Is Polysorbate 80 safe in cosmetics?
Polysorbate 80 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
Polysorbate 80
Also known as: Glycols, polyethylene, ether with sorbitan monooleate, Armotan pmo-20, Drewmulse poe-smo, FEMA No. 2917, Glycosperse O-20 (+15 more)
INCI: POLYSORBATE 80
Polysorbate 80 (CAS 9005-65-6) is a cosmetic emulsifier functioning as Emulsifier; solubilizer; surfactant. NOAEL 833.333 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 1,4-dioxane process impurity ≤10 ppm per EU GMP guidance. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Function
Emulsifier; solubilizer; surfactant
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
1,4-dioxane process impurity ≤10 ppm per EU GMP guidance
US US Status
permitted
US Notes
CIR assessed polysorbate esters as safe as used in cosmetics. Widely used in pharmaceutical applications (solubilizer for injectable formulations) with well-characterized safety profile. HLB 15.0. CMC 0.05–0.15 mM. 1,4-dioxane GMP control required as ethoxylated ingredient.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Polysorbate 80.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for Polysorbate 80. 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 | 1000 mg/kg bw/day | oral | monkey | Subchronic | COSMOS DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS DB |
| NOAEL | 10000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Polysorbate 80 across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Polysorbate 80, relevant to systemic exposure and MoS calculations.
Absorption %
1-4%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
1310 Da
Log P
1.2
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR Expert Panel
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOAEL | =2500 mg/kg-day | Rat | oral | chronic | EFSA |
| NOEL | =0.5 % | Mouse | injection | acute | ECOTOX |
| LEL | =7500 mg/kg-day | Mouse | oral | chronic | EPA ToxRefDB |
| LEL | =7500 mg/kg-day | Mouse | oral | chronic | EPA ToxRefDB |
| LEL | >2500 mg/kg-day | Rat | oral | chronic | EPA ToxRefDB |
| LEL | =2500 mg/kg-day | Rat | oral | chronic | EPA ToxRefDB |
| LOAEL | =7500 mg/kg-day | Mouse | oral | chronic | EPA ToxRefDB |
| LOAEL | =7500 mg/kg-day | Mouse | oral | chronic | EPA ToxRefDB |
| LOAEL | >2500 mg/kg-day | Rat | oral | chronic | EPA ToxRefDB |
| LOAEL | >2500 mg/kg-day | Rat | oral | chronic | EPA ToxRefDB |
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 15517.24 | - | - |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: surfactant
Receptor targets: ERα (limited evidence)
LOEC: 100 µM
EU status: allowed
weak agonist
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.5–3 | 11.9 | CIR Safety Assessment |
| Perfume/Fragrance | 2–10 | 11.9 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Cleaning agent
Dispersing agent
Dye
Emulsifier
Flavouring and nutrient
Fragrance
Lubricating agent
Pharmaceutical
Preservative
Regulatory List Membership (3)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Polysorbate 80 — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
ethoxylated
peg-derived
1,4-dioxane-risk
penetration-enhancer
pharmaceutical-grade
not-cosmos
endocrine_disruptor
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 80 by CAS number or substance name.
Studies
4
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
1.000e+4 mg/kg bw/day
COSMOS DB
Known Synonyms
Glycols, polyethylene, ether with sorbitan monooleate
Armotan pmo-20
Drewmulse poe-smo
FEMA No. 2917
Glycosperse O-20
Glycosperse O-20X
Glycosperse O-20 VEG
NCI-C60286
Nikkol TO
Peg sorbitan oleate
Peg-20 sorbitan oleate
Polyethylene oxide sorbitan mono-oleate
Polyoxyethylene 20 sorbitan monooleate
Polyoxyethylene(20) sorbitan monooleate
Polyoxyethylene sorbitan oleate
Polysorbate 80 B.P.C.
Polysorbate 80, U.S.P.
Polysorbate 80 BPC
Polysorbate 80, USP
Protasorb O-20
Chemical Function
Emulsifier
Fragrance
Surfactant (surface active agent)
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
inert_ingredient; Pesticides
fracking; water
pharmaceutical
Europe; Personal care - body hygiene - hand soap
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
polysorbate 80
ChEMBL ID
CHEMBL1697847
Adverse Event Associations
105
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Polysorbate 80 (pharmaceutical grade)
E Number
E433-pharma
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Polysorbate 80 allowed in the EU?
Polysorbate 80 EU regulatory status: permitted. Maximum allowed concentration: 1,4-dioxane process impurity ≤10 ppm per EU GMP guidance. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 80 do in cosmetics?
Polysorbate 80 functions as: Emulsifier; solubilizer; surfactant. It is classified as a Emulsifier in our database. CAS number: 9005-65-6.
What is the NOAEL for Polysorbate 80?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 80 is 1000 mg/kg bw/day based on a Subchronic study via oral route in monkey. A total of 4 study endpoints are available. Source: COSMOS DB.
Is Polysorbate 80 used outside cosmetics?
Polysorbate 80 also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 80 compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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