Is Polysorbate 61 safe in cosmetics?
Polysorbate 61 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 9 toxicological study endpoint(s) are available in our database.
Polysorbate 61
Also known as: Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs., Ethoxylated sorbitan monostearate, Polyethylene glycol sorbitan monostearate, Polyoxyethylene sorbitan monostearate, FEMA No. 2916 (+9 more)
INCI: POLYSORBATE 61
Polysorbate 61 (CAS 9005-67-8) is a cosmetic cosmetic ingredient functioning as Surfactant – Emulsifying, Wetting Agent. NOAEL 960 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 and food safety data.
View industrial chemical safety profile for CAS 9005-67-8 →
Auto-generated CPSR Part A draft with source citations
Function
Surfactant – Emulsifying, Wetting Agent
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted for cosmetic use; CIR concluded safe when formulated to be nonirritating
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 61.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
9 study endpoints found for Polysorbate 61. 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 | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 7500 mg/kg bw/day | oral | hamster | Chronic | COSMOS DB |
| NOAEL | 7693 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | =960 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =5000 mg/kg bw/day | oral | Mouse | chronic | ECHA |
| NOAEL | =7693 mg/kg bw/day | oral | Rat | developmental | ECHA |
| NOAEL | =52000 mg/kg bw/day | oral | Mouse | developmental | ECHA |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Polysorbate 61 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 |
|---|---|---|---|---|---|
| ADI | <=25 mg/kg | Human | oral | - | WHO/JECFA |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
| LD50 | >20000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >5000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >60000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >38000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >33800 mg/kg | Rat | oral | - | ECHA |
| LOAEL | =5000 ppm | Mouse | oral | - | ECHA |
| NOAEL | =52000 mg/kg-day | Mouse | oral | - | ECHA |
| NOAEL | =52000 mg/kg-day | Mouse | oral | - | ECHA |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
2 property records from structured ingredient metadata.
emulsifier
{"cas_number": "9005-67-8", "ingredient_class": "O/W_emulsifier", "chemical_type": "ethoxylated_sorbitan", "HLB_value": "9.6", "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_s…
surfactant
{"cas_number": "9005-67-8", "surfactant_type": "nonionic", "chemical_class": "polysorbate", "charge_at_use_ph": "neutral", "cmc_critical_micelle_concentration_mm": "0.046367998768696614", "hlb_value": "9.6", "foam_volume_ml_ross_miles": "83", "foam_quality": "light", "foam_stability_5min_pct": "67", "cleansing_power_rating_1_to_10": "3.631420090860982", "oil_emulsification_capacity": "moderate", "…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Dispersing agent
Emulsifier
Flavouring and nutrient
Fragrance
Lubricating agent
Pharmaceutical
Processing aids not otherwise specified
Surfactant (surface active agent)
Thickening agent
Regulatory List Membership (4)
EU Restricted for Children (Cosmetics)
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 61.
Regulatory Flags
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 61 by CAS number or substance name.
Studies
9
Lowest NOAEL
960 mg/kg bw/day
Highest NOAEL
52000 mg/kg bw/day
ECHA
COSMOS DB
Known Synonyms
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Ethoxylated sorbitan monostearate
Polyethylene glycol sorbitan monostearate
Polyoxyethylene sorbitan monostearate
FEMA No. 2916
Glycosperse S-20
Peg sorbitan stearate
Peg-20 sorbitan stearate
Polyoxyethylene 20 sorbitan monostearate
Polyoxyethylene-40-sorbitan monostearate
UNII-CAL22UVI4M
UNII-3453J8557N
UNII-X61U1UH01B
UNII-073G38N8GC
Chemical Function
Emulsifier
Surfactant (surface active agent)
Regulatory Lists
fracking; water
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
pharmaceutical
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
pharmaceutical
SCIL (9/2019)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in food safety data.
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 60
E Number
E435
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Polysorbate 61 allowed in the EU?
Polysorbate 61 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 61 do in cosmetics?
Polysorbate 61 functions as: Surfactant – Emulsifying, Wetting Agent. It is classified as a cosmetic ingredient in our database. CAS number: 9005-67-8.
What is the NOAEL for Polysorbate 61?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 61 is 2500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS DB.
Is Polysorbate 61 used outside cosmetics?
Polysorbate 61 also appears in industrial chemical safety and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 61 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 61 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 61 in your formulation.