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CANTHAXANTHINE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Canthaxanthine is a naturally occurring orange carotenoid without vitamin A properties (Jones, 1987). It is administered for the cosmetic reason of coloring the skin orange-brown.
    B) Food coloring additive (Lober, 1985).
    C) Canthaxanthine has been moderately successful in the treatment of erythrohepatic protoporphyria (one of the photocutaneous manifestations of porphyria) (Eales, 1978), polymorphous light eruptions, drug induced photosensitivity, and solar urticaria (Suhonen & Plosila, 1981).

Specific Substances

    A) CONSTITUENTS OF THE GROUP
    1) 4,4-diketo-beta-carotene
    2) Beta, beta, carotene-4, 4-dione
    3) Carophyll red
    4) Roxanthin red 10
    5) C.I. Food Orange 8
    6) Color Index No. 40850
    7) CAS 514-78-3

Available Forms Sources

    A) SOURCES
    1) This is a naturally occurring product which may appear in various plants such as algae, sunflowers and seaweed, mushrooms such as the chanterelle, plumage of birds such as the scarlet ibis and roscato, and fish like trout and salmon (6:57-58).
    B) USES
    1) Canthaxanthine is available in oral tanning products sold in tanning salons or by mail order. Trade names include: Orobronze, Bronz Glo, and Easytan.
    2) Canthaxanthine may be combined with betacarotene in some oral tanning products to give a better over all coloration.
    3) Canthaxanthine is used as a tablet excipient to produce a peach or red color.
    4) It is approved as a direct food color additive, and as an animal feed additive for chicken skin and egg yolks.
    5) Canthaxanthine is NOT approved for use in the United States, but is readily available over-the-counter as a tanning agent (Bloomenstein & Pinkert, 1996). It is approved for use outside of the US.

Overview

Life Support

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

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Canthaxanthine is a naturally occurring orange carotenoid without vitamin A properties. It has not been shown to be acutely toxic, carcinogenic, or mutagenic to test animals. Long term human studies are lacking; animal studies indicate no adverse effects.
    0.2.4) HEENT
    A) The incidence of retinopathy ranges from 12 to 14% of consumers who ingest canthaxanthine. It is dose-related, with an incidence of 100% after a cumulative dose of 60 grams.
    B) While the development of bright yellow retinal deposits is often alarming, only minimal functional visual changes have been documented. Glare senses and abnormal dark adaptation are rarely reported.
    0.2.8) GASTROINTESTINAL
    A) Transient reports of gastrointestinal irritation have occurred with therapeutic use. Feces may be dyed red.
    0.2.9) HEPATIC
    A) Drug-induced hepatitis has occurred.
    0.2.13) HEMATOLOGIC
    A) Orange colored serum has been reported.
    B) Aplastic anemia was associated with canthaxanthine ingestion in a previously healthy 20-year-old female.
    0.2.14) DERMATOLOGIC
    A) Generalized itching and welts have been observed.
    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) Canthaxanthine interferes with carotene and vitamin A laboratory determinations.

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) Acute toxicity of canthaxanthine is minimal. Decontamination, supportive care and observation appear to be all that is necessary.

Range Of Toxicity

    A) Toxic blood concentrations have not been established in humans. A safe maximum daily adult dose is approximately 0.05 mg/kg.

Clinical Effects

Summary Of Exposure

    A) Canthaxanthine is a naturally occurring orange carotenoid without vitamin A properties. It has not been shown to be acutely toxic, carcinogenic, or mutagenic to test animals. Long term human studies are lacking; animal studies indicate no adverse effects.

Heent

    3.4.1) SUMMARY
    A) The incidence of retinopathy ranges from 12 to 14% of consumers who ingest canthaxanthine. It is dose-related, with an incidence of 100% after a cumulative dose of 60 grams.
    B) While the development of bright yellow retinal deposits is often alarming, only minimal functional visual changes have been documented. Glare senses and abnormal dark adaptation are rarely reported.
    3.4.3) EYES
    A) MACULOPATHY -
    1) INCIDENCE - Ranges from 12 to 14% of consumers who ingest pure canthaxanthine. It is a dose-related phenomenon, with patients ingesting at least 37 grams having a 50% incidence of retinal deposits (Espaillat et al, 1999), and a 100% incidence after a cumulative ingestion of 60 grams (Metge et al, 1984).
    a) Sharkey (1993) reported a case of idiopathic canthaxanthine retinopathy in the absence of a pure canthaxanthine ingestion in a 45-year-old female.
    2) FINDINGS - Characterized by gold or bright yellow colored deposits (flakes, crystals) in the retina in superficial layers of the macula. Visual acuity and color perception are usually preserved, but prolonged dark adaptation has been demonstrated. Glare senses are reported rarely (Weber & Goerz, 1985; Lonn, 1987; Barker, 1988; Chang et al, 1995; Bloomenstein & Pinkert, 1996) Espaillat et al, 1999).
    a) CLINICAL SIGNIFICANCE - While the development of bright yellow retinal deposits is often alarming, only minimal functional visual changes have been documented, still within clinical normal ranges. Rarely, glare senses are reported, but the majority of patients are asymptomatic (Barker, 1988).
    1) Generally, the individual is unaffected by the retinal deposits; however, subtle alterations in retinal function may occur secondary to physiological abnormalities caused by the crystal deposits (Bloomenstein & Pinkert, 1996). Chang et al (1995) reported the asymmetrical occurrence of retinopathy in one adult.
    3) POTENTIAL CAUSES - Canthaxanthine crystals (amino acids) preferentially deposit in an annular pattern within the macula (area of increased blood flow), leading to an impaired ability to reabsorb the crystals (Chang et al, 1995; Bloomenstein & Pinkert, 1996). Another possible cause may be related to vascular incompetence due to retinal vein occlusion.
    4) PROGNOSIS - A 5-year follow-up study showed a decrease in the number of retinal deposits in 74% of patients following discontinuation of canthaxanthine. No change was observed in 19%, and an increase in 7%.
    a) Reversibility was a slow process, and only 2 of 9 patients had nearly complete reversal after up to 63 months. Significant decreases were not seen until 26 months after discontinuation (Harnois et al, 1989).

Gastrointestinal

    3.8.1) SUMMARY
    A) Transient reports of gastrointestinal irritation have occurred with therapeutic use. Feces may be dyed red.
    3.8.2) CLINICAL EFFECTS
    A) ABNORMAL COLOR
    1) The feces may be dyed red and could release this color in toilet water, causing concern (Anon, 1983; Fenner, 1982).
    B) GASTRITIS
    1) Transient gastrointestinal symptoms of irritation have been seen with therapeutic use (Mathews-Roth, 1983; (Suhonen & Plosila, 1981).
    2) CASE REPORT - Severe diarrhea, nausea, and stomach cramps have been reported in a woman taking 2 tablets daily for 2 months (Jones, 1987).

Hepatic

    3.9.1) SUMMARY
    A) Drug-induced hepatitis has occurred.
    3.9.2) CLINICAL EFFECTS
    A) TOXIC HEPATITIS
    1) CASE REPORT - Drug-induced hepatitis was reported in a woman taking 2 tablets daily for 2 months (Jones, 1987).

Hematologic

    3.13.1) SUMMARY
    A) Orange colored serum has been reported.
    B) Aplastic anemia was associated with canthaxanthine ingestion in a previously healthy 20-year-old female.
    3.13.2) CLINICAL EFFECTS
    A) ABNORMAL COLOR
    1) Orange colored serum has been reported (Rock et al, 1981).
    B) APLASTIC ANEMIA
    1) CASE REPORT - Aplastic anemia was associated with canthaxanthine ingested for tanning purposes in a 20-year-old previously healthy female (Bluhm et al, 1990).

Dermatologic

    3.14.1) SUMMARY
    A) Generalized itching and welts have been observed.
    3.14.2) CLINICAL EFFECTS
    A) URTICARIA
    1) CASE REPORT - Severe itching and generalized welts occurred in a man who took 8 tanning tablets over 2 days and resolved upon discontinuation of the tanning tablets (Fenner, 1982).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) Persons hypersensitive to vitamin A or carotenoids may also be hypersensitive to canthaxanthine (Jones, 1987).

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.
    3.20.3) EFFECTS IN PREGNANCY
    A) LACK OF INFORMATION
    1) There is no information on the effects of canthaxanthine as a tanning agent in pregnancy. It is reasonable not to ingest canthaxanthine during pregnancy (Jones, 1987).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS514-78-3 (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) CARCINOMA
    1) In experimental animals and human tumor cell cultures, canthaxanthine has shown some activity AGAINST cancers, but this has not been used clinically (Mathews-Roth, 1982; Schwartz & Shklar, 1992).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Canthaxanthine interferes with carotene and vitamin A laboratory determinations.
    4.1.2) SERUM/BLOOD
    A) LABORATORY INTERFERENCE
    1) Canthaxanthine interferes with carotene and vitamin A laboratory determinations (Rock et al, 1981).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Canthaxanthine interferes with carotene and vitamin A laboratory determinations.

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) The toxicity of canthaxanthine is minimal. Decontamination, supportive care, and observation appears to be all that is necessary.
    2) Canthaxanthine should be discontinued at the first sign of retinal pigmentation.
    B) GENERAL TREATMENT
    1) The orange-brown coloration of the skin should fade in 2 to 6 weeks after discontinuation of the drug.

Abstracts

Case Reports

    A) ROUTE OF EXPOSURE
    1) Retinopathy (maculopathy with gold colored flakes) was seen in 6 of 51 patients who had ingested 100 or more capsules of canthaxanthine over 24 months. The presence of these deposits was related to total dose ingested. There was no change in vision or eye function (Boudreault et al, 1983; (Lonn, 1987).
    2) In fifty persons who had taken over 200 tablets of a tanning agent containing canthaxanthine, examination of the fundi of the eyes revealed that 12% had crystalline gold-colored deposits on their retinas (Rousseau, 1983).
    3) A 50-year-old man consuming 100 capsules of Orobronze(R) 30 mg over 3 months had gold dust retinopathy without changes in vision (McGuiness & Beaumont, 1985). Canthaxanthine retinopathy without apparent visual changes has also been reported following long term use (10 years) in an adult (Bloomenstein & Pinkert, 1996).
    4) Asymmetric canthaxanthine retinopathy, with numerous golden crystalline deposits, was reported in a 60-year-old woman following a 10-year history of using an oral canthaxanthine (a 30 mg tablet taken 4 times/day) daily (Chang et al, 1995).

Range Of Toxicity

Summary

    A) Toxic blood concentrations have not been established in humans. A safe maximum daily adult dose is approximately 0.05 mg/kg.

Therapeutic Dose

    7.2.1) ADULT
    A) GENERAL
    1) For tanning, 120 milligrams/day for several days (which may be reduced to 30 to 60 milligrams for subsequent days) has been recommended (Boudreault et al, 1983).
    2) ADI - The World Health Organization has set a temporary maximum acceptable daily intake of 0.05 milligram/kilogram, based on the minimum required to produce retinal pigmentation adjusted using a 10-fold safety factor (WHO, 1987).

Minimum Lethal Exposure

    A) ACUTE
    1) Median lethal dose is estimated to be greater than 10 grams/kilogram (Jones, 1987).

Maximum Tolerated Exposure

    A) CHRONIC
    1) No retinal changes were associated with doses of 15 milligrams/day for one month. An increase to sixty milligrams/day for an additional month produced noticeable retinal pigmentation (Arden et al, 1989).
    2) Retinopathy is dose-related. In a review of 259 cases of canthaxanthine ingestion, the incidence was 50 percent after a total dose of 37 grams and 100 percent after a total dose of 60 grams (Harnois et al, 1989).

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) CONCENTRATION LEVEL
    a) Toxic blood concentrations have not been established in humans.

Workplace Standards

    A) ACGIH TLV Values for CAS514-78-3 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS514-78-3 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS514-78-3 :
    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 CAS514-78-3 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (ORAL)MOUSE:
    1) 10 grams/kg ((RTECS, 2000))

Pharmacology Toxicology

Pharmacologic Mechanism

    A) This is a carotene dye which stains skin and fat deposits orange-brown to red.

Physicochemical

Physical Characteristics

    A) CRYSTAL COLOR: Brownish violet to violet.
    B) SOLUTION COLOR: Orange-red
    C) Color of sugar coated tablets with various concentrations of canthaxanthin (Magid, 1966):
    Amount of 15% canthaxanthine beadlet per tabletColor
    1 mgRed
    0.3 mgOrange-red
    0.1 mgOrange-yellow
    0.03 mgRed-peach

Molecular Weight

    A) 564.92 (RTECS , 2000)

References

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