NOAEL Data Cosmetic Ingredient

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)

CAS 9005-65-6

Polysorbate 80 (CAS 9005-65-6) is a chemical substance. Key regulatory status: 27 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS.

View cosmetic safety profile for Polysorbate 80 →

SOURCE NOAEL studies
NOAEL studies
47
SOURCE Chemical inventory jurisdictions
Regulatory lists
27
SOURCE EU CLP Annex VI
GHS signal
Not classified

Chemical Identity

CAS, identifiers, formula, and alternate names for the matched substance record.

SOURCE DSSTox identifiers 22 fields
Name
Polysorbate 80
CAS Number
9005-65-6
Synonyms
Glycols, polyethylene, ether with sorbitan monooleateArmotan pmo-20Drewmulse poe-smoFEMA No. 2917Glycosperse O-20Glycosperse O-20XGlycosperse O-20 VEGNCI-C60286Nikkol TOPeg sorbitan oleatePeg-20 sorbitan oleatePolyethylene oxide sorbitan mono-oleate

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 60 records
EmulsifierFragranceSurfactant (surface active agent)Cleaning agentWetting agent (non-aqueous)Flavouring and nutrientPharmaceuticalSolvent

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 27 records
ListKeywordSource
drinking_water; Europe; manufacturing; plastic_additiveBelgaquaCPCat
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesState of CaliforniaState of California
active_ingredient; PesticidesCalifornia Department of Pesticide RegulationState of California
inert_ingredient; PesticidesEPACPCat
fracking; waterNY Department of ConservationCPCat
pharmaceuticalUS International Trade CommissionCPCat
Europe; Personal care - body hygiene - hand soapDanish Environmental Protection AgencyDanish EPA
active_ingredient; animal_products; Europe; pharmaceutical; residueEUCPCat
Europe; Personal care - hair styling and care - shampoo-dandruffDanish Environmental Protection AgencyDanish EPA
Europe; Personal care - hair styling and care - shampoo-dandruffDanish Environmental Protection AgencyDanish EPA
Europe; Personal care - hair styling and care - shampoo-dandruffDanish Environmental Protection AgencyDanish EPA
Europe; Personal care - linimentDanish Environmental Protection AgencyDanish EPA
IFRA TransparencyIFRAIFRA
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
SCIL (9/2019)USEPASafer Chemical Ingredients List
Canada; pharmaceuticalDrugBankDrugBank
Personal care; Southeast AsiaAseanASEAN Cosmetics
pharmaceuticalUS International Trade CommissionCPCat
Canada; consumer_product; Substances in Products - Canada (4/2014)Government of CanadaCPCat
inert_ingredient; non_food_use; PesticidesEPACPCat

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 47 of 47 studies
ValueUnitEndpointRouteSpeciesSource
=25mg/kg bw/dayADI (group)-ConsumersEFSA
8.73ug/mLCD86, EC150Dermal-NTP ICE skin sensitization
>200ug/mLCV70Dermal-NTP ICE skin sensitization
5000ug/mLCV75Dermal-NTP ICE skin sensitization
10.2%Depletion CysDermal-NTP ICE skin sensitization
0%Depletion LysDermal-NTP ICE skin sensitization
0unitlessDraize rabbit irritation scoreOcularRabbitNTP ICE eye irritation
<65.91uMEC1.5Dermal-NTP ICE skin sensitization
115.5uMEC1.5Dermal-NTP ICE skin sensitization
677.4uMEC3Dermal-NTP ICE skin sensitization
4unitlessEPA ClassificationOcularRabbitNTP ICE eye irritation
2MSF640LWMUNIIFDA UNII substance identifier--openFDA substances
58O7V09UCIUNIIFDA UNII substance identifier--openFDA substances
6OZP39ZG8HUNIIFDA UNII substance identifier--openFDA substances
>164uMIC50Dermal-NTP ICE skin sensitization
813.1uMIC50Dermal-NTP ICE skin sensitization
4000uMIC50Dermal-NTP ICE skin sensitization
3.08ratioImaxDermal-NTP ICE skin sensitization
3.085ratioImaxDermal-NTP ICE skin sensitization
3.764ratioImaxDermal-NTP ICE skin sensitization
0%Incidence of positive responsesDermalHumanNTP ICE skin sensitization
1.552e+4ug/cm2Induction dose per skin areaDermalHumanNTP ICE skin sensitization
0.02%/secIntensityOcular-NTP ICE eye irritation
>2500mg/kg bw/dayLELoralrat (fischer; Fischer 344)EPA ToxRefDB v3
=7500mg/kg bw/dayLELoralMouseToxValDB ToxRefDB
=7500mg/kg bw/dayLELoralmouse (b6c3f1; B6C3F1)EPA ToxRefDB v3
>180sLag timeOcular-NTP ICE eye irritation
0unitlessModel Score--NTP ICE endocrine
=1250mg/kg bw/dayNELoralRatToxValDB ToxRefDB
=1250mg/kg bw/dayNELoralrat (fischer; Fischer 344)EPA ToxRefDB v3
=3750mg/kg bw/dayNELoralMouseToxValDB ToxRefDB
=3750mg/kg bw/dayNELoralmouse (b6c3f1; B6C3F1)EPA ToxRefDB v3
1000mg/kg bw/dayNOAELoralmonkeyCOSMOS DB
2500mg/kg bw/dayNOAELoralratCOSMOS DB
=2500mg/kg bw/dayNOAELoralRatEFSA
=2500mg/kg bw/dayNOAELoral: unspecifiedRatEFSA
5000mg/kg bw/dayNOAELoralratCOSMOS DB
7500mg/kg bw/dayNOAELoralmouseCOSMOS DB
1.000e+4mg/kg bw/dayNOAELoralratCOSMOS DB
=0.5%NOELinjectionMouseToxValDB ECOTOX
=4800mg/kg bw/dayNOELoralRatToxValDB HESS
5.000e+4ppmPOLY-3 lowest doseDosed feedRatNTP ICE cancer
0%Plateau levelOcular-NTP ICE eye irritation
3.5%Positive reactionDermalHumanNTP ICE skin irritation
3.8%Positive reactionDermalHumanNTP ICE skin irritation
1unitlessRelative reliability scoreDermalHumanNTP ICE skin sensitization
5%Top doseDosed feedRatNTP ICE cancer

Showing 47 of 47 studies

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
permitted
Max
1,4-dioxane process impurity ≤10 ppm per EU GMP guidance
Category
emulsifier
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed polysorbate 80
ChEMBL Phase
Not listed
Adverse Events
105
Bioactivity
0
View full pharmaceutical profile →

Food Safety Data

Same-CAS food additive, ADI, and GRAS records where available.

SOURCE EFSA 1 records

E433-pharma — ADI: 25 mg/kg bw

View full food safety profile →

Cannabis Data

Same-CAS cannabis compliance and lab records where available.

SOURCE Cannabis regulatory / lab data efsa substances

1 cannabis record found in efsa substances.

View full cannabis profile →

Frequently Asked Questions

What is the NOAEL for Polysorbate 80?

Polysorbate 80 has 47 NOAEL studies in the database. The lowest reported value is 0 % via Dermal. Source: NTP ICE skin sensitization.

What regulatory lists include Polysorbate 80?

Polysorbate 80 appears on 16 regulatory/inventory lists including drinking_water; Europe; manufacturing; plastic_additive, active_ingredient; Pesticides, inert_ingredient; Pesticides, and 13 more. Source: EPA CPDat.

Is Polysorbate 80 used in cosmetics?

Yes, Polysorbate 80 is also indexed as a cosmetic ingredient under the name Polysorbate 80. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.

Where does the safety data for Polysorbate 80 come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, CosIng / Ingredients DB, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.

Is Polysorbate 80 used outside industrial chemicals?

Polysorbate 80 also appears in cosmetics, pharmaceutical, food safety, cannabis databases.