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DI(2-ETHYLHEXYL) PHTHALATE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Di(2-ethylhexyl) phthalate is produced by esterification of 2-ethylhexanol with phthalic anhydride.

Specific Substances

    A) No Synonyms were found in group or single elements
    1.2.1) MOLECULAR FORMULA
    1) C24-H38-O4 C6H4(COOCH2CH(C2H5)C4H9)2

Available Forms Sources

    A) FORMS
    1) Editor's note: Dioctyl phthalate occurs commercially in two isomeric forms: di-n-octyl phthalate and di(2-ethylhexyl) phthalate. These isomers share the same molecular summation formula, but they differ structurally. Both isomers are liquids, and they are used in similar fashions (Sittig, 1991; Lewis, 1997).
    2) Di(2-ethylhexyl) phthalate is available in the US in a variety of technical grades. Typical product specifications are: 99.0-99.6% minimal ester content; 0.1% maximal moisture content; 0.007-0.01% acidity (as acetic acid or phthalic acid); specific gravity, 0.980-0.985 (25/25 degrees C); refractive index, 1.4850-1.4870 (23 degrees C); and minimal flash-point, (216 degrees C) (IARC, 1982).
    3) In Western Europe, di(2-ethylhexyl) phthalate is available with the following specifications: maximal acid value, 0.06; maximal weight loss on heating at 140 degrees C for 3 hours, 1% and saponification value, 284-290 mg KOH/g" (IARC, 1982).
    4) In Japan, di(2-ethylhexyl) phthalate must fulfill the following specifications: maximal acid value, 0.05; maximal weight loss on heating at 125 degrees C for 3 hours, 0.10%; and specific gravity, 0.983-0.989 (20/20 degrees C)(IARC, 1982).
    B) SOURCES
    1) Di(2-ethylhexyl) phthalate is produced by esterification of 2-ethylhexanol with phthalic anhydride (Ashford, 1994; Lewis, 1997).
    2) Di(2-ethylhexyl) phthalate is released into the environment during the production and disposal of plastic products for which it is used as a plasticizer (Howard, 1989; HSDB , 2000).
    3) Di(2-ethylhexyl)phthalate was detected in particulate and gaseous hydrocarbons from diesel-fuel exhaust gases (IARC, 1982).
    4) Di(2-ethylhexyl)phthalate has been detected in the following commercial organic solvents (IARC, 1982):
    1) diethyl ether (43.6 mcg/L)
    2) methane (78.7 mcg/L)
    3) ethanol (61.7 mg/L)
    4) acetonitrile (180 mcg/L)
    5) benzene (1960 mcg/L)
    C) USES
    1) Dioctyl phthalate is used primarily in the manufacture of plastics, serving as a plasticizer for vinyl resins (polyvinyl chloride), polystrene resins, cellulose ester resins, adhesives, rubber materials, emulsion paints, laquers, and other materials (HSDB , 2000; IARC, 1982; Sittig, 1991).
    2) The chemical properties of di(2-ethylhexyl) phthalate make it the preferential plasticizer for many flexible polyvinyl chloride products. This compound is also used as a replacement for polychlorinated biphenyls in dielectric fluids (IARC, 1982). It is especially used in the manufacture of PVC medical devices, where it may make up 40% of the weight of a final product (Gosselin et al, 1984; Plonait et al, 1993).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) The phthalates are generally considered to be of slight to moderate toxicity. Di(2-ethylhexyl) phthalate (DEHP) may be irritating to the eyes, skin, and mucous membranes. Mild gastric disturbances and diarrhea may occur following ingestion of larger doses. CNS depression may occur if large amounts of phthalate acid esters are absorbed. However DEHP is considered innocuous at small doses.
    B) DEHP has a low order of toxicity. At significant concentrations irritation of mucous membranes may occur. Ingestion of large amounts during an experiment resulted in mild gastric upset and diarrhea.
    0.2.3) VITAL SIGNS
    A) With most exposures, one would not expect to see alternations in vital signs. However, with large oral or inhalation exposures, tachypnea and tachycardia may be expected.
    0.2.4) HEENT
    A) DEHP may cause irritation of the eyes and mucosa of the nose and throat.
    0.2.5) CARDIOVASCULAR
    A) No evidence of cardiotoxicity has been reported in humans.
    0.2.6) RESPIRATORY
    A) DEHP may cause irritation of the mucosa of the nose and throat and may be expected to cause mild upper respiratory tract irritation.
    0.2.7) NEUROLOGIC
    A) Central nervous system depression might develop if large amounts are absorbed.
    0.2.8) GASTROINTESTINAL
    A) As DEHP may be irritating to mucous membranes, gastrointestinal tract or esophageal mucosal irritation might be seen following significant ingestions.
    0.2.9) HEPATIC
    A) Cholestasis has been suggested, but has not been reported in other studies.
    0.2.13) HEMATOLOGIC
    A) No clinically significant evidence of hematological toxicity has been reported in humans.
    0.2.14) DERMATOLOGIC
    A) No significant dermatologic effects have been identified. There is no evidence of irritation or allergic dermatitis with patch testing.
    0.2.15) MUSCULOSKELETAL
    A) Histopathological studies on mice and rats fed doses ranging from 0 to 25,000 ppm did not demonstrate any evidence of musculoskeletal toxicity.
    0.2.16) ENDOCRINE
    A) Phthalate exposure has been linked to metabolic syndrome. Decreased blood sugar and serum cholesterol have been noted in experimental animals.
    0.2.17) METABOLISM
    A) Inhibition of various enzymes (glucose-6-phosphate dehydrogenase in yeast and malate dehydrogenase from pig heart) have been demonstrated in vitro. These effects have not been described in exposed humans.
    0.2.20) REPRODUCTIVE
    A) Prematurity and low birth weight ehave been reported following exposure to DEHP. Rodent studies suggest testicular atrophy.
    0.2.21) CARCINOGENICITY
    A) There is no data to indicate that DEHP is a human carcinogen.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) Induction of emesis should be avoided.
    B) GASTRIC LAVAGE: Consider after ingestion of a potentially life-threatening amount of poison if it can be performed soon after ingestion (generally within 1 hour). Protect airway by placement in the head down left lateral decubitus position or by endotracheal intubation. Control any seizures first.
    1) CONTRAINDICATIONS: Loss of airway protective reflexes or decreased level of consciousness in unintubated patients; following ingestion of corrosives; hydrocarbons (high aspiration potential); patients at risk of hemorrhage or gastrointestinal perforation; and trivial or non-toxic ingestion.
    C) ACTIVATED CHARCOAL: Administer charcoal as a slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.
    D) Observe patients with ingestion carefully for the possible development of esophageal or gastrointestinal tract irritation or burns. If signs or symptoms of esophageal irritation or burns are present, consider endoscopy to determine the extent of injury.
    E) Carefully observe patients with ingestion exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    F) Monitor level of consciousness in patients ingesting large amounts. If central nervous system depression occurs, ensure that adequate respirations and oxygenation are maintained.
    G) If hypoglycemia occurs, administer glucose as needed until corrected.
    0.4.3) INHALATION EXPOSURE
    A) INHALATION: Move patient to fresh air. Monitor for respiratory distress. If cough or difficulty breathing develops, evaluate for respiratory tract irritation, bronchitis, or pneumonitis. Administer oxygen and assist ventilation as required. Treat bronchospasm with an inhaled beta2-adrenergic agonist. Consider systemic corticosteroids in patients with significant bronchospasm.
    0.4.4) EYE EXPOSURE
    A) DECONTAMINATION: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, the patient should be seen in a healthcare facility.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Range Of Toxicity

    A) A probable lethal human oral dose is between 0.5 and 15 grams per kilogram, or between one ounce and one quart in a 70-kilogram adult.

Clinical Effects

Summary Of Exposure

    A) The phthalates are generally considered to be of slight to moderate toxicity. Di(2-ethylhexyl) phthalate (DEHP) may be irritating to the eyes, skin, and mucous membranes. Mild gastric disturbances and diarrhea may occur following ingestion of larger doses. CNS depression may occur if large amounts of phthalate acid esters are absorbed. However DEHP is considered innocuous at small doses.
    B) DEHP has a low order of toxicity. At significant concentrations irritation of mucous membranes may occur. Ingestion of large amounts during an experiment resulted in mild gastric upset and diarrhea.

Vital Signs

    3.3.1) SUMMARY
    A) With most exposures, one would not expect to see alternations in vital signs. However, with large oral or inhalation exposures, tachypnea and tachycardia may be expected.
    3.3.2) RESPIRATIONS
    A) WITH POISONING/EXPOSURE
    1) Acute larger inhalation exposure may result in tachypnea or dyspnea.
    3.3.3) TEMPERATURE
    A) WITH POISONING/EXPOSURE
    1) Fever may be anticipated to develop following large inhalations that could potentially cause pneumonitis.
    3.3.5) PULSE
    A) WITH POISONING/EXPOSURE
    1) A nonspecific increase in heart rate may be expected occur following large inhalation exposure, however, no specific data is available at the time of this writing.

Heent

    3.4.1) SUMMARY
    A) DEHP may cause irritation of the eyes and mucosa of the nose and throat.
    3.4.3) EYES
    A) Eye irritation may occur (Lewis, 1996; EPA, 1985), although this agent was not irritating to the eyes of experimental animals (Hathaway, 1996).
    3.4.4) EARS
    A) Contact dermatitis has been reported following the use of headphones that contained DEHP (Walker 2000).
    3.4.5) NOSE
    A) DEHP may cause irritation of the mucosa of the nose and throat (EPA, 1985).
    3.4.6) THROAT
    A) DEHP may cause irritation of the mucosa of the nose and throat (EPA, 1985).

Cardiovascular

    3.5.1) SUMMARY
    A) No evidence of cardiotoxicity has been reported in humans.
    3.5.2) CLINICAL EFFECTS
    A) CARDIOVASCULAR FINDING
    1) WITH POISONING/EXPOSURE
    a) LACK OF EFFECT/PEDIATRIC
    1) Echocardiograms have been done on infants undergoing extracorporeal membrane oxygenation (ECMO) and have not demonstrated a dose-response impairment in contractility (Karle et al, 1997).

Respiratory

    3.6.1) SUMMARY
    A) DEHP may cause irritation of the mucosa of the nose and throat and may be expected to cause mild upper respiratory tract irritation.
    3.6.2) CLINICAL EFFECTS
    A) ASTHMA
    1) WITH POISONING/EXPOSURE
    a) In a case series of intubated children, it was suggested that PVC tubing increased the risk of bronchial asthma (Roth et al, 1988; Swan, 2008).
    B) IRRITATION SYMPTOM
    1) WITH POISONING/EXPOSURE
    a) DEHP is irritating to mucous membranes, and could cause respiratory tract irritation. However, the material's low vapor pressure generally precludes inhalation of any significant amount (EPA, 1985).
    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) It should be noted that methacholine dose-response curves of rat tracheal tissue did not react to DEHP (Doelman et al, 1990). In a study by Jaakkola (2000), results of comparing plastic wall building materials and asthma were not statistically significant (OR = 1.52, 95% CI = 0.35-6.71).

Neurologic

    3.7.1) SUMMARY
    A) Central nervous system depression might develop if large amounts are absorbed.
    3.7.2) CLINICAL EFFECTS
    A) DEPRESSIVE DISORDER
    1) WITH POISONING/EXPOSURE
    a) Central nervous system depression might develop if large amounts are absorbed (EPA, 1985), although this has not been documented.

Gastrointestinal

    3.8.1) SUMMARY
    A) As DEHP may be irritating to mucous membranes, gastrointestinal tract or esophageal mucosal irritation might be seen following significant ingestions.
    3.8.2) CLINICAL EFFECTS
    A) GASTROINTESTINAL IRRITATION
    1) WITH POISONING/EXPOSURE
    a) Necrotizing enterocolitis has been observed in neonates with increased serum levels of DEHP after exchange transfusion or extracorporeal membrane oxygenation (Plonait et al, 1993). Cause and effect has not been established.
    b) In a volunteer study, individuals consumed 5 and 10 grams of DEHP. Only gastritis and diarrhea developed in this acute and subacute toxicity study (Shaffer et al, 1945).
    c) As DEHP may be irritating to mucous membranes (EPA, 1985), gastrointestinal tract or esophageal mucosal irritation might be seen following significant ingestions.
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) Dogs given 5 grams/kg by feeding tube for 14 weeks were found to have only slight weight loss (Harris, 1956). In a two-year feeding study, rats were found to have a LOEL of 200 mg/kg/day and a NOEL of 60 mg/kg/day. The only findings were loss of body weight and a relative increase in kidney weight. (Harris, 1956).

Hepatic

    3.9.1) SUMMARY
    A) Cholestasis has been suggested, but has not been reported in other studies.
    3.9.2) CLINICAL EFFECTS
    A) CHOLESTASIS
    1) WITH POISONING/EXPOSURE
    a) PEDIATRIC - Elevated levels of DEHP have been associated with cholestasis in neonates receiving exchange transfusion or extracorporeal membrane oxygenation. However, in a study of newborn infants undergoing exchange transfusion and exposed to the plasticizer DEHP, no cholestasis was observed (Plonait et al, 1993).
    b) LACK OF EFFECT/PEDIATRIC
    1) As a part of a study of infants on extracorporeal membrane oxygenation (ECMO), liver function tests were obtained and did not demonstrate a difference between groups or across time (Karle et al, 1997).
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LIVER ABNORMALITIES
    a) Hepatomegaly and proliferation of hepatic peroxisomes has been noted in chronic feeding studies in rats (Gosselin et al, 1984; (Piekacz, 1971). Elevations in serum transaminase levels have also been described in experimental animals (Piekacz, 1971). These effects have not been reported in exposed humans.
    b) A 1-year feeding study of dogs given capsulated DEHP at 0.06 and 0.09 mL/kg/day found a low order of toxicity. Fatty vacuolization of the liver was found at the higher dose, but liver function studies were normal. A NOAEL of 0.06 was reported (Clayton & Glayton, 1994).
    c) A study of rats given DEHP by gavage found an increase in cytochrome P450. Increased activity of epoxide hydratase and glutathione-s-transferase were also noted (Aitio & Parkki, 1978).
    d) In an animal study, Rhesus monkeys received multiple transfusions from polyvinyl chloride bags over a period of 6 to 12 months to mimic infant exchange transfusions. The dose was 21.3 mg/kg per treatment period. Four of the 7 monkeys had abnormal 99mTc liver-spleen scan ratios, 4 of the 7 monkeys had abnormal BSP clearance, and 6 of the 7 monkeys had abnormal liver histopathology.
    1) Control animals received products from polyethylene bags and did not develop abnormalities (Jacobson et al, 1977). The findings must be interpreted with caution in the absence of hepatitis, as this has not been confirmed by others (Rhodes et al, 1986).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) UREMIA
    1) WITH POISONING/EXPOSURE
    a) It has been suggested that pruritus in uremic patients on dialysis is caused by DEHP, however this is not supported by most clinical experience of uremic non-dialyzed patients (Mettang et al, 1996).
    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RENAL FUNCTION ABNORMAL
    a) A 1-year feeding study of dogs given capsulated DEHP at 0.06 and 0.09 mL/kg/day found a low order of toxicity. Cloudy swelling of the kidney was found at the higher dose. A NOAEL of 0.06 was reported (Clayton & Glayton, 1994).
    b) Relative increased kidney weight without histological evidence of tissue damage has been seen in chronic feeding studies in experimental animals (Piekacz, 1971) Nagasaki et al, 1975). This effect has not been reported in exposed humans.

Hematologic

    3.13.1) SUMMARY
    A) No clinically significant evidence of hematological toxicity has been reported in humans.
    3.13.2) CLINICAL EFFECTS
    A) HEMATOLOGY FINDING
    1) WITH POISONING/EXPOSURE
    a) LACK OF EFFECT
    1) No clinically significant evidence of hematological toxicity has been reported in humans.
    3.13.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) ANEMIA
    a) Mild anemia has been seen in subacute dietary rat studies of 4,000 ppm in males and 25,000 in females (Hazelton, 1992). This was not confirmed in other long-term studies in rats (NTP, 1982).

Dermatologic

    3.14.1) SUMMARY
    A) No significant dermatologic effects have been identified. There is no evidence of irritation or allergic dermatitis with patch testing.
    3.14.2) CLINICAL EFFECTS
    A) CONTACT DERMATITIS
    1) WITH POISONING/EXPOSURE
    a) LACK OF EFFECT
    1) No irritant or allergic effects are reported (Clayton & Glayton, 1994). There is no evidence of irritation or allergic dermatitis with patch testing (Clayton & Glayton, 1994).
    3.14.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) DERMAL IRRITATION
    a) Studies using two different esters (DA68P and DA79P) on rodents found local irritation at high concentrations. Animals were given doses of 10, 100, or 500 mg/kg in sunflower oil for up to 5 months. No signs of dermal toxicity were noted with DA79P at any dose. DA68P was noted to cause dermal irritation at 100 mg/kg, and a 50% mortality rate was observed at 500 mg/kg after 5 to 23 applications. It is not clear if these esters were DEHP (Statsek, 1980).

Musculoskeletal

    3.15.1) SUMMARY
    A) Histopathological studies on mice and rats fed doses ranging from 0 to 25,000 ppm did not demonstrate any evidence of musculoskeletal toxicity.
    3.15.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) Histopathological studies on mice and rats fed doses ranging from 0 to 25,000 ppm did not demonstrate any evidence of musculoskeletal toxicity (NTP, 1982; Hazelton, 1992).

Endocrine

    3.16.1) SUMMARY
    A) Phthalate exposure has been linked to metabolic syndrome. Decreased blood sugar and serum cholesterol have been noted in experimental animals.
    3.16.2) CLINICAL EFFECTS
    A) METABOLIC SYNDROME X
    1) WITH POISONING/EXPOSURE
    a) A relationship between metabolic syndrome and phthalate exposure was evaluated in adult men using waist circumference and HOMA, a measure of insulin resistance. Results showed a significant association between 4 phthalate metabolites (MBzP, MEHHP, MEOHP, MEP) and increased waist circumference (p value equal to or less than 0.013 for each metabolite). Three metabolites (MBP, MBzP, and MEP) were significantly associated with increased HOMA (p value equal to or less than 0.011 for each metabolite) (Stahlhut et al, 2007).
    3.16.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HYPOGLYCEMIA
    a) Decreased blood sugar has been noted in exposed experimental animals (Nagasaki et al, 1974; Nagasaki et al, 1975).
    2) HYPOCHOLESTEREMIA
    a) At dosage levels of 0.1%, serum total cholesterol levels were decreased in Fischer 344 rats (BIBRA, 1984).

Reproductive

    3.20.1) SUMMARY
    A) Prematurity and low birth weight ehave been reported following exposure to DEHP. Rodent studies suggest testicular atrophy.
    3.20.2) TERATOGENICITY
    A) HUMAN DATA
    1) A study of boys born to mothers exposed to environmental DEHP during pregnancy reported that anogenital distance (AGD), the most sensitive marker of antiandrogen action, was shortened and testicular descent impaired (Swan et al, 2005).
    a) A follow-up study confirmed earlier results. Three metabolites of DEHP (MEHP, MEOHP, and MEHHP) were significantly and inversely related to AGD. Also, a significant relationship between higher DEHP metabolite concentrations and probability of incomplete testicular decent was found, as well as the sum of DEHP metabolites being significantly associated with penial width. These new results suggest a "phthalate syndrome" previously described in rodents is occurring in male children of mothers exposed to phthalates during pregnancy (Swan, 2008).
    B) ANIMAL STUDIES
    1) An animal study of high dose DEHP intraperitoneal injection, found no teratogenicity at 5 mL/kg, but 9 of the 41 fetuses in the 10 mL/kg dose group exhibited hemangiomas of the legs, and one had twisted hind legs (Singh et al, 1972). Of the six phthalates studied, DEHP was found to have the lowest toxicity under these conditions.
    3.20.3) EFFECTS IN PREGNANCY
    A) STILLBIRTH
    1) Human data on the possible pregnancy effects of intravenous DEHP was studies in 19 gravid women exposed to hemodialysis for renal failure or drug overdose. These pregnancies resulted in 2 stillbirths and more than half of the infants were premature and of low birth weight; however, no malformations were observed, and neonatal growth was normal (Fine, 1981).
    a) There is no evidence that the adverse outcomes reported were due to DEHP rather than to the medical complications of the pregnancies.
    B) PREMATURITY
    1) In a study of cord serum samples, a significantly lower gestational age was observed in MEHP-positive newborns, compared with MEHP-negative newborns (38.16 +/- 2.34 vs 39.35 +/- 1.35). No significant associations were observed between DEHP or MEHP concentrations and sex of the newborn, mode of delivery, maternal smoking, premature membrane rupture, presence of cord loops, neonatal jaundice, small size for gestational age, or 1- or 5-minute Apgar scores (Latini et al, 2003).
    C) LACK OF EFFECT
    1) Despite an absence of defined embryotoxic effects, the restriction of exposure to DEHP during pregnancy has often been recommended (Autian, 1973; Kaul, 1982).
    a) A specific focus has been placed on the use of freshly drawn blood products for transfusions during pregnancy to avoid the intravenous administration of DEHP, which may reach a concentration of 5 mg/dL in whole blood when it has been stored in PVC blood bags for 21 days (Jacobson, 1974). More recently, the use of other plasticizers in blood and intravenous fluid delivery systems has obviated concerns associated with DEHP.
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) ANIMAL STUDIES
    a) Both DEHP and MEHP may cross into breast milk. Following maternal dosing, rat pups were found to have elevated levels of DEHP (Parmar et al, 1995). In studies in rats, there is a high milk/plasma ratio (greater than 200) for DEHP indicating extraction into the milk (Dostal et al, 1987).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) DEHP caused a dose-dependent decrease in fertility and in the number and the proportion of pups born alive. A crossover mating trial showed that both genders were affected by exposure to DEHP (Lamb et al, 1987).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS117-81-7 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) IARC Classification
    a) Listed as: Di(2-ethylhexyl) phthalate
    b) Carcinogen Rating: 3
    1) The agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans. This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals. Exceptionally, agents (mixtures) for which the evidence of carcinogenicity is inadequate in humans but sufficient in experimental animals may be placed in this category when there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans. Agents, mixtures and exposure circumstances that do not fall into any other group are also placed in this category.
    3.21.2) SUMMARY/HUMAN
    A) There is no data to indicate that DEHP is a human carcinogen.
    3.21.3) HUMAN STUDIES
    A) NEOPLASM
    1) Although dioctyl phthalate is a non-genotoxic hepatocarcinogen in rats and mice (James et al, 1998), the average daily dose received by patients undergoing hemodialysis as leachate from plastic medical supplies is at least 16-fold lower than the LOEL for peroxisome proliferation and about 100-fold less than the LOEL for hepatic tumors in rats (Huber et al, 1996).
    3.21.4) ANIMAL STUDIES
    A) CARCINOMA
    1) ONCOGENIC TRANSFORMATION (ORAL) HAMSTER - 750 mg/kg (RTECS , 1999).
    2) POSITIVE for oncogenic transformation in hamster embryo cells at 4 mg/L (RTECS , 1999) .
    3) Classified as carcinogenic by RTECS criteria (RTECS , 1999) .
    4) IARC report sufficient evidence for carcinogenicity of dioctyl phthalate in mice and rats (IARC, 1982).
    5) A study using B6C3F1 mice given a diet of 0, 3000 or 6000 mg/kg for 103 weeks were followed for 105 weeks. Liver tumors in the treated groups were similar to controls (IARC, 1982).
    6) In a rodent study addressing peroxisomal proliferation as a cause for hepatocarcinogenesis, male F344 rats and female B6C3F1 mice were treated for 14 days with di (2-ethylhexyl) phthalate. Activities of enzymes responsible for the production of hydrogen peroxide were assayed in liver homogenates prepared from treated animals.
    a) The activities of the peroxisomal enzymes were enhanced 5 to 25 fold (POC) and 1.5 to 3 (CAT) fold respectively by treatment with the peroxisome proliferator. The activity of GSHPX, a cytoplasmic enzyme, was decreased 40 to 60% in liver homogenates prepared from treated animals compared to control animals.
    b) Increases in peroxisomal steady-state hydrogen peroxide for the F344 rat liver homogenates correlated with the carcinogenic potential of di(2-ethylhexyl) phthalate. Decreases in liver lipid peroxidation were observed after treatment with di(2-ethylhexyl) phthalate in both species (Tomaszewski et al, 1986).
    7) Di(2-ethylhexyl) phthalate (DEHP) is a peroxisome proliferator that was hepatocarcinogenic in female rats in a National Toxicology Program 2-year bioassay. It was shown to have neither promotional or initiator activities in this study. DEHP was negative for promotional activity when tested using the same sex and strain of rat and dosing regimen that resulted in hepatocarcinogenicity.
    8) The carcinogenic response of peroxisome proliferators may be related to excess production of reactive oxygen species in the cell. In view of this and the negative promotion data, the initiating activity of DEHP was examined after single and sub-chronic dosing.
    9) No initiating activity was found when DEHP was administered in a single, oral dose (10 g/kg) or after 12 weeks of feeding at a dietary concentration of 1.2% when each was followed by a promotion regimen. There was no increase in number or mean volume of foci when liver sections were examined using multiple histologic markers and no tumors were identified (Garvey, 1987).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Oral Exposure

    6.5.2) PREVENTION OF ABSORPTION
    A) EMESIS
    1) Due to potential esophageal or gastrointestinal tract irritation. Do NOT induce emesis.
    B) DILUTION
    1) DILUTION: If no respiratory compromise is present, administer milk or water as soon as possible after ingestion. Dilution may only be helpful if performed in the first seconds to minutes after ingestion. The ideal amount is unknown; no more than 8 ounces (240 mL) in adults and 4 ounces (120 mL) in children is recommended to minimize the risk of vomiting (Caravati, 2004).
    C) GASTRIC LAVAGE
    1) INDICATIONS: Consider gastric lavage with a large-bore orogastric tube (ADULT: 36 to 40 French or 30 English gauge tube {external diameter 12 to 13.3 mm}; CHILD: 24 to 28 French {diameter 7.8 to 9.3 mm}) after a potentially life threatening ingestion if it can be performed soon after ingestion (generally within 60 minutes).
    a) Consider lavage more than 60 minutes after ingestion of sustained-release formulations and substances known to form bezoars or concretions.
    2) PRECAUTIONS:
    a) SEIZURE CONTROL: Is mandatory prior to gastric lavage.
    b) AIRWAY PROTECTION: Place patients in the head down left lateral decubitus position, with suction available. Patients with depressed mental status should be intubated with a cuffed endotracheal tube prior to lavage.
    3) LAVAGE FLUID:
    a) Use small aliquots of liquid. Lavage with 200 to 300 milliliters warm tap water (preferably 38 degrees Celsius) or saline per wash (in older children or adults) and 10 milliliters/kilogram body weight of normal saline in young children(Vale et al, 2004) and repeat until lavage return is clear.
    b) The volume of lavage return should approximate amount of fluid given to avoid fluid-electrolyte imbalance.
    c) CAUTION: Water should be avoided in young children because of the risk of electrolyte imbalance and water intoxication. Warm fluids avoid the risk of hypothermia in very young children and the elderly.
    4) COMPLICATIONS:
    a) Complications of gastric lavage have included: aspiration pneumonia, hypoxia, hypercapnia, mechanical injury to the throat, esophagus, or stomach, fluid and electrolyte imbalance (Vale, 1997). Combative patients may be at greater risk for complications (Caravati et al, 2001).
    b) Gastric lavage can cause significant morbidity; it should NOT be performed routinely in all poisoned patients (Vale, 1997).
    5) CONTRAINDICATIONS:
    a) Loss of airway protective reflexes or decreased level of consciousness if patient is not intubated, following ingestion of corrosive substances, hydrocarbons (high aspiration potential), patients at risk of hemorrhage or gastrointestinal perforation, or trivial or non-toxic ingestion.
    D) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) MONITORING OF PATIENT
    1) Monitor liver function tests and blood glucose.
    2) Observe patients with ingestion carefully for the possible development of esophageal or gastrointestinal tract irritation or burns. If signs or symptoms of esophageal irritation or burns are present, consider endoscopy to determine the extent of injury.
    3) Carefully observe patients with ingestion exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    4) Monitor level of consciousness in patients ingesting large amounts. If central nervous system depression occurs, ensure that adequate respirations and oxygenation are maintained.
    B) HYPOGLYCEMIA
    1) Monitor blood glucose frequently.
    2) If hypoglycemia occurs, administer glucose as needed until corrected.

Inhalation Exposure

    6.7.1) DECONTAMINATION
    A) Move patient from the toxic environment to fresh air. Monitor for respiratory distress. If cough or difficulty in breathing develops, evaluate for hypoxia, respiratory tract irritation, bronchitis, or pneumonitis.
    B) OBSERVATION: Carefully observe patients with inhalation exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    C) INITIAL TREATMENT: Administer 100% humidified supplemental oxygen, perform endotracheal intubation and provide assisted ventilation as required. Administer inhaled beta-2 adrenergic agonists, if bronchospasm develops. Consider systemic corticosteroids in patients with significant bronchospasm (National Heart,Lung,and Blood Institute, 2007). Exposed skin and eyes should be flushed with copious amounts of water.
    6.7.2) TREATMENT
    A) SUPPORT
    1) Carefully observe patients with inhalation exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Eye Exposure

    6.8.1) DECONTAMINATION
    A) EYE IRRIGATION, ROUTINE: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, an ophthalmologic examination should be performed (Peate, 2007; Naradzay & Barish, 2006).

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DECONTAMINATION: Remove contaminated clothing and wash exposed area thoroughly with soap and water for 10 to 15 minutes. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).
    6.9.2) TREATMENT
    A) IRRITATION SYMPTOM
    1) Treat dermal irritation or burns with standard topical therapy. Patients developing dermal hypersensitivity reactions may require treatment with systemic or topical corticosteroids or antihistamines.
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Range Of Toxicity

Summary

    A) A probable lethal human oral dose is between 0.5 and 15 grams per kilogram, or between one ounce and one quart in a 70-kilogram adult.

Minimum Lethal Exposure

    A) A probable lethal human oral dose is between 0.5 and 15 grams per kilogram, or between one ounce and one quart in a 70-kilogram adult (EPA, 1985).

Workplace Standards

    A) ACGIH TLV Values for CAS117-81-7 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Editor's Note: The listed values are recommendations or guidelines developed by ACGIH(R) to assist in the control of health hazards. They should only be used, interpreted and applied by individuals trained in industrial hygiene. Before applying these values, it is imperative to read the introduction to each section in the current TLVs(R) and BEI(R) Book and become familiar with the constraints and limitations to their use. Always consult the Documentation of the TLVs(R) and BEIs(R) before applying these recommendations and guidelines.
    a) Adopted Value
    1) Di(2-ethylhexyl)phthalate (DEHP)
    a) TLV:
    1) TLV-TWA: 5 mg/m(3)
    2) TLV-STEL:
    3) TLV-Ceiling:
    b) Notations and Endnotes:
    1) Carcinogenicity Category: A3
    2) Codes: Not Listed
    3) Definitions:
    a) A3: Confirmed Animal Carcinogen with Unknown Relevance to Humans: The agent is carcinogenic in experimental animals at a relatively high dose, by route(s) of administration, at site(s), of histologic type(s), or by mechanism(s) that may not be relevant to worker exposure. Available epidemiologic studies do not confirm an increased risk of cancer in exposed humans. Available evidence does not suggest that the agent is likely to cause cancer in humans except under uncommon or unlikely routes or levels of exposure.
    c) TLV Basis - Critical Effect(s): LRT irr
    d) Molecular Weight: 390.54
    1) For gases and vapors, to convert the TLV from ppm to mg/m(3):
    a) [(TLV in ppm)(gram molecular weight of substance)]/24.45
    2) For gases and vapors, to convert the TLV from mg/m(3) to ppm:
    a) [(TLV in mg/m(3))(24.45)]/gram molecular weight of substance
    e) Additional information:

    B) NIOSH REL and IDLH Values for CAS117-81-7 (National Institute for Occupational Safety and Health, 2007):
    1) Listed as: Di-sec octyl phthalate
    2) REL:
    a) TWA: 5 mg/m(3)
    b) STEL: 10 mg/m(3)
    c) Ceiling:
    d) Carcinogen Listing: (Ca) NIOSH considers this substance to be a potential occupational carcinogen (See Appendix A in the NIOSH Pocket Guide to Chemical Hazards).
    e) Skin Designation: Not Listed
    f) Note(s): See Appendix A
    3) IDLH:
    a) IDLH: 5000 mg/m3
    b) Note(s): Ca
    1) Ca: NIOSH considers this substance to be a potential occupational carcinogen (See Appendix A).

    C) Carcinogenicity Ratings for CAS117-81-7 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): A3 ; Listed as: Di(2-ethylhexyl)phthalate (DEHP)
    a) A3 :Confirmed Animal Carcinogen with Unknown Relevance to Humans: The agent is carcinogenic in experimental animals at a relatively high dose, by route(s) of administration, at site(s), of histologic type(s), or by mechanism(s) that may not be relevant to worker exposure. Available epidemiologic studies do not confirm an increased risk of cancer in exposed humans. Available evidence does not suggest that the agent is likely to cause cancer in humans except under uncommon or unlikely routes or levels of exposure.
    2) EPA (U.S. Environmental Protection Agency, 2011): B2 ; Listed as: Di (2-ethylhexyl)phthalate (DEHP)
    a) B2 : Probable human carcinogen - based on sufficient evidence of carcinogenicity in animals.
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): 3 ; Listed as: Di(2-ethylhexyl) phthalate
    a) 3 : The agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans. This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals. Exceptionally, agents (mixtures) for which the evidence of carcinogenicity is inadequate in humans but sufficient in experimental animals may be placed in this category when there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans. Agents, mixtures and exposure circumstances that do not fall into any other group are also placed in this category.
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Ca ; Listed as: Di-sec octyl phthalate
    a) Ca : NIOSH considers this substance to be a potential occupational carcinogen (See Appendix A in the NIOSH Pocket Guide to Chemical Hazards).
    5) MAK (DFG, 2002): Category 4 ; Listed as: Di(2-ethylhexyl)phthalate (DEHP)
    a) Category 4 : Substances with carcinogenic potential for which genotoxicity plays no or at most a minor part. No significant contribution to human cancer risk is expected provided the MAK value is observed. The classification is supported especially by evidence that increases in cellular proliferation or changes in cellular differentiation are important in the mode of action. To characterize the cancer risk, the manifold mechanisms contributing to carcinogenesis and their characteristic dose-time-response relationships are taken into consideration.
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): R ; Listed as: di(2-Ethylhexyl) Phthalate (DEHP)
    a) R : RAHC = Reasonably anticipated to be a human carcinogen

    D) OSHA PEL Values for CAS117-81-7 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Listed as: Di-sec octyl phthalate (Di-(2-ethylhexyl) phthalate)
    2) Table Z-1 for Di-sec octyl phthalate (Di-(2-ethylhexyl) phthalate):
    a) 8-hour TWA:
    1) ppm:
    a) Parts of vapor or gas per million parts of contaminated air by volume at 25 degrees C and 760 torr.
    2) mg/m3: 5
    a) Milligrams of substances per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.
    3) Ceiling Value:
    4) Skin Designation: No
    5) Notation(s): Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: Clayton & Clayton, 1994 HSDB, 2000 IARC, 1982 Lewis, 1996 RTECS, 2000 Note: All values are from RTECS, unless otherwise indicated.
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) ICR, Male, 37.8 g/kg (IARC, 1982)
    b) 14 g/kg -- blood pressure lowering; excitement
    c) 14-75 g/kg (HSDB, 2000)
    2) LD50- (ORAL)MOUSE:
    a) 33.5 g/kg (IARC, 1982)
    b) 30 g/kg (Lewis, 1996)
    c) 1500 mg/kg - somnolence; necrotic changes in gastrointestinal system; structural or functional change in trachea or bronchii
    3) LD50- (INTRAPERITONEAL)RAT:
    a) Male, 30,700 mg/kg (IARC, 1982)
    4) LD50- (ORAL)RAT:
    a) >25 g/kg (HSDB, 2000)
    b) >26 g/kg (Clayton & Clayton, 1994)
    c) 30 g/kg
    d) Male, 30,600 mg/kg (Lewis, 1996; IARC, 1982)
    5) TCLo- (INHALATION)RAT:
    a) 940 mg/m(3) for 6H/4W intermittent -- changes in lung and liver weights; changes in serum composition

Physicochemical

Physical Characteristics

    A) Di(2-ethylhexyl) phthlate is a clear to light-colored, oily, and odorless liquid at room temperature (HSDB , 2000) ILO, 1998; (Lewis, 1996; Lewis, 1997; Lewis, 1998).

Molecular Weight

    A) 390.56

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