FD&C Blue No. 1: Brilliant Blue FCF Food Dye
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Posted on 04 Aug 2015 19:32

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FD&C Blue no. 1 is a synthetic food colorant (aka artificial color) with a greenish-blue hue used to color beverages, dairy powders, jellies, candies, condiments, icings, syrups, extracts, and many drugs and cosmetics. It is also used to color paper or paper board that comes into contact with foods. It is often used together with FD&C Yellow No. 5 to make green food coloring.

A triphenylmethane dye, it is available as a bronze-purple powder which dissolves easily in water. It is also available in an aluminum lake, the water insoluble form. It's ammonium salt is D&C Blue No. 4 which is used in drugs and cosmetics. FD&C Blue 1 is permanently listed by the FDA as a certified synthetic dye for use in foods, drugs, and cosmetics, including drugs and cosmetics of the eye area.

Brilliant Blue is the disodium salt of 4-{4-(N-ethyl-p-sulfobenzylamino-phenyl)-(2-sulfoniumphenyl)-methyene}-[1-(N-ethyl-N-p-sulfobenzyl)-Δ2, 5-cyclohexadienimine]. It is manufactured by a condensation reaction of benzaldehyde-o-sulfonic acid and α-(N-ethylanilino)-m-toluenesulfonic acid. It is very soluble in water, glycerol, and glycol, and slightly soluble in ethanol. It is stable in a wide range of pH.

Other Names and Synonyms for FD&C Blue No. 1

Acid Blue 9 [MeSH: acid blue 9]
Brilliant Blue FCF [MeSH: brilliant blue FCF]
Alphazurine FG
FD & C Blue no. 1
Fenazo Blue XI
Food Blue No. 1
Japan Blue 1
Merantine Blue EG
Cosmetic Blue Lake

Safety of FD&C Blue No. 1 Food Coloring

Like other dyes of its class, FD%C Blue No. 1 is poorly absorbed, with over 90% remaining unchanged in feces. After being introduced in 1929, it was tested for chronic toxicity an reproduction affects, before being permanently listed for food use. More recent studies on mice and rats found toxicity to be concentration dependent, with a no-observed-effect level of 0.5% of the dye in the diet. The WHO acceptable daily intake is 12.5 mg/kg a day as a food additive.

Injection site tumors are associated with this dye, as with other similar dyes but the significance of this is debated, as no evidence of tumors or similar adverse effects occurs in feeding studies. The FDA considers the feeding data to be more critical to decisions concerning food color safety, as dyes are obviously not meant to be injected. However, the United Kingdom and most European countries did not initially approve it's use because of the injection studies. The UK reinstated the dye after discovering that injection site tumors were caused by many colors, and intakes were found to be 5000 times less than the acceptable daily intake (AKI).

Hypersensitivity

Although triphenylmethane dyes are generally not thought to cause very many sensitivity reactions, they are rarely tested in routine screening, including in patients with suspected food or drug allergies. There is very little report of adverse reactions to this dye and azo dyes or other dyes are more likely to be the cause of sensitivity. However, if these are ruled out, Brilliant Blue and other triphenylmethane dyes should be considered as a possibility.

References
1. Smolinske, Susan C. Handbook of Food, Drug, and Cosmetic Excipients. Boca Raton, FL: CRC LLC, 1992.
2. Deshpande, S. S. Handbook of Food Toxicology. New York: Dekker, 2002.
3. Sabnis, R. W. Handbook of Biological Dyes and Stains: Synthesis and Industrial Applications. Hoboken, NJ: Wiley, 2010.
4. Maga, Joseph A., and Anthony T. Tu. Food Additive Toxicology. New York: M. Dekker, 1995.
5. Reineccius, Gary, and Henry B. Heath. Source Book of Flavors. New York: Chapman & Hall, 1994.
6. "Brilliant Blue - PubChem." The PubChem Project. Web. 17 April 2012. <http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?q=all&cid=19700#ec>
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