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GENTIAN VIOLET

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) GENTIAN VIOLET is a topical antifungal and antibacterial agent.

Specific Substances

    1) Adergon
    2) Aniline violet
    3) Axuris
    4) Badil
    5) CI Basic Violet 3
    6) Crystal violet
    7) Gentiaverm
    8) Hexamethylpararosaniline chloride
    9) Meroxyl
    10) Meroxylan
    11) Methylrosaniline chloride
    12) Methyl violet
    13) Pentamethylrosaniline chloride
    14) Pyoktanin
    15) Triaminophenylmethane dye
    16) Triphenylmethane dye
    17) Vianin
    18) Viocid
    19) Molecular Formula: C25-H30-Cl-N3
    20) CAS 548-62-9
    21) CRYSTALLINA, VIOLA
    22) GENTIAVERIN
    23) HEXAMETHYLPARAROSANILINE HYDROCHLORIDE
    24) MEROXYLAR
    25) PYOCTANINUM CAERULEUM
    26) TRIARYLMETHANE
    27) VIOLA CRYSTALLINA
    28) VIOLET, CRYSTAL
    29) VIOLETA DE METILO
    30) VLANIN
    31) VOICID

Available Forms Sources

    A) FORMS
    1) In October 3, 1990, Key Pharmaceuticals removed Genapax(R) from the market (Personal Communication, 2000). In the UK, this product is no longer permitted for use in foods (S Sweetman , 2002).
    2) Gentian violet is available as a 1% and 2% topical solutions (USPDI , 2002). In addition, topical gentian violet solution or cream 0.25% to 2% have been used (S Sweetman , 2002).
    3) Oral enteric-coated tablets containing 9.8 mg of gentian violet were formerly available over-the-counter for pinworm therapy, but were removed from the market in 1982 (FDA, 1982).
    B) USES
    1) Gentian violet has been used in the topical treatment of cutaneous and mucocutaneous infections caused by Candida (Monilia) albicans, such as oral (thrush), intertriginous and paronychial candidiasis (USPDI , 2002).
    2) Crystal violet is an ingredient in triple dye for prophylaxis of neonatal staphylococcal infection. Gentian violet has also been used as a feed additive in poultry production (FDA, 1990).

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) WITH POISONING/EXPOSURE
    1) Overdose data is limited.
    2) Nausea, vomiting, abdominal cramps, and diarrhea are the most common manifestations of toxicity.
    0.2.4) HEENT
    A) WITH THERAPEUTIC USE
    1) Mucous membrane irritation, eye injury, oral ulceration and gingivoglossostomatitis have occurred in infants treated with 0.5 to 1% solutions of gentian violet for thrush.
    0.2.5) CARDIOVASCULAR
    A) WITH THERAPEUTIC USE
    1) Transient hypertension followed by marked hypotension has occurred after IV administration to animals.
    0.2.6) RESPIRATORY
    A) ANIMAL STUDIES - Pulmonary emboli occurred after IV administration to animals.
    B) WITH THERAPEUTIC USE
    1) Dyspnea and partial airway obstruction were reported in an infant after application of a 0.5% solution for thrush.
    0.2.7) NEUROLOGIC
    A) WITH THERAPEUTIC USE
    1) Headache, dizziness, and lethargy may occur.
    0.2.8) GASTROINTESTINAL
    A) WITH THERAPEUTIC USE
    1) Nausea, vomiting, abdominal pain and diarrhea may occur in up to 50% of children treated with anthelmintic doses.
    0.2.10) GENITOURINARY
    A) WITH THERAPEUTIC USE
    1) Causes vaginal mucosal ulceration.
    B) WITH POISONING/EXPOSURE
    1) Causes vaginal mucosal ulceration.
    0.2.13) HEMATOLOGIC
    A) WITH THERAPEUTIC USE
    1) Although gentian violet is an aniline dye, no cases of methemoglobinemia have been reported.
    0.2.14) DERMATOLOGIC
    A) WITH THERAPEUTIC USE
    1) Necrotic skin ulcerations, contact dermatitis and permanent pigmentation have occurred from topical administration.
    0.2.19) IMMUNOLOGIC
    A) WITH THERAPEUTIC USE
    1) Anaphylactic shock was reported after application of 1% gentian violet to a leg ulcer.
    0.2.20) REPRODUCTIVE
    A) The children of 40 women treated topically with gentian violet showed no increase in frequency of congenital anomalies.
    B) Gavage studies in rats indicate that gentian violet causes teratogenic effects (hydroureter, hydronephrosis, and short ribs), but only at doses causing maternal toxicity.
    0.2.21) CARCINOGENICITY
    A) Chronic dietary feeding studies indicated carcinogenic potential, supported by positive genotoxic studies. Animals developed hepatocellular carcinomas, reticular cell sarcomas, thyroid adenocarcinoma, and mononuclear cell leukemia.

Laboratory Monitoring

    A) Vomitus, feces and skin may be colored purple.

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) Symptomatic and supportive care is all that is necessary.
    0.4.4) EYE EXPOSURE
    A) DECONTAMINATION: Remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation, or photophobia persist after 15 minutes of irrigation, the patient should be seen in a healthcare facility.
    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Range Of Toxicity

    A) No level has been set for human overdoses.
    B) The minimum lethal dose in rabbits is 22 mg/kg/day for 6 days.

Clinical Effects

Summary Of Exposure

    A) WITH POISONING/EXPOSURE
    1) Overdose data is limited.
    2) Nausea, vomiting, abdominal cramps, and diarrhea are the most common manifestations of toxicity.

Heent

    3.4.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Mucous membrane irritation, eye injury, oral ulceration and gingivoglossostomatitis have occurred in infants treated with 0.5 to 1% solutions of gentian violet for thrush.
    3.4.3) EYES
    A) WITH POISONING/EXPOSURE
    1) Conjunctival staining and periorbital swelling with corneal and conjunctival abrasions were observed in a 3-month-old female after a 2% gentian violet solution was inadvertently splashed into her eye. The infant was treated with erythromycin ophthalmic ointment and recovered without sequelae (Pessah et al, 1998).
    2) INTRAOCULAR PRESSURE - Splashes in the eye may cause increases in intraocular pressure that may be sustained for seven days (Ballantyne et al, 1973).
    3) INFLAMMATION - Keratoconjunctivitis and uveitis have occurred after ocular instillation (Parker & Binder, 1979; Dhir, 1982).
    4) SCARRING - Permanent corneal vascularization and scarring have been reported after ocular instillation (Parker & Binder, 1979; Dhir, 1982).
    5) BLEPHAROSPASM and a dark purple staining of the cornea were reported when one drop (concentration unknown) was instilled in a human eye. The eye was normal in 5 weeks (Parker & Binder, 1979).
    3.4.5) NOSE
    A) WITH POISONING/EXPOSURE
    1) EPISTAXIS due to nasal mucosal ulceration has occurred after inhaling gentian violet dust (Quinby, 1968).
    3.4.6) THROAT
    A) WITH THERAPEUTIC USE
    1) IRRITATION of mucous membranes occurs with 0.5 to 1% solutions of gentian violet for thrush (Horsfield, 1976; John, 1968).
    2) ULCERATION - Oral ulceration has been reported in infants (Horsfield, 1976; John, 1968).
    a) CASE REPORT - A one-month-old male developed difficulty breastfeeding and ulcerations of the oral mucosa and tongue after six days of gentian violet use for oral thrush. The infant was given supplemental nutrition through a syringe until able to feed (Utter, 1990).
    3) INFLAMMATION - Gingivoglossostomatitis has been reported in infants treated with 0.5 to 1% solutions of gentian violet for thrush (Horsfield, 1976; John, 1968).
    a) Several cases of infants having difficulty breastfeeding and developing oral mucosal lesions after oral use of gentian violet have been reported. The strength of gentian violet solution, duration of therapy, and the general safety of gentian violet for oral thrush in infants has been questioned, and in some clinics use of gentian violet is being discouraged (Utter, 1990; Piatt & Bergeson, 1992; Utter, 1992; Phillips, 1993; Wilson-Clay, 1991).
    b) CASE REPORT - A 26-day-old male who was treated with a 2% gentian violet for oral thrush refused to feed on the 5th day of therapy. Upon examination, the child had a markedly swollen tongue and plaques covering the gingival grooves and floor of the mouth which, when scraped off, resulted in bleeding. After discontinuation of the gentian violet, the child recovered, started feeding normally, and was discharged on day 3 (Piatt & Bergeson, 1992).

Cardiovascular

    3.5.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Transient hypertension followed by marked hypotension has occurred after IV administration to animals.
    3.5.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) HYPOTENSION
    a) Transient hypertension followed by marked hypotension has occurred after IV administration to animals, presumably due to hypersensitivity.

Respiratory

    3.6.1) SUMMARY
    A) ANIMAL STUDIES - Pulmonary emboli occurred after IV administration to animals.
    B) WITH THERAPEUTIC USE
    1) Dyspnea and partial airway obstruction were reported in an infant after application of a 0.5% solution for thrush.
    3.6.2) CLINICAL EFFECTS
    A) DISORDER OF RESPIRATORY SYSTEM
    1) WITH THERAPEUTIC USE
    a) Dyspnea and partial airway obstruction were reported in a one-month-old infant after application of a 0.5% solution for thrush (John, 1968).
    b) OBSTRUCTIVE LARYNGOTRACHEITIS - An infant diagnosed with oral candidiasis experienced airway obstruction requiring intubation secondary to treatment with 1% gentian violet. Symptoms presented as cough and difficulty feeding as early as the day following the initiation of gentian violet. Symptoms worsened and a hoarse cry and stridor developed which required hospitalization and intubation. Anatomic causes for airway obstruction were negative, as were viral, bacterial, and fungal cultures. The progressive worsening of the infant's symptoms related to the administration of gentian violet as the dose was increased also makes gastroesophageal reflux an unlikely cause (Baca et al, 2001).
    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) EMBOLISM PULMONARY
    a) Pulmonary emboli occurred after IV administration to animals.

Neurologic

    3.7.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Headache, dizziness, and lethargy may occur.
    3.7.2) CLINICAL EFFECTS
    A) HEADACHE
    1) WITH THERAPEUTIC USE
    a) Headache may occur.
    B) DIZZINESS
    1) WITH THERAPEUTIC USE
    a) Dizziness may occur.
    C) DROWSY
    1) WITH THERAPEUTIC USE
    a) Lethargy may occur.

Gastrointestinal

    3.8.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Nausea, vomiting, abdominal pain and diarrhea may occur in up to 50% of children treated with anthelmintic doses.
    3.8.2) CLINICAL EFFECTS
    A) NAUSEA AND VOMITING
    1) WITH THERAPEUTIC USE
    a) Nausea, vomiting and abdominal pain may occur in up to 33 to 50% of children treated with anthelmintic doses.
    B) DIARRHEA
    1) WITH THERAPEUTIC USE
    a) Diarrhea may occur in up to 33 to 50% of children treated with anthelmintic doses.

Genitourinary

    3.10.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Causes vaginal mucosal ulceration.
    B) WITH POISONING/EXPOSURE
    1) Causes vaginal mucosal ulceration.
    3.10.2) CLINICAL EFFECTS
    A) HEMORRHAGIC CYSTITIS
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT - A 32-year-old women accidentally instilled gentian violet 1% in alcohol 2% into her urethra using a plastic syringe. She reported burning pain in the lower abdomen within a few seconds.
    1) She also reported urinary frequency and urgency, dysuria and 2 days later she noticed hematuria.
    2) An intravenous pyelogram suggested a mass lesion, cystoscopy showed gross inflammation and edema with acute ulceration of the overlying mucosa and histological examination showed extensive ulceration and non-specific inflammatory changes with large numbers of eosinophils.
    3) The urine was reported to be sterile (Walsh & Walsh, 1986).
    B) VAGINITIS
    1) WITH THERAPEUTIC USE
    a) VAGINAL ULCERATION has resulted from topical gentian violet used to treat vaginal moniliasis (Jennison & Llywelyn-Jones, 1957).

Hematologic

    3.13.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Although gentian violet is an aniline dye, no cases of methemoglobinemia have been reported.
    3.13.2) CLINICAL EFFECTS
    A) METHEMOGLOBINEMIA
    1) WITH THERAPEUTIC USE
    a) Although gentian violet is an aniline dye, no cases of methemoglobinemia have been reported.

Dermatologic

    3.14.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Necrotic skin ulcerations, contact dermatitis and permanent pigmentation have occurred from topical administration.
    3.14.2) CLINICAL EFFECTS
    A) SKIN ULCER
    1) WITH THERAPEUTIC USE
    a) Necrotic ulcerations may develop on injured skin following the topical application of gentian violet 1% solution (Mobacken, 1986).
    b) Necrotic skin reactions have also been reported when gentian violet solution (1%) was applied to submammary folds, the genitalia, the gluteal fold, and the toe-webs (S Sweetman , 2002).
    B) CONTACT DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Contact dermatitis has occurred from topical administration (Bielicky & Novak, 1969).
    C) DISCOLORATION OF SKIN
    1) WITH THERAPEUTIC USE
    a) Permanent pigmentation has occurred from topical application.
    D) HYPERSENSITIVITY REACTION
    1) WITH POISONING/EXPOSURE
    a) CASE REPORT - An office clerk using carbonless copy paper developed an irritant vesicular rash on her hands which resolved when she stopped work. She was positive on a patch test to a component of the paper, crystal violet lactone, which is chemically different from gentian violet (Shehade et al, 1987).

Immunologic

    3.19.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Anaphylactic shock was reported after application of 1% gentian violet to a leg ulcer.
    3.19.2) CLINICAL EFFECTS
    A) ANAPHYLACTOID REACTION
    1) WITH THERAPEUTIC USE
    a) Anaphylactic shock was reported after application of 1% gentian violet to a leg ulcer (Michel et al, 1958).

Reproductive

    3.20.1) SUMMARY
    A) The children of 40 women treated topically with gentian violet showed no increase in frequency of congenital anomalies.
    B) Gavage studies in rats indicate that gentian violet causes teratogenic effects (hydroureter, hydronephrosis, and short ribs), but only at doses causing maternal toxicity.
    3.20.2) TERATOGENICITY
    A) LACK OF EFFECT
    1) CASE SERIES - The children of 40 women treated topically with gentian violet showed no increase in frequency of congenital anomalies (TERIS , 1991).
    B) ANIMAL STUDIES
    1) Gavage studies in rats indicate that gentian violet causes teratogenic effects (hydroureter, hydronephrosis, and short ribs), but only at doses causing maternal toxicity (Wolkowski-Tyl et al, 1982; (Kimmel et al, 1986).
    2) Pregnant rabbits given gentian violet showed maternal deaths and reduced fetal weights at all doses tested in a dose-related study (Kimmel et al, 1986).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    GENTIAN VIOLETC
    Reference: Briggs et al, 1998

Carcinogenicity

    3.21.2) SUMMARY/HUMAN
    A) Chronic dietary feeding studies indicated carcinogenic potential, supported by positive genotoxic studies. Animals developed hepatocellular carcinomas, reticular cell sarcomas, thyroid adenocarcinoma, and mononuclear cell leukemia.
    3.21.4) ANIMAL STUDIES
    A) CARCINOMA
    1) Chronic dietary feeding studies indicated carcinogenic potential, supported by positive genotoxic studies. Animals developed hepatocellular carcinomas, reticular cell sarcomas, thyroid adenocarcinoma, and mononuclear cell leukemia (Littlefield, 1986).

Genotoxicity

    A) Gentian violet is cytotoxic to DNA and produces genetic damage in vitro. Positive studies include clastogenic effects, direct-acting frameshift mutagenicity, and bacterial point mutagenicity (Au et al, 1978) Thomas & McPhee, 1984; (Aidoo et al, 1990). Negative studies in Chinese hamster ovary cells and mouse lymphocytes have also been reported (Aidoo et al, 1990). Because of these studies and structural similarity to other carcinogenic compounds, gentian violet is considered to be potentially carcinogenic.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Vomitus, feces and skin may be colored purple.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Vomitus, feces and skin may be colored purple.

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) Treatment is symptomatic and supportive.

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) MONITORING OF PATIENT
    1) Monitor intraocular pressure.
    B) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

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).

Range Of Toxicity

Summary

    A) No level has been set for human overdoses.
    B) The minimum lethal dose in rabbits is 22 mg/kg/day for 6 days.

Therapeutic Dose

    7.2.1) ADULT
    A) In October 3, 1990, Key Pharmaceuticals removed Genapax(R) from the market (Personal Communication, 2000).
    B) VAGINAL: In the treatment of vaginal candidiasis, one tampon, containing 5 mg gentian violet, should be inserted vaginally for 3 to 4 hours once or twice daily for 12 days. In resistant cases, a tampon may be used overnight. If the infection persists, a second course of treatment may be required. Treatment can be continued during the menstrual cycle (Prod Info Genapax(R), gentian violet, 1990).
    C) TOPICAL: Topical solution 1% or 2% is applied directly to the wound or by a cotton tipped applicator once or twice daily; also contains 10% ethyl alcohol as a preservative (Prod Info gentian violet topical solution, 2006).

Minimum Lethal Exposure

    A) ANIMAL DATA
    1) Rabbits - 22 milligrams/kilogram/day for 6 days.

Maximum Tolerated Exposure

    A) ANIMAL DATA
    1) 10 to 40 milliliters intravenously of 1 percent solution produced pulmonary emboli in dogs.
    2) IRRITATION - The maximum non-irritating concentration in rabbit eyes was 0.01 percent. This concentration produced only slight irritation at one hour and no symptoms by 18 hours. The rabbits had 2 drops instilled 6 times, with 5 minute intervals between applications (Thompson et al, 1937).
    3) A 2 percent solution in rabbit eyes caused progressive, severe keratitis with gross corneal opacification and vascularization. Concentrations of 0.025 percent or less did not produce damage (Ballantyne et al, 1973).

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) ANIMAL DATA
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 5100 mcg/kg (RTECS, 2002)
    2) LD50- (ORAL)MOUSE:
    a) 96 mg/kg (RTECS, 2002)
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 8900 mcg/kg (RTECS, 2002)
    4) LD50- (ORAL)RAT:
    a) 420 mg/kg (RTECS, 2002)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Gentian violet is a mixture of penta and hexamethyl pararosaniline chloride. Crystal violet is pure hexamethyl and methyl violet is the pure pentamethyl derivative.
    B) EYES - This dye binds to the extracellular mucoproteins of the cornea rather than the stromal collagen (Kein & Grant, 1961), causing denaturization of the mucoprotein and subsequent corneal opacification, vascular infiltration, and necrosis (Parker & Binder, 1979).

Physicochemical

Physical Characteristics

    A) Faint odor

Molecular Weight

    A) 407.98

Animal Toxicology

Clinical Effects

    11.1.3) CANINE/DOG
    A) Gentian violet has caused fatal pulmonary toxicity in dogs and cattle, following intravenous injection, due to thrombosis and infarction (Cutlip & Monlux, 1987).

References

General Bibliography

    1) Aidoo A, Gao N, & Neft RE: Evaluation of the genotoxicity of gentian violet in bacterial and mammalian cell systems. Teratogenesis Carcinog Mutagen 1990; 10:449-462.
    2) Alaspaa AO, Kuisma MJ, Hoppu K, et al: Out-of-hospital administration of activated charcoal by emergency medical services. Ann Emerg Med 2005; 45:207-12.
    3) Au W, Pathak S, & Collie CJ: Cytogenetic testing of gentian violet and crystal violet on mammalian cells in vitro. Mut Res 1978; 58:269-276.
    4) Baca D, Drexler C, & Cullen E: Obstructive laryngotracheitis secondary to gentian violet exposure. Clin Pediatr 2001; 40:233-235.
    5) Ballantyne B, Gazzard MF, & Swanston DW: Eye damage caused by crystal violet. Br J Pharmacol 1973; 49:181-182P.
    6) Bielicky T & Novak M: Contact group sensitization to triphenylmethane dyes. Arch Dermatol 1969; 100:540-543.
    7) Budavari S: The Merck Index, 11th ed, Merck & Co, Inc, Rahway, New Jersey, 1989.
    8) Burgess JL, Kirk M, Borron SW, et al: Emergency department hazardous materials protocol for contaminated patients. Ann Emerg Med 1999; 34(2):205-212.
    9) Chyka PA, Seger D, Krenzelok EP, et al: Position paper: Single-dose activated charcoal. Clin Toxicol (Phila) 2005; 43(2):61-87.
    10) Dagnone D, Matsui D, & Rieder MJ: Assessment of the palatability of vehicles for activated charcoal in pediatric volunteers. Pediatr Emerg Care 2002; 18:19-21.
    11) Dhir SP: Keratoconjunctivitis sicca following instillation of gentian violet. Indian J Ophthalmol 1982; 30:21-22.
    12) Elliot CG, Colby TV, & Kelly TM: Charcoal lung. Bronchiolitis obliterans after aspiration of activated charcoal. Chest 1989; 96:672-674.
    13) FDA: 47 FR 37063, Department of Health and Human Services Food and Drug Administration, Washington, DC, 1982.
    14) FDA: 55 FR 5194, Department of Health and Human Services, Food and Drug Administration, Washington, DC, 1990.
    15) FDA: Poison treatment drug product for over-the-counter human use; tentative final monograph. FDA: Fed Register 1985; 50:2244-2262.
    16) Golej J, Boigner H, Burda G, et al: Severe respiratory failure following charcoal application in a toddler. Resuscitation 2001; 49:315-318.
    17) Graff GR, Stark J, & Berkenbosch JW: Chronic lung disease after activated charcoal aspiration. Pediatrics 2002; 109:959-961.
    18) 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.
    19) Harris CR & Filandrinos D: Accidental administration of activated charcoal into the lung: aspiration by proxy. Ann Emerg Med 1993; 22:1470-1473.
    20) Horsfield P: Oral irritation with gentian violet. Br Med J 1976; 2:529.
    21) John RW: Necrosis of oral mucosa after local application of crystal violet. Br Med J 1968; 1:157.
    22) Kimmel CA, Price CJ, & Tyl RW: Developmental toxicity of gentian violet (GV) in rats and rabbits (abstract). Teratology 1986; 33:64C-65C.
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