NOAEL Data REACH Registered Cosmetic Ingredient

Polysorbate 60

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)

CAS 9005-67-8

Polysorbate 60 (CAS 9005-67-8) is a chemical substance. Key regulatory status: REACH registered, 11 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, ECHA REACH.

View cosmetic safety profile for Polysorbate 60 →

SOURCE NOAEL studies
NOAEL studies
20
SOURCE Chemical inventory jurisdictions
Regulatory lists
11
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 16 fields
Name
Polysorbate 60
CAS Number
9005-67-8
Synonyms
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.Ethoxylated sorbitan monostearatePolyethylene glycol sorbitan monostearatePolyoxyethylene sorbitan monostearateFEMA No. 2916Glycosperse S-20Peg sorbitan stearatePeg-20 sorbitan stearatePolyoxyethylene 20 sorbitan monostearatePolyoxyethylene-40-sorbitan monostearateUNII-CAL22UVI4MUNII-3453J8557N

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 60 records
EmulsifierSurfactant (surface active agent)FragranceWetting agent (non-aqueous)Flavouring and nutrientPharmaceuticalLubricating agentAnti-static agentDispersing agent

Regulatory Lists

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

SOURCE EPA CPDat 11 records
ListKeywordSource
fracking; waterNY Department of ConservationCPCat
inert_ingredient; PesticidesEPACPCat
inert_ingredient; non_food_use; PesticidesEPACPCat
pharmaceuticalUS International Trade CommissionCPCat
children; Europe; Personal careDanish Environmental Protection AgencyDanish EPA
children; Europe; Personal care - general moisturizing - hand/body lotionDanish Environmental Protection AgencyDanish EPA
IFRA TransparencyIFRAIFRA
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
Canada; pharmaceuticalDrugBankDrugBank
pharmaceuticalUS International Trade CommissionCPCat
SCIL (9/2019)USEPASafer Chemical Ingredients List

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 20 of 20 studies
ValueUnitEndpointRouteSpeciesSource
<=25mg/kgADIoralHumanWHO/JECFA
=98.7mg/m3DNEL systemicinhalationHumanToxValDB GESTIS DNEL
073G38N8GCUNIIFDA UNII substance identifier--openFDA substances
3453J8557NUNIIFDA UNII substance identifier--openFDA substances
90SOR12GHGUNIIFDA UNII substance identifier--openFDA substances
CAL22UVI4MUNIIFDA UNII substance identifier--openFDA substances
HD40WR33LCUNIIFDA UNII substance identifier--openFDA substances
X61U1UH01BUNIIFDA UNII substance identifier--openFDA substances
=5000ppmLOAELoralMouseECHA
=960mg/kg bw/dayNOAELoralRatECHA
=1000mg/kg bw/dayNOAELoralRatECHA
2500mg/kg bw/dayNOAELoralratCOSMOS DB
5000mg/kg bw/dayNOAELoralratCOSMOS DB
=5000mg/kg bw/dayNOAELoralMouseECHA
7500mg/kg bw/dayNOAELoralhamsterCOSMOS DB
7693mg/kg bw/dayNOAELoralratCOSMOS DB
=7693mg/kg bw/dayNOAELoralRatECHA
1.500e+4mg/kg bw/dayNOAELoralmouseCOSMOS DB
=5.200e+4mg/kg bw/dayNOAELoralMouseECHA
=1.000e+7ppmNOAELoralRatECHA

Showing 20 of 20 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records
StatusNameEC NumberLink
RegisteredSorbitan monostearate, ethoxylated500-020-4ECHA overview →

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 →

Food Safety Data

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

SOURCE EFSA 1 records

E435 — 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 60?

Polysorbate 60 has 20 NOAEL studies in the database. The lowest reported value is 25 mg/kg via oral in Human. Source: WHO/JECFA.

What regulatory lists include Polysorbate 60?

Polysorbate 60 appears on 10 regulatory/inventory lists including fracking; water, inert_ingredient; Pesticides, inert_ingredient; non_food_use; Pesticides, and 7 more. Source: EPA CPDat.

Is Polysorbate 60 used in cosmetics?

Yes, Polysorbate 60 is also indexed as a cosmetic ingredient under the name Polysorbate 60. 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 60 come from?

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

Is Polysorbate 60 used outside industrial chemicals?

Polysorbate 60 also appears in cosmetics, food safety, cannabis databases.