Good Preservative NOAEL Data

Sodium Dehydroacetate

INCI: SODIUM DEHYDROACETATE

CAS Number
4418-26-2
Function
Preservative
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 20%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel has assessed this ingredient three times (1985, 2003/2006, 2023/2024) and consistently concluded it is safe as used in the 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
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Sodium Dehydroacetate. 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 50 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 428 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 124 mg/kg bw/day oral monkey Chronic COSMOS_DB
NOAEL 50 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 46 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
LOEL ca.300 mg/kg bw/day oral rat oral REACH
NOAEL ca.1000 ppm oral rat oral REACH
LOAEL >=200 mg/kg bw/day oral monkey oral REACH
LOEL ca.300 mg/kg bw/day oral - oral REACH
NOAEL ca.1000 ppm oral - oral REACH

Expert Verdict

Sodium Dehydroacetate is a preservative assessed safe by CIR Expert Panel for use in cosmetics at established concentration limits, with restricted use in EU (maximum 20%) and permitted status in US.

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Concern Level: Low

Regulatory Flags

EU Restricted fda_food_additive

Frequently Asked Questions

Is Sodium Dehydroacetate safe in cosmetics?

Sodium Dehydroacetate is a preservative assessed safe by CIR Expert Panel for use in cosmetics at established concentration limits, with restricted use in EU (maximum 20%) and permitted status in US. The EU classifies Sodium Dehydroacetate as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Sodium Dehydroacetate allowed in the EU?

Sodium Dehydroacetate EU regulatory status: restricted. Maximum allowed concentration: 20%. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Dehydroacetate do in cosmetics?

Sodium Dehydroacetate functions as: Preservative. It is classified as a Preservative in our database. CAS number: 4418-26-2.

What is the Margin of Safety for Sodium Dehydroacetate?

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 Sodium Dehydroacetate?

The NOAEL (No Observed Adverse Effect Level) for Sodium Dehydroacetate is 50 mg/kg bw/day based on a Developmental study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS_DB.

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