Excellent Emulsifier NOAEL Data GHS Classified Dermal Penetration

Stearic Acid

INCI: STEARIC ACID

CAS Number
57-11-4
Function
emulsifier
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
EU Max Conc. 20-40%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes GRAS status (FDA); widely used at high concentrations in shaving soaps; low irritation potential

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

8 study endpoints found for Stearic Acid. 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 10000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 3200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 10000 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 3200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 3000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 300 mg/kg bw/day oral rat Subchronic COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Stearic Acid, relevant to systemic exposure and MoS calculations.

Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
284.5 Da
Log P
7.0
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low

Source: CIR

Expert Verdict

Fatty acid used as in situ soap emulsifier when neutralized by TEA (triethanolamine) during hot-mix to form triethanolamine stearate, an anionic O/W emulsifier with pearlescent finish. Use level 2-5% with 0.5-1.5% TEA; requires pH >7 for complete neutralization.

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Concern Level: None

Regulatory Flags

peg-free in-situ-soap-precursor eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Stearic Acid safe in cosmetics?

Fatty acid used as in situ soap emulsifier when neutralized by TEA (triethanolamine) during hot-mix to form triethanolamine stearate, an anionic O/W emulsifier with pearlescent finish. Use level 2-5% with 0.5-1.5% TEA; requires pH >7 for complete neutralization. The EU classifies Stearic Acid as "permitted". Safety rating: EXCELLENT. 8 toxicological study endpoint(s) are available in our database.

Is Stearic Acid allowed in the EU?

Stearic Acid EU regulatory status: permitted. Maximum allowed concentration: 20-40%. This is based on EU Regulation 1223/2009 and its amendments.

What does Stearic Acid do in cosmetics?

Stearic Acid functions as: emulsifier. It is classified as a Emulsifier in our database. CAS number: 57-11-4.

What is the Margin of Safety for Stearic Acid?

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 Stearic Acid?

The NOAEL (No Observed Adverse Effect Level) for Stearic Acid is 10000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

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