Excellent Colorant GHS Classified

CI 77491 (Red Iron Oxide)

INCI: CI 77491

CAS Number
1309-37-1
Function
Colorant
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Regulated under 21 CFR 73.2250 as a listed color additive. Permitted in all cosmetics including eye-area products. Exempt from FDA batch certification. No numerical concentration limit โ€” use per GMP. Must be synthetically prepared; naturally mined iron oxides prohibited. Verify heavy metal specs (As, Pb, Hg) on CoA.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
May cause mechanical irritation.
Long-term Exposure Effects
Repeated or prolonged inhalation of dust particles may cause effects on the lungs. This may result in siderosis, a benign condition.

Expert Verdict

EU Annex IV Entry 135 permits CI 77491 in all cosmetic product types including eyes and mucous membranes with no concentration limit, meeting E 172 purity standards. FDA 21 CFR 73.2250 lists it as a color additive permitted in all cosmetics including eye-area, exempt from batch certification, with no numerical concentration limit. CIR reviewed as safe. Primary safety concern is impurity profile (As, Pb, Hg, Cr) โ€” verify CoA against E 172 and 21 CFR 73.2250(b) specifications. Nano-form flagged as inconclusive; conventional micron-sized pigment is the safer regulatory path.

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Concern Level: None

Regulatory Flags

nano-form-inconclusive impurity-control-critical eye-area-approved no-concentration-limit fda-batch-cert-exempt genotoxicity-signal-oral-context-only eu_children_restricted fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 77491 (Red Iron Oxide) safe in cosmetics?

EU Annex IV Entry 135 permits CI 77491 in all cosmetic product types including eyes and mucous membranes with no concentration limit, meeting E 172 purity standards. FDA 21 CFR 73.2250 lists it as a color additive permitted in all cosmetics including eye-area, exempt from batch certification, with no numerical concentration limit. CIR reviewed as safe. Primary safety concern is impurity profile (As, Pb, Hg, Cr) โ€” verify CoA against E 172 and 21 CFR 73.2250(b) specifications. Nano-form flagged as inconclusive; conventional micron-sized pigment is the safer regulatory path. The EU classifies CI 77491 (Red Iron Oxide) as "permitted". Safety rating: EXCELLENT.

Is CI 77491 (Red Iron Oxide) allowed in the EU?

CI 77491 (Red Iron Oxide) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 77491 (Red Iron Oxide) do in cosmetics?

CI 77491 (Red Iron Oxide) functions as: Colorant. It is classified as a Colorant in our database. CAS number: 1309-37-1.

What is the Margin of Safety for CI 77491 (Red Iron Oxide)?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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