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DIOCTYL PHTHALATE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Dioctyl phthalate is a phthalate compound used as a solvent, a plasticizer, and in vacuum pumps, plastics, rubber materials, cellulose ester resins, polystyrene resins, and vinyl resins (Hathaway, 1996; (EPA, 1985; Budavari, 1996).

Specific Substances

    A) DI(2-ETHYLHEXYL) PHTHALATE (CAS 117-81-7)
    1) AI3-04273
    2) 1,2-BENZENEDICARBOXYLIC ACID, BIS(2-ETHYLHEXYL) ESTER
    3) 1,2-BENZENEDICARBOXYLIC ACID, BIS(ETHYLHEXYL) ESTER
    4) BEHP
    5) BIS(2-ETHYLHEXYL)-1,2-BENZENEDICARBOXYLATE
    6) BIS(2-ETHYLHEXYL)PHTHALATE
    7) BIS-(2-ETHYLHEXYL)ESTER KYSELINY FTALOVE (Czech)
    8) BISOFLEX 81
    9) BISOFLEX DOP
    10) CELLUFLEX DOP(N-)
    11) COMPOUND 889
    12) DAF 68
    13) DEHP
    14) DI(2-ETHYLHEXYL)ORTHOPHTHALATE
    15) DI(2-ETHYLHEXYL) ORTHO-PHTHALATE
    16) DI(2-ETHYLHEXYL)PHTHALATE
    17) DI-2-ETHYLHEXYLPHTHALATE
    18) DI(ETHYLHEXYL) PHTHALATE
    19) DI-SEC-OCTYL PHTHALATE
    20) DINOPOL NOP(N-)
    21) DIOCTYL PHTHALATE
    22) DIOCTYL PHTHALATE (N-)
    23) DNOP(N-)
    24) DOF (RUSSIAN PLASTICIZER)
    25) DOP
    26) ERGOPLAST FDO
    27) ERGOPLAST FDO-S
    28) ETHYLHEXYL PHTHALATE
    29) 2-ETHYLHEXYL PHTHALATE
    30) EVIPLAST 80
    31) EVIPLAST 81
    32) FLEXIMEL
    33) FLEXOL DOP
    34) FLEXOL PLASTICIZER DOP
    35) GOOD-RITE GP 264
    36) HATCOL DOP
    37) HERCOFLEX 260
    38) JAYFLEX DOP
    39) KODAFLEX DOP
    40) MOLLAN O
    41) NCI-C52733
    42) NUOPLAZ DOP
    43) OCTOIL
    44) OCTYL PHTHALATE
    45) OCTYL PHTHALATE(N-)
    46) PALATINOL AH
    47) PC PLASTICIZER DOP
    48) PHTHALIC ACID, BIS(2-ETHYLHEXYL) ESTER
    49) PHTHALIC ACID DIOCTYL ESTER
    50) PHTHALIC ACID, DIOCTYL ESTER(N-)
    51) PITTSBURGH PX-138
    52) PLATINOL AH
    53) PLATINOL DOP
    54) RC PLASTICIZER DOP
    55) RCRA WASTE NUMBER U028
    56) REOMOL D 79P
    57) REOMOL DOP
    58) SICOL 150
    59) STAFLEX DOP
    60) TRUFLEX DOP
    61) VESTINOL AH
    62) VINICIZER 80
    63) WITCIZER 312
    64) CAS 117-81-7
    65) References: HSDB, 2000; IARC, 1982; RTECS, 2000
    DI-N-OCTYL PHTHALATE (CAS 117-84-0)
    1) AI3-15071
    2) BENZENEDICARBOXYLIC ACID DI-N-OCTYL ESTER
    3) 1,2-BENZENEDICARBOXYLIC ACID, DIOCTYL ESTER
    4) CELLUFLEX DOP
    5) DI-N-OCTYL PHTHALATE
    6) DINOPOL NOP
    7) DIOCTYL O-BENZENEDICARBOXYLATE
    8) DIOCTYL 1,2-BENZENEDICARBOXYLATE
    9) DIOCTYL PHTHALATE
    10) DIOKTYLESTER KYSELINY FTALOVE (Czech)
    11) DNOP
    12) DOP
    13) N-OCTYL PHTHALATE
    14) O-BENZENEDICARBOXYLIC ACID, DIOCTYL ESTER
    15) OCTYL PHTHALATE
    16) PHTHALIC ACID, DIOCTYL ESTER
    17) POLYCIZER 162
    18) PX-138
    19) VINICIZER 85
    20) CAS 117-84-0
    21) References: HSDB, 2000; IARC, 1982; RTECS, 2000

    1.2.1) MOLECULAR FORMULA
    1) C24-H38-O4

Available Forms Sources

    A) FORMS
    1) This document includes information on the two isomers of dioctyl phthalate, di(2-ethylhexyl) phthalate and di-n-octyl-phthalate. When indicated, a distinction between the two isomers is made. It should be noted, however, that "di-n-octyl phthalate is sometimes mistakenly reported as its isomer, bis(2-ethylhexyl) phthalate, in the literature" (HSDB , 2001).
    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). 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. 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 the esterification of 2-ethylhexanol with phthalic anhydride (Ashford, 1994; Lewis, 1997).
    2) Di-n-octyl-phthalate is produced by the esterification of n-octanol with phthalic anhydride in the presence of a catalyst (sulfuric acid or p-toluenesulfonic acid) or noncatalytically at high temperature (HSDB , 2001; Bingham et al, 2001).
    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)
    5) Dioctyl phthalate is widely distributed throughout the environment, and has been found in various species of fish and in bovine tissues (Ohyama, 1977).
    6) As dioctyl phthalate is soluble in blood and lipoprotein-containing fluids, it can leach into stored blood from PVC bags and has been found in the tissues of patients transfused with stored blood (Gosselin et al, 1984).
    7) Patients undergoing dialysis and catheterized with PVC catheters have also been found to have dioctyl phthalate in their tissues, as may children undergoing extracorporeal membrane oxygenation (ECMO) (Karle et al, 1997; Mettang et al, 1996).
    8) Dioctyl phthalate may also leach into food stored in PVC wrapping materials (Gosselin et al, 1984).
    9) Dioctyl phthalate is an environmental contaminant that may accumulate in food chains (Gosselin et al, 1984).
    10) Dioctyl phthalate leaching from plasticized polyvinyl chloride blood bags caused increased lipid peroxidation and decreased vitamin E concentrations in stored erythrocytes (Deepa Devi et al, 1998; Manojkumar et al, 1998).
    C) USES
    1) Dioctyl phthalate occurs in two isomeric forms, di-n-octyl phthalate and di(2-ethylhexyl) phthalate; the two forms are used in similar fashions.
    2) 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 (Bingham et al, 2001; HSDB , 2001; IARC, 1982; Sittig, 1991).
    3) 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 percent 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) Dioctyl phthalate is generally considered to be of low toxicity via the oral and dermal routes. Mucous membrane and eye irritation may occur. Central nervous system depression may occur. Dermal irritation is seldom seen. Skin sensitization does not occur in humans. The low vapor pressure usually precludes inhalation of any significant amount except perhaps as an aerosol adsorbed to airborne particulates.
    0.2.4) HEENT
    A) Irritation of eyes, nose, and throat may occur.
    0.2.6) RESPIRATORY
    A) Respiratory irritation is uncommon, but possible.
    0.2.7) NEUROLOGIC
    A) Central nervous system depression may occur with ingestion of large amounts.
    0.2.8) GASTROINTESTINAL
    A) GI tract or esophageal irritation may occur.
    0.2.9) HEPATIC
    A) Mild hepatotoxicity has been reported in experimental animals.
    0.2.14) DERMATOLOGIC
    A) Dermal irritation may sometimes develop.
    0.2.16) ENDOCRINE
    A) Hypoglycemia has been noted in experimental animals.
    0.2.20) REPRODUCTIVE
    A) At the time of this review, no studies were found on the potential adverse reproductive effects of dioctyl phthalate in humans.

Laboratory Monitoring

    A) Monitor liver function tests and blood glucose.

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 kg adult.

Clinical Effects

Summary Of Exposure

    A) Dioctyl phthalate is generally considered to be of low toxicity via the oral and dermal routes. Mucous membrane and eye irritation may occur. Central nervous system depression may occur. Dermal irritation is seldom seen. Skin sensitization does not occur in humans. The low vapor pressure usually precludes inhalation of any significant amount except perhaps as an aerosol adsorbed to airborne particulates.

Heent

    3.4.1) SUMMARY
    A) Irritation of eyes, nose, and throat may occur.
    3.4.3) EYES
    A) Eye irritation may occur (HSDB , 2001; Lewis, 1996; EPA, 1985), although this agent was not irritating to the eyes of experimental animals (Hathaway, 1996).
    3.4.5) NOSE
    A) Dioctyl phthalate may cause irritation of the mucosa of the nose and throat (HSDB , 2001; EPA, 1985).
    3.4.6) THROAT
    A) Dioctyl phthalate may cause irritation of the mucosa of the nose and throat (HSDB , 2001; EPA, 1985).

Respiratory

    3.6.1) SUMMARY
    A) Respiratory irritation is uncommon, but possible.
    3.6.2) CLINICAL EFFECTS
    A) IRRITATION SYMPTOM
    1) Dioctyl phthalate is irritating to mucous membranes, and could cause respiratory tract irritation (EPA, 1985). However, the material's low vapor pressure generally precludes inhalation of any significant amount (EPA, 1985).
    2) Exposure to dioctyl phthalate from building materials as an aerosol adsorbed to particulate matter might trigger asthma attacks through a process that causes inflammation by mimicking prostaglandin release (Oie et al, 1997).

Neurologic

    3.7.1) SUMMARY
    A) Central nervous system depression may occur with ingestion of large amounts.
    3.7.2) CLINICAL EFFECTS
    A) CENTRAL NERVOUS SYSTEM DEFICIT
    1) Central nervous system depression might develop if large amounts are absorbed (EPA, 1985).

Gastrointestinal

    3.8.1) SUMMARY
    A) GI tract or esophageal irritation may occur.
    3.8.2) CLINICAL EFFECTS
    A) GASTROINTESTINAL IRRITATION
    1) As dioctyl phthalate is irritating to mucous membranes (HSDB , 2001; EPA, 1985), gastrointestinal tract or esophageal mucosal irritation might be seen in ingestions.
    B) ENTEROCOLITIS
    1) Necrotizing enterocolitis has been observed in neonates with increased serum levels of diethylhexyl phthalate (DEHP) after exchange transfusion or extracorporeal membrane oxygenation (Plonait et al, 1993).

Hepatic

    3.9.1) SUMMARY
    A) Mild hepatotoxicity has been reported in experimental animals.
    3.9.2) CLINICAL EFFECTS
    A) CHOLESTATIC HEPATITIS
    1) 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).
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATOMEGALY
    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.

Genitourinary

    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) NEPHROPATHY TOXIC
    a) 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.
    2) TESTIS DISORDER
    a) RATS - Testicular atrophy was observed in rats in chronic feeding experiments with dioctyl phthalate (Gosselin et al, 1984; Oishi, 1994) Arsadi et al, 1998). This effect has not been reported in exposed humans.
    3) OTHER
    a) Leaching of dioctyl phthalate from plastic medical supplies has been implicated in the development of uremic pruritus in hemodialysis patients (Mettang et al, 1999).

Dermatologic

    3.14.1) SUMMARY
    A) Dermal irritation may sometimes develop.
    3.14.2) CLINICAL EFFECTS
    A) SKIN IRRITATION
    1) Dioctyl phthalate does not produce skin sensitization in humans (EPA, 1985). Dermal irritation is seldom seen (EPA, 1985), although moderate irritation may sometimes occur (Mallette & Von Haam, 1952; Bingham et al, 2001).

Endocrine

    3.16.1) SUMMARY
    A) Hypoglycemia has been noted in experimental animals.
    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). This effect has not been reported in exposed humans.

Reproductive

    3.20.1) SUMMARY
    A) At the time of this review, no studies were found on the potential adverse reproductive effects of dioctyl phthalate in humans.
    3.20.2) TERATOGENICITY
    A) CONGENITAL ANOMALY
    1) Administration of 15 percent of the LD50 dose to pregnant rats on days 5, 10, and 15 of gestation produced resorptions in 27 percent and gross fetal abnormalities in 22 percent (Singh et al, 1972).
    2) Dioctyl phthalate is teratogenic in mice and rats causing decreased liver and kidney weights and histologic damage in the liver, kidney and testes (Hathaway, 1996; (Arcadi et al, 1998; Peters et al, 1997).
    B) BIRTH DEFECTS
    1) Teratogenic effects, fetotoxicity, specific developmental anomalies, and testicular damage have been reported in rats, mice, guinea pigs, and unspecified mammals (HSDB , 2001; RTECS , 2001). An increased incidence of resorptions, late fetal death, exophthalmia, exencephaly, tail defects, major vessel malformations, and hepatobiliary and skeletal defects have been reported in rats, mice, and guinea pigs (ACGIH, 1991; (RTECS , 2001; HSDB , 2001).
    3.20.3) EFFECTS IN PREGNANCY
    A) GESTATIONAL ZINC DEFICIENCY
    1) In pregnant rats, administration of dioctyl phthalate causes a functional zinc deficiency (Peters et al, 1997).

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.
    B) IARC Carcinogenicity Ratings for CAS117-84-0 (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) Not Listed
    3.21.4) ANIMAL STUDIES
    A) CARCINOMA
    1) ONCOGENIC TRANSFORMATION (ORAL) HAMSTER - 750 mg/kg (RTECS , 2001)
    2) POSITIVE for oncogenic transformation in hamster embryo cells at 4 mg/L (RTECS , 2001)
    3) Classified as carcinogenic by RTECS criteria (RTECS , 2001)
    4) IARC report sufficient evidence for carcinogenicity of dioctyl phthalate in mice and rats (IARC, 1982).
    5) 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).

Genotoxicity

    A) Results of numerous tests indicate that dioctyl phthalate is not a direct-acting genotoxic agent in vitro.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor liver function tests and blood glucose.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Monitor liver function tests and blood glucose.
    2) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count and liver and kidney function tests is suggested for patients with significant exposure.
    4.1.3) URINE
    A) URINALYSIS
    1) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring urinalysis is suggested for patients with significant exposure.
    4.1.4) OTHER
    A) OTHER
    1) MONITORING
    a) If respiratory tract irritation is present, monitor arterial blood gases and chest x-ray.

Radiographic Studies

    A) CHEST RADIOGRAPH
    1) If respiratory tract irritation is present, monitor chest x-ray.

Methods

    A) CHROMATOGRAPHY
    1) DEHP serum levels have been measured using a gas-liquid chromatographic method (Plonait et al, 1993).
    2) Urine concentrations of 2-ethylhexanoic acid (EHXA), a metabolite of DEHP, have been measured using a gas chromatography-mass spectrometry method (Plonait et al, 1993).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients symptomatic following exposure should be observed in a controlled setting until all signs and symptoms have fully resolved.

Monitoring

    A) Monitor liver function tests and blood glucose.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) 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).
    B) EMESIS/ NOT RECOMMENDED -
    1) Due to potential esophageal or gastrointestinal tract irritation, EMESIS SHOULD BE AVOIDED.
    C) ACTIVATED CHARCOAL -
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    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).
    6.5.2) PREVENTION OF ABSORPTION
    A) EMESIS
    1) Due to potential esophageal or gastrointestinal tract irritation, EMESIS SHOULD BE AVOIDED.
    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) SKIN IRRITATION
    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.

Enhanced Elimination

    A) LACK OF INFORMATION
    1) No studies have addressed the utilization of extracorporeal elimination techniques in poisoning with this agent.

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 kg adult.

Minimum Lethal Exposure

    A) ACUTE
    1) 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).
    B) CARCINOGENICITY - The International Agency for Research on Cancer places di(2-ethylhexyl) phthalate in its Group 2B classification, indicating that this compound is a possible human carcinogen (IARC, 1982). This compound has produced experimental carcinogenic, tumorigenic, and reproductive effects (Lewis, 1996).
    C) ANIMAL DATA
    1) Intraperitoneal injection of 2 grams of dioctyl phthalate per kilogram was fatal in rats (Mallette & Von Haam, 1952).
    2) LDLo (SKIN) RAT - 4 grams/kg (RTECS , 2001)
    3) LDLo (SKIN) MOUSE - 4 grams/kg (RTECS , 2001)

Maximum Tolerated Exposure

    A) ACUTE
    1) Humans have developed mild gastrointestinal disturbances after ingesting 10 milliliters of dioctyl phthalate (Gosselin et al, 1984).
    2) TDLo (ORAL) HUMAN - 143 mg/kg (RTECS , 2001)

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) CASE REPORTS
    a) Plonait et al (1993) measured serum levels of diethylhexyl phthalate (DEHP), a plasticizer in transfusion bags, in infants undergoing exchange transfusion and found undetectable levels prior to transfusion, and levels of 6.1 to 21.6 micrograms/milliliter after one transfusion. No clinical toxicity was identified.
    b) In a group of 7 patients undergoing regular continuous peritoneal dialysis, serum levels of dioctyl phthalate ranged from 0.027 to 0.231 micrograms/milliliter and were significantly higher than those of control patients (0.016 to 0.025 micrograms/milliliter) (Mettang et al, 1996).

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) ACGIH TLV Values for CAS117-84-0 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    C) 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).

    D) NIOSH REL and IDLH Values for CAS117-84-0 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    E) 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

    F) Carcinogenicity Ratings for CAS117-84-0 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    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): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    G) 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

    H) OSHA PEL Values for CAS117-84-0 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Pharmacology Toxicology

Toxicologic Mechanism

    A) Enlarged livers and elevated levels of serum transaminases have been demonstrated in experimental animals (Piekacz, 1971). Inhibition of various enzymes (glucose-6-phosphate dehydrogenase in yeast and malate dehydrogenase from pig heart) have been demonstrated in vitro (Ohyama, 1977). Dioctyl phthalate is a peroxisome proliferator in rodents (James et al, 1998; Huber et al, 1996).
    B) Decreased blood glucose has been noted in exposed experimental animals, but it is unclear whether this is a direct effect of the administered dioctyl phthalate, or a result of effects on hormones or metabolic processes (Nagasaki et al, 1974; Nagasaki et al, 1975).
    C) Dioctyl phthalate is teratogenic and its metabolite mono(2-ethylhexyl) phthalate is a testicular toxicant in experimental animals (Singh et al, 1972; Boekelheide et al, 1998) Lee et al, 1998; (Li et al, 1998) Avcadi et al, 1998; (Peters et al, 1997).
    D) Dioctyl phthalate is a moderate direct skin irritant (Lewis, 1996; Mallette & Von Haam, 1952). It may or may not be irritating to the eyes in experimental animals (RTECS , 1999) Hathaway, 1996).
    E) Dioctyl phthlate is a non-genotoxic rodent carcinogen and may be released from plastic materials used in medicine (Huber et al, 1996). In patients undergoing hemodialysis, daily doses received are at least 16-fold less than the LOEL for peroxisome proliferation and about 100-fold less than the LOEL for hepatic tumorigenesis in rats (Huber et al, 1996).

Physicochemical

Molecular Weight

    A) 390.56

Physical Characteristics

    A) Both isomers of dioctyl phthalate are clear to light-colored, oily, and odorless liquids at room temperature (HSDB , 2001) ILO, 1998; (Lewis, 1996; Lewis, 1997; Lewis, 1998).

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