Microsoft Word - DEHP

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

This Public Health Statement is the summary

chapter from the Toxicological Profile for Di(2-

ethylhexyl) phthalate (DEHP). It is one in a series

of Public Health Statements about hazardous

substances and their health effects. A shorter

version, the ToxFAQs

TM

is also available. This

information is important because this substance may

harm you. The effects of exposure to any hazardous

substance depend on the dose, the duration, how

you are exposed, personal traits and habits, and

whether other chemicals are present. For more

information, call the ATSDR Information Center at

1-888-422-8737.

_____________________________________

This public health statement tells you about di(2-

ethylhexyl) phthalate (DEHP) and the effects of

exposure.

The Environmental Protection Agency (EPA)

identifies the most serious hazardous waste sites in

the nation. These sites make up the National

Priorities List (NPL) and are the sites targeted for

long-term federal cleanup activities. DEHP has

been found in at least 737 of the 1,613 current or

former NPL sites. However, the total number of

NPL sites evaluated for DEHP is not known. As

more sites are evaluated, the sites at which DEHP is

found may increase. This information is important

because exposure to DEHP may harm you and

because these sites may be sources of exposure.

When a substance is released from a large area,

such as an industrial plant, or from a container, such

as a drum or bottle, it enters the environment. This

release does not always lead to exposure. You are

exposed to a substance only when you come in

contact with it. You may be exposed by breathing,

eating, or drinking the substance, or by skin contact.

If you are exposed to DEHP, many factors

determine whether you'll be harmed. These factors

include the dose (how much), the duration (how

long), and how you come in contact with it. You

must also consider the other chemicals you're

exposed to and your age, sex, diet, family traits,

lifestyle, and state of health.

1.1 WHAT IS DEHP?

DEHP, which is an abbreviation for di(2-

ethylhexyl) phthalate, is a manufactured chemical

that is commonly added to plastics to make them

flexible. Other names for this compound are dioctyl

phthalate (DOP) and bis(2-ethylhexyl) phthalate

(BEHP). (Note that di-n-octyl phthalate, however, is

the name for a different chemical.) Trade names

used for DEHP include Platinol DOP, Octoil,

Silicol 150, Bisoflex 81, and Eviplast 80. DEHP is a

colorless liquid with almost no odor. It does not

evaporate easily, and little will be present in the air

even near sources of production. It dissolves more

easily in materials such as gasoline, paint removers,

and oils than it does in water. It is present in many

plastics, especially vinyl materials, which may

contain up to 40% DEHP, although lower levels are

common. DEHP is present in plastic products such

as wall coverings, tablecloths, floor tiles, furniture

upholstery, shower curtains, garden hoses,

swimming pool liners, rainwear, baby pants, dolls,

some toys, shoes, automobile upholstery and tops,

packaging film and sheets, sheathing for wire and

cable, medical tubing, and blood storage bags.

1.2 WHAT HAPPENS TO DEHP WHEN IT

ENTERS THE ENVIRONMENT?

DEHP can enter the environment through releases

from factories that make or use DEHP and from

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

household items containing it. Over long periods of

time, it can move out of plastic materials into the

environment. Therefore, DEHP is widespread in the

environment; about 291,000 pounds were released

in 1997 from industries. It is often found near

industrial settings, landfills, and waste disposal

sites. A large amount of plastic that contains DEHP

is buried at landfill sites. DEHP has been found in

groundwater near waste disposal facilities.

When DEHP is released to soil, it usually attaches

strongly to the soil and does not move very far away

from where it was released. When DEHP is released

to water, it dissolves very slowly into underground

water or surface waters that contact it. It takes many

years before DEHP in buried or discarded materials

disappears from the environment. Because DEHP

does not evaporate easily, normally very little goes

into the air. DEHP in air will bind to dust particles

and will be carried back down to earth through

gravity and rain or snow. Indoor releases of DEHP

to the air from plastic materials, coatings, and

flooring in home and work environments, although

small, can lead to higher indoor levels than are

found in the outdoor air.

DEHP can break down in the presence of other

chemicals to produce mono(2-ethylhexyl)phthalate

(MEHP) and 2-ethylhexanol. Many of the

properties of MEHP are like those of DEHP, and

therefore its fate in the environment is similar. In

the presence of oxygen, DEHP in water and soil can

be broken down by microorganisms to carbon

dioxide and other simple chemicals. DEHP does not

break down very easily when deep in the soil or at

the bottom of lakes or rivers where there is little

oxygen. It can be found in small amounts in fish

and other animals, and some uptake by plants has

been reported.

1.3 HOW MIGHT I BE EXPOSED TO DEHP?

You can be exposed to DEHP through air, water, or

skin contact with plastics that have DEHP in them.

Food may also contain DEHP, but it is not certain

how much.

It is not clear, but it is likely that a little DEHP is

transferred by skin contact with plastic clothing or

other articles that contain DEHP. Exposure through

this route is expected to be low since plastic articles

of clothing, like raincoats, do not have direct

contact with your skin, and transfer is probably very

low even if they do touch you.

You may be exposed to DEHP through drinking

water, but it is not known how common this is. If

you drink water from a well located near a landfill

or waste site, you may be exposed to higher-than-

average levels of DEHP.

You can breathe in DEHP that has been released to

the environment. The average air level of DEHP is

very low, less than 2 parts of DEHP per trillion

parts of air (ppt) in cities and industrial areas.

DEHP levels in the indoor air in a room with

recently installed flooring could be higher than

levels in the outdoor air. Workers in factories that

make or use DEHP also breathe in higher-than-

average levels of this compound.

DEHP also can enter your body during certain

medical procedures, and medical exposures are

likely to be greater than any environmental

exposures. Blood products that are stored in plastic

bags and used for transfusions contain from 4.3 to

1,230 parts of DEHP per million parts of blood

(ppm). Other plastic medical products also release

DEHP. Flexible tubing used to administer fluids or

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

medication can transfer DEHP to the patient. The

plastic tubing used for kidney dialysis frequently

contains DEHP and causes DEHP to enter the

patient's blood. DEHP also is present in the plastic

tubing of respirators and is carried from it to the

lungs.

1.4 HOW CAN DEHP ENTER AND LEAVE

MY BODY?

DEHP enters your body when you eat food or drink

water containing this material or when you breathe

in contaminated air. Small amounts of DEHP might

enter your body by skin contact with plastics, but

scientists are fairly certain that very little enters this

way. Most DEHP that enters your body in food,

water, or air is taken up into the blood from the

intestines and lungs. DEHP can be introduced

directly into your bloodstream if you get a blood

transfusion, receive medicines through flexible

plastic tubing, or have dialysis treatments.

After DEHP is ingested, most of it is rapidly broken

down in the gut to MEHP and 2-ethylhexanol.

Breakdown is much slower if DEHP enters your

blood directly by way of a transfusion. Although

some MEHP is absorbed into the bloodstream from

the gut, MEHP is poorly absorbed, so that much of

ingested DEHP leaves the body in the feces. The

compounds that do enter the blood travel through

the bloodstream to your liver, kidneys, testes, and

other tissues, and small amounts might become

stored in your fat and could possibly be secreted in

breast milk. Most of the DEHP, MEHP, and 2-

ethylhexanol leaves your body within 24 hours in

the urine and feces.

1.5 HOW CAN DEHP AFFECT MY HEALTH?

To protect the public from the harmful effects of

toxic chemicals and to find ways to treat people

who have been harmed, scientists use many tests.

One way to see if a chemical will hurt people is to

learn how the chemical is absorbed, used, and

released by the body; for some chemicals, animal

testing might be necessary. Animal testing might

also be used to identify health effects such as cancer

or birth defects. Without laboratory animals,

scientists would lose a basic method to get

information needed to make wise decisions to

protect public health. Scientists have the

responsibility to treat research animals with care

and compassion. Laws today protect the welfare of

research animals, and scientists must comply with

strict animal care guidelines.

DEHP, at the levels found in the environment, is not

expected to cause adverse health effects in humans.

A man who voluntarily swallowed 10 g

(approximately 0.4 ounces) of DEHP had stomach

irritation and diarrhea. Most of what we know about

the health effects of DEHP comes from studies of

rats and mice that were given DEHP in their food,

or the DEHP was placed in their stomach with the

aid of a tube through their mouth. In most of these

studies, the amounts of DEHP given to the animals

were much higher than the amounts found in the

environment. Rats and mice appear to be

particularly sensitive to some of the effects of

DEHP. Thus, because certain animal models may

not apply to humans, it is more difficult to predict

some of the health effects of DEHP in humans

using information from these studies.

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

Breathing DEHP does not appear to have serious

harmful effects. Studies in rats have shown that

DEHP in the air has no effect on lifespan or the

ability to reproduce. As mentioned previously,

almost no DEHP evaporates into air. You probably

will not have any health effects from skin contact

with DEHP because it cannot be taken up easily

through the skin.

Short-term oral exposures to levels of DEHP much

higher than those found in the environment

interfered with sperm formation in mice and rats.

These effects were reversible, but sexual maturity

was delayed when the animals were exposed before

puberty. Short-term exposures to low levels of

DEHP appeared to have no effect on male fertility.

Studies of long-term exposures in rats and mice

have shown that high oral doses of DEHP caused

health effects mainly in the liver and testes. These

effects were induced by levels of DEHP that are

much higher than those received by humans from

environmental exposures. Toxicity of DEHP in

other tissues is less well characterized, although

effects in the thyroid, ovaries, kidneys, and blood

have been reported in a few animal studies. The

potential for kidney effects is a particular concern

for humans because this organ is exposed to DEHP

during dialysis and because structural and

functional kidney changes have been observed in

some exposed rats. Since changes in the kidneys of

long-term dialysis patients might be due to the

underlying kidney disease, and kidney changes have

not been consistently seen in animals exposed to

DEHP, the significance of the rat kidney changes is

not clear.

Humans absorb and breakdown DEHP in the body

differently than rats and mice. Therefore, many of

the effects seen in rats and mice after exposures to

DEHP might not occur in humans and higher

animals like monkeys (primates).

No studies have evaluated the potential for DEHP to

cause cancer in humans. Eating high doses of

DEHP for a long time resulted in liver cancer in rats

and mice.

The Department of Health and Human Services

(DHHS) has determined that DEHP may reasonably

be anticipated to be a human carcinogen. 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 recently changed its classification for

DEHP from "possibly carcinogenic to humans" to

"cannot be classified as to its carcinogenicity to

humans," because of the differences in how the

livers of humans and primates respond to DEHP as

compared with the livers of rats and mice.

1.6 HOW CAN DEHP AFFECT CHILDREN?

This section discusses potential health effects from

exposures during the period from conception to

maturity at 18 years of age in humans.

Children can be exposed to DEHP if they eat food

or drink water contaminated with DEHP or if they

breathe in the chemical from ambient or indoor air.

Small children can also be exposed by sucking on

or skin contact with plastic objects (toys) and

pacifiers that contain DEHP, as well as by ingestion

of breast milk containing DEHP. Children also can

be exposed to DEHP if they undergo certain

medical procedures that require the use of flexible

tubing such as that used to administer fluids or

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

medication to the patient. However, there is no

conclusive evidence of adverse health effects in

children exposed to DEHP in any of these ways.

In studies of pregnant mice and rats orally exposed

to large doses of DEHP, effects on the development

of the fetus, including birth defects and even fetal

death, were observed. Researchers observed

alterations in the structure of bones and of parts of

the brain, and in the liver, kidney, and testes of the

young animals. These harmful effects suggested

that DEHP or some of its breakdown products

passed across the placenta and reached the fetus.

Therefore, humans exposed to sufficiently high

levels of DEHP during pregnancy could possibly

have babies with low birth weights and/or skeletal

or nervous system developmental problems, but this

is not certain. Studies in animals also have shown

that DEHP or some of its breakdown products can

pass from mother to babies via the breast milk and

alter the development of the young animals. This

could also happen in humans because DEHP has

been detected in human milk.

We do not know whether children differ from adults

in their susceptibility to health effects from DEHP.

However, studies suggest that young male animals

are more susceptible than older ones to the adverse

effects of DEHP on the sex organs.

1.7 HOW CAN FAMILIES REDUCE THE

RISK OF EXPOSURE TO DEHP?

If your doctor finds that you have been exposed to

significant amounts of DEHP, ask whether your

children might also be exposed. Your doctor might

need to ask your state health department to

investigate. As discussed in Section 1.8, tests for

DEHP only provide a measure of recent exposure to

the chemical.

DEHP is used in many products that are made from

plastic, but especially a plastic known as polyvinyl

chloride (PVC) or vinyl. When it is found in

products, DEHP is at a higher level when that

product is new. Less is found in products that are

old. Items made from PVC include many plastic

toys, some plastic furniture, car and furniture

upholstery, shower curtains, some garden hoses,

tablecloths, and some flooring (vinyl flooring). Not

all PVC products contain DEHP, but it is found in

many products. Because DEHP might be in some

toys, there is a concern that children chewing on

such toys might be exposed. One study has shown

that DEHP can go from plastics to laboratory-

simulated saliva.

1.8 IS THERE A MEDICAL TEST TO

DETERMINE WHETHER I HAVE BEEN

EXPOSED TO DEHP?

The most specific test that can be used to determine

if you have been exposed to DEHP is the

measurement of MEHP and other breakdown

chemicals in your urine or blood. This test only

provides a measure of recent exposure, since DEHP

is rapidly broken down into other substances and

excreted from your body. You also could be tested

for another breakdown product (phthalic acid), but

this test would not be specific for DEHP. One or 2

days after exposure, your feces could be tested for

the presence of DEHP metabolites. These tests are

not routinely available through health care

providers.

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

1.9 WHAT RECOMMENDATIONS HAS THE

FEDERAL GOVERNMENT MADE TO

PROTECT HUMAN HEALTH?

The federal government develops regulations and

recommendations to protect public health.

Regulations can be enforced by law. Federal

agencies that develop regulations for toxic

substances include the Environmental Protection

Agency (EPA), the Occupational Safety and Health

Administration (OSHA), and the Food and Drug

Administration (FDA). Recommendations provide

valuable guidelines to protect public health but

cannot be enforced by law. Federal organizations

that develop recommendations for toxic substances

include the Agency for Toxic Substances and

Disease Registry (ATSDR) and the National

Institute for Occupational Safety and Health

(NIOSH).

Regulations and recommendations can be expressed

in not-to-exceed levels in air, water, soil, or food

that are usually based on levels that affect animals;

then they are adjusted to help protect people.

Sometimes these not-to-exceed levels differ among

federal organizations because of different exposure

times (an 8-hour workday or a 24-hour day), the use

of different animal studies, or other factors.

Recommendations and regulations are also

periodically updated as more information becomes

available. For the most current information, check

with the federal agency or organization that

provides it. Some regulations and recommendations

for DEHP include the following:

Several federal guidelines regulate DEHP in

consumer products, drinking water, and the work

environment. FDA limits the types of food

packaging materials that can contain DEHP. EPA

limits the amount of DEHP in drinking water to 6

parts of DEHP per billion parts of water (6 ppb).

EPA requires that spills of 100 pounds or more of

DEHP to the environment be reported to the

agency. The average concentration of DEHP in

workplace air is limited by OSHA to 5 milligrams

of DEHP per cubic meter (mg/m³) of air over an 8-

hour workday. The short-term (15-minute) exposure

limit is 10 mg/m³. The guidelines established by the

American Conference of Governmental Industrial

Hygienists (ACGIH) for the workplace are the same

as the OSHA regulations.

1.10 WHERE CAN I GET MORE

INFORMATION?

If you have any more questions or concerns,

please contact your community or state health or

environmental quality department or:

Agency for Toxic Substances and Disease Registry

Division of Toxicology

1600 Clifton Road NE, Mailstop F-32

Atlanta, GA 30333

Information line and technical assistance:

Phone: 888-422-8737

FAX: (770)-488-4178

ATSDR can also tell you the location of

occupational and environmental health clinics.

These clinics specialize in recognizing, evaluating,

and treating illnesses resulting from exposure to

hazardous substances.

PUBLIC HEALTH STATEMENT

Di(2-ethylhexyl)phthalate (DEHP)

CAS#: 117-81-7

Division of Toxicology September 2002

__________________________________________________________________________________________

DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service

Agency for Toxic Substances and Disease Registry

www.atsdr.cdc.gov/ Telephone: 1-888-422-8737 Fax: 770-488-4178 E-Mail: [email protected]

To order toxicological profiles, contact:

National Technical Information Service

5285 Port Royal Road

Springfield, VA 22161

Phone: 800-553-6847 or 703-605-6000

Reference

Agency for Toxic Substances and Disease Registry

(ATSDR). 2002. Toxicological profile for di(2-

ethylhexyl)phthalate (DEHP). Atlanta, GA: U.S.

Department of Health and Human Services, Public

Health Service.