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CI 45430.

Questionable CAS 16423-68-0 / 12227-78-0 / COLORANT

CI 45430, also known as Erythrosine or FD&C Red No. 3, is a synthetic organic dye utilized primarily as a cosmetic colorant to impart a vivid red hue. Its regulatory approval and safe use parameters for topical applications diverge significantly across international markets.

Summary

Cosmetic Colorant

Science

Mechanism of Action

CI 45430 functions exclusively as a chromatic agent, delivering a vibrant red pigment to formulations without conferring any direct dermatological benefits or therapeutic actions on the skin.

Research

Clinical Evidence

Low confidence
Effective range N/A
Optimal

N/A

Transparency

Dusting Analysis

Not commonly dusted

The Formula

Formulation

Solubility
Water
Optimal pH 6 – 9
0 7 14

Stability

Erythrosine (CI 45430) exhibits diminished stability under prolonged exposure to light and elevated temperatures. However, the release of free iodide, a potential concern, is observed only at temperatures exceeding 200°C, suggesting stability within typical cosmetic processing conditions. It maintains a viable shelf-life of 6 years at ambient temperature.

Conflicts

  • Strong oxidizing agents
  • Strong acids (e.g., HCl, leading to a yellow-brown precipitate)
  • Strong bases (e.g., NaOH, leading to a red precipitate)

Safety

Safety Profile

CIR Status
Not reviewed
Max tested
0.0025%
Sensitization risk Moderate

The regulatory landscape for CI 45430 in cosmetic applications is complex and region-dependent. The European SCCS has deemed it safe for consumers when used as a colorant in toothpaste at a maximum concentration of 0.0025% (25 ppm), concluding it is not genotoxic, mutagenic, or carcinogenic based on submitted scientific data. In the EU, it is a permitted colorant in most cosmetic products without general concentration limits, though its use in hair dyes is prohibited. Conversely, the U.S. FDA de-listed FD&C Red No. 3 (CI 45430) for use in cosmetics and externally applied drugs in 1990, due to initial suggested findings of potential carcinogenicity in rats, aligning with the Delaney clause. While it remains temporarily approved for food and ingested drug use in the U.S., it will no longer be permanently listed for food use after January 15, 2027, and for drug use after January 18, 2028. Furthermore, some studies suggest that synthetic dyes like CI 45430 may pose potential risks, including allergic reactions and skin sensitivities, necessitating a patch test for individuals with predisposed sensitive skin.

Your Skin

Skin Compatibility

No Normal
No Dry
No Oily
No Sensitive
Irritancy Medium
Comedogenicity Unknown

Our Assessment

Verdict

Questionable

CI 45430 presents a questionable ingredient choice for precision skincare due to significant regulatory restrictions in key markets like the US and documented potential for skin sensitivities, despite its approval in other regions for specific cosmetic uses.

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