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ATSDR - ToxFAQstrade Di(2-ethylhexyl)phthalate (DEHP) of 3

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ATSDR Home gt ToxFAQstrade Di(2-etliylhexyl)phthalate (DEHP)

ToxFAQstrade

ToxFAQstrade for

Dl(2-ethylhexyl)phthalate (DEHP) m(2L^tiltLWllfiSL9S0jDEHP))

September 2002

B PDF Version 33 KB

CAS 117-81-7

This fact sheet answers the most frequently asked health questions about di(2ethylhexyl) phthalate (DEHP) For more information you may call the ATSDR Information Center at 1 -888-422-8737 This fact sheet is one in a series of summaries about hazardous substances and their health effects 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

gt Highlights gt What is DEHP gt What happens to DEHP when il enters the environment gt How might I be exposed to DEHP gt How can DEHP affect my health gt How likely is DEHP to cause cancer gt How can DEHP affect children gt How can families reduce the risk of exposure to DEHP Is there a medical test to show whether Ive been exposed to DEHP gt Has the federal government made recommendations to protect human health gt References gt Contact Information

Highlights

Di(2-ethylhexyl) phthalate (DEHP) is found in many plastics 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 the low levels usually present in the environment In animals high levels of DEHP damaged the liver and kidney and affected the ability to reproduce DEHP has been found in at least 733 of the 1613 National Priorities List sites identified by the Environmental Protection Agency (EPA)

What is DEHP

Di(2-ethylhexyl) phthlate (DEHP) is a manufactured chemical that is commonly added to plastics to make them flexible DEHP is a colorless liquid with almost no odor

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

What happens to DEHP when it enters the environment

bull DEHP is everywhere in the environment because of its use in plastics but it does not evaporate easily or dissolve in water easily bull DEHP can be released in small amounts to indoor air from plastic materials coatings and flooring bull It dissolves faster in water if gas oil or paint removers are present bull It attaches strongly to soil particles bull DEHP in soil or water can be broken down by microorganisms into harmless compounds bull DEHP does not break down easily when it is deep in the soil or at the bottom of lakes or rivers bull It is in plants fish and other animals but animals high on the food chain are able to break down DEHP so tissue levels are usually low

How might I be exposed to DEHP

DEHP is usually present at very low levels in

Medical products packaged in plastic such as blood products shySome foods packaged in plastics especially fatty foods like milk products fish or seafood and oils Well water near waste sites Workplace air or indoor air where DEHP is released but usually not at levels of concern Fluids from plastic intravenous tubing if used extensively as for kidney dialysis

SDMS DocID 485601

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I l^r iyD bullbullbullbull i - ^ V i i j ( f

How cari DEHP affect my health

_ At the levels found in the environment DEHP is not expected to cause harmful health effects In humans Most of what we know about the health effects of DEHP comes from studies of rats and mice given high amounts of DEHP

Harmful effects in animals generally occurred only with high amounts of DEHP or with prolonged exposures Moreover absorption and breakdown of DEHP in humans is different than in rats or mice so the effects seen in rats and mice may not occur in humans

Rats that breathed DEHP In the air showed no serious harmful effects Their lifespan and ability to reproduce were not affected

Brief oral exposure to very high levels of DEHP damaged sperm in mice Although the effect reversed when exposure ceased sexual maturity was delayed in the animals

High amounts of DEHP damaged the liver of rats and mice Whether or not DEHP contributes to human kidney damage is unclear

Skin contact with products containing DEHP will probably cause no harmful effects because it cannot be taken up easily through the skin

How likely is DEHP to cause cancer

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 (lARC) has stated that DEHP cannot be classified as to its carcinogenicity to humans

How can DEHP affect children

Children can be exposed to DEHP in the same manner as adults In addition small children can be exposed by sucking on or skin contact with plastic toys and pacifiers that contain DEHP but there is no conclusive evidence of adverse health effects after such exposures Nonetheless because of concern for childrens health many toy manufacturers have discontinued use of DEHP in their products In pregnant rats and mice exposed to high amounts of DEHP researchers observed birth defects and fetal deaths

How can families reduce the risk of exposure to DEHP

bull It is almost impossible to completely avoid contact with some DEHP because it is commonly found in plastics bull Prevent babies and small children from chewing on plastic objects not designed for that purpose

Is there a medical test to show whether Ive been exposed to DEHP

There is a test available that measures a breakdown product of DEHP called mono(2-ethylhexyl) phthalate (MEHP) in your urine or blood This test can only detect recent exposure because DEHP is rapidly broken down and eliminated from your body This test is not routinely available at the doctors office because it requires special equipment

Has the federal government made recommendations to protect human health

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 mgm^) in the workplaceduring an 8-hour shift The short-term (15-minute) exposure limit is 10 mgm^

References

Agency for Toxic Substances and Disease Registry (ATSDR) 2002 Toxicological Profile for Di(2-ethvlhexyl) phthlate Update Atlanta GA US Department of Health and Human Services Public Health Service

Where can I get more information

ATSDR can tell you where to find occupational and environmental health clinics Their specialists can recognize evaluate and treat illnesses resulting from exposure to hazardous substances You can also contact your community or state health or environmental quality department if you have any more questions or concerns

For more Information contact

Agency for Toxic Substances and Disease Registry Division of Toxicology and Environmental Medicine 1600 Clifton Road NE Mailstop F-62 AtlantaGA 30333 Phone 1-800-CDC-INFO bull 888-232-6348 (TTY) FAX 770-488-4178 Email cdcinfofacdeqov

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B is (2-ethv lhexvn phthaiate (DEHP) 117-81-7

Hazard Summary-Created in Apri l 1992 Revised in January 2000 Bis(2-ethylhexyl) phthalate (DEHP) is used in the production of polyvinyl chloride (PVC) I t 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

bull 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

Please Note The main sources of information for this fact sheet are EPAs Integrated Risllt Information System (IRIS) which contains information on oral chronic toxicity and the Reference Dose (RfD) and the carcinogenic effects of DEHP including the unit cancer risllt for oral exposure and the Agency for Toxic Substances and Disease Registrys (ATSDRs) Toxicological Profile for Bis(2-ethylhexyI)phthalate

Uses bull The major use of DEHP is in the production of PVC and vinyl chloride resins where it

is added to plastics to make them flexible ( i )

Sources and Potential Exposure bull The most probable route of exposure to DEHP is through food with an average

contribution of DEHP from footj of 025 milligrams per day (mgd) DEHP migrates into food from plastics during processing and storage (1)

bull Exposure to DEHP can also occur during certain medical procedures such as blood transfusions and kidney dialysis and use of respirators (1)

bull In one study DEHP was found in drinking water at levels ranging from 004 to 30 parts per billion (ppb) (1)

bull The average ambient air concentration of DEHP is very low with lt 0002 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 (1)

bull Occupational exposure to DEHP may occur for those workers in factories that manufacture or use the-chemical (1)

Assessing Personal Exposure

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bull Breakdown products of DEHP may be measured in urine or blood to determine exposure to DEHP However this test only provides a measure of recent exposure to the chemical (1)

Health Hazard In format ion Acu te Ef fec ts

bull No information is available on the acute effects of DEHP in humans via inhalation exposure(1)

bull Acute exposure to large oral doses of DEHP (5 to 10 grams) can cause gastrointestinal distress in humans ( i )

bull Animal studies have noted effects on the liver and kidney and adverse effects on weight gain and food consumption from oral exposure to DEHP ( i )

bull Acute animal tests in rats have shown DEHP to have low acute toxicity from oral exposure (2)

Chron ic Ef fects ( N o n c a n c e r ) bull No information is available on the chronic effects of DEHP in humans ( i ) bull Animal studies have reported increased lung and liver weights from chronic inhalation

exposure to DEHP (1) bull Oral animal studies have reported effects on the liver from DEHP exposure ( i ) bull EPA has not established a Reference Concentration (RfC) for DEHP (3) bull The Reference Dose (RfD) for DEHP is 002 milligrams per kilogram body weight per

day (mgkgd) based on increased relative liver weights in guinea pigs The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (Including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime I t is not a direct estimator of risk but rather a reference point to gauge the potential effects At exposures increasingly greater than the RfD the potential for adverse health effects increases Lifetime exposure above the RfD does not imply that an adverse health effect would necessarily occur(3)

bull EPA has medium confidence in the study on which the RfD was based because it utilized sufficient numbers of guinea pigs and measured multiple endpoints but only used two dose levels medium confidence in the database because there are corroborating chronic animal bioassays and consequently medium confidence in the RfD (3)

bull The California Environmental Protection Agency (CalEPA) has calculated a chronic reference exposure level of 001 milligrams per cubic meter (mgm^) based on increased liver and lung weights in rats The CalEPA reference exposure level is a concentration at or below which adverse health effects are not likely to occur (S)

R e p r o d u c t i v e D e v e l o p m e n t a l E f fec ts bull No information is available on the reproductive or developmental effects of DEHP in

humans ( i ) bull No reproductive or developmental effects were observed in animal studies from

inhalation exposure to DEHP (1) bull DEHP has been demonstrated to cause developmental toxicity such as birth defects

in rats and mice from oral exposure Reproductive effects such as decreased fertil ity proportion of pups born alive and testicular weights and tubular atrophy have also been noted from oral exposure to DEHP in animals ( i )

Cancer Risk bull No information is available on the carcinogenic effects of DEHP in humans (1) bull In the only available animal inhalation cancer study lifetime exposure of hamsters to

a very low dose of DEHP did not result in any significant increase in the incidence of tumors However because this is a very low dose it is not possible to reach a conclusion as to whether or not higher concentrations might produce different results (1)

bull A study by the NTP showed that DEHP administered in the diet increased the



incidence of liver tumors in rats and mice (6) bull EPA has classified DEHP as a Group B2 probable human carcinogen (3) bull EPA uses mathematical models based on animal studies to estimate the probability of

a person developing cancer from ingesting water containing a specified concentration of a chemical EPA calculated an oral cancer slope factor of 0014 (mgkgd)-^ and an oral unit risk estimate of 40 x 10^ (|jgL)^ EPA estimates that if an individual were to continuously ingest water containing DEHP at an average of 3 |jgL (0003 mgL) over his or her entire lifetime that person would theoretically have no more than a one-in-a-million increased chance of developing cancer as a direct result of ingesting water containing this chemical Similarly EPA estimates that ingesting water containing 30 |jgL (003 mgL) would result in not greater than a one-in-a-hundred thousand increased chance of developing cancer and water containing 300 |jgL (03 mgL) would result in not greater than a one-in-ten thousand increased chance of developing cancer For a detailed discussion of confidence in the potency factors please see IRIS (3)

Physical Properties bull Bis(2-ethylhexyl phthalate is also called di(2-ethylhexyl)phthalate or DEHP ( i ) bull DEHP is a colorless liquid with almost no odor (1) bull The chemical formula for DEHP is CHj04 ^ d the molecular weight is 39057

gmol (1) bull The vapor pressure for DEHP is 62 x 10^ mm Hg at 25 degC and it has a log

octanolwater partition coefficient (log K^^) of 4 2-511 (1)

Convers ion Factors (on l y fo r t he gaseous f o r m )

To convert concentrations in air (at 25 degC) from ppm to mg m^ mg m^ = (ppm) x (molecular weight of the compound)(2445) For DEHP 1 ppm = 159 mgm^

Health Data f rom Inhalat ion Exposure


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Bis(2-Ethylhexyl)Phthalate Regu la to ry adv isory

Hea l th numbers numbers

100000

WIOSH IDLH (5000 rmgm^ 10000

LO^EL(rat) (1000 mgn^

1000

N I 0 H T E L W mgnf) 100 - NQiiEL (rat) (50 TTQnh

g er NICJH PEL OSHA

PEL H- JM TLV s S 10 15 mgyni^

a w c

CalEPA chn^nic 01 r

Pifilt

(001 mgrrf)

OJOI

bull shy

0001

ACGIH TLV--American Conference of Governmental and Industrial Hygienists threshold limit value expressed as a time-weighted average the concentration of a substance to which most workers can be exposed without adverse effect NIOSH IDLHmdashNational Institute of Occupational Safety and Health immediately dangerous to life and health NIOSH concentration representing the maximum level of a pollutant from which an individual could escape within 30 minutes without escape-impairing symptoms or irreversible health effects NIOSH RELmdashNIOSHs recommended exposure limit NIOSH-recommended exposure limit for an 8- or 10-h time-weighted-average exposure andor ceiling NIOSH STELmdashNIOSHs recommended short-term exposure limit a 15-minute TWA exposure which should not be exceeded at any time during a workday OSHA PELmdashOccupational Safety and Health Administrations permissible exposure limit expressed as a time-weighted average the concentration of a substance to which most workers can be exposed without adverse effect averaged over a normal 8-h workday or a 40shyh workweek

The health and regulatory values cited in this factsheet were obtained in December 1999 ^ Health numbers are toxicological numbers from animal testing or risk assessment values developed by EPA



deg Regulatory numbers are values that have been incorporated in Government regulations while advisory numbers are nonregulatory values provided by the Government or other groups as advice OSHA numbers are regulatory whereas NIOSH and ACGIH numbers are advisory bull The NOAEL and LOAEL are from the critical study used as the basis for CalEPAs chronic reference exposure level

References

1 Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profile for Di(2-ethylhexyl)phthalate Public Health Service US Department of Health and Human Services Atlanta GA 1993

2 US Department of Health and Human Services Registry of Toxic Effects of Chemical Substances (RTECS online database) National Toxicology Information Program National Library of Medicine Bethesda MD 1993

3 US Environmental Protection Agency Integrated Risk Information System (IRIS) on Di(2-ethylhexyl)phthalate National Center for Environmental Assessment Office of Research and Development Washington DC 1999

4 US Department of Health and Human Services Hazardous Substances Data Bank (HSDB online database) National Toxicology Information Program National Library of Medicine Bethesda MD 1993

5 California Environmental Protection Agency (CalEPA) Air Toxics Hot Spots Program Risk Assessment Guidelines Part I I I Technical Support Document for the Determination of Noncancer Chronic Reference Exposure Levels SRP Draft Office of Environmental Health Hazard Assessment Berkeley CA 1999

6 National Toxicology Program Carcinogenesis Bioassay of Di(2-ethylhexyl)phthalate (CAS No 117-81-7) in F344 Rats and B6C3F^ Mice (Feed Studies) NTP TR 217 US Department of Health and Human Services Public Health Service National Institutes of Health Bethesda MD 1982

7 American Conference of Governmental Industrial Hygienists (ACGIH) 1999 TLVs and BEIs Threshold Limit Values for Chemical Substances and Physical Agents Biological Exposure Indices Cincinnati OH 1999

8 National Institute for Occupational Safety and Health (NIOSH) Pocket Guide to Chemical Hazards US Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention Cincinnati OH 1997

9 Occupational Safety and Health Administration (OSHA) Occupational Safety and Health Standards Toxic and Hazardous Substances Code of Federal Regulations 29 CFR 19101000 1998


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Integrated Risllt Information System

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Reference Dose for Chronic Oral Exposure (RfD)

0014

D i ( 2 - e t h y l h e x y l ) p h t h a l a t e (DEHP) CASRN 117 -81 -7 ( 0 3 0 1 1 9 9 7 )

Health assessment information on a chemical substance is included in IRIS only after a comprehensive review of chronic toxicity data by US EPA health scientists from several Program Offices and the Office of Research and Development The summaries presented in Sections I and I I represent a consensus reached in the review process Background information and explanations of the methods used to derive the values given in IRIS are provided in the Background Documents

STATUS OF DATA FOR DEHP

File First On-L ine 0 1 3 1 1 9 8 7

Category (sec t ion ) S ta tus Last Revised

Oral RfD Assessment (IA) on-line 05011991

Inhalation RfC Assessment (IB) no data

Carcinogenicity Assessment (I I ) on-line 02011993

_ I Chronic Health Hazard Assessments for Noncarcinogenic Effects

_ I A Reference Dose f o r Chronic Oral Exposure (RfD)

Substance Name mdash Di(2-ethylhexyl)phthalate (DEHP) CASRN - 117-81-7 Primary Synonym mdash Bis(2-ethylhexyl)phthalate Last Revised - 05011991

The oral Reference Dose (RfD) is based on the assumption that thresholds exist for certain

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toxic effects such as cellular necrosis I t is expressed in units of mgkg-day In general the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime Please refer to the Background Document for an elaboration of these concepts RfDs can also be derived for the noncarcinogenic health effects of substances that are also carcinogens Therefore it is essential to refer to other sources of information concerning the carcinogenicity of this substance If the US EPA has evaluated this substance for potential human carcinogenicity a summary of that evaluation will be contained in Section I I of this file

I A I Oral RfD S u m m a r y

Cr i t ical Effect Exper imenta l Doses UF MF RfD

NOAEL none 1000 1 2E-2 Increased relative liver weight LOAEL 004 of diet

(19 mgkg bwday)

mgkgday

Guinea Pig Sub-chronic-to-Chronic Oral Bioassay

Carpenter et al 1953

Conversion Factors none

I A2 Pr inc ipal and Suppor t i ng Stud ies (Ora l RfD)

Carpenter CP C S Weil and HF Smyth 1953 Chronic oral toxicity of di(2-ethylhexyl) phthalate for rats and guinea pigs Arch Indust Hyg Occup Med 8 219-226

The following numbers of guinea pigs were fed diets containing DEHP for a period of 1 year 24 males and 23 females consumed feed containing 013 DEHP 23 males and 23 females consumed feed containing 004 DEHP and 24 males and 22 females were fed the control diet These dietary levels corresponded to 64 or 19 mgkg bwday based on measured food consumption No treatment-related effects were observed on mortality body weight kidney weight or gross pathology and histopathology of kidney liver lung spleen or testes Statistically significant increases in relative liver weights were observed in both groups of treated females (64 and 19 mgkg bwday)

Groups of 32 male and 32 female Sherman rats were maintained for 2 years on diets containing either 004 013 or 04 DEHP (equivalent to 20 60 and about 195 mgkg bwday based on measured food consumption) An F l group of 80 animals was fed the 004 diet for 1 year Mortality in the F l treated and control groups was high 462 and 427 respectively survived to 1 year There was however no effect of treatment on either parental or F l group mortality life expectancy hematology or histopathology of organs Both parental and F l rats receiving the 04 DEHP diet were retarded in growth and had increased kidney and liver weights

I t appears that guinea pigs offer the more sensitive animal model for DEHP toxicity A LOAEL in this species is determined to be 19 mgkgday

I A3 Uncer ta in ty and Mod i fy ing Factors (Ora l RfD)



UF mdash Factors of 10 each were used for interspecies variation and for protection of sensitive human subpopulations An additional factor of 10 was used since the guinea pig exposure was longer than subchronic but less than lifetime and because while the RfD is set on a LOAEL the effect observed was considered to be minimally adverse

MF mdash None

I A4 Add i t i ona l S t u d i e s C o m m e n t s (Ora l RfD)

Dietary levels of 0 0 01 0 1 and 03 DEHP (greater than 99 pure) were administered to male and female CD- I mice that were examined for adverse fertility and reproductive effects using a continuous breeding protocol DEHP was a reproductive toxicant in both sexes significantly decreasing fertility and the proportion of pups born alive per litter at the 03 level and inducing damage to the seminiferous tubules (NTP 1984) DEHP has been observed to be both fetotoxic and teratogenic (Singhe 1972 Shiot and Nishimura 1982)

I A5 Conf idence in t he Oral RfD

Study mdash Medium Database mdash Medium RfD mdash Medium

The study by Carpenter et al (1953) utilized sufficient numbers of guinea pigs and measured multiple endpoints The fact that there were only two concentrations of DEHP tested precludes a rating higher than medium Since there are corroborating chronic animal bioassays the database is likewise rated medium Medium confidence in the RfD follows

I A6 EPA Documen ta t i on and Rev iew of t he Oral RfD

The RfD has been reviewed by the RfD Work Group Documentation may be found in the meeting notes of 01221986

Other EPA Documentation mdash None

Agency Work Group Review mdash 01221986

Verification Date - 01221986

I A7 EPA Contacts (Ora l RfD)

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS in general at (202)566-1676 (phone) (202)566-1749 (FAX) or hotlineiris(g)epagov (internet address)

_ I B Reference Concen t ra t ion fo r Chronic I n h a l a t i o n Exposure (RfC)

Substance Name mdash Di(2-ethylhexyl)phthalate (DEHP) CASRN - 117-81-7 Primary Synonym mdash Bis(2-ethylhexyl)phthalate



Not available at this t ime

_ I I Carcinogenicity Assessment for Lifetime Exposure


Section I I provides information on three aspects of the carcinogenic assessment for the substance in question the weight-of-evidence judgment of the likelihood that the substance is a human carcinogen and quantitative estimates of risk from oral exposure and from inhalation exposure The quantitative risk estimates are presented in three ways The slope factor is the result of application of a low-dose extrapolation procedure and is presented as the risk per (mgkg)day The unit risk is the quantitative estimate in terms of either risk per ugL drinking water or risk per ugcum air breathed The third form in which risk is presented is a drinking water or air concentration providing cancer risks of 1 in 10000 1 in 100000 or 1 in 1000000 The rationale and methods used to develop the carcinogenicity information in IRIS are described in The Risk Assessment Guidelines of 1986 (EPA6008shy87045) and in the IRIS Background Document IRIS summaries developed since the publication of EPAs more recent Proposed Guidelines for Carcinogen Risk Assessment also utilize those Guidelines where indicated (Federal Register 61(79)17960-18011 April 23 1996) Users are referred to Section I of this IRIS file for information on long-term toxic effects other than carcinogenicity

_ I I A Evidence fo r Human Carc inpgen ic i ty

I I A I We igh t -o f -Ev idence Charac ter iza t ion

Classification mdash B2 probable human carcinogen

Basis mdash Orally administered DEHP produced significant dose-related increases in liver tumor responses in rats and mice of both sexes

I I A 2 Human Carc inogen ic i ty Data

Inadequate Thiess et al (1978) conducted a mortality study of 221 DEHP production workers exposed to unknown concentrations of DEHP for 3 months to 24 years Workers were followed for a minimum of 5 to 10 years (mean follow-up time was 115 years) Eight deaths were reported in the exposed population Deaths attributable to pancreatic carcinoma (1 case) and uremia (1 case in which the workers also had urethral and bladder papillomas) were significantly elevated in workers exposed for gt15 years when compared to the corresponding age groups in the general population The study is limited by a short follow-up period and unquantified worker exposure Results are considered inadequate for evidence of a causal association

I I A 3 An ima l Carc inogen ic i ty Data

Sufficient In an NTP (1982) study 50 male and 50 female fisher 344 rats per group were fed

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diets containing 0 6000 or 12000 ppm DEHP for 103 weeks Similarly groups of 50 male arid 50 female B6C3F1 mice were given 0 3000 or 6000 ppm DEHP in the diet for 103 weeks Animals were killed and examined histologically when morbund or after 105 weeks No clinical signs of toxicity were observed in either rats or mice A statistically significant increase in the incidence of hepatocellular carcinomas and combined incidence of carcinomas and adenoma were observed in female rats and both sexes of mice The combined incidence of neoplastic nodules and hepatocellular carcinomas was statistically significantly increased in the high-dose male rats A positive dose response trend was also noted

Carpenter et al (1953) found no malignant tumors in treated groups of 32 male and 32 female Sherman rats Animals were given 400 1300 or 4000 ppm DEHP in the diet for 1 year and reduced to a maximum of 8 males and 8 females and treated for another year Controls F l and 4000 ppm groups were sacrificed after being maintained on control or 4000 ppm diets for 1 year Only 40 to 47 of the animals in each group including F l animals survived 1 year Thus an insufficient number of animals were available for a lifetime evaluation

Carpenter et al (1953) did not find a carcinogenic effect in guinea pigs and dogs exposed to 1300 or 4000 ppm DEHP Both guinea pigs and dogs were terminated after 1 year of exposure The treatment and survival periods for these animals were considerably below their lifetimes

I I A 4 Suppo r t i ng Data fo r Carc inogen ic i ty

Studies indicate that DEHP is not a direct acting mutagen in either a forward mutation assay in Salmonella typhimurium (Seed 1982) or the rec assay in Bacillus subtilis (Tomita et al 1982) DEHP did not induce mutations in a modified reverse mutation plate incorporation assay in Salmonella strains TAIOO and TA98 at concentrations up to 1000 ugplate in the presence or absence of S9 hepatic homogenate (Kozumbo et al 1982) MEHP the monoester form of DEHP and a metabolite is positive in the rec assay and in the reverse mutation assay in Salmonella In the absence of exogenous metabolism MEHP produced chromosomal aberrations and sister chromatid exchanges in V79 cells Both DEHP and MEHP induced chromosomal aberrations and morphological transformation in cultured fetal Syrian hamster cells exposed in utero (Tomita et al 1982) Chromosomal effects were not found in CHO mammalian cells (Phillips et al 1982) exposed to DEHP DEHP was weakly positive with metabolic activation in only one of several studies testing for mutagenic activity at the thymidine kinase locus in L5178Y mouse lymphoma cells (Ashby et al 1985) DEHP is a potent inducer of hepatic peroxisomal enzyme activity (Canning et al 1984)

_ I I B Quan t i t a t i ve Est imate of Carc inogenic Risk f r o m Oral Exposure

I I B l S u m m a r y of Risk Est imates

Oral Slope Factor mdash 14E-2mgkgday

Drinking Water Unit Risk mdash 40E-7 per (ugL)

Extrapolation Method mdash Linearized multistage procedure extra risk

Drinking Water Concentrations at Specified Risk Levels

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Risk Level I Concent ra t ion

E-4 (1 in 10000) 3E-I-2 ugL Z O O A l l j yU - t ^

E-5 (1 in 100000) 3E-I-1 ugL ^Ok^lA

E-6 (1 in 1000000) 3E-I-0 ugL illLJL S ^ ^ i ^ l bull

I I B 2 Dose-Response Data (Carc inogen ic i ty Oral Exposure)

Tumor Type hepatocellular carcinoma and adenoma Test animals MouseB6C3Fl male Route diet Reference NTP 1982

-Dose-

Admin i s te red j Human Equiva lent Tumor ( p p m ) ( m g k g ) d a y Inc idence

0 0 1450

3000 32 2548

6000 65 2950

I I B 3 Add i t i ona l Comments (Carc inogen ic i t y Oral Exposure)

In this study powdered rodent meal was provided in such a way that measured food consumption could include significant waste and spillage rather than true food intake For this reason a standard food consumption rate of 13 mouse body weight was used in the dose conversion

DEHP is hydrolyzed to monoesters including MEHP (Pollack et al 1985 Lhuguenot et al 1985 Kluwe 1982) Although several species of animals have been determined to excrete glucuronide conjugates of monoethylhexyl phthalate (MEHP) upon exposure to DEHP rats do not (Tanaka et al 1975 Williams and Blanchfield 1975 Albro et al 1982)

Slope factors based on combined hepatocellular carcinoma and neoplastic nodule incidences were 45E3mgkgday for female rats 32E-3mgkgday for male rats A slope factor based on hepatocellular adenomas or carcinomas in female mice is l OE-2mgkgday

The unit risk should not be used if the water concentration exceeds 4E-I-4 ugL since above this concentration the slope factor may differ from that stated

I I B 4 Discussion of Conf idence (Carc inogen ic i ty Oral Exposure)

An adequate number of animals was observed and a statistically significant increase in incidence of liver tumors was seen in both sexes and were dose dependent in both sexes of mice and female rats A potential source of variability in the NTP study is the possibility of feed scattering The above calculations are based on standard food consumption rates for mice (13 of body weight) and rats (5 of body weight)



_ I I C Quan t i t a t i ve Est imate o f Carc inogenic Risk f r o m I n h a l a t i o n Exposure

Not available

_ I I D EPA D o c u m e n t a t i o n Rev iew and Contacts (Carc inogen ic i t y Assessment )

I I D l EPA Documen ta t i on

Source Document mdash US EPA 1988

The values in the 1988 Drinking Water Criteria Document for Phthalic Acid Esters (External Review Draft) have received Agency Reviewshy

I I D 2 EPA Rev iew (Carc inogen ic i t y Assessment )

Agency Work Group Review mdash 08261987 10071987

Verification Date mdash 10071987

I I D 3 EPA Contacts (Carc inogen ic i t y Assessment )


_ I I I [ reserved] _ IV [ reserved] _V [ reserved]

_ V I Bibliography

Substance Name mdash Di(2-ethylhexyl)phthalate (DEHP) CASRN - 117-81-7 Primary Synonym mdash Bis(2-ethylhexyl)phthalate Last Revised mdash 05011990

_V I A Oral RfD References


NTP (National Toxicology Program) 1984 Di(2-ethylhexyl)phthalate Reproduction and fertility assessment in CD-I mice when administered by gavage Final Report NTP-84-079 NTP Research Triangle Park NC



Shiota K and H Nishimura 1982 Teratogenicity of di-2-ethylhexyl phthalate and di-n-butyl phthalate in mice Environ Health Perspect 45(0) 65-70

Singhe AR WH Lawrence and J Autian 1972 Teratogenicity of phthalate esters in rats J Pharmacol Sci 6 1 5 1

_ V I B I n h a l a t i o n RfC References

None

_VI C Carc inogenic i ty Assessment References

Albro PW JT Corbett JL Schroeder et al 1982 Pharmacokinetics interactions with macromolecules and species differences in metabolism of DEHP Environ Health Perspect 45 19-25

Ashby J FJ de Serres M Draper et al 1985 Evaluation of short-term tests for carcinogens Report of the International Programme on Chemical Safetys Collaborative Study on In Vitro Assays Elsevier Science Publishers Amsterdam

Carpenter CP CS Weil and HF Smith Jr 1953 Chronic oral toxicity of di-(2-ethylhexyl) phthalate for rats guinea pigs and dogs AMA Arch Ind Hyg Occup Med 8 219-226

Canning AE V Brunk and G Dallner 1984 Phthalate esters and their effect on the liver Hepatology 4(3) 541-547

Kluwe WM 1982 Overview of phthalate ester pharmacokinetics in mammalian species Environ Health Perspect 45 3-10

Kozumbo WJ R Kroll and RJ Rubin 1982 Assessment of the mutagenicity of phthalate esters Environ Health Perspect 45 103-109

Lhuguenot J C AM Mitchell G Milner EA Lock and CR Elcombe 1985 The metabolism of di-(2-ethylhexyl)phthalate (DEHP) and mono-(2-ethylhexyl)phthalate (MEHP) in rats In vivo and in vitro dose and time dependency of metabolism Toxicol Appl Pharmacol 80 1 1 shy22

NTP (National Toxicology Program) 1982 Carcinogenesis bioassay of di-(2-ethylhexyl) phthalate (CAS No 117-81-7) in F344 rats and B6C3F mice (feed study) NTP Tech Rep Ser TR No 217 NTP Research Triangle Park NC

Phillips BJ TEB James and SD Gangolli 1982 Genotoxicity studies of di-(2-ethylhexyl) phthalate and its metabolites in CHO cells Mutat Res 102 297-304

Pollack GM RC Li JC Ermer and DD Shen 1985 Effects of route of administration and repetitive dosing on the disposition kinetics of di-(2-ethylhexyl)phthalate and its mono-deshyesterified metabolite in rats Toxicol Appl Pharmacol 79 246-256



Seed JL 1982 Mutagenic activity of phthalate esters in bacterial liquid suspension assays Environ Health Perspect 45 111-114

Tanaka A T Adachi T Takahashi and T Yamaha 1975 Biochemical studies on phthalic esters I Elimination distribution and metabolism of di-(2-ethylhexyl)phthalate in rats Toxicology 4 253-264

Thiess AM R Frentzel-Beyme and R Wieland 1978 Mortality study in workers exposed to di-(2-ethylhexyl)phthalate (DOP) I n Moglichkerten und Grenzen des Biological Monitoring Arbeitsmedizinische Probleme des Dienstleistungsqewerbes Arbeitsmedizinische kolloquium [Possibilities and Limits of Biological Monitoring Problems of Occupational Medicine in Small Industries Colloquim in Occupational Medicine] FrankfurtM May 1978 Stuttgart AW Centner p 155-164 (Ger)

Tomita I Y Nakamura N Aoki and N Inui 1982 Mutageniccarcinogenic potential of DEHP and MEHP Environ Health Perspect 45 119-125

Williams DT and BJ Blanchfield 1975 The retention distribution excretion and metabolism ofdibutylphthalate-7-14C in the rat J Agric Food Chem 23 854-857

US EPA 1988 Drinking Water Criteria Document for Phthalic Acid Esters Prepared by the Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Cincinnati OH for the Office of Drinking Water Washington DC (External Review Draft)

_ V I I Revision History


Date Sect ion I Descr ip t ion

03011988 IA2 Text added to paragraph 1

09071988 I I Carcinogen summary on-line

02011989 II A2 Study description revised

02011989 I I D3 Primary contacts phone number corrected

07011989 VI Bibliography on-line

08011989 IA4 Text revised

05011990 II A4 Text revised

05011990 VI C Kozumbo et al 1982 citation added

05011991 IA2 Corrected principal study title

05011991 IA2 2nd para line 3 units corrected from gkg to mgkg

08011991 I I D3 Primary and secondary contacts changed



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05041998 IA4

12101998 I I I

EPA contact changed

Primary name changed from Bis(2-ethylhexyl)phthalate

Secondary contact changed

Regulatory actions updated

Primary contact changed

Drinking Water Health Advisories EPA Regulatory Actions and Supplementary Data were removed from IRIS on or before April 1997 IRIS users were directed to the appropriate EPA Program Offices for this information

NTP 1984 citation added for clarification

This chemical is being reassessed under the IRIS Program

_VIII Synonyms


117-81-7 BEHP Bis(2-ethylhexyl)-l2-benzene-dicarboxylate Bis(2-ethylhexyl)phthalate Bisoflex 81 Bisoflex DOP ^ Compound 889 DAF68 DEHP Di(2-ethylhexyl)orthophthalate Di(2-ethylhexyl)phthalate Dioctyl phthalate Di-sec-octyl phthalate DOP Ergoplast FDO Ethylhexyl phthalate 2-Ethylhexyl phthalate Eviplast 80 Eviplast 81 Fleximel Flexol DOP Flexol plasticizer DOP Good-Rite GP 264 Hatcol DOP Hercoflex 260 Kodaflex DOP Mollan 0 NCI- C52733 Nuoplaz DOP Octoil Octyl phthalate



Palatinol AH Phthal ic ac id B is (2 -e thy lhexy l ) ester Phthal ic ac id d iocty l ester P i t tsburgh PX-138 Platinol DOP RC Plasticizer DOP RCRA waste n u m b e r U028 Reomol D 79P Reomol DOP Sicol 150 Staf lex DOP Truf lex DOP Vest inol AH Vinic izer 80 Witcizer 312

I R I S Home

Chronic Heal th Hazards fo r Non -

Carc inogenic Effects

Reference Dose fo r Chronic Oral

Exposure (RfD)

bull Oral RfD Summary

bull Principal and Supporting Studies

bull Uncertainty and Modifying Factors

bull Additional StudiesComments

bull Confidence in the Oral RfD

bull EPA Documentation and Review

Reference Concent ra t ion f o r

Chronic I n h a l a t i o n Exposure (RfC)

bull Inhalation RfC Summary




bull Confidence in the Inhalation RfC


Carc inogen ic i ty Assessment f o r

L i f e t ime Exposure

Evidence fo r Human



Carc inogen ic i ty

bull Weight-of-Evidence Characterization

bull Human Carcinogenicity Data

bull Animal Carcinogenicity Data

bull Supporting Data for Carcinogenicity

Quantitative Est imate o f

Carc inogenic Risk f r o m Oral Exposure

bull Summary of Risk Estimates

bull Dose-Response Data

bull Additional Comments

bull Discussion of Confidence

Quan t i t a t i ve Est imate o f

Carc inogenic Risk f r o m I n h a l a t i o n

Exposure





bull EPA Documentation Review and Contacts

B ib l iography

Revis ion H is to ry

Synonyms


ATSDR - ToxFAQstrade Di(2-ethylhexyl)phthalate (DEHP) of 3

I l^r iyD bullbullbullbull i - ^ V i i j ( f

How cari DEHP affect my health

_ At the levels found in the environment DEHP is not expected to cause harmful health effects In humans Most of what we know about the health effects of DEHP comes from studies of rats and mice given high amounts of DEHP

Harmful effects in animals generally occurred only with high amounts of DEHP or with prolonged exposures Moreover absorption and breakdown of DEHP in humans is different than in rats or mice so the effects seen in rats and mice may not occur in humans

Rats that breathed DEHP In the air showed no serious harmful effects Their lifespan and ability to reproduce were not affected

Brief oral exposure to very high levels of DEHP damaged sperm in mice Although the effect reversed when exposure ceased sexual maturity was delayed in the animals

High amounts of DEHP damaged the liver of rats and mice Whether or not DEHP contributes to human kidney damage is unclear

Skin contact with products containing DEHP will probably cause no harmful effects because it cannot be taken up easily through the skin

How likely is DEHP to cause cancer

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 (lARC) has stated that DEHP cannot be classified as to its carcinogenicity to humans

How can DEHP affect children

Children can be exposed to DEHP in the same manner as adults In addition small children can be exposed by sucking on or skin contact with plastic toys and pacifiers that contain DEHP but there is no conclusive evidence of adverse health effects after such exposures Nonetheless because of concern for childrens health many toy manufacturers have discontinued use of DEHP in their products In pregnant rats and mice exposed to high amounts of DEHP researchers observed birth defects and fetal deaths

How can families reduce the risk of exposure to DEHP

bull It is almost impossible to completely avoid contact with some DEHP because it is commonly found in plastics bull Prevent babies and small children from chewing on plastic objects not designed for that purpose

Is there a medical test to show whether Ive been exposed to DEHP

There is a test available that measures a breakdown product of DEHP called mono(2-ethylhexyl) phthalate (MEHP) in your urine or blood This test can only detect recent exposure because DEHP is rapidly broken down and eliminated from your body This test is not routinely available at the doctors office because it requires special equipment

Has the federal government made recommendations to protect human health

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 mgm^) in the workplaceduring an 8-hour shift The short-term (15-minute) exposure limit is 10 mgm^

References

Agency for Toxic Substances and Disease Registry (ATSDR) 2002 Toxicological Profile for Di(2-ethvlhexyl) phthlate Update Atlanta GA US Department of Health and Human Services Public Health Service

Where can I get more information

ATSDR can tell you where to find occupational and environmental health clinics Their specialists can recognize evaluate and treat illnesses resulting from exposure to hazardous substances You can also contact your community or state health or environmental quality department if you have any more questions or concerns

For more Information contact

Agency for Toxic Substances and Disease Registry Division of Toxicology and Environmental Medicine 1600 Clifton Road NE Mailstop F-62 AtlantaGA 30333 Phone 1-800-CDC-INFO bull 888-232-6348 (TTY) FAX 770-488-4178 Email cdcinfofacdeqov

This page was updated on 02182010


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