NOAEL Data REACH Registered Cosmetic Ingredient

Anhydrosorbitol stearate

Also known as: Sorbitan, monostearate, Stearic acid, monoester with sorbitan, Arlacel 60, Span 60, Sorbitan, monooctadecanoate (+9 more)

CAS 1338-41-6

Anhydrosorbitol stearate (CAS 1338-41-6) 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 Sorbitan Stearate →

SOURCE NOAEL studies
NOAEL studies
18
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
Anhydrosorbitol stearate
CAS Number
1338-41-6
Synonyms
Sorbitan, monostearateStearic acid, monoester with sorbitanArlacel 60Span 60Sorbitan, monooctadecanoatesorbitan stearateEINECS 215-664-9FEMA No. 3028D-Glucitol, anhydro-, monooctadecanoateGlycomul SLiposorb S-20Sorbitan monooctadecanoate

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 19 records
EmulsifierSurfactant (surface active agent)Dispersing agentHumectantProcessing aids not otherwise specifiedSolventThickening agentFlavouring and nutrientSurface modifier

Regulatory Lists

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

SOURCE EPA CPDat 11 records
ListKeywordSource
Canada; Personal care; Substances in PCP - Canada (4/2014)Government of CanadaCPCat
inert_ingredient; PesticidesEPACPCat
inert_ingredient; non_food_use; PesticidesEPACPCat
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)FDAUnited States Food and Drug Administration (FDA)
SCIL (9/2019)USEPASafer Chemical Ingredients List
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
Europe; plastic_additiveEuropean Chemicals AgencyEuropean Chemicals Agency (ECHA)
Europe; Personal careDanish Environmental Protection AgencyDanish EPA
Europe; Personal careDanish Environmental Protection AgencyDanish EPA

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 18 of 18 studies
ValueUnitEndpointRouteSpeciesSource
<=25mg/kgADIoralHumanWHO/JECFA
=10mg/kg bw/dayADI (group)-ConsumersEFSA
NVZ4I0H58XUNIIFDA UNII substance identifier--openFDA substances
>2000mg/kg bwLD50oralRatNTP ICE acute oral
>1.590e+4mg/kg bwLD50oralRatNTP ICE acute oral
>3.100e+4mg/kg bwLD50oralRatNTP ICE acute oral
=485mg/kg bw/dayLOAELoralDogToxValDB HPVIS
=0.5% dietNOAELdermalMouseToxValDB HPVIS
=5% dietNOAELdermalDogToxValDB HPVIS
>638mg/kg bw/dayNOAELoralDogECHA
1000mg/kg bw/dayNOAELoralratCOSMOS DB
>=1000mg/kg bw/dayNOAELoralRatECHA
1250mg/kg bw/dayNOAELoraldogCOSMOS DB
2500mg/kg bw/dayNOAELoralratCOSMOS DB
=2600mg/kg bw/dayNOAELoralMouseEFSA
=2600mg/kg bw/dayNOAELoral: feedMouseEFSA
5000mg/kg bw/dayNOAELoralratCOSMOS DB
=1000mg/kg bw/dayNOELoralRatToxValDB HESS

Showing 18 of 18 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records
StatusNameEC NumberLink
RegisteredSorbitan stearate215-664-9ECHA 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
-
Category
emulsifier
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed SORBITAN MONOSTEARATE
ChEMBL Phase
2
Adverse Events
0
Bioactivity
1
View full pharmaceutical profile →

Food Safety Data

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

SOURCE EFSA 1 records

E491 — 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 Anhydrosorbitol stearate?

Anhydrosorbitol stearate has 18 NOAEL studies in the database. The lowest reported value is 0.5 % diet via dermal in Mouse. Source: ToxValDB HPVIS.

What regulatory lists include Anhydrosorbitol stearate?

Anhydrosorbitol stearate appears on 10 regulatory/inventory lists including Canada; Personal care; Substances in PCP - Canada (4/2014), inert_ingredient; Pesticides, inert_ingredient; non_food_use; Pesticides, and 7 more. Source: EPA CPDat.

Is Anhydrosorbitol stearate used in cosmetics?

Yes, Anhydrosorbitol stearate is also indexed as a cosmetic ingredient under the name Sorbitan Stearate. 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 Anhydrosorbitol stearate 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 Anhydrosorbitol stearate used outside industrial chemicals?

Anhydrosorbitol stearate also appears in cosmetics, pharmaceutical, food safety, cannabis databases.