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BENZYL ALCOHOL

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Benzyl alcohol is an aromatic organic alcohol. Benzyl alcohol lotion is a pediculicide used to treat head lice. Benzyl alcohol poisoning can result from oral, parenteral, dermal, inhalational, and ocular exposures.

Specific Substances

    1) Benzal alcohol
    2) Benzene carbinol
    3) Benzene methanol
    4) Benzoyl alcohol
    5) Benzylicum
    6) (Hydroxymethyl) benzene
    7) Hydroxytoluene
    8) alpha-Hydroxytoluene
    9) Methanol, phenyl-
    10) Phenmethylol
    11) Phenolcarbinol
    12) Phenylcarbinol
    13) Phenylmethanol
    14) Phenylmethyl alcohol
    15) alpha-Toluenol
    16) Molecular Formula: C7-H8-O
    17) CAS 100-51-6
    1.2.1) MOLECULAR FORMULA
    1) C7H8O

Available Forms Sources

    A) FORMS
    1) MEDICINAL
    a) Benzyl alcohol is available in the United States as 5% lotion in 8-ounce bottles (Prod Info Ulesfia topical lotion, 2010).
    2) INDUSTRIAL
    a) Benzyl alcohol is commercially available as free from chlorine (FFC) grade, technical, NF (National Formulary), photographic, reagent, textile, perfume, FCC grades, and 99% minimum purity (HSDB, 2004; Lewis, 2001a).
    B) SOURCES
    1) Benzyl alcohol poisoning can result from oral, parenteral, dermal, inhalational, and ocular exposures (Lewis, 2000a).
    2) Benzyl alcohol is found in (HSDB, 2004; Bingham et al, 2001; Thomas, 1984; FDA, 1979; FDA, 1982a; FDA, 1982b):
    1) Cosmetics and acne treatment preparations
    2) Foods:
    a) baked goods (220 ppm)
    b) candy (47 ppm)
    c) chewing gum (1200 ppm)
    d) gelatins and puddings (21 to 45 ppm)
    e) ice cream (160 ppm)
    f) non-alcoholic beverages (15 ppm)
    3) Lozenges at 0.05 to 10% (equivalent to 100 to 500 mg per lozenge)
    4) Mouth rinses, mouthwashes, drops or sprays at 0.05 to 10%
    5) Ophthalmic solutions
    6) Toothache products in 1 to 2% solutions
    7) Topical analgesic, anesthetic and antipruritic products at 10 to 33%
    3) COMMERCIAL SOURCES
    a) Benzyl alcohol is produced commercially through hydrolysis of benzyl chloride using sodium carbonate, and by catalytic reduction of benzaldehyde (Cannizzano reaction) (Ashford, 2001; Lewis, 2001a).
    4) NATURAL SOURCES
    a) Benzyl alcohol is found in oil of jasmine, hyacinth, and ylang-ylang, and in at least two dozen other essential oils (Lewis, 2000a).
    b) It is a component of the aroma of Darjeeling tea (Kawakami et al, 1995).
    c) Benzyl alcohol is a metabolite of toluene (Bingham et al, 2001a).
    C) USES
    1) MEDICINAL
    a) Benzyl alcohol lotion (5%) is indicated for the topical treatment of head lice in patients 6 months of age and older (Prod Info Ulesfia topical lotion, 2010).
    b) Benzyl alcohol is also used as a solvent and antimicrobial preservative in parenteral medication (0.9% to 1.5%), antiseptic, and local anesthetic (Van der Hal et al, 1987; Humma, 1982).
    c) Benzyl alcohol has been used as an antipruritic agent in veterinary medicine (Budavari, 2001).
    2) INDUSTRIAL
    a) Most benzyl alcohol is used in the textile industry as a dye assistant (HSDB, 2004).
    b) It is used in perfumes and flavors, as a photographic developer for films and lithography, as a dye assistant for textiles, nylon carpets, and sheet plastics; in heat-sealing polyethylene films; as a chemical intermediate for benzyl esters and ethers; as a solvent in inks, paint strippers, and dyestuffs; and as a bacteriostatic or viricidal agent in cosmetics, ointments, emulsions, and lotions (HSDB, 2004; Lewis, 2001a).
    c) Other uses are in insect repellents; as a degreasing agent in rug cleaners; as a stabilizer in insecticidal formulations; and for treating fruits and vegetables (Bingham et al, 2001).
    d) Benzyl alcohol is widely used as a preservative in allergenic extracts for scratch and intracutaneous testing, and can lead to false positive results (Fisher, 1975).

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Benzyl alcohol lotion (5%) is indicated for the topical treatment of head lice in patients 6 months of age and older. Benzyl alcohol is a common preservative in parenteral medications. It is also used in perfumes and flavors, as a bacteriostatic or viricidal agent in cosmetics, ointments, emulsions, and lotions, as a photographic developer for films and lithography, and as a dye for textiles, nylon carpets, and sheet plastics.
    B) PHARMACOLOGY: In studies, benzyl alcohol inhibited lice from closing their respiratory spiracles, which allowed the vehicle to obstruct the spiracles and asphyxiate the lice. Benzyl alcohol is a weak local anesthetic with disinfectant properties.
    C) TOXICOLOGY: Benzyl alcohol is oxidized in the liver to benzoic acid, then conjugated with glycine, and excreted in the urine as hippuric acid. Infants are less able to metabolize benzoic acid to hippuric acid, possibly because of glycine deficiency. Therefore, benzoic acid will be accumulated, causing "gasping syndrome" in the neonates receiving an IV product containing benzyl alcohol.
    D) EPIDEMIOLOGY: Exposure to IV products containing benzyl alcohol is common, but severe toxicity is rare, and generally only develops in neonates. Severe toxicity has not been reported after ingestion or dermal application.
    E) WITH THERAPEUTIC USE
    1) TOPICAL: Eye irritation, allergic or irritant dermatitis, including pruritus and pyoderma have been reported in patients using topical benzyl alcohol.
    F) WITH POISONING/EXPOSURE
    1) TOXICITY: Benzyl alcohol poisoning can result from oral, parenteral, dermal, inhalational, and ocular exposures. Neonates receiving IV products containing benzyl alcohol may experience "gasping syndrome", characterized by severe metabolic acidosis, gasping respirations, CNS depression, seizures, intraventricular hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, progressive hypotension, bradycardia, cardiovascular collapse, and death. A 5-year-old girl developed severe metabolic acidosis following a continuous diazepam infusion. Benzyl alcohol toxicity was confirmed from benzoic acid serum and urine concentrations.
    0.2.4) HEENT
    A) Dilute solutions (1%) produce local anesthesia and slight irritation when instilled into the eye. Pure benzyl alcohol produces corneal necrosis.
    B) The vapor is irritating to the eyes, nose, and throat.
    0.2.5) CARDIOVASCULAR
    A) Hypotension may occur.
    0.2.6) RESPIRATORY
    A) Respiratory depression and gasping have been noted in neonates with parenteral benzyl alcohol toxicity.
    0.2.7) NEUROLOGIC
    A) Lethargy, seizures, intraventricular hemorrhage, and neurological sequelae (cerebral palsy, developmental delay) have been seen in neonates with parenteral benzyl alcohol toxicity.
    B) CNS depression has occurred after ingestion of large volumes.
    C) Intrathecal administration has produced paraplegia.
    0.2.11) ACID-BASE
    A) Metabolic acidosis with an anion gap was a common finding with parenteral toxicity in neonates.
    0.2.14) DERMATOLOGIC
    A) Pure benzyl alcohol produces primary irritation.
    B) Local anesthesia is produced with concentrations of 1% or greater.
    0.2.18) PSYCHIATRIC
    A) Delirium was attributed to benzyl alcohol absorbed by the dermal route.
    0.2.20) REPRODUCTIVE
    A) Benzyl alcohol topical lotion is classified as FDA pregnancy category B. In animal studies, there was no evidence of teratogenicity when benzyl alcohol was administered subcutaneously, although maternal toxicity and reduced fetal weights occurred at the highest doses.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, the manufacturer does not report any carcinogenic potential of benzyl alcohol in humans.

Laboratory Monitoring

    A) In patients with symptoms of gasping syndrome, monitor vital signs, CBC, mental status, renal function, and hepatic enzymes.
    B) Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Neonatal gasping syndrome has been reported in patients receiving IV products containing benzyl alcohol. Treat hypotension with IV fluids and pressors if needed. Treat seizures with benzodiazepines; barbiturates or propofol may be needed if seizures persist or recur. Severe metabolic acidosis (arterial pH less than 7.1) should be corrected with IV sodium bicarbonate (a reasonable starting dose is 1 to 2 mEq/kg).
    C) DECONTAMINATION
    1) PREHOSPITAL: Solutions greater than 30% are extremely irritating and may cause spontaneous vomiting. Serious toxicity is not expected after ingestion of benzyl alcohol alone, and prehospital gastrointestinal decontamination is not routinely required.
    2) HOSPITAL: Significant toxicity is not expected after oral ingestion; gastrointestinal decontamination is generally not necessary. Activated charcoal should be considered after extremely large ingestions or if more toxic coingestants are involved.
    D) AIRWAY MANAGEMENT
    1) Ensure adequate ventilation and perform endotracheal intubation early in patients with significant CNS depression or pulmonary toxicity.
    E) ANTIDOTE
    1) None
    F) PATIENT DISPOSITION
    1) OBSERVATION CRITERIA: All patients with deliberate self-harm ingestions should be evaluated in a health care facility and monitored until symptoms resolve. Children with unintentional ingestions who are symptomatic should be observed in a health care facility.
    2) ADMISSION CRITERIA: Patients who remain symptomatic despite adequate treatment should be admitted.
    3) CONSULT CRITERIA: Consult a Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.
    G) PITFALLS
    1) When managing a suspected benzyl alcohol overdose, the possibility of multi-drug involvement should be considered.
    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).
    2) Treatment of allergic dermatitis with topical or systemic steroids and/or antihistamines may be of benefit.
    0.4.6) PARENTERAL EXPOSURE
    A) Refer to oral overview for information on treatment of benzyl alcohol poisoning.

Range Of Toxicity

    A) TOXICITY: Deaths in neonates were associated with administration of 99 to 234 mg/kg/day in large volume parenteral solutions or endotracheal solutions. Rectal administration of 45 mL was reportedly fatal. Severe toxicity has not been reported after ingestion or dermal application.
    B) One death reportedly resulted from dermal exposure to an impure benzyl benzoate skin massage product containing benzyl alcohol.

Clinical Effects

Summary Of Exposure

    A) USES: Benzyl alcohol lotion (5%) is indicated for the topical treatment of head lice in patients 6 months of age and older. Benzyl alcohol is a common preservative in parenteral medications. It is also used in perfumes and flavors, as a bacteriostatic or viricidal agent in cosmetics, ointments, emulsions, and lotions, as a photographic developer for films and lithography, and as a dye for textiles, nylon carpets, and sheet plastics.
    B) PHARMACOLOGY: In studies, benzyl alcohol inhibited lice from closing their respiratory spiracles, which allowed the vehicle to obstruct the spiracles and asphyxiate the lice. Benzyl alcohol is a weak local anesthetic with disinfectant properties.
    C) TOXICOLOGY: Benzyl alcohol is oxidized in the liver to benzoic acid, then conjugated with glycine, and excreted in the urine as hippuric acid. Infants are less able to metabolize benzoic acid to hippuric acid, possibly because of glycine deficiency. Therefore, benzoic acid will be accumulated, causing "gasping syndrome" in the neonates receiving an IV product containing benzyl alcohol.
    D) EPIDEMIOLOGY: Exposure to IV products containing benzyl alcohol is common, but severe toxicity is rare, and generally only develops in neonates. Severe toxicity has not been reported after ingestion or dermal application.
    E) WITH THERAPEUTIC USE
    1) TOPICAL: Eye irritation, allergic or irritant dermatitis, including pruritus and pyoderma have been reported in patients using topical benzyl alcohol.
    F) WITH POISONING/EXPOSURE
    1) TOXICITY: Benzyl alcohol poisoning can result from oral, parenteral, dermal, inhalational, and ocular exposures. Neonates receiving IV products containing benzyl alcohol may experience "gasping syndrome", characterized by severe metabolic acidosis, gasping respirations, CNS depression, seizures, intraventricular hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, progressive hypotension, bradycardia, cardiovascular collapse, and death. A 5-year-old girl developed severe metabolic acidosis following a continuous diazepam infusion. Benzyl alcohol toxicity was confirmed from benzoic acid serum and urine concentrations.

Vital Signs

    3.3.2) RESPIRATIONS
    A) RESPIRATORY INSUFFICIENCY progressing to gasping respirations has been noted in neonates receiving intravenous benzyl alcohol-containing fluids (Prod Info Ulesfia topical lotion, 2010; Gershanik et al, 1982).
    3.3.4) BLOOD PRESSURE
    A) HYPOTENSION may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010; Gershanik et al, 1981).

Heent

    3.4.1) SUMMARY
    A) Dilute solutions (1%) produce local anesthesia and slight irritation when instilled into the eye. Pure benzyl alcohol produces corneal necrosis.
    B) The vapor is irritating to the eyes, nose, and throat.
    3.4.3) EYES
    A) EYE IRRITATION: In a pooled analysis of 2 randomized, double-blind, vehicle-controlled clinical trials and one open-label study, ocular irritation was reported in 6% of patients who received benzyl alcohol topical lotion (n=428) compared with 1% of patients who received placebo (n=313) (Prod Info Ulesfia topical lotion, 2010).
    B) CONJUNCTIVITIS: Intraocular application of dilute solutions produces immediate smarting, but no permanent injury if exposure is brief (Grant & Schuman, 1993a).
    C) EYE INJURY may occur following ocular exposure.
    1) HUMANS: Use in cataract surgery of sodium chloride solution preserved with 2% benzyl alcohol produced severe straite keratopathy, chronic edema of the cornea, vesicles, bullae, a "dirty" pigmented appearance of the endothelium, and damage to the iris. Intraocular use of solutions preserved with benzyl alcohol should be avoided (Grant & Schuman, 1993a).
    2) EXPERIMENTAL ANIMALS: Instillation of pure benzyl alcohol into rabbit conjunctival sacs produced corneal necrosis which resolved after several weeks. Instillation of 1% aqueous solutions produced slight irritation and local anesthesia (Macht, 1918).
    D) VISUAL DISTURBANCES were attributed to benzyl alcohol contamination of benzyl benzoate in a skin massage product (Grant & Schuman, 1993a).
    3.4.5) NOSE
    A) IRRITATION: The vapors are irritating to the nose (HSDB , 2000).
    3.4.6) THROAT
    A) IRRITATION: The vapors are irritating to the throat (HSDB , 2000).

Cardiovascular

    3.5.1) SUMMARY
    A) Hypotension may occur.
    3.5.2) CLINICAL EFFECTS
    A) CARDIOVASCULAR FINDING
    1) WITH POISONING/EXPOSURE
    a) Hypotension, bradycardia, and cardiovascular collapse may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    B) HYPOTENSIVE EPISODE
    1) WITH POISONING/EXPOSURE
    a) Hypotension, bradycardia, and cardiovascular collapse may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010; Lopez-Herce et al, 1995; Kimura et al, 1971).
    b) CASE REPORT: Hypotension (70/40 mm Hg) was reported in a 5-year-old girl following high dose infusion of diazepam containing benzyl alcohol (Lopez-Herce et al, 1995).
    C) BRADYCARDIA
    1) WITH POISONING/EXPOSURE
    a) Hypotension, bradycardia, and cardiovascular collapse may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).

Respiratory

    3.6.1) SUMMARY
    A) Respiratory depression and gasping have been noted in neonates with parenteral benzyl alcohol toxicity.
    3.6.2) CLINICAL EFFECTS
    A) RESPIRATORY FAILURE
    1) Gasping respirations may develop in neonates after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    2) Respiratory depression, paralysis, and "gasping" respirations have been noted in animal experiments and in neonates with parenteral benzyl alcohol toxicity (Gruber, 1923).
    a) Gasping respirations were first thought to be the hallmark of benzyl alcohol toxicity; however, gasping was observed in only one of four infants in one study (Menon et al, 1984).
    B) HEMOPTYSIS
    1) CASE REPORT: Inhalation of bacteriostatic saline solution (containing 9 mg/mL of benzyl alcohol) was associated with episodes of hemoptysis and severe bronchitis in a 64-year-old man; symptoms resolved after substitution of preservative-free saline (Reynolds, 1990).
    C) BRONCHITIS
    1) CASE SERIES: 4 out of 5 volunteers inhaling nebulized bacteriostatic saline containing benzyl alcohol developed bronchitis with lymphocytic mucosal infiltrate (Reynolds & Smith, 1995).

Neurologic

    3.7.1) SUMMARY
    A) Lethargy, seizures, intraventricular hemorrhage, and neurological sequelae (cerebral palsy, developmental delay) have been seen in neonates with parenteral benzyl alcohol toxicity.
    B) CNS depression has occurred after ingestion of large volumes.
    C) Intrathecal administration has produced paraplegia.
    3.7.2) CLINICAL EFFECTS
    A) LETHARGY
    1) Lethargy was a frequent finding in neonates with benzyl alcohol toxicity (Menon et al, 1984).
    B) CENTRAL NERVOUS SYSTEM DEPRESSION
    1) CNS depression may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    C) SEIZURE
    1) Seizures may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010; Brown, 1982; Gershanik et al, 1981; Lovejoy, 1982).
    D) PARAPLEGIA
    1) Paraplegia has been reported following intrathecal administration of benzyl alcohol-preserved chemotherapeutic agents (Hahn et al, 1983; Craig & Habib, 1977; Feasby et al, 1983; Saiki et al, 1972). Paralysis was reversible in some cases (Feasby et al, 1983), and partially reversible in other cases (Saiki et al, 1972).
    E) INTRACRANIAL HEMORRHAGE
    1) WITH POISONING/EXPOSURE
    a) Intraventricular hemorrhage may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010; Jardine & Rogers, 1989; Hiller et al, 1986).
    F) IMPAIRED COGNITION
    1) CEREBRAL PALSY: Very low birthweight infants receiving intravascular flush solutions containing benzyl alcohol had a higher incidence of cerebral palsy and developmental delays than similar low birthweight infants not receiving these solutions (Benda et al, 1986).
    G) KERNICTERUS OF NEWBORN
    1) WITH POISONING/EXPOSURE
    a) Kernicterus was positively associated with the use of benzyl alcohol in one study of over 400 infants (Jardine & Rogers, 1989), but could not be associated with benzyl alcohol in another study (Cronin et al, 1991).
    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) SOMNOLENCE
    a) RATS: Staggering gait and lethargy were seen in rats given subchronic doses up to 800 mg/kg for 13 weeks. The behavioral symptoms were identical to those produced by ethanol (Clayton & Clayton, 1994).

Gastrointestinal

    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) GASTROENTERITIS
    a) Vomiting and diarrhea have been noted in orally-administered large doses (0.2 mL/kg or greater) of benzyl alcohol in animals (Gruber, 1923).

Hepatic

    3.9.2) CLINICAL EFFECTS
    A) HEPATIC FAILURE
    1) WITH POISONING/EXPOSURE
    a) Hepatic failure may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    B) KERNICTERUS OF NEWBORN
    1) WITH POISONING/EXPOSURE
    a) Kernicterus was positively associated with the use of benzyl alcohol in one study of over 400 infants (Jardine & Rogers, 1989), but could not be associated with benzyl alcohol in another study (Cronin et al, 1991).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) ACUTE RENAL FAILURE SYNDROME
    1) WITH POISONING/EXPOSURE
    a) Renal failure may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    3.10.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) POLYURIA
    a) Diuresis has been noted in experimental animal studies.

Acid-Base

    3.11.1) SUMMARY
    A) Metabolic acidosis with an anion gap was a common finding with parenteral toxicity in neonates.
    3.11.2) CLINICAL EFFECTS
    A) ACIDOSIS
    1) WITH POISONING/EXPOSURE
    a) Severe metabolic acidosis may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    b) Metabolic acidosis was the most common and significant finding in cases of parenteral benzyl alcohol toxicity in neonates. Acidosis was typically refractory to therapy, and was associated with an average anion gap of 30 nmol/L (Brown, 1982; Gershanik et al, 1981; Menon et al, 1984; Lovejoy, 1982).
    c) CASE REPORT: A 5-year-old girl developed severe metabolic acidosis (pH 7.17, bicarbonate 8 mmol/L, anion gap 37.4) following a continuous diazepam infusion. Benzyl alcohol toxicity was confirmed from benzoic acid concentrations (18 mg/mL in serum and 120 mg/dL in urine) (Lopez-Herce et al, 1995).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) HEMATOLOGY FINDING
    1) WITH POISONING/EXPOSURE
    a) Hematologic abnormalities may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    B) THROMBOCYTOPENIC DISORDER
    1) WITH POISONING/EXPOSURE
    a) Thrombocytopenia was a delayed feature of benzyl alcohol toxicity in neonates (Menon et al, 1984).
    C) INTRACRANIAL HEMORRHAGE
    1) WITH POISONING/EXPOSURE
    a) Intraventricular hemorrhage may develop in neonates with "gasping syndrome" after receiving an IV product containing benzyl alcohol (Prod Info Ulesfia topical lotion, 2010; Jardine & Rogers, 1989; Hiller et al, 1986).
    3.13.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEMOLYSIS
    a) Hemolysis was seen in vitro using a 1.5% solution of benzyl alcohol (McOrmond et al, 1980).

Dermatologic

    3.14.1) SUMMARY
    A) Pure benzyl alcohol produces primary irritation.
    B) Local anesthesia is produced with concentrations of 1% or greater.
    3.14.2) CLINICAL EFFECTS
    A) ITCHING OF SKIN
    1) WITH THERAPEUTIC USE
    a) In a pooled analysis of 2 randomized, vehicle-controlled clinical trials and one open-label study, pruritus was reported in 12% of patients who received benzyl alcohol topical lotion (n=116) compared with 4% of patients who received placebo (n=67) (Prod Info Ulesfia topical lotion, 2010).
    B) PYODERMA
    1) WITH THERAPEUTIC USE
    a) In a pooled analysis of 2 randomized, vehicle-controlled clinical trials and one open-label study, pyoderma was reported in 7% of patients who received benzyl alcohol topical lotion (n=308) compared with 4% of patients who received placebo (n=230) (Prod Info Ulesfia topical lotion, 2010).
    C) APPLICATION SITE IRRITATION
    1) WITH THERAPEUTIC USE
    a) In a pooled analysis of 2 randomized, vehicle-controlled clinical trials and one open-label study, application site irritation was reported in 2% of patients who received benzyl alcohol topical lotion (n=478) compared with 1% of patients who received placebo (n=336) (Prod Info Ulesfia topical lotion, 2010).
    D) CONTACT DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Allergic or irritant dermatitis has been reported in patients using topical benzyl alcohol (Prod Info Ulesfia topical lotion, 2010).
    2) WITH POISONING/EXPOSURE
    a) Contact dermatitis and urticaria may occur, but are rare (Shoji, 1983; Edwards, 1981).
    E) ANGIOEDEMA
    1) CASE REPORT: Angioedema was noted in a 55-year-old man following IM injection of Vitamin B12 preserved with benzyl alcohol (Grant et al, 1982).
    F) ANESTHESIA OF SKIN
    1) Adequate local anesthesia is produced on skin and mucous membranes with 1% to 4% solutions (Thomas, 1984). Anesthesia lasts up to 2 hours with 100% solutions, and up to 30 minutes with 1% solutions (Macht, 1918).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) Reactions to topical preparations have been rarely reported (Jacobs, 1949; Schwartz et al, 1947; Lazzarini, 1982; Fisher, 1975; Sreget, 1963).
    a) Benzyl alcohol is widely used as a preservative in allergenic extracts for scratch and intracutaneous testing, and can lead to false positive results (Fisher, 1975).
    2) Skin and joint reactions (not anaphylaxis) were reported after administration of benzyl alcohol (as a preservative) in a psoriatic patient (Lagerholm et al, 1958). The "reaction" was difficult to separate from the illness being treated.
    3) Parenterally administered benzyl alcohol produced a reaction consisting of a fever and maculopapular rash in one patient. Hypersensitivity was confirmed by skin testing (Wilson et al, 1986).

Reproductive

    3.20.1) SUMMARY
    A) Benzyl alcohol topical lotion is classified as FDA pregnancy category B. In animal studies, there was no evidence of teratogenicity when benzyl alcohol was administered subcutaneously, although maternal toxicity and reduced fetal weights occurred at the highest doses.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) LACK OF EFFECT
    a) RATS, RABBITS: There was no evidence of teratogenicity when rats and rabbits were given benzyl alcohol subcutaneously at doses up to 500 and 400 mg/kg/day, respectively (Prod Info ULESFIA(R) topical lotion, 2014).
    2) SKELETAL MALFORMATION
    a) CHICKENS: Meningoceles and skeletal defects were produced in chicks by injection of 0.01 or 0.02 mL into the yolk sac (Duraiswami, 1954).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) The manufacturer has classified benzyl alcohol topical lotion as FDA pregnancy category B. There are no adequate and well-controlled studies of topical benzyl alcohol use in pregnant women. In animals, there was no evidence of teratogenicity when rats and rabbits were given subQ doses of benzyl alcohol; however, maternal toxicity and reduced fetal weights were reported at the highest doses. Therefore, use benzyl alcohol topical lotion during pregnancy only if clearly needed (Prod Info ULESFIA(R) topical lotion, 2014).
    B) ANIMAL STUDIES
    1) RATS: Maternal toxicity and reduced fetal weight were observed at subQ benzyl alcohol doses of 500 mg/kg/day (Prod Info ULESFIA(R) topical lotion, 2014).
    2) RABBITS: Maternal toxicity was observed at subQ benzyl alcohol doses of 250 and 400 mg/kg/day and reduced fetal weights were observed at 400 mg/kg/day (Prod Info ULESFIA(R) topical lotion, 2014).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) It is not known if benzyl alcohol is excreted into human breast milk or whether it can cause harm in the nursing infant. Because there is the potential for some systemic absorption of topically applied drugs, use benzyl alcohol topical lotion with caution in a nursing mother (Prod Info ULESFIA(R) topical lotion, 2014).
    3.20.5) FERTILITY
    A) LACK OF INFORMATION
    1) At the time of this review, fertility studies have not been conducted with benzyl alcohol (Prod Info ULESFIA(R) topical lotion, 2014).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS100-51-6 (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
    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, the manufacturer does not report any carcinogenic potential of benzyl alcohol in humans.
    3.21.4) ANIMAL STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, the manufacturer does not report any carcinogenic potential of benzyl alcohol in long-term animal studies (Prod Info Ulesfia topical lotion, 2010).
    B) LACK OF EFFECT
    1) RATS, MICE: In a 2-year oral gavage study conducted by the National Toxicology Program, there was no evidence of carcinogenicity when rats and mice were given oral benzyl alcohol at doses up to 400 mg/kg 5 days per week and up to 200 mg/kg 5 days per week, respectively (Prod Info Ulesfia topical lotion, 2010; NTP, 1989).

Genotoxicity

    A) There was no evidence of genotoxicity or mutagenicity in the following tests: the Ames test with and without metabolic activation, sex-linked recessive lethal assay, a replicative DNA synthesis assay done in male rats, and the mouse lymphoma assay with metabolic activation (Prod Info Ulesfia topical lotion, 2010). Benzyl alcohol was also negative in S. typhimurium with or without metabolic activation (Mortelmans et al, 1986).
    B) There was evidence of genotoxicity or mutagenicity in the following tests: the mouse lymphoma assay without metabolic activation at a concentration producing a high level of cellular toxicity and the Chinese hamster ovary chromosomal aberration assay without metabolic activation (Prod Info Ulesfia topical lotion, 2010). Benzyl alcohol was also positive for inducing mutations in the mouse lymphoma TK +/- system, but only at concentrations which were toxic (McGregor et al, 1988).
    C) According to the National Toxicology Program, the results were equivocal for the following test: inducing sister chromatid exchanges in cultured Chinese hamster ovary (CHO) cells (NTP, 1989).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) In patients with symptoms of gasping syndrome, monitor vital signs, CBC, mental status, renal function, and hepatic enzymes.
    B) Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) The presence of benzyl alcohol or benzoic acid in plasma may be diagnostically helpful.
    4.1.3) URINE
    A) OTHER
    1) Hippuric acid in urine may be diagnostically helpful.
    4.1.4) OTHER
    A) OTHER
    1) MONITORING
    a) Monitor pulmonary function tests in patients with significant inhalation exposure.

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 who remain symptomatic despite adequate treatment should be admitted.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) All patients with deliberate self-harm ingestions should be evaluated in a health care facility and monitored until symptoms resolve. Children with unintentional ingestions who are symptomatic should be observed in a health care facility.

Monitoring

    A) In patients with symptoms of gasping syndrome, monitor vital signs, CBC, mental status, renal function, and hepatic enzymes.
    B) Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Solutions greater than 30% are extremely irritating and may cause spontaneous vomiting. Serious toxicity is not expected after ingestion of benzyl alcohol alone, and prehospital gastrointestinal decontamination is not routinely required.
    6.5.2) PREVENTION OF ABSORPTION
    A) Significant toxicity is not expected after oral ingestion; gastrointestinal decontamination is generally not necessary. Activated charcoal should be considered after extremely large ingestions or if more toxic coingestants are involved.
    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) 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) In patients with symptoms of gasping syndrome, monitor vital signs, CBC, mental status, renal function, and hepatic enzymes.
    2) Monitor arterial blood gases, pulse oximetry, and pulmonary function tests, and obtain a chest x-ray in any patient with respiratory symptoms.
    B) SEIZURE
    1) SUMMARY
    a) Attempt initial control with a benzodiazepine (eg, diazepam, lorazepam). If seizures persist or recur, administer phenobarbital or propofol.
    b) Monitor for respiratory depression, hypotension, and dysrhythmias. Endotracheal intubation should be performed in patients with persistent seizures.
    c) Evaluate for hypoxia, electrolyte disturbances, and hypoglycemia (or, if immediate bedside glucose testing is not available, treat with intravenous dextrose).
    2) DIAZEPAM
    a) ADULT DOSE: Initially 5 to 10 mg IV, OR 0.15 mg/kg IV up to 10 mg per dose up to a rate of 5 mg/minute; may be repeated every 5 to 20 minutes as needed (Brophy et al, 2012; Prod Info diazepam IM, IV injection, 2008; Manno, 2003).
    b) PEDIATRIC DOSE: 0.1 to 0.5 mg/kg IV over 2 to 5 minutes; up to a maximum of 10 mg/dose. May repeat dose every 5 to 10 minutes as needed (Loddenkemper & Goodkin, 2011; Hegenbarth & American Academy of Pediatrics Committee on Drugs, 2008).
    c) Monitor for hypotension, respiratory depression, and the need for endotracheal intubation. Consider a second agent if seizures persist or recur after repeated doses of diazepam .
    3) NO INTRAVENOUS ACCESS
    a) DIAZEPAM may be given rectally or intramuscularly (Manno, 2003). RECTAL DOSE: CHILD: Greater than 12 years: 0.2 mg/kg; 6 to 11 years: 0.3 mg/kg; 2 to 5 years: 0.5 mg/kg (Brophy et al, 2012).
    b) MIDAZOLAM has been used intramuscularly and intranasally, particularly in children when intravenous access has not been established. ADULT DOSE: 0.2 mg/kg IM, up to a maximum dose of 10 mg (Brophy et al, 2012). PEDIATRIC DOSE: INTRAMUSCULAR: 0.2 mg/kg IM, up to a maximum dose of 7 mg (Chamberlain et al, 1997) OR 10 mg IM (weight greater than 40 kg); 5 mg IM (weight 13 to 40 kg); INTRANASAL: 0.2 to 0.5 mg/kg up to a maximum of 10 mg/dose (Loddenkemper & Goodkin, 2011; Brophy et al, 2012). BUCCAL midazolam, 10 mg, has been used in adolescents and older children (5-years-old or more) to control seizures when intravenous access was not established (Scott et al, 1999).
    4) LORAZEPAM
    a) MAXIMUM RATE: The rate of intravenous administration of lorazepam should not exceed 2 mg/min (Brophy et al, 2012; Prod Info lorazepam IM, IV injection, 2008).
    b) ADULT DOSE: 2 to 4 mg IV initially; repeat every 5 to 10 minutes as needed, if seizures persist (Manno, 2003; Brophy et al, 2012).
    c) PEDIATRIC DOSE: 0.05 to 0.1 mg/kg IV over 2 to 5 minutes, up to a maximum of 4 mg/dose; may repeat in 5 to 15 minutes as needed, if seizures continue (Brophy et al, 2012; Loddenkemper & Goodkin, 2011; Hegenbarth & American Academy of Pediatrics Committee on Drugs, 2008; Sreenath et al, 2010; Chin et al, 2008).
    5) PHENOBARBITAL
    a) ADULT LOADING DOSE: 20 mg/kg IV at an infusion rate of 50 to 100 mg/minute IV. An additional 5 to 10 mg/kg dose may be given 10 minutes after loading infusion if seizures persist or recur (Brophy et al, 2012).
    b) Patients receiving high doses will require endotracheal intubation and may require vasopressor support (Brophy et al, 2012).
    c) PEDIATRIC LOADING DOSE: 20 mg/kg may be given as single or divided application (2 mg/kg/minute in children weighing less than 40 kg up to 100 mg/min in children weighing greater than 40 kg). A plasma concentration of about 20 mg/L will be achieved by this dose (Loddenkemper & Goodkin, 2011).
    d) REPEAT PEDIATRIC DOSE: Repeat doses of 5 to 20 mg/kg may be given every 15 to 20 minutes if seizures persist, with cardiorespiratory monitoring (Loddenkemper & Goodkin, 2011).
    e) MONITOR: For hypotension, respiratory depression, and the need for endotracheal intubation (Loddenkemper & Goodkin, 2011; Manno, 2003).
    f) SERUM CONCENTRATION MONITORING: Monitor serum concentrations over the next 12 to 24 hours. Therapeutic serum concentrations of phenobarbital range from 10 to 40 mcg/mL, although the optimal plasma concentration for some individuals may vary outside this range (Hvidberg & Dam, 1976; Choonara & Rane, 1990; AMA Department of Drugs, 1992).
    6) OTHER AGENTS
    a) If seizures persist after phenobarbital, propofol or pentobarbital infusion, or neuromuscular paralysis with general anesthesia (isoflurane) and continuous EEG monitoring should be considered (Manno, 2003). Other anticonvulsants can be considered (eg, valproate sodium, levetiracetam, lacosamide, topiramate) if seizures persist or recur; however, there is very little data regarding their use in toxin induced seizures, controlled trials are not available to define the optimal dosage ranges for these agents in status epilepticus (Brophy et al, 2012):
    1) VALPROATE SODIUM: ADULT DOSE: An initial dose of 20 to 40 mg/kg IV, at a rate of 3 to 6 mg/kg/minute; may give an additional dose of 20 mg/kg 10 minutes after loading infusion. PEDIATRIC DOSE: 1.5 to 3 mg/kg/minute (Brophy et al, 2012).
    2) LEVETIRACETAM: ADULT DOSE: 1000 to 3000 mg IV, at a rate of 2 to 5 mg/kg/min IV. PEDIATRIC DOSE: 20 to 60 mg/kg IV (Brophy et al, 2012; Loddenkemper & Goodkin, 2011).
    3) LACOSAMIDE: ADULT DOSE: 200 to 400 mg IV; 200 mg IV over 15 minutes (Brophy et al, 2012). PEDIATRIC DOSE: In one study, median starting doses of 1.3 mg/kg/day and maintenance doses of 4.7 mg/kg/day were used in children 8 years and older (Loddenkemper & Goodkin, 2011).
    4) TOPIRAMATE: ADULT DOSE: 200 to 400 mg nasogastric/orally OR 300 to 1600 mg/day orally divided in 2 to 4 times daily (Brophy et al, 2012).
    C) HYPOTENSIVE EPISODE
    1) SUMMARY
    a) Infuse 10 to 20 milliliters/kilogram of isotonic fluid and keep the patient supine. If hypotension persists, administer dopamine or norepinephrine. Consider central venous pressure monitoring to guide further fluid therapy.
    2) DOPAMINE
    a) DOSE: Begin at 5 micrograms per kilogram per minute progressing in 5 micrograms per kilogram per minute increments as needed (Prod Info dopamine hcl, 5% dextrose IV injection, 2004). If hypotension persists, dopamine may need to be discontinued and a more potent vasoconstrictor (eg, norepinephrine) should be considered (Prod Info dopamine hcl, 5% dextrose IV injection, 2004).
    b) CAUTION: If ventricular dysrhythmias occur, decrease rate of administration (Prod Info dopamine hcl, 5% dextrose IV injection, 2004). Extravasation may cause local tissue necrosis, administration through a central venous catheter is preferred (Prod Info dopamine hcl, 5% dextrose IV injection, 2004).
    3) NOREPINEPHRINE
    a) PREPARATION: 4 milligrams (1 amp) added to 1000 milliliters of diluent provides a concentration of 4 micrograms/milliliter of norepinephrine base. Norepinephrine bitartrate should be mixed in dextrose solutions (dextrose 5% in water, dextrose 5% in saline) since dextrose-containing solutions protect against excessive oxidation and subsequent potency loss. Administration in saline alone is not recommended (Prod Info norepinephrine bitartrate injection, 2005).
    b) DOSE
    1) ADULT: Dose range: 0.1 to 0.5 microgram/kilogram/minute (eg, 70 kg adult 7 to 35 mcg/min); titrate to maintain adequate blood pressure (Peberdy et al, 2010).
    2) CHILD: Dose range: 0.1 to 2 micrograms/kilogram/minute; titrate to maintain adequate blood pressure (Kleinman et al, 2010).
    3) CAUTION: Extravasation may cause local tissue ischemia, administration by central venous catheter is advised (Peberdy et al, 2010).

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) DERMATITIS
    1) Treatment of allergic dermatitis with topical or systemic steroids and/or antihistamines may be of benefit.
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Enhanced Elimination

    A) HEMODIALYSIS
    1) EFFICACY - Hemodialysis has been highly effective for eliminating other alcohols (Demey et al, 1988) Peterson, 1981). Its efficacy has not been proven for benzyl alcohol.
    2) INDICATIONS - Severe acid-base (Malmlund et al, 1991), and/or fluid-electrolyte disturbances despite conventional therapy; renal failure.

Range Of Toxicity

Summary

    A) TOXICITY: Deaths in neonates were associated with administration of 99 to 234 mg/kg/day in large volume parenteral solutions or endotracheal solutions. Rectal administration of 45 mL was reportedly fatal. Severe toxicity has not been reported after ingestion or dermal application.
    B) One death reportedly resulted from dermal exposure to an impure benzyl benzoate skin massage product containing benzyl alcohol.

Therapeutic Dose

    7.2.1) ADULT
    A) TOPICAL CREAM
    1) Apply directly on the affected area throughout the day as needed (OTC Product Information, as posted to the DailyMed site 03/2014).
    B) TOPICAL GEL
    1) Apply to the affected area up to 4 times daily for up to 7 days (OTC Product Information, as posted to the DailyMed site 08/2013).
    C) TOPICAL LOTION
    1) TOPICAL: 4 to 48 ounces (1/2 to 6 bottles) of lotion per application (based on the hair length) to dry hair, using enough to completely saturate the scalp and hair. The lotion should be rinsed off with water after 10 minutes and application repeated in 7 days (Prod Info Ulesfia topical lotion, 2010).
    D) ORAL SOLUTION
    1) Apply to the affected area and gargle, swish around, or allow to remain in place for at least 1 minute, then spit out. Use up to 4 times daily for up to 7 days (OTC Product Information, as posted to the DailyMed site 01/2013).
    7.2.2) PEDIATRIC
    A) TOPICAL GEL
    1) TOPICAL (2 YEARS OF AGE OR OLDER): Apply to the affected area up to 4 times daily for up to 7 days (OTC Product Information, as posted to the DailyMed site 08/2013).
    2) Safety and efficacy have not been established in children younger than 2 years (OTC Product Information, as posted to the DailyMed site 08/2013).
    B) TOPICAL LOTION
    1) TOPICAL (6 MONTHS OF AGE OR OLDER): 4 to 48 ounces (1/2 to 6 bottles) of lotion per application (based on the hair length) to dry hair, using enough to completely saturate the scalp and hair. The lotion should be rinsed off with water after 10 minutes and application repeated in 7 days (Prod Info Ulesfia topical lotion, 2010).
    2) Safety in pediatric patients below the age of 6 months has not been established (Prod Info Ulesfia topical lotion, 2010).
    C) ORAL SOLUTION
    1) ORAL (2 YEARS OF AGE OR OLDER): Apply to the affected area and gargle, swish around, or allow to remain in place for at least 1 minute, then spit out. Use up to 4 times daily for up to 7 days (OTC Product Information, as posted to the DailyMed site 01/2013).

Minimum Lethal Exposure

    A) HUMAN NEONATE DATA
    1) Doses of 99 to 245 mg/kg/day were lethal to neonates when given in large volume parenteral solutions or endotracheal solutions containing 0.9% benzyl alcohol (Gershanik et al, 1982).
    2) Estimated exposure to 99 to 405 mg/kg/body weight in very low birth weight infants for 2 to 28 days produced severe adverse effects (neurologic deterioration, metabolic acidosis) and death. No effects were reported at doses of 27 to 99 mg/kg body weight for a similar exposure period (HSDB, 2004; Bingham et al, 2001).
    3) A dose of 32 to 105 mg/kg body weight for 7 days produced breathing difficulty in one neonate (Bingham et al, 2001).
    B) HUMAN ADULT DATA
    1) Rectal administration of 45 mL has reportedly been fatal (HSDB, 2004; Gosselin et al, 1984).
    2) One death and one serious poisoning reportedly occurred after dermal exposure to benzyl alcohol present in an impure benzyl benzoate preparation used to massage skin (HSDB, 2004; Grant & Schuman, 1993).

Maximum Tolerated Exposure

    A) HUMAN DATA - DERMAL
    1) Dermal patches containing 0.05% benzyl alcohol in either an ethanol or cream base produced skin irritation in 18 of 614 patients (Bingham et al, 2001).
    a) In another study, patients who used five, 48 hours patches containing 10% benzyl alcohol over a 10-day period reported no adverse skin reactions (Bingham et al, 2001).
    2) Dermal exposure to 16 mg for 48 hours can result in a mild skin reaction (RTECS, 2004).
    a) Local anesthesia can result from application of solutions containing 1% or higher benzyl alcohol to skin or mucous membranes (Thomas, 1984).
    3) An accidental injection of pure benzyl alcohol prior to circumcision produced local tissue necrosis (HSDB, 2004).
    B) HUMAN DATA - INHALATION
    1) Human inhalation of 10 ppm for 45 days (intermittent) produced headache, somnolence, and nausea/vomiting (RTECS, 2004).
    2) Inhalation of a bacteriostatic saline solution containing 9 mg/mL benzyl alcohol produced hemoptysis episodes and severe bronchitis in a 64-year-old man; substitution of preservative-free salines resolved the symptoms (Reynolds, 1990).
    C) HUMAN DATA - OCULAR
    1) Severe complications resulted from intraocular use of sodium benzoate preserved with 2% benzyl alcohol (Grant & Schuman, 1993).
    2) Patients using eyedrops containing 0.7% benzyl alcohol applied every 8 hours for 22 months reported no adverse effects (Grant & Schuman, 1993).
    D) HUMAN DATA - ORAL
    1) An acute oral dose of approximately 288 mg benzyl alcohol in adult males did not produce symptoms different from those in a control group (Novak et al, 1972).
    E) HUMAN DATA - PARENTERAL
    1) Severe metabolic acidosis occurred in a 5-year-old girl following administration of a 36 hour-continuous intravenous infusion of diazepam, in which the patient received 180 mg/kg/day of benzyl alcohol. Benzoic acid serum and urine levels were 18 mg/mL and 120 mg/mL, respectively (Bingham et al, 2001)

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) PEDIATRIC
    a) Serum benzoic acid (metabolite of benzyl alcohol) levels were measured at 18 mg/mL in a 5-year-old girl following a high dose infusion of diazepam (Lopez-Herce et al, 1995).

Workplace Standards

    A) ACGIH TLV Values for CAS100-51-6 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS100-51-6 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS100-51-6 :
    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

    D) OSHA PEL Values for CAS100-51-6 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) ANIMAL - INHALATION EXPOSURE
    B) ANIMAL - ORAL EXPOSURE
    1) LD50- (ORAL)MOUSE:
    a) 1,360 mg/kg (RTECS, 2004)
    b) 1.58 g/kg (Bingham et al, 2001)
    2) LD50- (ORAL)RAT:
    a) 1,230 mg/kg; and 1,660 mg/kg (RTECS, 2004)
    b) 3.1 g/kg and 2.08 g/kg (Bingham et al, 2001)
    C) ANIMAL - OTHER EXPOSURE ROUTES
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 1000 mg/kg for 4H - neonatal mice(McCloskey et al, 1986)
    b) 650 mg/kg (RTECS, 2004)
    2) LD50- (INTRAARTERIAL)RAT:
    a) 441 mg/kg (RTECS, 2004)
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 400 mg/kg(RTECS, 2004)
    7.7.2) RISK ASSESSMENT VALUES
    A) UNASSIGNED- (OCULAR)RABBIT:
    1) Exposure to 750 mcg produced severe irritation in rabbit eyes (Lewis, 2000a; Bingham et al, 2001).
    B) UNASSIGNED- (INHALATION)RAT:
    1) All rats survived a 2H inhalation exposure to a saturated vapor of benzyl alcohol (Bingham et al, 2001).
    C) UNASSIGNED- (ORAL)UNASSIGNED:
    1) The reported oral LD50 for rabbits is 1,040 mg/kg and for guinea pigs it's 2,500 mg/kg (RTECS, 2004).
    D) UNASSIGNED- (ORAL)UNASSIGNED:
    1) An oral LD50 of 100 mg/kg is reported for wild birds (RTECS, 2004).
    E) UNASSIGNED- (ORAL)UNASSIGNED:
    1) B6C3F1 mice and Fischer 344 rats given oral doses of 50, 100, 200, 400, and 800 mg/kg for 13 weeks exhibited neurotoxicity only at the highest dose (Bingham et al, 2001).

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Benzyl alcohol is a weak local anesthetic with disinfectant properties.

Toxicologic Mechanism

    A) GASPING SYNDROME: Benzyl alcohol is oxidized in the liver to benzoic acid, then conjugated with glycine, and excreted in the urine as hippuric acid. Infants are less able to metabolize benzoic acid to hippuric acid, possibly because of glycine deficiency. Therefore, benzoic acid will be accumulated, causing "gasping syndrome" in the neonates receiving an IV product containing benzyl alcohol (HSDB, 2009).
    B) Acute toxicity in mice (CNS depression, dyspnea, and loss of motor function) are due to benzoic acid and not its metabolites (McCloskey et al, 1986).
    C) Metabolic acidosis can be explained by a direct effect of benzoic acid and/or secondary lactic acid production through depression of cellular metabolism.

Physicochemical

Physical Characteristics

    A) Benzyl alcohol is a clear, colorless liquid with a faint, pleasant aromatic odor and a sharp burning taste (Prod Info Ulesfia topical lotion, 2010; CHRIS, 2004; Lewis, 2001a) that is soluble in the following organic solvents:
    1) alcohol, ether, and chloroform (Budavari, 2001; Lewis, 2001)
    2) ethanol, ether, acetone, benzene, and methanol (Lide, 2003)
    3) benzene (greater than 10% soluble) (HSDB, 2004) and
    4) 50% ethanol, 1:1.5 (Budavari, 2001)
    B) Benzyl alcohol is considered slightly soluble (Lewis, 2001; NFPA, 2002) to soluble in water (Lide, 2003). Benzyl alcohol also has the following water solubility based on weight and temperature:
    1) 1 g benzyl alcohol dissolves in approximately 25 mL (Budavari, 2001)
    2) 35,000 mg/L (at 20 degrees C) (Verschueren, 2001)
    3) 40,000 mg/L (at 17 degrees C) (Verschueren, 2001)
    4) 42,900 mg/L (at 25 degrees C) (HSDB, 2004)

Ph

    A) solution in water is neutral (HSDB, 2004)

Molecular Weight

    A) 108.14 g/mol (molecular mass) (Prod Info Ulesfia topical lotion, 2010)

Other

    A) ODOR THRESHOLD
    1) 5.5 ppm (CHRIS, 2004)

References

General Bibliography

    1) 40 CFR 372.28: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Lower thresholds for chemicals of special concern. National Archives and Records Administration (NARA) and the Government Printing Office (GPO). Washington, DC. Final rules current as of Apr 3, 2006.
    2) 40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Apr 3, 2006.
    3) 49 CFR 172.101 - App. B: Department of Transportation - Table of Hazardous Materials, Appendix B: List of Marine Pollutants. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 29, 2005.
    4) 49 CFR 172.101: Department of Transportation - Table of Hazardous Materials. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 11, 2005.
    5) 62 FR 58840: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 1997.
    6) 65 FR 14186: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.
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