr.cdc.gov/tfacts9.html
International Program
on Chemical Safety
http://www.inchem.org/documents/ehc/ehc/ehc131.htm
U.S. Environmental
Protection Agency
http://www.epa.gov/ttn/atw/hlthef/eth-phth.html
U.S. Food and Drug
Administration
http://www.fda.gov/cdrh/safety/dehp.html
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