What is the NOAEL for Polysorbate 20?
Polysorbate 20 has 100 NOAEL studies in the database. The lowest reported value is 3 unitless via Ocular in Rabbit. Source: NTP_ICE_eye_irritation.
NOAEL Data
REACH Registered
Cosmetic Ingredient
Polysorbate 20
Also known as: Tween 20, Armotan pml-20, Dxewmulse poe-sml, FEMA No. 2915, Glycosperse L-20 (+15 more)
CAS 9005-64-5
Polysorbate 20 (CAS 9005-64-5) is a chemical substance. Key regulatory status: REACH registered, 24 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, ECHA REACH.
SOURCE
noael studies public
NOAEL studies
100
SOURCE
chemical inventory jurisdictions
Regulatory lists
24
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
23 fields
Name
Polysorbate 20
CAS Number
9005-64-5
DTXSID
DTXSID3031949
Synonyms
Tween 20Armotan pml-20Dxewmulse poe-smlFEMA No. 2915Glycosperse L-20Glycosperse L-20XHodag psml-20Liposorb L-20Peg sorbitan lauratePeg-20 sorbitan lauratePoe 20 sorbitan monolauratePolyoxyethylene 20 sorbitan monolaurate
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 nutrientPharmaceutical
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
24 records
| List | Keyword | Source |
|---|---|---|
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - body hygiene - body wash | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - hair styling and care - shampoo | Danish Environmental Protection Agency | Danish EPA |
| drinking_water; Europe; manufacturing; plastic_additive | Belgaqua | CPCat |
| active_ingredient; Pesticides | California Department of Pesticide Regulation | State of California |
| inert_ingredient; Pesticides | EPA | CPCat |
| pharmaceutical | US International Trade Commission | CPCat |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - hair styling and care - shampoo | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - specialized bath products - bubble bath | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care - hair styling and care - shampoo-dandruff | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care - hair styling and care - shampoo-dandruff | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care - hair styling and care - shampoo-dandruff | 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 |
| Europe; Personal care - oral and dental care - teeth whitener | Danish Environmental Protection Agency | Danish EPA |
| pharmaceutical | US International Trade Commission | CPCat |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - hair styling and care - shampoo | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care - body hygiene - hand soap | Danish Environmental Protection Agency | Danish EPA |
| SCIL (9/2019) | USEPA | Safer Chemical Ingredients List |
| inert_ingredient; non_food_use; Pesticides | EPA | CPCat |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 50 of 100 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| =25 | mg/kg bw/day | ADI (group) | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| =25 | mg/kg bw/day | ADI (group) | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| 4 | unitless | Draize rabbit irritation score | Ocular | Rabbit | NTP_ICE_eye_irritation |
| 3 | unitless | EPA Classification | Ocular | Rabbit | NTP_ICE_eye_irritation |
| 239B50Y732 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 239B50Y732 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 239B50Y732 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 239B50Y732 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 31JQ3WOL8T | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 31JQ3WOL8T | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 31JQ3WOL8T | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 31JQ3WOL8T | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4Z93U4C2WN | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4Z93U4C2WN | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4Z93U4C2WN | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 4Z93U4C2WN | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 59IO08SBZU | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 59IO08SBZU | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 59IO08SBZU | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 59IO08SBZU | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 7T1F30V5YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 7T1F30V5YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 7T1F30V5YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 7T1F30V5YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| I42X3Q0FMF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| I42X3Q0FMF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| I42X3Q0FMF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| I42X3Q0FMF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0.03 | %/sec | Intensity | Ocular | - | NTP_ICE_eye_irritation |
| >180 | s | Lag time | Ocular | - | NTP_ICE_eye_irritation |
| =0.15 | g/kg/d | NOAEL | Gavage | Sprague-Dawley rats | CIR_vision_codex |
| =0.15 | g/kg/d | NOAEL | Gavage | Sprague-Dawley rats | CIR_vision_codex |
| =0.15 | g/kg/d | NOAEL | Gavage | Sprague-Dawley rats | CIR_vision_codex |
| =0.15 | g/kg/d | NOAEL | Gavage | Sprague-Dawley rats | CIR_vision_codex |
| =0.2 | % | NOAEL | oral | rat | CIR_vision_codex |
| =0.2 | % | NOAEL | oral | rat | CIR_vision_codex |
| =0.2 | % | NOAEL | oral | rat | CIR_vision_codex |
| =0.2 | % | NOAEL | oral | rat | CIR_vision_codex |
| =5 | mL/kg/d | NOAEL | Oral | Dog | CIR_vision_codex |
| =5 | mL/kg | NOAEL | Oral | Primate | CIR_vision_codex |
| =5 | mL/kg/d | NOAEL | Oral | Dog | CIR_vision_codex |
| =5 | mL/kg | NOAEL | Oral | Primate | CIR_vision_codex |
| =5 | mL/kg/d | NOAEL | Oral | Dog | CIR_vision_codex |
| =5 | mL/kg | NOAEL | Oral | Primate | CIR_vision_codex |
| =5 | mL/kg/d | NOAEL | Oral | Dog | CIR_vision_codex |
| =5 | mL/kg | NOAEL | Oral | Primate | CIR_vision_codex |
| =10 | mg/kg/d | NOAEL | oral | rat | CIR_vision_codex |
| =10 | mL/kg/d | NOAEL | Oral | Rat | CIR_vision_codex |
| =10 | µL/nostril/d | NOAEL | Intranasal | Mouse | CIR_vision_codex |
| =10 | mg/kg/d | NOAEL | oral | rat | CIR_vision_codex |
Showing 50 of 100 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Sorbitan monolaurate, ethoxylated | 500-018-3 | 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
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
ChEMBL Phase
Not listed
Adverse Events
103
Bioactivity
0
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA / FDA GRAS
1 records
E432 — 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 20?
Polysorbate 20 appears on 16 regulatory/inventory lists including children; Europe; Personal care, children; Europe; Personal care - body hygiene - body wash, children; Europe; Personal care - hair styling and care - shampoo, and 13 more. Source: EPA CPDat.
Is Polysorbate 20 used in cosmetics?
Yes, Polysorbate 20 is also indexed as a cosmetic ingredient under the name Polysorbate 20. 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 20 come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.
Is Polysorbate 20 used outside industrial chemicals?
Polysorbate 20 also appears in cosmetics, pharmaceutical, food safety, cannabis databases.