Good Antioxidant NOAEL Data GHS Classified

Gallic Acid

INCI: GALLIC ACID

CAS Number
149-91-7
Function
Chelating agent (secondary); antioxidant; antimicrobial synergist
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted without restriction in cosmetics. Naturally derived from plant sources (galls, tea, oak bark). Widely used in natural and botanical formulations. No adverse FDA findings.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Gallic Acid. 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 119 mg/kg bw/day oral rat oral REACH
NOAEL 1000 mg/kg bw/day oral mouse oral REACH

GHS Hazard Classification

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

Hazard Statements
No hazard classification according to GHS criteria
Short-term Exposure Effects
See Notes.
Long-term Exposure Effects
See Notes.
Routes of Exposure
The substance can be absorbed into the body by ingestion.

Expert Verdict

Gallic acid is a plant-derived polyphenol functioning as both an antioxidant and secondary chelator. It forms iron complexes that may cause discoloration; co-formulate with stronger primary chelators like disodium EDTA or sodium phytate to prevent visible complexes. HPbCD complexation improves solubility and anti-biofilm activity. Suitable for botanical and clean-label formulations with low sensitization potential at cosmetic concentrations.

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Concern Level: Low

Regulatory Flags

natural-derived polyphenol antioxidant chelator-secondary iron-discoloration-risk hpbcd-compatible anti-biofilm botanical

Frequently Asked Questions

Is Gallic Acid safe in cosmetics?

Gallic acid is a plant-derived polyphenol functioning as both an antioxidant and secondary chelator. It forms iron complexes that may cause discoloration; co-formulate with stronger primary chelators like disodium EDTA or sodium phytate to prevent visible complexes. HPbCD complexation improves solubility and anti-biofilm activity. Suitable for botanical and clean-label formulations with low sensitization potential at cosmetic concentrations. The EU classifies Gallic Acid as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Gallic Acid allowed in the EU?

Gallic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Gallic Acid do in cosmetics?

Gallic Acid functions as: Chelating agent (secondary); antioxidant; antimicrobial synergist. It is classified as a Antioxidant in our database. CAS number: 149-91-7.

What is the Margin of Safety for Gallic Acid?

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.

What is the NOAEL for Gallic Acid?

The NOAEL (No Observed Adverse Effect Level) for Gallic Acid is 119 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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