Erythrosine Al Lake (FD&C Red 3, CI 45430:1) - Properties, Applications, and Safety

1. Introduction

Erythrosine (FD&C Red 3, CI 45430:1, CAS 16423-68-0) is a xanthene-based synthetic dye known for its intense bright red to pinkish-red color. It is a water-soluble anionic dye, but its commercial form often includes an aluminum lake (FD&C Red 3 Lake), where the dye is adsorbed onto an aluminum hydroxide substrate. This lake form significantly improves its stability, lightfastness, and resistance to bleeding, making it suitable for a wide range of applications in food, cosmetics, pharmaceuticals, and other industrial products. Erythrosine is one of the most widely used red colorants globally.

2. Chemical and Physical Properties

Erythrosine (free dye) has the molecular formula C₂₀H₆I₄Na₂O₅ and a molecular weight of 879.86 g/mol (disodium salt). The aluminum lake form (CI 45430:1) is produced by precipitating the dye onto an aluminum hydroxide substrate, resulting in an insoluble pigment. Key properties of the lake pigment include:

  • Molecular Formula (free acid): C₂₀H₆I₄O₅

  • Molecular Weight (free acid): 835.88 g/mol

  • Molecular Weight (disodium salt): 879.86 g/mol

  • Appearance: Bright red fine powder

  • Solubility: Insoluble in water (lake form); dispersible in oils and organic media

  • Stability: Resistant to light, heat, and oxygen due to the lake substrate

  • pH Range: Stable in the pH range of 2–10

  • Color Index: CI 45430:1

3. Mechanism of Action and Function

Erythrosine Al Lake functions primarily as a colorant. The pigment particles scatter and absorb light, producing a vivid red hue. The aluminum lake substrate provides a stable platform that prevents dye migration and ensures uniform color distribution in formulations. It is non-reactive under typical processing conditions and does not bleed into surrounding materials.

4. Applications

Food Industry: Erythrosine is approved as a food colorant in many countries for applications such as confectionery, candies, baked goods, cake decorations, and some beverages. The lake form is particularly useful in low-moisture, high-fat, or emulsion-based products where water-soluble dyes might migrate.

Cosmetics and Personal Care: Erythrosine Al Lake is used in lipsticks, lip glosses, blushes, eye shadows, foundations, and other color cosmetics. Its non-bleeding nature ensures long-lasting, vibrant color on the skin and lips.

Pharmaceuticals: It is used as a colorant in tablets, capsules, and liquid oral medications to improve appearance and patient acceptance, as well as in topical preparations.

Other Applications: Erythrosine is also used in paints, inks, plastics, and as a color standard in analytical chemistry and microscopy.

5. Safety and Regulatory Status

Erythrosine and its aluminum lakes are subject to strict regulatory oversight:

  • FDA (US): Erythrosine is approved as FD&C Red No. 3 and listed in 21 CFR. The aluminum lake is permitted for use in cosmetics and drugs in accordance with 21 CFR 74.1303 and 74.2303.

  • EU: Erythrosine has been subject to usage restrictions, and its use in foods is limited to certain categories (e.g., maraschino cherries). The lake form may also be subject to specific usage levels.

  • IARC: Erythrosine has been evaluated by the International Agency for Research on Cancer and is not classified as a carcinogen to humans. However, it has been the subject of safety reviews due to concerns about thyroid effects in animal studies at very high doses.

6. Storage and Handling

Erythrosine Al Lake should be stored in cool, dry, and well-ventilated areas, protected from moisture and direct light. It is stable under normal conditions and has a long shelf life. Standard dust control measures should be followed when handling the powder.

7. Conclusion

Erythrosine Al Lake (FD&C Red 3, CI 45430:1, CAS 16423-68-0) is a high-performance red pigment with excellent stability, color intensity, and non-bleeding properties. Its versatility makes it an indispensable colorant in food, cosmetics, pharmaceuticals, and other industrial applications. While subject to specific regulatory limits in certain regions, it remains widely used due to its safety profile and reliable color performance. Ongoing research continues to support its safe use in diverse products.

Menu