Excellent Cosmetic Ingredient NOAEL Data

Calcium Disodium EDTA

INCI: CALCIUM DISODIUM EDTA

CAS Number
62-33-9
Function
Chelating agent — binds metal ions to protect formulation stability and appearance
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes CIR: Safe as used — originally assessed 1998, reaffirmed 2019

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.

Toxicological Studies

7 study endpoints found for Calcium Disodium 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 250 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 1340 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 250 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
dose_tested 250 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 250 mg/kg bw/day oral dog Chronic COSMOS_DB

Expert Verdict

Chelating agent with excellent safety profile as used in cosmetics; poor environmental biodegradability and potential to remobilize heavy metals in aquatic sediments are concerns at higher concentrations well above typical cosmetic use levels.

⚠️
Concern Level: Low

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Calcium Disodium EDTA safe in cosmetics?

Chelating agent with excellent safety profile as used in cosmetics; poor environmental biodegradability and potential to remobilize heavy metals in aquatic sediments are concerns at higher concentrations well above typical cosmetic use levels. The EU classifies Calcium Disodium EDTA as "permitted". Safety rating: EXCELLENT. 7 toxicological study endpoint(s) are available in our database.

Is Calcium Disodium EDTA allowed in the EU?

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

What does Calcium Disodium EDTA do in cosmetics?

Calcium Disodium EDTA functions as: Chelating agent — binds metal ions to protect formulation stability and appearance. It is classified as a cosmetic ingredient in our database. CAS number: 62-33-9.

What is the Margin of Safety for Calcium Disodium EDTA?

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 Calcium Disodium EDTA?

The NOAEL (No Observed Adverse Effect Level) for Calcium Disodium EDTA is 250 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.

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