Good Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

EDTA

CAS Number
60-00-4
Function
Chelating
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No specific cosmetic restrictions under FD&C Act or MoCRA; Calcium Disodium EDTA and Disodium EDTA permitted as food additives under 21 CFR 172.120 and 172.135

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for EDTA. 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 >=938 mg/kg bw/day oral mouse oral REACH
NOAEL >=500 mg/kg bw/day oral rat oral REACH
NOAEL >=500 mg/kg bw/day oral rat oral REACH
NOAEL >=500 mg/kg bw/day oral - oral REACH
NOAEL 1125 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

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

Signal Word
WARNING
Hazard Statements
May be harmful if swallowed Causes eye irritation
Short-term Exposure Effects
The substance is irritating to the eyes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of dust, by inhalation of its aerosol and by ingestion.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir 6 June 2002
Verdict: unknown
NOAEL: 563 mg/kg/day (oral)

Expert Verdict

Safe as used at conventional cosmetic concentrations (less than 0.5% leave-on); not permitted in COSMOS/ECOCERT formulations; penetration-enhancement effect on co-ingredients is key formulator risk.

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Concern Level: Low

Regulatory Flags

chelating-agent synthetic not-cosmos-permitted penetration-enhancer poorly-biodegradable occupational-inhalation-risk eu_children_restricted

Frequently Asked Questions

Is EDTA safe in cosmetics?

Safe as used at conventional cosmetic concentrations (less than 0.5% leave-on); not permitted in COSMOS/ECOCERT formulations; penetration-enhancement effect on co-ingredients is key formulator risk. The EU classifies EDTA as "permitted". Safety rating: GOOD. 5 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is EDTA allowed in the EU?

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

What does EDTA do in cosmetics?

EDTA functions as: Chelating. It is classified as a cosmetic ingredient in our database. CAS number: 60-00-4.

What is the Margin of Safety for EDTA?

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 EDTA?

The NOAEL (No Observed Adverse Effect Level) for EDTA is >=938 mg/kg bw/day based on a oral study via oral route in mouse. A total of 5 study endpoints are available. Source: REACH.

Is EDTA classified as hazardous under GHS?

EDTA carries a GHS signal word of "WARNING". Hazard statements: May be harmful if swallowed Causes eye irritation. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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