Good Cosmetic Ingredient NOAEL Data

Sodium Levulinate

INCI: SODIUM LEVULINATE

CAS Number
19856-23-6
Function
Skin conditioning, preservative booster, antimicrobial
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Listed in FDA VCRP; parent acid is FDA-approved food additive under 21 CFR 172 section 515

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Sodium Levulinate. 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 1000 mg/kg bw/day oral rat oral REACH
NOAEL 1000 mg/kg bw/day oral - oral REACH

Expert Verdict

CIR Expert Panel concluded safe as used when formulated to be non-irritating. COSMOS/ECOCERT eligible. Main caution: penetration enhancement properties for co-formulated actives.

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Concern Level: Low

Frequently Asked Questions

Is Sodium Levulinate safe in cosmetics?

CIR Expert Panel concluded safe as used when formulated to be non-irritating. COSMOS/ECOCERT eligible. Main caution: penetration enhancement properties for co-formulated actives. The EU classifies Sodium Levulinate as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Sodium Levulinate allowed in the EU?

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

What does Sodium Levulinate do in cosmetics?

Sodium Levulinate functions as: Skin conditioning, preservative booster, antimicrobial. It is classified as a cosmetic ingredient in our database. CAS number: 19856-23-6.

What is the Margin of Safety for Sodium Levulinate?

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 Sodium Levulinate?

The NOAEL (No Observed Adverse Effect Level) for Sodium Levulinate is 1000 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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