Excellent Emulsifier NOAEL Data Dermal Penetration

Glyceryl Stearate

INCI: GLYCERYL STEARATE

CAS Number
31566-31-1
Function
emulsifier
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS for direct human food use (21 CFR 184.1324) with no limitation beyond GMP. Permitted indirect food additive (21 CFR 175.105, 175.300, 176.200, 176.210). Permitted inactive excipient in OTC and Rx drug formulations. EPA Safer Chemical program Green Circle designation (low concern).

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

7 study endpoints found for Glyceryl Stearate. 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 75000 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 14571 mg/kg bw/day oral syrian hamster Chronic COSMOS_DB
NOAEL 18000 mg/kg bw/day oral syrian hamster Subchronic COSMOS_DB
NOAEL 12500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 12500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 14571 mg/kg bw/day oral syrian hamster Chronic COSMOS_DB
dose_tested 12500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Dermal Penetration Profile

Skin absorption and penetration characteristics of Glyceryl Stearate, relevant to systemic exposure and MoS calculations.

Absorption %
0.5-2%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
358.6 Da
Log P
7.8
Systemic Absorption
minimal
Topical Bioavailability
0.2-1%
Safety Margin Factor
minimal
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

Expert Verdict

CIR safe 1982, re-reviewed 2015 and reaffirmed 2020. Used in 5,153+ formulations up to 17% leave-on/18.9% rinse-off. Not sensitizing, phototoxic, or a tumor promoter. GRAS for food use and EPA Safer Chemical Green Circle designated. EU: no restrictions, not in Annex II/III.

⚠️
Concern Level: None

Regulatory Flags

cir-reviewed gras epa-safer-chemical non-sensitizing non-genotoxic wide-use eu_children_restricted epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Glyceryl Stearate safe in cosmetics?

CIR safe 1982, re-reviewed 2015 and reaffirmed 2020. Used in 5,153+ formulations up to 17% leave-on/18.9% rinse-off. Not sensitizing, phototoxic, or a tumor promoter. GRAS for food use and EPA Safer Chemical Green Circle designated. EU: no restrictions, not in Annex II/III. The EU classifies Glyceryl Stearate as "permitted". Safety rating: EXCELLENT. 7 toxicological study endpoint(s) are available in our database.

Is Glyceryl Stearate allowed in the EU?

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

What does Glyceryl Stearate do in cosmetics?

Glyceryl Stearate functions as: emulsifier. It is classified as a Emulsifier in our database. CAS number: 31566-31-1.

What is the Margin of Safety for Glyceryl Stearate?

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 Glyceryl Stearate?

The NOAEL (No Observed Adverse Effect Level) for Glyceryl Stearate is 75000 mg/kg bw/day based on a Short Term Toxicity study via oral route in mouse. A total of 7 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Glyceryl Stearate compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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