Is Polysorbate 81 safe in cosmetics?
Polysorbate 81 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 81
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 81
Polysorbate 81 (CAS 9005-65-6) is a cosmetic cosmetic ingredient functioning as Emulsifier (HLB ~10), surfactant (detergent), emollient. NOAEL 833.333 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. 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.
View industrial chemical safety profile for CAS 9005-65-6 →
Auto-generated CPSR Part A draft with source citations
Function
Emulsifier (HLB ~10), surfactant (detergent), emollient
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR: Safe as used (original 1984, reaffirmed 2015); FDA UNII: 2MSF640LWM
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 81.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 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 | 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 81 across SCCS product categories, with measured dermal absorption where available.
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
Additional Ingredient Properties
2 property records from structured ingredient metadata.
emulsifier
{"cas_number": "9005-65-6", "ingredient_class": "O/W_emulsifier", "chemical_type": "ethoxylated_sorbitan", "HLB_value": "10.0", "HLB_required_for_oil_phase": "9-11", "emulsion_type_primary": "O/W", "droplet_size_typical_um": "1-3", "critical_micelle_concentration_pct": "0.001-0.01", "surface_tension_reduction_mN_m": "25-29", "interfacial_tension_reduction": "28-32", "foam_formation": "low", "foam_…
surfactant
{"cas_number": "9005-65-6", "surfactant_type": "nonionic", "chemical_class": "polysorbate", "charge_at_use_ph": "neutral", "cmc_critical_micelle_concentration_mm": "0.03044719703056021", "hlb_value": "10.0", "foam_volume_ml_ross_miles": "87", "foam_quality": "light", "foam_stability_5min_pct": "66", "cleansing_power_rating_1_to_10": "3.9783658412625122", "oil_emulsification_capacity": "moderate", …
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)
Expert Verdict
Expert safety assessment and concern-level summary for Polysorbate 81.
Regulatory Flags
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 81 by CAS number or substance name.
Studies
4
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
10000 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 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 NOAEL for Polysorbate 81?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 81 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 81 used outside cosmetics?
Polysorbate 81 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 81 compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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
Related Ingredients
Alpha-Glucan Oligosaccharide-1
Excellent
Same category
Skin conditioning, cleansing, smoothi...
Ammonium Acryloyl Dimethyltaurate/Carboxyethyl Acrylate Crosspolymer
Excellent
Same category
Dispersing agent (nonsurfactant), vis...
Ammonium Cocoyl Isethionate
Excellent
Same category
Surfactant – cleansing, foaming
Ammonium Lauryl Sulfosuccinate
Excellent
Same category
Cleansing, foaming, surfactant
Ammonium Stearate
Excellent
Same category
Cleansing, surfactant, emulsifying
Apricot Kernel Oil Polyglyceryl-10 Esters
Excellent
Same category
Skin conditioning, emollient, surfact...
(AGARICUS BLAZEI FERMENT + GANODERMA LUCIDUM FERMENT + GANODERMA MULTIPILEUM FERMENT) EXTRACT
Good
Similar safety
Anti-sebum, Antioxidant, Skin Protecting
(ANGELICA ACUTILOBA/PAEONIA LACTIFLORA/REHMANNIA GLUTINOSA) ROOT/CNIDIUM OFFICINALE RHIZOME EXTRACT
Good
Similar safety
Skin Conditioning, Skin Conditioning ...
(ANGELICA ACUTILOBA/PAEONIA LACTIFLORA/REHMANNIA GLUTINOSA/SCUTELLARIA BAICALENSIS) ROOT/(CNIDIUM OFFICINALE/COPTIS CHINENSIS) RHIZOME/GARDENIA JASMINOIDES FRUIT/PHELLODENDRON CHINENSE BARK EXTRACT
Good
Similar safety
(ANGELICA GIGAS/GLYCYRRHIZA URALENSIS/REHMANNIA GLUTINOSA ROOT)/ANGELICA GIGAS STEM/CARTHAMUS TINCTORIUS FLOWER/(CARTHAMUS TINCTORIUS/PRUNUS PERSICA SEED)PORIA COCOS WATER
Good
Similar safety
Humectant, Skin Conditioning, Skin Pr...
(ANGELICA KEISKEI/CHRYSANTHEMUM ZAWADSKII) LEAF/STEM/CINNAMOMUM CASSIA BARK/TRICHOSANTES KIRILOWII FRUIT/ULMUS DAVIDIANA BARK/ROOT/(PAEONIA JAPONICA/BUPLEURUM FALCATUM/POLYGALA TENUIFOLIA ROOT)/VISCUS ALBUM STEM EXTRACT
Good
Similar safety
Anti-seborrheic, Anti-sebum, Antioxid...
(APPLE/CITRUS JUNOS/LENTIL/PEAR/PUMPKIN/STRAWBERRY/TOMATO FRUIT)/CORN KERNEL/(ARCTIUM LAPPA/BRASSICA OLERACEA ACEPHALA/CABBAGE/CAMELLIA SINENSIS/MORINGA OLEIFERA/RADISH/SPINACH LEAF)/(SORGHUM BICOLOR LEAF/STEM)/OAT MEAL/POTATO PULP/(CARROT/NELUMBO NUCIFERA/RADISH/WILD YAM ROOT)/(AMARANTHUS HYPOCHONDRIACUS/CASHEW/CICER ARIETINUM/COIX LACRYMA-JOBI MA-YUEN /MACADAMIA TERNIFOLIA/PHASEOLUS ANGULARIS/PISTACIA VERA/RHYNCHOSIA NULUBILIS/RICE/SESAME/SETARIA ITALICA/SOYBEAN/SWEET ALMOND/WHEAT SEED)/HORDEUM VULGARE SPROUT/CYPERUS ESCULENTUS TUBER/ARTEMISIA PRINCEPS/BROCCOLI/CHENOPODIUM QUINOA/ENTEROMORPHA COMPRESSA/HORDEUM VULGARE/IPOMOEA BATATAS/LAMINARIA JAPONICA/LENTINUS EDODES/PLEUROTUS OSTREATUS/PORPHYRA TENERA/UNDARIA PINNATIFIDA EXTRACT
Good
Similar safety
Antioxidant
Algin
Excellent
Chemical family
gelling agent, thickener, film-formin...
Alginate (Sodium Alginate)
Good
Chemical family
Thickener
Alginic Acid
Excellent
Chemical family
Binding Agent, Viscosity Controlling,...
Is Polysorbate 81 in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Polysorbate 81 in your formulation.