Is PEG-20 SORBITAN OLEATE safe in cosmetics?
PEG-20 SORBITAN OLEATE has a safety rating of "GOOD" in our database. EU status: permitted. US status: allowed. 4 toxicological study endpoint(s) are available in our database.
PEG-20 SORBITAN OLEATE
Also known as: Glycols, polyethylene, ether with sorbitan monooleate, Armotan pmo-20, Drewmulse poe-smo, FEMA No. 2917, Glycosperse O-20 (+14 more)
PEG-20 SORBITAN OLEATE (CAS 9005-65-6) is a cosmetic cosmetic ingredient functioning as Cleansing, Surfactant - Cleansing, Surfactant - Emulsifying. NOAEL 833.333 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, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 9005-65-6 →
Auto-generated CPSR Part A draft with source citations
Function
Cleansing, Surfactant - Cleansing, Surfactant - Emulsifying
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
allowed
US Notes
Allowed — also FDA-approved as a food additive (21 CFR 172.840) and pharmaceutical excipient, reflecting extensive safety evaluation.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Toxicological Studies
4 study endpoints found for PEG-20 SORBITAN OLEATE. 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 | 1000 mg/kg bw/day | oral | monkey | Subchronic | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 10000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for PEG-20 SORBITAN OLEATE 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 |
|---|---|---|---|---|---|
| NOAEL | =2500 mg/kg-day | Rat | oral | chronic | EFSA |
| NOEL | =0.5 % | Mouse | injection | acute | ECOTOX |
| LEL | =7500 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LEL | =7500 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LEL | >2500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LEL | =2500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LOAEL | =7500 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LOAEL | =7500 mg/kg-day | Mouse | oral | chronic | ToxRefDB |
| LOAEL | >2500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
| LOAEL | >2500 mg/kg-day | Rat | oral | chronic | ToxRefDB |
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 15517.24 | - | - |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: surfactant
Receptor targets: ERα (limited evidence)
LOEC: 100 µM
EU status: allowed
weak agonist
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Cleaning agent
Dispersing agent
Dye
Emulsifier
Flavouring and nutrient
Fragrance
Lubricating agent
Pharmaceutical
Preservative
Regulatory List Membership (3)
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 PEG-20 SORBITAN OLEATE.
Regulatory Flags
cosing-sourced
eu-permitted
surfactant
needs-enrichment
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to PEG-20 SORBITAN OLEATE by CAS number or substance name.
Studies
4
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
10000 mg/kg bw/day
COSMOS_DB
Known Synonyms
Glycols, polyethylene, ether with sorbitan monooleate
Armotan pmo-20
Drewmulse poe-smo
FEMA No. 2917
Glycosperse O-20
Glycosperse O-20X
Glycosperse O-20 VEG
NCI-C60286
Nikkol TO
Peg sorbitan oleate
Polyethylene oxide sorbitan mono-oleate
Polyoxyethylene 20 sorbitan monooleate
Polyoxyethylene(20) sorbitan monooleate
Polyoxyethylene sorbitan oleate
Polysorbate 80 B.P.C.
Polysorbate 80, U.S.P.
Polysorbate 80 BPC
Polysorbate 80, USP
Protasorb O-20
Chemical Function
Emulsifier
Fragrance
Surfactant (surface active agent)
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
inert_ingredient; Pesticides
fracking; water
pharmaceutical
Europe; Personal care - body hygiene - hand soap
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
polysorbate 80
ChEMBL ID
CHEMBL1697847
Adverse Event Associations
105
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 80 (pharmaceutical grade)
E Number
E433-pharma
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is PEG-20 SORBITAN OLEATE allowed in the EU?
PEG-20 SORBITAN OLEATE EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does PEG-20 SORBITAN OLEATE do in cosmetics?
PEG-20 SORBITAN OLEATE functions as: Cleansing, Surfactant - Cleansing, Surfactant - Emulsifying. It is classified as a cosmetic ingredient in our database. CAS number: 9005-65-6.
What is the NOAEL for PEG-20 SORBITAN OLEATE?
The NOAEL (No Observed Adverse Effect Level) for PEG-20 SORBITAN OLEATE is 1000 mg/kg bw/day based on a Subchronic study via oral route in monkey. A total of 4 study endpoints are available. Source: COSMOS_DB.
Is PEG-20 SORBITAN OLEATE used outside cosmetics?
PEG-20 SORBITAN OLEATE also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check PEG-20 SORBITAN OLEATE 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
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