What is the NOAEL for Polysorbate 60?
Polysorbate 60 has 38 NOAEL studies in the database. The lowest reported value is 25 mg/kg via oral in Human. Source: ToxValDB_WHO_JECFA_ADI.
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.
SOURCE
noael studies public
NOAEL studies
38
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
17 fields
Name
Polysorbate 60
CAS Number
9005-67-8
DTXSID
DTXSID9029300
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
| List | Keyword | Source |
|---|---|---|
| fracking; water | NY Department of Conservation | CPCat |
| inert_ingredient; Pesticides | EPA | CPCat |
| inert_ingredient; non_food_use; Pesticides | EPA | CPCat |
| pharmaceutical | US International Trade Commission | CPCat |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - general moisturizing - hand/body lotion | Danish Environmental Protection Agency | Danish EPA |
| IFRA Transparency | IFRA | IFRA |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| Canada; pharmaceutical | DrugBank | DrugBank |
| pharmaceutical | US International Trade Commission | CPCat |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 38 of 38 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| <=25 | mg/kg | ADI | oral | Human | ToxValDB_WHO_JECFA_ADI |
| =98.7 | mg/m3 | DNEL systemic | inhalation | Human | ToxValDB_GESTIS_DNEL |
| 073G38N8GC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 073G38N8GC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 073G38N8GC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 073G38N8GC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3453J8557N | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3453J8557N | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3453J8557N | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3453J8557N | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 90SOR12GHG | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 90SOR12GHG | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 90SOR12GHG | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 90SOR12GHG | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| CAL22UVI4M | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| CAL22UVI4M | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| CAL22UVI4M | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| CAL22UVI4M | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| HD40WR33LC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| HD40WR33LC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| HD40WR33LC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| HD40WR33LC | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X61U1UH01B | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X61U1UH01B | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X61U1UH01B | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X61U1UH01B | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| =5000 | ppm | LOAEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| =960 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =1000 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| 2500 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| 5000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| =5000 | mg/kg bw/day | NOAEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| 7500 | mg/kg bw/day | NOAEL | oral | hamster | COSMOS_DB |
| 7693 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| =7693 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| 15000 | mg/kg bw/day | NOAEL | oral | mouse | COSMOS_DB |
| =52000 | mg/kg bw/day | NOAEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| =10000000 | ppm | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
Showing 38 of 38 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Sorbitan monostearate, ethoxylated | 500-020-4 | ECHA 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
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA / FDA GRAS
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 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.