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CI 45370.

Questionable CAS 4372-02-5 / 596-03-2 / COLORANT

CI 45370, also known as D&C Orange No. 5, is a synthetic orange dye primarily used in cosmetic formulations to impart a vibrant orange or reddish hue. This fluorescein-based colorant enhances product appearance, notably exhibiting a glow effect due to its light-emitting properties. However, its application is significantly restricted due to potential irritation and environmental concerns.

Summary

Colorant Fluorescent Agent

Science

Mechanism of Action

This synthetic colorant functions by imparting an orange or reddish pigment to cosmetic products. As a fluorescein derivative, it also possesses fluorescent qualities, absorbing light and re-emitting it at a longer wavelength, which can create a noticeable glowing effect in formulations.

Research

Clinical Evidence

Insufficient-data confidence
Effective range N/A
Optimal

N/A

Transparency

Dusting Analysis

Not commonly dusted

The Formula

Formulation

Solubility
Both
Optimal pH 6 – 8
0 7 14

Stability

CI 45370 demonstrates reliable color stability and vibrant pigmentation, particularly in oil-based cosmetic formulations. Its final color presentation can be influenced by the pH of the skin.

Safety

Safety Profile

CIR Status
Deferred evaluation (by FDA assessment)
Max tested
5%
Sensitization risk Moderate

While D&C Orange No. 5 is permanently listed and FDA-certified for specific uses in drugs and cosmetics in the U.S., its application is highly restricted. It is expressly not approved for use around the eyes and is limited to 5% concentration in products like lipsticks and mouthwashes. The European Union permits its use in all cosmetics with precursor limits. Despite regulatory approvals, several countries have banned CI 45370 due to potential irritation risks, and patch testing is recommended. It is also flagged as a suspected environmental toxin, harmful to aquatic life, and deemed 'Unacceptable' for EWG Verified products due to concerns including persistence and bioaccumulation.

Your Skin

Skin Compatibility

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

Our Assessment

Verdict

Questionable

While an effective cosmetic colorant with unique fluorescent properties, CI 45370 presents significant safety and environmental concerns, leading to high use restrictions and making its inclusion in precision skincare formulations highly debatable.

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