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UNDECYLENIC ACID

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Undecylenic acid is an antifungal (fungistatic) used on skin in concentrations of 5% for the basic acid, and 20% of various salts.
    B) The four compounds in this class are undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate.
    C) Undecylenic acid is a constituent of sweat and has been used as an insect repellent and treatment for pruritus ani and vulvae.

Specific Substances

    A) Undecylenic Acid
    1) Acidum Undecylenicum
    2) 9-Undecylenic Acid
    3) 10-Hendecenoic Acid
    4) 10-Undecenoic Acid
    5) Undec-1-enoic acid
    6) Undecenoic acid
    7) CAS 112-38-9
    ZINC UNDECYLENATE
    1) Undecilinate de Zinco
    2) Zinc di(undec-10-enoate)
    3) Zinci Undecylenas
    4) Zinc undecenoate
    5) CAS 557-08-4

Available Forms Sources

    A) FORMS
    1) Brand names of undecylenic acid include Cruex(R), Declid(R), Desenex(R), Renselin(R), Sevinon(R).
    2) Undecylenic acid is available in the following forms for the treatment of tinea pedis: ointment containing 5% undecylenic acid and 20% zinc undecylenate in a vanishing type base; in a powder containing 2% undecylenic acid and 20% zinc undecylenate; and in a liquid containing 10% undecylenic acid (Fuerst et al, 1980).
    3) Undecylenic acid and its salts are marketed primarily as antifungals in concentrations ranging from 1.5 to 25%. Dosage forms include powders, aerosols, ointments, solutions, and gels. The most common are powders and aerosols (Anon, 1982).
    4) Calcium undecylenate is used as a 10% powder (JEF Reynolds , 1989). Trade names include Caldesene(R).
    5) Liquids and foams may contain isopropyl alcohol as a vehicle.
    B) USES
    1) Undecylenic acid, an eleven-carbon monounsaturated fatty acid, and its salts are used as antifungals (Anon, 1982) and has moderate antibacterial activity (Fuerst et al, 1980).
    a) Undecylenic acid has been shown to be effective in preventing fungal overgrowth of candidiasis (ie, gastrointestinal and vaginal). It has been used to treat all of the following: thrush, dermatomycoses, herpes simplex infection, and denture stomatitis (None Listed, 2002).
    b) In one double-blind, placebo-controlled trial, undecylenic acid 15% cream was able to reduce viral shedding in recurrent herpes labialis, but clinical benefits were minimal and largely limited to patients starting therapy during the prodrome (Shafran et al, 1997).
    2) It is produced commercially by the vacuum distillation of castor bean oil, via the pyrolysis of ricinoleic acid. Undecylenic acid has an objectionable taste and odor (None Listed, 2002).
    3) Undecylenic acid is a constituent of sweat (None Listed, 2002) and has been used as an insect repellent (Reynolds, 1982) and treatment for pruritus ani and vulvae (Aldrich, 1947).

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: Undecylenic acid is a monounsaturated fatty acid that is found naturally in the body. It is a component of human sebum and has been postulated to be a local defense against skin infection. Undecylenic acid and its salts are used as an antifungal in concentrations ranging from 1.5% to 25% and are found in many topical over-the-counter antifungal preparations. They are most commonly available as powders and aerosols. It also has reported antibacterial and antiviral (including herpes simplex infection) activity and has been used as an insect repellent. Based on its fungicidal activity it has been used to treat vaginal/gastrointestinal candidiasis, thrush, dermatomycoses, and denture stomatitis (inhibits proliferation of yeast).
    B) PHARMACOLOGY: As an antifungal, it inhibits morphogenesis of Candida albicans; it can prevent fungal overgrowth associated with vaginal and gastrointestinal candidiasis via its fungicidal activity. Its possible mechanism of antiviral action is due to removal of essential viral envelope glycoproteins.
    C) EPIDEMIOLOGY: Exposure can occur. Acute toxicity is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: ORAL: It has a reported objectionable odor and taste. Its generally recommended to swallow the capsules and/or gelcaps whole to avoid possible mucous membrane irritation. Nausea, vomiting, diarrhea, constipation, anorexia, and heartburn were seen in patients ingesting 6 to 14 g/day. Conjunctivitis occurred after oral administration for the treatment of psoriasis. Urticaria and folliculitis have been observed after oral administration. TOPICAL: Following topical application, undecylenic acid has produced burning (most common), stinging, tingling, itching, numbness and a bad taste. It may also be irritating to mucous membranes and cause sensitization. Acute dermatitis has been reported infrequently.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: These products have a very limited toxicity. Often the vehicle (isopropyl alcohol or talc) is at least as toxic; if these vehicles are present, see appropriate POISINDEX(R) management for further information.

Laboratory Monitoring

    A) No specific laboratory tests are necessary unless otherwise clinically indicated. Toxic levels have not been established.
    B) Monitor fluids and electrolytes in patients that develop significant vomiting.
    C) Monitor neuro status and vital signs if the patient develops evidence of CNS toxicity. Monitor respiratory function if the patient shows signs of CNS depression secondary to the vehicle(s) (ie, isopropyl alcohol) used to produce topical preparations (ie, sprays, liquids).

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Its unpleasant taste and odor may limit inadvertent exposure. Acute ingestions of compounds containing undecylenic acid or its salts are unlikely to cause significant toxicity. Monitor fluid and electrolytes in patients with significant vomiting. Treat significant fluid loss with IV fluids and replace electrolytes as indicated.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Severe toxicity is not anticipated following an oral exposure. Inadvertent or intentional exposure of topical ointments or solutions may be dispersed in potentially toxic vehicles (ie, isopropyl alcohol, talc). Monitor neuro status and vital signs. Monitor respiratory effort in patient's exhibiting signs of CNS depression.
    C) DECONTAMINATION
    1) PREHOSPITAL: ORAL: Gastric decontamination is seldom necessary unless a significant amount has recently been ingested or there is a history of coingestants with known toxicity. DERMAL: Topical exposure can produce burning and skin irritation. Remove contaminated clothing and wash exposed area with soap and water. A physician may need to examine the area if irritation or pain persist. OCULAR: Irrigate exposed eyes with copious amounts of room temperature water for at least 15 minutes. If irritation, pain, swelling, or lacrimation persist after 15 minutes of irrigation, an ophthalmologic examination should be considered.
    2) HOSPITAL: ORAL: Gastric decontamination is seldom necessary unless a significant amount has recently been ingested or there is a history of coingestants with known toxicity. Consider administration of activated charcoal after a potentially toxic ingestion or coingestant, if the overdose is recent, the patient is not vomiting, and is able to maintain their airway. DERMAL: Topical exposure can produce burning and skin irritation. Remove contaminated clothing and wash exposed area with soap and water. A physician may need to examine the area if irritation or pain persists after washing. OCULAR: 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.
    D) ANTIDOTE
    1) There is no known antidote for undecylenic acid.
    E) AIRWAY MANAGEMENT
    1) Airway management is unlikely to be necessary following a mild to moderate oral exposure. Ensure adequate ventilation and airway support in patients that have been significantly exposed to the vehicle (eg, isopropyl alcohol causing CNS depression) used to produce topical undecylenic acid products.
    F) ENHANCED ELIMINATION
    1) Enhanced elimination is unlikely to be necessary following an exposure.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: A child with a minor exposure (1 to 2 capsules/tablets) who is asymptomatic or has mild gastrointestinal symptoms (ie, nausea and vomiting) can be monitored at home with adult supervision.
    2) OBSERVATION CRITERIA: A child with an inadvertent ingestion to a topical undecylenic acid product may need to be monitored in healthcare setting depending on the vehicle used (ie, isopropyl alcohol) and the amount ingested. Patients that develop persistent symptoms (ie, nausea, vomiting) or evidence of CNS depression may need to be treated in a healthcare facility.
    3) ADMISSION CRITERIA: Healthcare admission is unlikely to be necessary with this chemical. Persistent symptoms of CNS toxicity that may occur secondary to vehicle exposure (eg, isopropyl alcohol) may require hospital admission.
    4) CONSULT CRITERIA: A medical toxicologist or poison control center should be consulted in cases that involve significant toxicity or in whom the diagnosis is not clear.
    H) PITFALLS
    1) Failure to obtain information regarding the ingredients contained in some over-the-counter undecylenic acid products (eg, creams, powders, liquids), in particular the vehicle used. These compounds are dispersed in vehicles such as talc or alcohols, which should be considered for their toxic potential.
    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.
    B) Undecylenic acid and its salts have shown minimal or no toxicity when evaluated by the Draize test. Eye irritation may occur due to the vehicle (e.g., alcohol).

Range Of Toxicity

    A) TOXICITY: A toxic dose has not been established. Acute exposure has not been reported. Minor clinical effects including gastrointestinal disturbances have been reported in patients ingesting 6 to 14 g/day for several days. It is unlikely that acute exposures would cause significant symptoms.
    B) THERAPEUTIC DOSE: ADULT: ORAL: 450 to 750 mg daily in 3 divided doses.

Clinical Effects

Summary Of Exposure

    A) USES: Undecylenic acid is a monounsaturated fatty acid that is found naturally in the body. It is a component of human sebum and has been postulated to be a local defense against skin infection. Undecylenic acid and its salts are used as an antifungal in concentrations ranging from 1.5% to 25% and are found in many topical over-the-counter antifungal preparations. They are most commonly available as powders and aerosols. It also has reported antibacterial and antiviral (including herpes simplex infection) activity and has been used as an insect repellent. Based on its fungicidal activity it has been used to treat vaginal/gastrointestinal candidiasis, thrush, dermatomycoses, and denture stomatitis (inhibits proliferation of yeast).
    B) PHARMACOLOGY: As an antifungal, it inhibits morphogenesis of Candida albicans; it can prevent fungal overgrowth associated with vaginal and gastrointestinal candidiasis via its fungicidal activity. Its possible mechanism of antiviral action is due to removal of essential viral envelope glycoproteins.
    C) EPIDEMIOLOGY: Exposure can occur. Acute toxicity is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: ORAL: It has a reported objectionable odor and taste. Its generally recommended to swallow the capsules and/or gelcaps whole to avoid possible mucous membrane irritation. Nausea, vomiting, diarrhea, constipation, anorexia, and heartburn were seen in patients ingesting 6 to 14 g/day. Conjunctivitis occurred after oral administration for the treatment of psoriasis. Urticaria and folliculitis have been observed after oral administration. TOPICAL: Following topical application, undecylenic acid has produced burning (most common), stinging, tingling, itching, numbness and a bad taste. It may also be irritating to mucous membranes and cause sensitization. Acute dermatitis has been reported infrequently.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: These products have a very limited toxicity. Often the vehicle (isopropyl alcohol or talc) is at least as toxic; if these vehicles are present, see appropriate POISINDEX(R) management for further information.

Heent

    3.4.3) EYES
    A) ANIMAL DATA: A Draize test was done on rabbits using a mixture of 5% undecylenic acid and 20% zinc undecylenate. The combination, in doses of 0.5 mL, was found to be non-irritating (Anon, 1982).
    B) WITH THERAPEUTIC USE
    1) Conjunctivitis was associated with ingestion of 6 to 14 g/day of undecylenic acid for the treatment of psoriasis (Perlman & Milberg, 1949). This is the only report; the dosage form was solid perles.
    2) Dermatologic therapy has rarely been associated with keratoconjunctivitis (Grant & Schuman, 1993).
    3.4.6) THROAT
    A) WITH THERAPEUTIC USE
    1) Undecylenic acid is a mild mucous membrane irritant, so most products are less than 1% concentration. If the zinc salt is used, products are less irritating and up to 5% of the acid may be used (Shapiro & Rothman, 1945).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) ATRIAL FIBRILLATION
    1) WITH THERAPEUTIC USE
    a) Rattner & Rodin (1951) reported one case of atrial fibrillation and one of coronary pain, both of which resolved when the drug was discontinued and recurred when administration (Rattner & Roden, 1951).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) DIZZINESS
    1) WITH THERAPEUTIC USE
    a) Dizziness was reported in patients ingesting 6 to 14 g/day for psoriasis (Perlman & Milberg, 1949).
    B) HEADACHE
    1) WITH THERAPEUTIC USE
    a) Headache was reported in patients taking 6 to 14 g/day for psoriasis (Perlman & Milberg, 1949).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) GASTRITIS
    1) WITH THERAPEUTIC USE
    a) CASE SERIES: Gastrointestinal disturbances were reported in patients ingesting 6 to 14 g/day for several days. Signs and symptoms included nausea, vomiting, diarrhea, constipation, anorexia and heartburn (Perlman & Milberg, 1949).
    b) CASE REPORT: Rattner & Rodin (1951) reported activation of a quiescent peptic ulcer, with serious hemorrhage. The vehicle is unknown (Rattner & Roden, 1951)

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Urticaria and folliculitis were reported in patients ingesting 6 to 14 g/day for psoriasis (Perlman & Milberg, 1949).
    b) Undecylenic acid may cause irritation and sensitization, which would require discontinuation of the medication, but this is not common (Prod Info Gordochom(R), 2001; Zanowiak & Jacobs, 1982).
    c) In one study, only 2 of 22 cases developed irritation (Lubome & Wexler, 1965) and in another, no cases of irritation were seen in 1213 men (Anon, 1982).
    d) Topical treatment may result in burning, stinging, numbness, mucous membrane irritation, and tingling (Shafran et al, 1997). .
    B) ALLERGIC CONTACT DERMATITIS
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT: Allergic contact dermatitis developed in a 61-year-old woman after using a topical product for onychomycosis that contained undecylenic acid for 6 months. Patch testing was positive for undecylenic acid only and not tioconazole (1%) or ethyl acetate (20%) (Anguita et al, 2002).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) No specific laboratory tests are necessary unless otherwise clinically indicated. Toxic levels have not been established.
    B) Monitor fluids and electrolytes in patients that develop significant vomiting.
    C) Monitor neuro status and vital signs if the patient develops evidence of CNS toxicity. Monitor respiratory function if the patient shows signs of CNS depression secondary to the vehicle(s) (ie, isopropyl alcohol) used to produce topical preparations (ie, sprays, liquids).

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) Healthcare admission is unlikely to be necessary with this chemical. Persistent symptoms of CNS toxicity that may occur secondary to vehicle exposure (eg, isopropyl alcohol) may require hospital admission.
    6.3.1.2) HOME CRITERIA/ORAL
    A) A child with a minor exposure (1 to 2 capsules/tablets) who is asymptomatic or has mild gastrointestinal symptoms (ie, nausea and vomiting) can be monitored at home with adult supervision.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) A medical toxicologist or poison control center should be consulted in cases that involve significant toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) A child with an inadvertent ingestion to a topical undecylenic acid product may need to be monitored in healthcare setting depending on the vehicle used (ie, isopropyl alcohol) and the amount ingested. Patients that develop persistent symptoms (ie, nausea, vomiting) or evidence of CNS depression may need to be treated in a healthcare facility.

Monitoring

    A) No specific laboratory tests are necessary unless otherwise clinically indicated. Toxic levels have not been established.
    B) Monitor fluids and electrolytes in patients that develop significant vomiting.
    C) Monitor neuro status and vital signs if the patient develops evidence of CNS toxicity. Monitor respiratory function if the patient shows signs of CNS depression secondary to the vehicle(s) (ie, isopropyl alcohol) used to produce topical preparations (ie, sprays, liquids).

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) Gastric decontamination is seldom necessary unless a significant amount has recently been ingested or there is a history of coingestants with known toxicity
    B) ACTIVATED CHARCOAL
    1) Consider prehospital administration in patients who are symptomatic or have ingested very large amounts.
    2) 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).
    3) 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) SUMMARY
    1) Acute ingestions of compounds containing undecylenic acid or its salts are unlikely to cause significant problems, gastrointestinal decontamination is generally not necessary. Consider activated charcoal only after very large ingestions or when a coingestant with significant toxicity are involved.
    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).
    6.5.3) TREATMENT
    A) SUPPORT
    1) MANAGEMENT OF MILD TO MODERATE TOXICITY
    a) Treatment is symptomatic and supportive. Its unpleasant taste and odor may limit inadvertent exposure. Acute ingestions of compounds containing undecylenic acid or its salts are unlikely to cause significant toxicity. Monitor fluid and electrolytes in patients with significant vomiting. Treat significant fluid loss with IV fluids and replace electrolytes as indicated.
    2) MANAGEMENT OF SEVERE TOXICITY
    a) Treatment is symptomatic and supportive. Severe toxicity is not anticipated following an oral exposure. Inadvertent or intentional exposure of topical ointments or solutions may be dispersed in potentially toxic vehicles (ie, isopropyl alcohol, talc). Monitor neuro status and vital signs. Monitor respiratory effort in patient's exhibiting signs of CNS depression.
    B) MONITORING OF PATIENT
    1) No specific laboratory tests are necessary unless otherwise clinically indicated.
    2) Toxic levels have not been established.
    3) Monitor fluids and electrolytes in patients that develop significant vomiting.
    4) Monitor neuro status and vital signs if the patient develops evidence of CNS toxicity.
    5) Monitor respiratory function if the patient shows signs of CNS depression secondary to the vehicle(s) (ie, isopropyl alcohol) used to produce topical preparations.

Inhalation Exposure

    6.7.2) TREATMENT
    A) PULMONARY ASPIRATION
    1) Some undecylenic acid preparations are dispersed in talc. Although not reported, the potential exists for talc pneumonitis. Toxicity is unlikely unless products are aspirated or used intravenously. See Poisindex management TALC for further information as needed.
    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).
    6.8.2) TREATMENT
    A) IRRITATION SYMPTOM
    1) Undecylenic acid and its salts have shown minimal or no toxicity when evaluated by the Draize test. Eye irritation may occur due to the vehicle (e.g., isopropyl alcohol).
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Range Of Toxicity

Summary

    A) TOXICITY: A toxic dose has not been established. Acute exposure has not been reported. Minor clinical effects including gastrointestinal disturbances have been reported in patients ingesting 6 to 14 g/day for several days. It is unlikely that acute exposures would cause significant symptoms.
    B) THERAPEUTIC DOSE: ADULT: ORAL: 450 to 750 mg daily in 3 divided doses.

Therapeutic Dose

    7.2.1) ADULT
    A) ORAL
    1) ADULT: ORAL: 450 to 750 mg orally in 3 divided doses. The oral formulation is typically in an oil-based gelcap or as a powder in a 2-part capsule (None Listed, 2002).
    2) Avoid opening or chewing the capsules due to objectionable odor and taste and it may be irritating to the mucous membranes. The capsules may be taken with food or drink to avoid the taste (None Listed, 2002).
    B) TOPICAL
    1) Thoroughly clean and dry the affected area. Spray or spread onto treatment area twice daily, usually morning and night, or before and after athletic activity (Prod Info Cruex(R), undecylenic acid cream, powder. Physicians' Desk Reference (electronic version), 1999; Prod Info Desenex(R), undecylenic acid cream, powder. Physicians' Desk Reference (electronic version), 1999).

Maximum Tolerated Exposure

    A) SUMMARY
    1) Limited data. Significant toxicity has not been reported.
    2) Minor clinical effects including gastrointestinal disturbances have been reported in patients ingesting 6 to 14 g/day for several days (Perlman & Milberg, 1949).
    3) Topical treatment may result in burning, stinging, numbness, mucous membrane irritation, and tingling (Shafran et al, 1997). Allergic contact dermatitis was reported in one adult following topical application of undecylenic acid (Anguita et al, 2002).
    B) ANIMAL DATA
    1) Up to 400 mg/kg/day of undecylenic acid was given orally to rats for 6 to 9 months. No toxicity was noted (Patty, 1967).

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (ORAL)MOUSE:
    1) 8.5 g/kg (RTECS, 1989)
    B) LD50- (INTRAPERITONEAL)RAT:
    1) 888 mg/kg (Anon, 1982)
    C) LD50- (ORAL)RAT:
    1) 2.5 g/kg (RTECS, 1989)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Undecylenic acid is a fatty acid active against various pathogenic fungi including Epidermophyton, Trichophyton, and Microsporum species. It is used primarily as the calcium or zinc salts, although there is a copper salt also available.
    B) It has its greatest activity at an acid pH (JEF Reynolds , 1989). Zinc salts are thought to release undecylenic acid upon contact with water (Popovich, 1982). The zinc salts may also have an astringent action (Popovich, 1982).

Physicochemical

Physical Characteristics

    A) UNDECYLENIC ACID: Odor is suggestive of perspiration and has disagreeable, "fishy" taste (Perlman & Milberg, 1949).

Molecular Weight

    A) UNDECYLENIC ACID: 184.27
    B) ZINC UNDECYLENATE: 431.9

References

General Bibliography

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    2) Aldrich RH: Undecylenic acid. Indust Med 1947; 16:491.
    3) Anguita JL, Escutia B, Mari JI, et al: Allergic contact dermatitis from undecylenic acid in a commercial antifungal nail solution. Contact Dermatitis 2002; 46(2):109.
    4) Anon: Undecylenic acid and its salts (calcium undecylenate, copper undecylenate and zinc undecylenate). Fed Reg 1982; 47:12509-12511.
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    7) Elliot CG, Colby TV, & Kelly TM: Charcoal lung. Bronchiolitis obliterans after aspiration of activated charcoal. Chest 1989; 96:672-674.
    8) FDA: Poison treatment drug product for over-the-counter human use; tentative final monograph. FDA: Fed Register 1985; 50:2244-2262.
    9) Fuerst JF, Cox GF, Weaver SM, et al: Comparison between undecylenic acid and tolnaftate in the treatment of tinea pedis. Cutis 1980; 25(5):544-546, 549.
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    11) Graff GR, Stark J, & Berkenbosch JW: Chronic lung disease after activated charcoal aspiration. Pediatrics 2002; 109:959-961.
    12) Grant WM & Schuman JS: Toxicology of the Eye, 4th ed, Charles C Thomas, Springfield, IL, 1993.
    13) Guenther Skokan E, Junkins EP, & Corneli HM: Taste test: children rate flavoring agents used with activated charcoal. Arch Pediatr Adolesc Med 2001; 155:683-686.
    14) Harris CR & Filandrinos D: Accidental administration of activated charcoal into the lung: aspiration by proxy. Ann Emerg Med 1993; 22:1470-1473.
    15) JEF Reynolds : Martindale: The Extra Pharmacopoeia, (CD-ROM Version). The Pharmaceutical Press. London, UK (Internet Version). Edition expires 1989; provided by Truven Health Analytics Inc., Greenwood Village, CO.
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