Good Cosmetic Ingredient NOAEL Data

Polysorbate 81

INCI: POLYSORBATE 81

CAS Number
9005-65-6
Function
Emulsifier (HLB ~10), surfactant (detergent), emollient
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes CIR: Safe as used (original 1984, reaffirmed 2015); FDA UNII: 2MSF640LWM

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Polysorbate 81. 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

Ethoxylated ingredient with potential 1,4-dioxane and ethylene oxide residues; requires purification controls and residual testing per GMP

⚠️
Concern Level: Low

Regulatory Flags

epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Polysorbate 81 safe in cosmetics?

Ethoxylated ingredient with potential 1,4-dioxane and ethylene oxide residues; requires purification controls and residual testing per GMP The EU classifies Polysorbate 81 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Polysorbate 81 allowed in the EU?

Polysorbate 81 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Polysorbate 81 do in cosmetics?

Polysorbate 81 functions as: Emulsifier (HLB ~10), surfactant (detergent), emollient. It is classified as a cosmetic ingredient in our database. CAS number: 9005-65-6.

What is the Margin of Safety for Polysorbate 81?

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 Polysorbate 81?

The NOAEL (No Observed Adverse Effect Level) for Polysorbate 81 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 Polysorbate 81 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
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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