Excellent Cosmetic Ingredient NOAEL Data

PEG-3 Sorbitan Oleate

INCI: PEG-3 SORBITAN OLEATE

CAS Number
9005-65-6
Function
Surfactant – emulsifying agent
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes CIR reviewed (Sorbitan Esters / Polysorbates group) — safe in present practices of use

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

10 study endpoints found for PEG-3 Sorbitan Oleate. 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 1000 mg/kg bw/day oral monkey Subchronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 7500 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 7500 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Chronic COSMOS_DB

Expert Verdict

1,4-Dioxane impurity from ethoxylation; at very high oral doses (≥10% of feed) GI irritation was observed in animal studies — not relevant at cosmetic use levels

⚠️
Concern Level: Low

Regulatory Flags

peg-ingredient epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is PEG-3 Sorbitan Oleate safe in cosmetics?

1,4-Dioxane impurity from ethoxylation; at very high oral doses (≥10% of feed) GI irritation was observed in animal studies — not relevant at cosmetic use levels The EU classifies PEG-3 Sorbitan Oleate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is PEG-3 Sorbitan Oleate allowed in the EU?

PEG-3 Sorbitan Oleate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does PEG-3 Sorbitan Oleate do in cosmetics?

PEG-3 Sorbitan Oleate functions as: Surfactant – emulsifying agent. It is classified as a cosmetic ingredient in our database. CAS number: 9005-65-6.

What is the Margin of Safety for PEG-3 Sorbitan Oleate?

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-3 Sorbitan Oleate?

The NOAEL (No Observed Adverse Effect Level) for PEG-3 Sorbitan Oleate is 5000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check PEG-3 Sorbitan Oleate compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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