Good Cosmetic Ingredient NOAEL Data

Tetrasodium Etidronate

INCI: TETRASODIUM ETIDRONATE

CAS Number
3794-83-0
Function
Chelating Agent, Emulsion Stabilising, Viscosity Controlling
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 1.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; CIR assessed โ€” safe in present practices of use and concentration

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Tetrasodium Etidronate. 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 41 mg/kg bw/day oral rat oral REACH
NOAEL 78 mg/kg bw/day oral rat oral REACH
NOAEL >=1620 other oral dog oral REACH
NOEL >300 mg/kg bw/day oral rat oral REACH
NOAEL ca.260 other oral rat oral REACH

Expert Verdict

Phosphonate โ€” environmental persistence concerns; strictly regulated under EU Annex III; ensure compliance with concentration limits per product type

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Concern Level: Low

Regulatory Flags

eu_children_restricted

Frequently Asked Questions

Is Tetrasodium Etidronate safe in cosmetics?

Phosphonate โ€” environmental persistence concerns; strictly regulated under EU Annex III; ensure compliance with concentration limits per product type The EU classifies Tetrasodium Etidronate as "restricted". Safety rating: GOOD. 5 toxicological study endpoint(s) are available in our database.

Is Tetrasodium Etidronate allowed in the EU?

Tetrasodium Etidronate EU regulatory status: restricted. Maximum allowed concentration: 1.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Tetrasodium Etidronate do in cosmetics?

Tetrasodium Etidronate functions as: Chelating Agent, Emulsion Stabilising, Viscosity Controlling. It is classified as a cosmetic ingredient in our database. CAS number: 3794-83-0.

What is the Margin of Safety for Tetrasodium Etidronate?

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 Tetrasodium Etidronate?

The NOAEL (No Observed Adverse Effect Level) for Tetrasodium Etidronate is 41 mg/kg bw/day based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.

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