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DIBUTYL PHTHALATE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Dibutyl phthalate is a liquid which appears to be of low toxicity in humans. It is mainly an eye, skin and mucous membrane irritant. Oral exposures are uncommon, but have been reported in GloStick (a novelty chemiluminescence light stick) ingestions in children, with minimal adverse effects.
    B) Dibutyl phthalate has been used extensively in glosticks and other glow compounds, for the manufacture of plastics and as an insect repellant for impregnation of clothing. Dibutyl phthalate is also used in lacquers, adhesives, leather, printing inks, safety glass, cellophane, dyes, and as a solvent for perfume oils.

Specific Substances

    1) 1,2-benzenedicarboxylic acid dibutyl ester
    2) phthalic acid dibutyl ester
    3) DBP
    4) N-butyl phthalate
    5) Benzene-o-dicarboxylic acid di-n-butyl ester
    6) Butyl phthalate
    7) Celluflex DPB
    8) Di-n-Butylphthalate
    9) Dibutyl 1,2-benzene dicarboxylate
    10) Dibutyl-o-phthalate
    11) Elaol
    12) Ergoplast FDB
    13) Genoplast B
    14) Hexaplast M/B
    15) o-benzenedicarboxylic acid, dibutyl ester
    16) Palatinol C
    17) Phthalic acid dibutyl ester
    18) Polycizer DBP
    19) PX 104
    20) RC Plasticizer DBP
    21) CAS 84-74-2
    22) DIBUTYL ESTER
    23) HEXAPLAS M/B
    24) POLYCIZER DPB
    25) STAFLEX DPB
    26) WITCIZER 300
    1.2.1) MOLECULAR FORMULA
    1) O-C6H4[COO(CH2)3CH3]2

Available Forms Sources

    A) FORMS
    1) Dibutyl phthalate is a clear, oily, colorless or very slightly yellow liquid which is practically insoluble in water (Grant & Schuman, 1993; JEF Reynolds , 2000).
    B) USES
    1) Dibutyl phthalate is used in a variety of ways, including insect repellant for impregnation into clothing, plasticizer in nitrocellulose lacquers, elastomers, explosives, nail polish, and solid rocket propellants. It is also a solvent for perfume oils, perfume fixative, textile lubricating agent, safety glass, printing inks, resin solvent, paper coatings, and adhesives. It is not a registered pesticide in the United States (EPA, 1985; ITI, 1985; Budavari, 1996; JEF Reynolds , 2000).
    2) Dibutyl phthalate is a major ingredient in glowsticks and other glow products which are popular with children (Keys et al, 1995).

Overview

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) 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.
    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) Carefully observe patients with ingestion exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    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.
    B) Carefully observe patients with inhalation exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    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).
    2) Some chemicals can produce systemic poisoning by absorption through intact skin. Carefully observe patients with dermal exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.

Range Of Toxicity

    A) Minimum lethal human exposure is unknown.
    B) 10 g have been tolerated in a human. The LD50s for rodents are in the 8 to 10 g/kg range.

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Dibutyl phthalate (DBP) is thought to have low acute toxicity based on animal studies. There have been few human overdose cases reported. Much of the work being done involves possible teratogenic and mutagenic activities. DBP is known to alter hepatic enzymes in laboratory and animal models. Contact with any body part may produce immediate stinging and burning sensation.
    0.2.4) HEENT
    A) Splash contact can cause an immediate stinging and burning sensation as well as profuse lacrimation.
    B) Various manifestations have been observed in animal studies and human exposures, including photophobia, conjunctivitis, edema, and keratitis.
    0.2.6) RESPIRATORY
    A) Animals that have been fatally poisoned developed labored breathing and died of respiratory paralysis.
    0.2.7) NEUROLOGIC
    A) Dizziness occurred in a human exposure to 10 grams of DBP.
    B) Polyneuritis was reported in one Soviet study.
    0.2.8) GASTROINTESTINAL
    A) Nausea occurred in a human case where 10 grams was reportedly ingested.
    0.2.9) HEPATIC
    A) There have been various studies done on animals evaluating the effect on the liver. In general, it is thought that exposure to DBP will increase the mean liver weights of tested animals.
    0.2.10) GENITOURINARY
    A) Testicular atrophy was reported in rats given 2 g/kg/day.
    B) Nephritis was reported in one human case where 10 grams was thought to be ingested.
    0.2.13) HEMATOLOGIC
    A) Rats that inhaled 1 mg/m(3) continuously for 90 days developed a reduction of white blood cells and an increased gamma-globulin content.
    0.2.14) DERMATOLOGIC
    A) There have been several cases of contact dermatitis to DBP-containing products and plastics.
    B) Splash contact usually results in an immediate burning sensation.
    0.2.17) METABOLISM
    A) Rat studies have shown abnormalities in cytochrome P-450 in both the lungs (when inhaled) and the liver (when ingested). NADPH-cytochrome-c-reductase, aminopyrine N-demethylase, and aniline hydroxylase were also found to be abnormal in one study.
    0.2.20) REPRODUCTIVE
    A) There have been several animal and laboratory tests done on the possible teratogenic effect of DBP. The results have been mixed. Studies done on Salmonella cultures have shown mildly positive mutagenic responses. DBP appears to affect females more than males, at least in the rodent studies performed.

Laboratory Monitoring

    A) No specific tests are indicated, only the general statements apply.
    B) 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.
    C) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring urinalysis is suggested for patients with significant exposure.
    D) If respiratory tract irritation is present, it may be useful to monitor pulmonary function tests.
    E) If respiratory tract irritation is present, monitor chest x-ray.

Clinical Effects

Summary Of Exposure

    A) Dibutyl phthalate (DBP) is thought to have low acute toxicity based on animal studies. There have been few human overdose cases reported. Much of the work being done involves possible teratogenic and mutagenic activities. DBP is known to alter hepatic enzymes in laboratory and animal models. Contact with any body part may produce immediate stinging and burning sensation.

Heent

    3.4.1) SUMMARY
    A) Splash contact can cause an immediate stinging and burning sensation as well as profuse lacrimation.
    B) Various manifestations have been observed in animal studies and human exposures, including photophobia, conjunctivitis, edema, and keratitis.
    3.4.3) EYES
    A) WITH POISONING/EXPOSURE
    1) Splash contact has caused immediate, severe, stinging pain (Keys et al, 1995) which stimulated profuse tearing. This tearing generally washes the liquid away and prevents the eyes from being damaged (Grant & Schuman, 1993).
    2) Conjunctivitis and edema of the eyelids were noted in rats fatally poisoned with dibutyl phthalate orally (Krauskopf, 1973). These symptoms were also mentioned in one human exposure (Cagianut, 1954), and a Soviet study on mice (ACGIH, 1986).
    3) Cagianut (1954) reported a case where a worker is said to have ingested 10 grams (140 mg/kg) by accident. No symptoms developed for several hours until a severe, transient keratitis was seen in both eyes. The corneal epithelium was lost.
    a) Because the history of ingestion was difficult to obtain from the patient, and because it would be difficult to ingest 10 grams of the strong, bitter liquid, Oettel has cast significant doubt about this case (Cagianut, 1954; Oettel, 1957).
    4) Photophobia has been reported after ingestion (EPA, 1985; Cagianut, 1954).

Respiratory

    3.6.1) SUMMARY
    A) Animals that have been fatally poisoned developed labored breathing and died of respiratory paralysis.
    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) PARALYSIS
    a) Respiratory paralysis was reported as the fatal event in animals poisoned by dibutyl phthalate. Respiratory irritation occurred at 250 mg/m(3), and progressed to labored breathing and respiratory paralysis (ACGIH, 1986).
    2) RESPIRATORY DISORDER
    a) An increase in mean lung weights, with increased foam-cell proliferation and thickening of the alveolar septi, was found in an inhalation study of diethylhexyl phthalate in rats (Klimisch et al, 1992).

Neurologic

    3.7.1) SUMMARY
    A) Dizziness occurred in a human exposure to 10 grams of DBP.
    B) Polyneuritis was reported in one Soviet study.
    3.7.2) CLINICAL EFFECTS
    A) DIZZINESS
    1) WITH POISONING/EXPOSURE
    a) Dizziness may occur after ingestion (Lefaux, 1968).
    B) NEURITIS
    1) WITH POISONING/EXPOSURE
    a) Polyneuritis was reported in one Soviet study, with 32% developing various neurological complaints. The report is complicated by the fact that the workers were exposed to several phthalate plasticizers including dioctyl phthalate and benzyl butyl phthalate, as well as sebacates and adipates(Milkov et al, 1973).

Gastrointestinal

    3.8.1) SUMMARY
    A) Nausea occurred in a human case where 10 grams was reportedly ingested.
    3.8.2) CLINICAL EFFECTS
    A) NAUSEA
    1) WITH POISONING/EXPOSURE
    a) Nausea was reported after ingestion of 10 grams of dibutyl phthalate in an adult (Lefaux, 1968).

Hepatic

    3.9.1) SUMMARY
    A) There have been various studies done on animals evaluating the effect on the liver. In general, it is thought that exposure to DBP will increase the mean liver weights of tested animals.
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATOMEGALY
    a) In one study, administration of di-n-butyl phthalate for three months to rats increased the mean liver weights of exposed animals (Nikonorow et al, 1973). Klimisch et al (1992) found increased mean liver weights in an inhalational study of effects of diethylhexyl phthalate on rats (Klimisch et al, 1992).

Genitourinary

    3.10.1) SUMMARY
    A) Testicular atrophy was reported in rats given 2 g/kg/day.
    B) Nephritis was reported in one human case where 10 grams was thought to be ingested.
    3.10.2) CLINICAL EFFECTS
    A) NEPHRITIS
    1) WITH POISONING/EXPOSURE
    a) Ingestion of 10 grams of dibutyl phthalate is said to have caused a toxic nephritis, with red and white blood cells and oxalate crystals in the urine. There is some doubt of the validity of this case, because of the difficulty in accidentally swallowing that amount (Cagianut, 1954; Oettel, 1957).
    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HYPOSPADIAS
    a) Testicular atrophy and loss of testicular zinc was seen in rats given 2 g/kg/day (by gastric tube) (Gosselin et al, 1984; Oishi & Hiraga, 1980).
    b) Young rats given 500 and 1000 mg/kg/day of dibutyl phthalate for 15 days exhibited a decrease in testes weight, degeneration of seminiferous tubules, and evidence of spermatogenic cell degeneration (Srivastava et al, 1990).
    2) RENAL CYST
    a) Mice given 10 and 100 mg/kg/day were reported to have increased formation of renal cysts in mothers and in the first two generation of offspring (Omori, 1976).
    b) Polycystic kidneys with atrophic glomeruli were reported in mice given 5 g/kg/day of dibutyl phthalate for 2 weeks. However, there is no evidence linking human cystic kidney disease and exposure to dibutyl phthalate (Woodward, 1990).

Hematologic

    3.13.1) SUMMARY
    A) Rats that inhaled 1 mg/m(3) continuously for 90 days developed a reduction of white blood cells and an increased gamma-globulin content.
    3.13.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LEUKOPENIA
    a) Exposure to 0.095 and 1 mg/m(3) continuously for 90 days resulted in a reduction of the number of white blood cells and an increase in the gamma-globulin content of blood (Daniel, 1978).

Dermatologic

    3.14.1) SUMMARY
    A) There have been several cases of contact dermatitis to DBP-containing products and plastics.
    B) Splash contact usually results in an immediate burning sensation.
    3.14.2) CLINICAL EFFECTS
    A) DERMATITIS
    1) WITH POISONING/EXPOSURE
    a) Several cases of allergic dermatitis have been reported after use of antiperspirants containing dibutyl phthalate (Calan, 1975). Dibutyl phthalate can cause hypersensitivity contact dermatitis (JEF Reynolds , 2000).
    b) CASE REPORT - A case of allergic contact dermatitis is reported in a 35-year-old male following use of a cream containing dibutyl phthalate, propyl gallate, and hydrocortisone. He had previous contact with dibutyl phthalate, and the authors speculate he developed a sensitization (Wilkinson & Beck, 1992).
    c) Sensitivity to plastics, such as those in a watch band, has also been attributed to dibutyl phthalate (Husain, 1975).
    B) PAIN
    1) WITH POISONING/EXPOSURE
    a) Splash contact with dibutyl phthalate from GloSticks resulted in a burning sensation of the skin, the most common complaint in a case series of 61 glow compound exposures. Treatment with soap and water was most effective (Keys et al, 1995).

Reproductive

    3.20.1) SUMMARY
    A) There have been several animal and laboratory tests done on the possible teratogenic effect of DBP. The results have been mixed. Studies done on Salmonella cultures have shown mildly positive mutagenic responses. DBP appears to affect females more than males, at least in the rodent studies performed.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) Teratogenicity studies done in rats have had both positive and negative results (Schardein, 1985; Cummings & Gray, 1987; Ema et al, 1994).
    2) Ema et al (1994) reported fetal malformations in rats when pregnant dams were exposed to 0.75 and 1.0 g/kg DBP daily on days 7 to 9 and days 13 to 15 of pregnancy. Major effects included cleft palate, fusion of sternebrae, fusion or absence of cervical or thoracic vertebral arches, and fusion or absence of ribs. Exposures on days 10 to 12 did not produce a significant number of malformations in pups.
    a) Postimplantation loses were seen in pregnant rats receiving 0.75 to 1.5 g/kg DBP via gastric intubation. Skeletal malformations were seen when 0.75 or 1.0 g/kg was given on days 7 to 9, and external malformations were seen when dibutyl phthalate was given on days 13 to 15 (Ema et al, 1994).
    3) Another study by Ema et al (1998) evaluated the impact of DBP exposure in rats during later stages of pregnancy (days 11 to 21). Pregnant rats were exposed to a diet containing DBP at a dose of 0 (control), 0.5, 1, or 2%. Results showed the weights of fetuses in the 2% DBP group were significantly lower than the control group. Anogenital distance (AGD) and the AGD:body weight ratio of male fetuses were significantly decreased in both the 1% and 2% DBP groups. Incidence of cleft palate was significantly higher for fetuses with maternal exposure of 2% DBP compared to controls, as was the incidence of skeletal malformations (fusion of the sternebrae). Undescended testes occurred in a significantly larger frequency to fetuses in the 1% and 2% groups when compared to controls (Ema et al, 1998).
    4) Rats fed 1% DBP during gestation showed borderline significance in the number of resorptions and external malformations in mice (Shiota & Nishimura, 1982).
    3.20.3) EFFECTS IN PREGNANCY
    A) ANIMAL STUDIES
    1) A study in rats evaluated the impact of DBP exposure during later stages of pregnancy (days 11 to 21). Pregnant rats were exposed to a diet containing DBP at a dose of 0 (control), 0.5, 1, or 2%. Results showed maternal weight gain and adjusted weight gain (indicates net weight gain during pregnancy) to be significantly less in the 1% and 2% DBP groups compared to the control group. Food intake was also significantly lower during the study period in the 1% and 2% DBP groups. The authors found that the decrease in each of these indexes was approximately proportional to the DBP exposure dose (Ema et al, 1998).
    3.20.5) FERTILITY
    A) INCREASED INCIDENCES OF REPRODUCTIVE EFFECTS IN HUMAN OFFSPRING
    1) A study found that children of men who were exposed to dibutyl phthalate had increased incidences of disorders affecting reproduction as compared with that of the general population (Carran & Shaw, 2012).
    B) ANIMAL STUDIES
    1) FERTILITY DECREASED FEMALE
    a) One study in rats indicated reduced fertility when the animals were fed DBP chronically, but not with short term dosing (Cummings & Gray, 1987).
    b) Intraperitoneal injection of female rats with 0.33 of the LD50 on days 5, 10 and 15 of gestation caused a 23% resorption rate and a 33% incidence of skeletal abnormalities (Singh et al, 1972).
    c) Rats fed 1% DBP showed a reduced number of litters per pair and of live pups per litter. Crossover studies indicated that it was the female, not the male rats that were affected (Lamb et al, 1987).
    2) MALE FERTILITY - No adverse effects on male fertility or testicular histology were found in a rat study of inhalational diethylhexyl phthalate (Klimisch et al, 1992).
    3) MALE REPRODUCTIVE TRACT LESIONS
    a) Di(n-butyl) phthalate (DBP) has been found to act as an antiandrogen when male rats are exposed in utero. Exposure results in decreased fetal testicular testosterone production. Other studies in rats have indicated that exposure to DBP can produce malformations of the epididymis, seminal vesicles, prostate, and penis following in utero exposure (Barlow et al, 2004).
    1) In one study, dams were gavaged daily from gestation day 12 to 21 with DBP (in corn oil) at 100 and 500 mg/kg/day. Male offspring were allowed to mature until 6, 12 or 18 months and then necropsied. Findings and histologic lesions were consistent with earlier studies. Mature male rats had malformations of the reproductive tract that included testicular lesions with atrophy and flaccid capsules, occasional enlargement with abundant amounts of interstitial fluid and rarely absence of the testis. Enlarged testes were only observed in the 500 mg/kg/day dose group and were usually accompanied by malformed epididymides. Testicular dysgenesis (aberrant seminiferous tubules associated with proliferative Leydig cells) was only seen in the high-dose group. In addition, hypospadias, were only observed in the high-dose group (Barlow et al, 2004).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS84-74-2 (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) LEYDIG CELL ADENOMAS
    1) In a study of male rats exposed in utero to di(n-butyl)phthalate (DBP), the findings indicated that exposure induced a proliferation of developmental lesions, which appeared similar to Leydig cell (LC) adenomas by morphologic criteria. However, the lesions were dissimilar to traditional LC adenomas as the LCs were poorly differentiated and these lesions contained aberrant seminiferous tubules. It was noted that the proliferation of these lesions occurred at each observation point (6, 12, and 18 months). Although the study revealed the morphology of these DBP-induced testicular lesions, the authors suggested that further detailed pathogenesis studies were needed (Barlow et al, 2004).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) No specific tests are indicated, only the general statements apply.
    B) 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.
    C) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring urinalysis is suggested for patients with significant exposure.
    D) If respiratory tract irritation is present, it may be useful to monitor pulmonary function tests.
    E) If respiratory tract irritation is present, monitor chest x-ray.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) 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) PULMONARY FUNCTION TESTS
    a) If respiratory tract irritation is present, it may be useful to monitor pulmonary function tests.

Radiographic Studies

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

Methods

    A) CHROMATOGRAPHY
    1) In water may be isolated via gas chromatography or gas chromatography plus mass spectrometry (Sittig, 1985).
    2) Ching et al (1981) discussed a gas chromatographic-mass spectrometric detection method of identifying circulating plasticizers in surgical patients.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.2) HOME CRITERIA/ORAL
    A) Most ingestions of dibutyl phthalate from glowsticks can be managed at home with water or milk dilution. Patients with severe or persistent symptoms should be referred to a health care facility.
    B) Keys et al (1995) reported 63% of glowstick exposures were treated at home in a case series of 61 patients. External exposures were treated with soap and water rinses while oral exposures were treated with water or milk dilution. No patient in this series was treated with charcoal, whole bowel irrigation or lavage.

Monitoring

    A) No specific tests are indicated, only the general statements apply.
    B) 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.
    C) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring urinalysis is suggested for patients with significant exposure.
    D) If respiratory tract irritation is present, it may be useful to monitor pulmonary function tests.
    E) If respiratory tract irritation is present, monitor chest x-ray.

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) 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) 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) 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).
    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.
    6.5.3) TREATMENT
    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) OBSERVATION REGIMES
    1) Carefully observe patients with ingestion exposure for the development of any systemic signs or symptoms and administer symptomatic treatment as necessary.
    C) OBSERVATION REGIMES
    1) Patients symptomatic following exposure should be observed in a controlled setting until all signs and symptoms have fully resolved.

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) OBSERVATION REGIMES
    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) DERMAL DECONTAMINATION
    1) 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 ABSORPTION
    1) Some chemicals can produce systemic poisoning by absorption through intact skin. Carefully observe patients with dermal 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.

Enhanced Elimination

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

Range Of Toxicity

Summary

    A) Minimum lethal human exposure is unknown.
    B) 10 g have been tolerated in a human. The LD50s for rodents are in the 8 to 10 g/kg range.

Minimum Lethal Exposure

    A) GENERAL/SUMMARY
    1) The minimum lethal human dose to this agent has not been delineated.

Maximum Tolerated Exposure

    A) ANIMAL DATA
    1) The largest single dose tolerated by rats was greater than 8 grams per kilogram (Budavari, 1996).
    2) Rats that were given 1 milligram/kilogram of a solution in oil twice weekly for six weeks developed no abnormalities. The same was true for a group of rats treated similarly for 1.5 years (Bornmann, 1956).
    3) Growth inhibition was seen in one group of rats who were given 0.25% (2500 ppm) in their diet for one year (Smith, 1953).
    B) ADULT
    1) The lowest published toxic dose (TDLo) for a human is 140 milligrams/kilogram orally, with toxic effects of hallucinations, nausea or vomiting, and kidney changes (RTECS , 2000).

Workplace Standards

    A) ACGIH TLV Values for CAS84-74-2 (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) Dibutyl phthalate
    a) TLV:
    1) TLV-TWA: 5 mg/m(3)
    2) TLV-STEL:
    3) TLV-Ceiling:
    b) Notations and Endnotes:
    1) Carcinogenicity Category: Not Listed
    2) Codes: Not Listed
    3) Definitions: Not Listed
    c) TLV Basis - Critical Effect(s): Testicular dam; eye and URT irr
    d) Molecular Weight: 278.34
    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) Under Study
    1) Dibutyl phthalate
    a) TLV:
    1) TLV-TWA:
    2) TLV-STEL:
    3) TLV-Ceiling:
    b) Notations and Endnotes:
    1) Carcinogenicity Category: Not Listed
    2) Codes: Not Listed
    3) Definitions: Not Listed
    c) TLV Basis - Critical Effect(s):
    d) Molecular Weight:
    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 CAS84-74-2 (National Institute for Occupational Safety and Health, 2007):
    1) Listed as: Dibutyl phthalate
    2) REL:
    a) TWA: 5 mg/m(3)
    b) STEL:
    c) Ceiling:
    d) Carcinogen Listing: (Not Listed) Not Listed
    e) Skin Designation: Not Listed
    f) Note(s):
    3) IDLH:
    a) IDLH: 4000 mg/m3
    b) Note(s): Not Listed

    C) Carcinogenicity Ratings for CAS84-74-2 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed ; Listed as: Dibutyl phthalate
    2) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed ; Listed as: Dibutyl phthalate
    3) EPA (U.S. Environmental Protection Agency, 2011): D ; Listed as: Dibutyl phthalate
    a) D : Not classifiable as to human carcinogenicity.
    4) 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
    5) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed ; Listed as: Dibutyl phthalate
    6) MAK (DFG, 2002): Not Listed
    7) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS84-74-2 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Listed as: Dibutyl phthalate
    2) Table Z-1 for Dibutyl 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) LD50- (INTRAPERITONEAL)RAT:
    1) 3.05 mL/kg (Singh et al,1972)
    2) 4000 mg/kg (Calley et al, 1966)
    B) LD50- (ORAL)RAT:
    1) 12,000 mg/kg (Lewis, 1996)
    2) >20 g/kg (Lehman, 1955)
    3) 8-10 g/kg (Krauskopf, 1973)
    4) 8 g/kg (Smith, 1953)

Pharmacology Toxicology

Toxicologic Mechanism

    A) Acts as an uncoupler of oxidative phosphorylation in rats (Gosselin et al, 1984)

Physicochemical

Physical Characteristics

    A) This compound is a colorless or slightly yellow, oily liquid with a strong, bitter taste, and a slight aromatic odor (CHRIS, 2005; Grant & Schuman, 1993; EPA, 1985). It is almost totally insoluble in water (JEF Reynolds , 2000).

Molecular Weight

    A) 278.34

Other

    A) ODOR THRESHOLD
    1) Odorless (CHRIS, 2005).

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