Good Preservative NOAEL Data

Sodium Salicylate

INCI: SODIUM SALICYLATE

CAS Number
54-21-7
Function
Denaturant, Preservative, Hair/Skin Conditioning
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5% (as acid) preservative (Annex V/3); 2.0% other / 3.0% rinse-off hair (Annex III)
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR 2019: safe when formulated to be non-irritating/non-sensitizing. Salicylate salt restrictions apply as combined salicylic acid equivalents.

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

7 study endpoints found for Sodium Salicylate. 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 >=138 mg/kg bw/day oral rat oral REACH
NOAEL >=1000 ppm oral rat oral REACH
LOAEL 200 mg/kg bw/day oral rat oral REACH
NOAEL >=150 mg/kg bw/day oral rat oral REACH
NOAEL 300 mg/kg bw/day oral rat oral REACH
LOAEL 400 mg/kg bw/day oral rat oral REACH
LOAEL 300 mg/kg bw/day oral dog oral REACH

Expert Verdict

Safe at 0.5% (as acid) preservative; 2% leave-on / 3% rinse-off hair. Not for children under 3 years except shampoo. Label warning required. Dissociates to salicylic acid; total salicylate equivalents must not exceed limits.

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Concern Level: Low

Regulatory Flags

EU_RESTRICTED

Frequently Asked Questions

Is Sodium Salicylate safe in cosmetics?

Safe at 0.5% (as acid) preservative; 2% leave-on / 3% rinse-off hair. Not for children under 3 years except shampoo. Label warning required. Dissociates to salicylic acid; total salicylate equivalents must not exceed limits. The EU classifies Sodium Salicylate as "restricted". Safety rating: GOOD. 7 toxicological study endpoint(s) are available in our database.

Is Sodium Salicylate allowed in the EU?

Sodium Salicylate EU regulatory status: restricted. Maximum allowed concentration: 0.5% (as acid) preservative (Annex V/3); 2.0% other / 3.0% rinse-off hair (Annex III). This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Salicylate do in cosmetics?

Sodium Salicylate functions as: Denaturant, Preservative, Hair/Skin Conditioning. It is classified as a Preservative in our database. CAS number: 54-21-7.

What is the Margin of Safety for Sodium Salicylate?

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 Salicylate?

The NOAEL (No Observed Adverse Effect Level) for Sodium Salicylate is >=138 mg/kg bw/day based on a oral study via oral route in rat. A total of 7 study endpoints are available. Source: REACH.

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