Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for PEG-100 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 | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | hamster | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | hamster | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
Dermal Penetration Profile
Skin absorption and penetration characteristics of PEG-100 Stearate, relevant to systemic exposure and MoS calculations.
Source: CIR
Expert Verdict
O/W emulsifier with high HLB ~18.8. Paired with Glyceryl Stearate (HLB ~3.8) to achieve blended HLB ~11 for stable O/W creams at 3–6% combined. PEG-derived with potential 1,4-dioxane trace; not COSMOS-eligible.
Regulatory Flags
Frequently Asked Questions
Is PEG-100 Stearate safe in cosmetics?
O/W emulsifier with high HLB ~18.8. Paired with Glyceryl Stearate (HLB ~3.8) to achieve blended HLB ~11 for stable O/W creams at 3–6% combined. PEG-derived with potential 1,4-dioxane trace; not COSMOS-eligible. The EU classifies PEG-100 Stearate as "permitted". Safety rating: GOOD. 4 toxicological study endpoint(s) are available in our database.
Is PEG-100 Stearate allowed in the EU?
PEG-100 Stearate EU regulatory status: permitted. Maximum allowed concentration: 25%. This is based on EU Regulation 1223/2009 and its amendments.
What does PEG-100 Stearate do in cosmetics?
PEG-100 Stearate functions as: emulsifier. It is classified as a Emulsifier in our database. CAS number: 9004-99-3.
What is the Margin of Safety for PEG-100 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 PEG-100 Stearate?
The NOAEL (No Observed Adverse Effect Level) for PEG-100 Stearate is 5000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 4 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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