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TETRACHLOROSALICYLANILIDE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Tetrachlorosalicylanilide is a bacteriostatic agent used in the manufacture of thermoplastic articles and formerly in formulations of surgical soaps, laundry soaps, rinses, deodorants, and preservatives in textiles.

Specific Substances

    1) Irgasan BS-200
    2) TCSA
    3) 3,3',4',5-tetrachlorosalicylanilide
    4) 3,5,3',4-tetrachlorosalicylanide
    5) CAS 1154-59-2

Available Forms Sources

    A) USES
    1) Tetrachlorosalicylanilide (TCSA) is a bacteriostatic agent used in various surgical soaps, laundry soaps, rinses, deodorants, shampoos and polishes. It may not be used in cosmetics (FDA ban) (Budavari, 1996).
    a) TCSA was particularly good in soaps because it had antibacterial action at low concentrations, had an affinity for the skin, adhered to the epidermis, and was not washed off (Solomon & Bluefarb, 1969).
    2) TCSA is used in the textile industry as a preservative, and similarly in cutting oils, coolants, and cellulose esters (Budavari, 1996).

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Most reports of exposures to TCSA involve photodermatitis. This agent was used in topical cosmetics and cleansers and caused contact dermatitis and serious photodermatitis. There is little information available on systemic effects.
    B) A few of the OTHER HALOGENATED SALICYLANILIDES (clioxanide, rafoxanide, oxyclozanide) have been used in animals as antihelmintics and caused anorexia, diarrhea, peripheral neuropathy, white matter damage, eye damage, blindness, hepatic and lymphatic necrosis, neutropenia and lymphopenia, and abnormal laboratory values. There were no specific reports of these effects caused by TCSA, but the possibility of these symptoms should be entertained until more data are available.
    0.2.4) HEENT
    A) There may be eyelid edema caused by the photodermatitis reaction.
    B) Various types of optic damage have been seen with related halogenated salicylanilides.
    0.2.7) NEUROLOGIC
    A) No neurologic adverse effects have been reported with TCSA. Related agents have caused white matter vacuolation, peripheral neuropathy, cerebral edema, and CNS depression in animals. No human data are available.
    0.2.8) GASTROINTESTINAL
    A) Anorexia and diarrhea were reported in animals given various halogenated salicylanilides.
    0.2.9) HEPATIC
    A) Local hepatic necrosis and elevated enzymes were seen in animals given halogenated salicylanilides. Elevated glutamic oxaloacetic transaminase and serum alkaline phosphatase levels were seen with various halogenated salicylanilides.
    0.2.13) HEMATOLOGIC
    A) Neutropenia and lymphopenia were reported in animals given oral doses of various halogenated salicylanilides.
    0.2.14) DERMATOLOGIC
    A) Photodermatitis is a common symptom seen with the various halogenated salicylanilides.
    0.2.20) REPRODUCTIVE
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.

Laboratory Monitoring

    A) Monitor CBC, urinalysis, and liver and kidney function tests in patients with significant exposure.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) 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.
    B) There is no specific antidote. Treatment is symptomatic and supportive. Since some halogenated salicylanilides have caused eye and liver damage and blood element abnormalities in animals, monitor liver function tests, CBC, and vision. Monitor for peripheral neuropathy.
    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) Steroids are the mainstay of treatment. Symptomatic measures may include cool soaks or dressings, oral antihistamines, and skin moisturizers.

Range Of Toxicity

    A) A specific minimum tetrachlorosalicylanilide toxic dose has not been established.

Clinical Effects

Summary Of Exposure

    A) Most reports of exposures to TCSA involve photodermatitis. This agent was used in topical cosmetics and cleansers and caused contact dermatitis and serious photodermatitis. There is little information available on systemic effects.
    B) A few of the OTHER HALOGENATED SALICYLANILIDES (clioxanide, rafoxanide, oxyclozanide) have been used in animals as antihelmintics and caused anorexia, diarrhea, peripheral neuropathy, white matter damage, eye damage, blindness, hepatic and lymphatic necrosis, neutropenia and lymphopenia, and abnormal laboratory values. There were no specific reports of these effects caused by TCSA, but the possibility of these symptoms should be entertained until more data are available.

Heent

    3.4.1) SUMMARY
    A) There may be eyelid edema caused by the photodermatitis reaction.
    B) Various types of optic damage have been seen with related halogenated salicylanilides.
    3.4.3) EYES
    A) EYELIDS - Edema of the eyelids may be seen in acute photodermatitis cases (Calnan et al, 1961).
    B) OPTIC TOXICITY - Has been seen with some halogenated salicylanilides.
    C) RELATED AGENTS - CLIOXANIDE has caused blindness in animals (O'Brien, 1970) and RAFOXANIDE has caused bilateral equatorial cataracts, papilledema, vacuolation of the optic nerve, and optic chiasma in dogs given 3 to 11 doses of 100 mg/kg/day (Brown et al, 1972). These effects have not been reported with TCSA.

Neurologic

    3.7.1) SUMMARY
    A) No neurologic adverse effects have been reported with TCSA. Related agents have caused white matter vacuolation, peripheral neuropathy, cerebral edema, and CNS depression in animals. No human data are available.
    3.7.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) ENCEPHALOPATHY
    a) BRAIN DAMAGE - Vacuolation of the white matter of the brain (and spinal cord) has been seen in dogs given 3 to 11 doses of 100 mg/kg/day of RAFOXANIDE and in sheep given CLIOXANIDE (Brown et al, 1972; O'Brien, 1970). This has not been reported with TCSA.
    2) NEUROPATHY PERIPHERAL
    a) Peripheral neuropathy was noted in rats poisoned by CLIOXANIDE, another halogenated salicylanilide (Kurtz et al, 1969). This has not been reported with TCSA.
    3) EDEMA CEREBRAL
    a) Cerebral edema has been reported by Kurtz et al (1969) in rats given the halogenated salicylanilide CLIOXANIDE. This has not been reported with TCSA.
    4) CNS DEPRESSION
    a) CNS depression was noted in sheep and cattle given 25 mg/kg/day of OXYCLOZANIDE, a halogenated salicylanilide (Walley, 1966).

Gastrointestinal

    3.8.1) SUMMARY
    A) Anorexia and diarrhea were reported in animals given various halogenated salicylanilides.
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) ANOREXIA
    a) SHEEP - Anorexia was seen in sheep given 25 mg/kg/day orally of the halogenated salicylanilide OXYCLOZANIDE (Walley, 1966).
    2) DIARRHEA
    a) SHEEP/CATTLE - Diarrhea was noted in sheep and cattle given 25 mg/kg/day orally of the halogenated salicylanilide, OXYCLOZANIDE (Walley, 1966). This has not been seen with TCSA.

Hepatic

    3.9.1) SUMMARY
    A) Local hepatic necrosis and elevated enzymes were seen in animals given halogenated salicylanilides. Elevated glutamic oxaloacetic transaminase and serum alkaline phosphatase levels were seen with various halogenated salicylanilides.
    3.9.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HEPATIC NECROSIS
    a) Local hepatic necrosis was seen in dogs given 100 mg/kg/day (3 to 11 doses) of the related salicylanilide, RAFOXANIDE (Brown et al, 1972). This effect was not reported with TCSA.
    2) HEPATIC ENZYMES INCREASED
    a) Elevated glutamic oxaloacetic transaminase and serum alkaline phosphatase levels were seen in dogs given 3 to 11 doses of 100 mg/kg/day of the related salicylanilide, RAFOXANIDE. This not been reported with TCSA (Brown et al, 1972).

Hematologic

    3.13.1) SUMMARY
    A) Neutropenia and lymphopenia were reported in animals given oral doses of various halogenated salicylanilides.
    3.13.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LEUKOPENIA
    a) Neutropenia and lymphopenia were seen in dogs given 100 mg/kg/day of RAFOXANIDE, a related salicylanilide (Brown, 1972). These symptoms have not been reported with TCSA.

Dermatologic

    3.14.1) SUMMARY
    A) Photodermatitis is a common symptom seen with the various halogenated salicylanilides.
    3.14.2) CLINICAL EFFECTS
    A) PHOTOSENSITIVITY
    1) Salicylanilides in soaps are known to cause photodermatitis. Tetrachlorosalicylanilide (used as a disinfectant) was a common cause in 1961; but has now been withdrawn from use (Epstein et al, 1968).
    2) In one study, the maximum photosensitivity observed on patch testing was in the range of 360 nm and no reaction occurred above 420 nm. The halogenated salicylanilides gave maximum absorption at 282 nm (Cripps & Enta, 1970).
    3) Patients with the photosensitivity may have confluent itchy, eczematous dermatitis of the face, arms, hands, ears, forehead and especially in women, the anterior legs (Calnan et al, 1961; Hazelrigg et al, 1976).
    4) BITHIONOL - Patients who photoreact to bithionol may also react to tetrachlorosalicylanilide (Baughman, 1964).
    5) Delayed reactions have been noted with halogenated salicylanilides, with an onset of up to 96 hours (Ison & Tucker, 1967).
    6) Chronic persistent photosensitive states may occur after reactions to halogenated salicylanilides (Epstein et al, 1968).
    B) CONTACT DERMATITIS
    1) Contact dermatitis which is not light generated has also been reported to tetrachlorosalicylanilide (Calnan et al, 1961).

Immunologic

    3.19.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) LYMPHADENOPATHY
    a) Lymphoid necrosis in the lymph nodes and the intestine were seen in dogs given 3 to 11 doses of RAFOXANIDE, a related salicylanilide (Brown et al, 1972). This has not been reported for TCSA.

Reproductive

    3.20.1) SUMMARY
    A) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.
    3.20.2) TERATOGENICITY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the teratogenic potential of this agent.
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy or lactation.

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS1154-59-2 (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
    3.21.3) HUMAN STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Genotoxicity

    A) At the time of this review, no data were available to assess the mutagenic or genotoxic potential of this agent.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor CBC, urinalysis, and liver and kidney function tests in patients with significant exposure.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) No specific tests are indicated; use a general approach.
    2) A number of chemicals produce abnormalities of the hematopoietic system, liver, and kidneys. Monitoring complete blood count, urinalysis, 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.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Monitor CBC, urinalysis, and liver and kidney function tests in patients with significant exposure.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) 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) 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) There is no specific antidote. Treatment is symptomatic and supportive. Since some halogenated salicylanilides have caused eye and liver damage and blood element abnormalities in animals, monitor liver function tests, CBC, and vision. Monitor for peripheral neuropathy.
    B) DERMATITIS
    1) Antihistamines and steroids may be used to treat dermal conditions that arise after exposure to tetrachlorosalicylanilide.

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) SUMMARY: The first step in the treatment of contact dermatitis is to avoid the offending substance and its cross-reactive agents, if known. Steroids are the mainstay of treatment for control of inflammation. Symptomatic measures may include cool soaks or dressings, oral antihistamines, and skin moisturizers.
    2) CORTICOSTEROIDS
    a) TOPICAL - Indicated for subacute eczematous inflammation and for mild, localized, acute eczematous inflammation.
    1) HYDROCORTISONE - Use for lesions on face and intertriginous area; apply to affected area in a thin film three times a day.
    2) TRIAMCINOLONE - Use for nonfacial, nonintertriginous lesions; apply to the affected area in a thin film three times a day (alternatives: desoximetasone, fluocinonide).
    3) BETAMETHASONE SPRAY - Use on moist, nonfacial lesions; also provides a cooling affect; apply to affected area sparingly (3 seconds) three times a day.
    b) SYSTEMIC - Indicated for moderate to severe or widespread eczematous inflammation; swelling of face, genitalia, feet, or ankles; progressive lesions; intractable pruritus or pruritus unresponsive to topical therapy.
    1) PREDNISONE - 40 to 60 milligrams/day (children: 1 to 2 milligrams/kilogram/day) orally initially, then gradually taper over a 2 to 3 week period.
    3) ANTIHISTAMINES
    a) ANTIPRURITICS - Systemic antihistamines relive itching and provide sedation to enable sleep. Topical measures for symptomatic relief include cook soaks or compresses and tub baths with starch or colloidal oatmeal.
    b) DIPHENHYDRAMINE - 25 to 50 milligrams orally every 4 to 6 hours (children: 5 milligrams/kilogram/day orally in 4 divided doses; maximum 300 milligrams/day).
    c) HYDROXYZINE - 25 milligrams orally three or four times a day (children: 2 milligrams/kilogram/day orally in 4 divided doses).
    4) WET DRESSINGS - Indicated in acute eczematous inflammation to suppress inflammation and pruritus, debride crusts and serum, and dry the lesions; apply cool, wet compresses to the blistered area for 15 to 30 minutes two to four times a day.
    5) MOISTURIZERS - Indicated in subacute eczematous inflammation to seal in skin moisture and prevent further dryness; emollient creams and lotions containing urea or lactic acid are preferable.
    B) SUPPORT
    1) SUMMARY: Most cases of contact dermatitis can be effectively treated and controlled once the offending allergen or irritant is identified and eliminated. Patients should be advised to eliminate activities at home or work that aggravate existing dermatitis or to protect themselves from the suspected allergen. Ordinary soaps, scrubbing, rubbing, and scratching should also be avoided. Patients with photodermatitis should avoid sun exposure with appropriate clothing and use of a sunscreen (Mallory, 1987).
    2) COOL COMPRESSES
    a) ACUTE ECZEMATOUS INFLAMMATION - The evaporative cooling produced by application of cool, wet compresses to the affected area reduces pruritus, removes heat from the inflamed surfaces, debrides crust and serum, and provides topical anesthesia. Compresses also help dry the lesions, particularly in the presence of weeping or oozing edematous areas or areas with broken vesicles or bullae. Sitz baths may be utilized with involvement of the genitalia and intertriginous areas (Sternback & Callen, 1985). Although tap water alone is effective, an astringent, eg, Burow's solution (aluminum acetate), may be used to suppress bacterial growth.
    b) RECOMMENDATION - Use plain tap water or Burow's solution (one tablet or powder packet dissolved in one pint cold water). Wet the dressing and apply to the blistered area for 15 to 30 minutes two to four times a day until the blisters dry. Do not cover the dressing with towels or plastic wrap because this prevents evaporation (Mallory, 1987).
    3) HEAT - Hot soapless showers several times a day may be effective in temporarily relieving pruritus associated with acute eczematous inflammation; however, the subsequent vasodilation and edema may cause a rebound itch. This treatment approach will also decrease the risk of secondary infection by removing any accumulated exudate, which may provide a culture medium for bacterial growth.
    4) SKIN LESIONS DEBRIDEMENT - Large bullae associated with acute eczematous inflammation may be aspirated aseptically with the roofs left intact. (NOTE: Blister fluid contains no allergen and, therefore, cannot transmit the dermatitis).
    C) ANTIHISTAMINE
    1) Most patients with acute eczematous inflammation will require an oral antihistamine, eg, diphenhydramine or hydroxyzine, for relief or pruritus; these agents also provide sedation to enable sleep.
    2) TOPICAL MEASURES - Topical treatment to help relieve itching includes cold compresses or soaks with Burow's solution, baths with starch or colloidal oatmeal, and application of shake lotion of 1% methanol in calamine lotion (Sauer, 1985; Davis, 1983). Topical preparations that contain benzocaine, zirconium, or antihistamines (eg, Caladryl(R)) are sensitizing agents and should not be used.
    3) DIPHENHYDRAMINE -
    a) INDICATIONS - Most patients with acute eczematous inflammation will require an oral antihistamine, eg, diphenhydramine, for relief of pruritus; these agents also provide sedation to enable sleep.
    b) RECOMMENDATION - 25 to 50 milligrams orally every four to six hours (children: 5 milligrams/kilogram/day orally in four divided doses; maximum 300 milligrams/day).
    c) DOSING IN SPECIAL SITUATIONS - Increase dosage interval in renal failure.
    d) MAJOR ADVERSE REACTIONS - Convulsions (large doses); dyskinesias; delirium and hallucinations.
    e) PRECAUTIONS - Contraindicated in narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer; use with caution in patients receiving CNS depressants or with bronchial asthma.
    4) HYDROXYZINE -
    a) INDICATIONS - Most patients with acute eczematous inflammation will require an oral antihistamine, eg, hydroxyzine, for relief of pruritus; these agents also provide sedation to enable sleep.
    b) RECOMMENDATION - 25 milligrams orally three to four times daily (children: 2 milligrams/kilogram/day orally in four divided doses).
    c) DOSING IN SPECIAL SITUATIONS - Reduce dose in severe liver disease and in elderly patients.
    d) MAJOR ADVERSE REACTIONS - Extreme sedation; respiratory depression and hypotension (with narcotic analgesics); tremor and seizures (rare; with high doses).
    e) PRECAUTIONS - Potentiates CNS depressants.
    D) CORTICOSTEROID
    1) INDICATIONS
    a) TOPICAL - Subacute eczematous inflammation or mild, localized, acute eczematous inflammation can be managed with a topical steroid cream or lotion, eg, hydrocortisone, triamcinolone, desoximetasone, or fluocinonide. An ointment may be indicated if the skin is particularly dry or fissured, or with palmar involvement. A gel or an aerosol is useful in scalp dermatitis and moist lesions. Topical steroids are ineffective when used on oozing, vesicular lesions.
    b) ORAL - Systemic steroids are indicated for controlling severe or widespread acute eczematous inflammation (Larsen & Maibach, 1985; Mallory, 1987). Patients with one or more of the following findings should be treated with systemic steroids (in the absence of contraindications to such treatment) (Davis, 1983).
    1) Moderate to severe, widespread, or progressive eczematous inflammation.
    2) Intractable pruritus that interferes with sleep or daily activities or pruritus unresponsive to topical therapy.
    3) Swelling of face, genitalia, feet, and/or ankles.
    c) HYDROCORTISONE, TOPICAL -
    1) INDICATIONS - Subacute eczematous inflammation or mild, localized, acute eczematous inflammation can be managed with a topical steroid. For lesions on the face and intertriginous areas, a less potent steroid such as 0.5 percent to 1 percent hydrocortisone cream or lotion is usually acceptable.
    2) RECOMMENDATION - Apply to affected areas of face or intertriginous regions in a thin film three times daily (children: apply sparingly because of greater susceptibility to adrenal suppression and Cushing's syndrome).
    3) MAJOR ADVERSE REACTIONS - With large amounts - reversible adrenal suppression, Cushing's syndrome, hyperglycemia, glucosuria, atrophy of epidermis, striae, epidermal thinning, telangiectasia, acneiform eruption; rosacea-like dermatoses; skin infection with occlusive dressings.
    4) PRECAUTIONS - Contraindicated in patients with markedly impaired circulation (skin ulceration) or hypersensitivity to corticosteroids; caution with occlusive dressings (adrenal suppression, skin infections); systemic effects usually do not occur unless weekly amounts exceed 30 grams in adults (10 grams in children).
    d) DESOXIMETASONE
    1) INDICATIONS - Subacute eczematous inflammation or mild, localized, acute eczematous inflammation can be managed with a topical steroid. For areas other than the face or intertriginous regions, a steroid such as desoximetasone 0.25 percent may be prescribed.
    2) RECOMMENDATION - Apply to the affected area in a thin film three times daily (children: apply sparingly because of greater susceptibility to adrenal suppression and Cushing's syndrome).
    3) MAJOR ADVERSE REACTIONS - With large amounts reversible adrenal suppression, Cushing's syndrome, hyperglycemia, glycosuria, atrophy of epidermis, striae, epidermal thinning, telangiectasia, acneiform eruption; rosacea-like dermatoses; skin infection with occlusive dressings.
    4) PRECAUTIONS - Contraindicated in patients with markedly impaired circulation (skin ulceration) or with hypersensitivity or corticosteroids; caution with occlusive dressings (adrenal suppression; skin infection).
    5) FLUOCINONIDE -
    a) INDICATIONS - Subacute eczematous inflammation or mild, localized, acute eczematous inflammation can be managed with a topical steroid. For areas other than the face or intertriginous regions, a steroid such as fluocinonide 0.05 percent may be prescribed.
    b) RECOMMENDATION - Apply to the affected area in a thin film three times daily (children: apply sparingly because of greater susceptibility to adrenal suppression and Cushing's syndrome).
    c) MAJOR ADVERSE REACTIONS - With large amounts - reversible adrenal suppression, Cushing's syndrome, hyperglycemia, glucosuria, atrophy of epidermis, striae, epidermal thinning, telangiectasia, acneiform eruption; rosacea-like dermatoses; skin infection with occlusive dressings.
    d) PRECAUTIONS - Contraindicated in patients with markedly impaired circulation (skin ulceration) or with hypersensitivity to corticosteroids; caution with occlusive dressings (adrenal suppression; skin infection).
    6) TRIAMCINOLONE, TOPICAL -
    a) INDICATIONS - Subacute eczematous inflammation or mild, localized, acute eczematous inflammation can be managed with a topical steroid. For areas other than the face or intertriginous regions, a steroid such as triamcinolone 0.025 percent to 0.1 percent may be prescribed.
    b) RECOMMENDATION - Apply to the affected area in a thin film three times daily (children: apply sparingly because of greater susceptibility to adrenal suppression and Cushing's syndrome).
    c) MAJOR ADVERSE REACTIONS - With large amounts - reversible adrenal suppression, Cushing's syndrome, hyperglycemia, glycosuria, atrophy of epidermis, striae, epidermal thinning, telangiectasia, acneiform eruption; rosacea-like dermatoses; skin infection wit occlusive dressings.
    d) PRECAUTIONS - Contraindicated in patient with markedly impaired circulation (skin ulceration) or hypersensitivity to corticosteroids; caution with occlusive dressings (adrenal suppression, skin infections); systemic effects usually do not occur unless weekly amounts exceed 30 grams in adults (10 grams in children).
    7) BETAMETHASONE, TOPICAL -
    a) INDICATIONS - A topical aerosol or gel steroid, eg, betamethsone, is useful for treating dermatitis involving the scalp or other hair-bearing areas and for moist lesions such as poison ivy. The aerosol formulation provides a cooling effect and is also a convenient form for patients who lack mobility or who may have difficulty reaching areas of dermatitis in less accessible areas, eg, the lower legs or back.
    b) RECOMMENDATIONS - Apply to the affected area in a thin film or a three-second spray three times a day (children: apply sparingly because of greater susceptibility to adrenal suppression and Cushing's syndrome).
    c) MAJOR ADVERSE REACTIONS - With large amounts - reversible adrenal suppression, Cushing's syndrome, hyperglycemia, glycosuria, atrophy of epidermis, striae, epidermal thinning, telangiectasia, acneiform eruption; rosacea-like dermatoses; skin infection with occlusive dressings.
    d) PRECAUTIONS - Contraindicated in patients with markedly impaired circulation (skin ulceration) or with hypersensitivity to corticosteroids; caution with occlusive dressings (adrenal suppression; skin infection).
    8) PREDNISONE -
    a) INDICATIONS - Oral steroids are indicated for generalized involvement and for relief of symptoms and associated edema (Larsen & Maibach, 1985; Mallory, 1987). Prednisone is the drug of choice because it is inexpensive and short-acting (Larsen & Maibach, 1985). Patients with one or more of the following findings should be treated with an oral steroid (in the absence of contraindications to such treatment) (Davis, 1983).
    1) Moderate to severe, widespread, or progressive eczematous inflammation.
    2) Intractable pruritus that interferes with sleep or daily activities or pruritus unresponsive to topical therapy.
    3) Swelling of face, genitalia, feet, and/or ankles.
    b) TREATMENT DURATION - Steroid therapy should be started and tapered over a period of at least 14 to 18 days. Shorter treatment periods, especially those under one week, often result in rebound flare of the hypersensitivity reaction, with eruption of new lesions when the drug is stopped (Davis, 1983; Simons, 1986; Sauer, 1985). Patients should be instructed to complete the full course of medication, even if the rash has completely subsided (Davis, 1983). Inflammation may reappear as diffuse erythema and possibly may be more extensive if the steroid dose is either too low to tapered too rapidly (Larsen & Maibach, 1985).
    c) ADULTS: Initiate therapy at a level equivalent to 40 to 60 milligrams/day, gradually taper over a 2 to 3 week period, and then discontinue. Representative and effective oral dosage regimens for severe cases in adults are as follows:
    1) TWO WEEK TAPERED COURSE -
    1) 60 milligrams/day orally for 2 day
    2) 50 milligrams/day orally for 2 day
    3) 40 milligrams/day orally for 2 day
    4) 30 milligrams/day orally for 2 day
    5) 20 milligrams/day orally for 4 day
    6) 10 milligrams/day orally for 2 day
    2) THREE WEEK TAPERED COURSE -
    1) 60 milligrams/day orally for 7 day
    2) 30 milligrams/day orally for 7 day
    3) 20 milligrams/day orally for 4 day
    4) 10 milligrams/day orally for 3 day
    d) CHILDREN - 1 to 2 milligrams/kilogram/day orally initially; when significant improvement is noted, give half the initial dose for four days, one fourth the initial dose for one week, and then discontinue.
    e) MAJOR ADVERSE REACTIONS - Gastric ulceration and resultant anemia with high doses; edema may precipitate CHF in susceptible patients.
    f) PRECAUTIONS - Contraindicated in system fungal infections; adrenal suppression may occur with high doses for prolonged periods; hypokalemia from large doses may be accentuated with concomitant diuretic therapy.
    E) APPLICATION OF MOISTURIZER TO SKIN
    1) MOISTURIZERS - Use of an emollient cream or lotion is indicated to the treatment of subacute eczematous inflammation to seal in moisture and prevent further drying of the skin. Moisturizers should me applied within minutes after drying from a bath or shower to "seal in" the hydrated skin. Preparations containing urea or lactic acid have special lubricating properties and may be more effective. Mild, nonalkaline, superfatted soaps should be used for washing.
    2) RECOMMENDATION - Apply lubricating cream or lotion a few hours after a topical steroid; apply three to four times a day and continue for at least a week after the inflammation has cleared.
    F) ANTIBIOTIC
    1) INDICATIONS - Antibiotic therapy is indicated in the presence of secondary infection of the inflamed area. Signs of superficial infection include pustules, purulent material, and crusting; deep infection (cellulitis) is rare.
    2) DRUGS OF CHOICE - An oral antibiotic effective against staphylococci, eg, erythromycin, cephalexin, dicloxacillin, or oxacillin, should be used. Topical antibiotics are much less effective (Sternbach & Callen, 1985).
    G) 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) A specific minimum tetrachlorosalicylanilide toxic dose has not been established.

Minimum Lethal Exposure

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

Maximum Tolerated Exposure

    A) GENERAL/SUMMARY
    1) The maximum tolerated human exposure to this agent has not been delineated.

Workplace Standards

    A) ACGIH TLV Values for CAS1154-59-2 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS1154-59-2 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS1154-59-2 :
    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 CAS1154-59-2 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (ORAL)RAT:
    1) 243 mg/kg (RTECS, 2002)

Pharmacology Toxicology

Toxicologic Mechanism

    A) Halogenated salicylanilides cause photodermatitis. Light causes the original material to be converted to a contact allergen (Willis & Kligman, 1968). In this way the photodermatitis seen due to tetrachlorosalicylanilide is actually a reaction to 4',5-dibromosalicylanilide and 4'-monobromosalicylanilide (Coxon et al, 1965; Horio, 1984). Free radials generated during light exposure may also be involved (Coxon et al, 1965; Horio & Ofuji, 1976; Harber et al, 1966).
    B) Optic and neural toxicity seen in animals with some halogenated salicylanilides appear to be related to increased cerebrospinal fluid pressure, brain swelling, and meningeal inflammation around the optic nerve and optic chiasma (Brown et al, 1972).

Physicochemical

Physical Characteristics

    A) Tetrachlorosalicylanilide is soluble in aqueous alkaline solutions, wetting agent solutions, and in many organic solvents. It is practically insoluble in water (Budavari, 1996).

Molecular Weight

    A) 351.01 (Budavari, 1996)

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