What is the NOAEL for Polysorbate 65?
Polysorbate 65 has 10 NOAEL studies in the database. The lowest reported value is 25 mg/kg bw/day in Consumers. Source: EFSA.
NOAEL Data
Cosmetic Ingredient
Polysorbate 65
Also known as: Polyoxyethylene 20 sorbitan tristearate, Ethoxylated sorbitan tristearate
CAS 9005-71-4
Polysorbate 65 (CAS 9005-71-4) is a chemical substance. Key regulatory status: 6 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS.
SOURCE
NOAEL studies
NOAEL studies
10
SOURCE
Chemical inventory jurisdictions
Regulatory lists
6
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
5 fields
Name
Polysorbate 65
CAS Number
9005-71-4
DTXSID
DTXSID30891988
Synonyms
Polyoxyethylene 20 sorbitan tristearateEthoxylated sorbitan tristearate
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
27 records
Surfactant (surface active agent)EmulsifierWetting agent (non-aqueous)Flavouring and nutrientPharmaceuticalThickening agent
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
6 records
| List | Keyword | Source |
|---|---|---|
| inert_ingredient; Pesticides | EPA | CPCat |
| inert_ingredient; non_food_use; Pesticides | EPA | CPCat |
| active_ingredient; Pesticides | California Department of Pesticide Regulation | State of California |
| pharmaceutical | US International Trade Commission | CPCat |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
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NOAEL studies
Showing 10 of 10 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| =25 | mg/kg bw/day | ADI (group) | - | Consumers | EFSA |
| 14BGY2Y3MJ | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 14BGY2Y3MJ | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 14BGY2Y3MJ | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 14BGY2Y3MJ | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 1000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| =2500 | mg/kg bw/day | NOAEL | oral: unspecified | Rat | EFSA |
| =2500 | mg/kg bw/day | NOAEL | oral: unspecified | Rat | EFSA |
| 5000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| 12500 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
Showing 10 of 10 studies
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
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AICIS inventory
1 records
Inventory Status
listed
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
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CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Emulsifier
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
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EFSA
1 records
E436 — ADI: 25 mg/kg bw
View full food safety profile →Cannabis Data
Same-CAS cannabis compliance and lab records where available.
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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 65?
Polysorbate 65 appears on 6 regulatory/inventory lists including inert_ingredient; Pesticides, inert_ingredient; non_food_use; Pesticides, active_ingredient; Pesticides, and 3 more. Source: EPA CPDat.
Is Polysorbate 65 used in cosmetics?
Yes, Polysorbate 65 is also indexed as a cosmetic ingredient under the name Polysorbate 65. 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 65 come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, 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 65 used outside industrial chemicals?
Polysorbate 65 also appears in cosmetics, food safety, cannabis databases.