Good Cosmetic Ingredient NOAEL Data

Ferrous Fumarate

INCI: FERROUS FUMARATE

CAS Number
141-01-5
Function
Skin Conditioning
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; FDA-approved OTC drug active ingredient (oral iron supplement); no specific cosmetic restriction

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Ferrous Fumarate. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 800 mg/kg bw/day oral dog Special Toxicology Study COSMOS_DB
NOAEL 152 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1369 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB
NOAEL 50 mg/kg bw/day oral rabbit Subchronic COSMOS_DB
NOAEL 16 mg/kg bw/day oral horse Special Toxicology Study COSMOS_DB
NOAEL 1.8 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 1369 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB
dose_tested 50 mg/kg bw/day oral rabbit Subchronic COSMOS_DB
dose_tested 1.8 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 50 mg/kg bw/day oral rat oral REACH

Expert Verdict

Oral toxicity risk only at very high oral doses not relevant at cosmetic-use levels; may cause staining; fumarate counterion is GRAS; limited cosmetic-specific dermal safety data despite extensive oral safety history.

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Concern Level: Moderate

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Ferrous Fumarate safe in cosmetics?

Oral toxicity risk only at very high oral doses not relevant at cosmetic-use levels; may cause staining; fumarate counterion is GRAS; limited cosmetic-specific dermal safety data despite extensive oral safety history. The EU classifies Ferrous Fumarate as "prohibited". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Ferrous Fumarate allowed in the EU?

Ferrous Fumarate EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Ferrous Fumarate do in cosmetics?

Ferrous Fumarate functions as: Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 141-01-5.

What is the Margin of Safety for Ferrous Fumarate?

not established 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.

What is the NOAEL for Ferrous Fumarate?

The NOAEL (No Observed Adverse Effect Level) for Ferrous Fumarate is 800 mg/kg bw/day based on a Special Toxicology Study study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

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