What is the NOAEL for Anhydrosorbitol stearate?
Anhydrosorbitol stearate has 22 NOAEL studies in the database. The lowest reported value is 10 mg/kg bw/day in Consumers. Source: EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx.
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.
SOURCE
noael studies public
NOAEL studies
22
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
Anhydrosorbitol stearate
CAS Number
1338-41-6
DTXSID
DTXSID1027396
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
| List | Keyword | Source |
|---|---|---|
| Canada; Personal care; Substances in PCP - Canada (4/2014) | Government of Canada | CPCat |
| inert_ingredient; Pesticides | EPA | CPCat |
| inert_ingredient; non_food_use; Pesticides | EPA | 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 |
| 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 |
| Europe; plastic_additive | European Chemicals Agency | European Chemicals Agency (ECHA) |
| Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 22 of 22 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| <=25 | mg/kg | ADI | oral | Human | ToxValDB_WHO_JECFA_ADI |
| =10 | mg/kg bw/day | ADI (group) | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| =10 | mg/kg bw/day | ADI (group) | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| NVZ4I0H58X | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| NVZ4I0H58X | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| NVZ4I0H58X | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| NVZ4I0H58X | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| >2000 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| >15900 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| >31000 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
| =485 | mg/kg bw/day | LOAEL | oral | Dog | ToxValDB_HPVIS |
| =0.5 | % diet | NOAEL | dermal | Mouse | ToxValDB_HPVIS |
| =5 | % diet | NOAEL | dermal | Dog | ToxValDB_HPVIS |
| >638 | mg/kg bw/day | NOAEL | oral | Dog | ToxValDB_ECHA_IUCLID |
| 1000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| >=1000 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| 1250 | mg/kg bw/day | NOAEL | oral | dog | COSMOS_DB |
| 2500 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| =2600 | mg/kg bw/day | NOAEL | oral | Mouse | ToxValDB_EFSA |
| =2600 | mg/kg bw/day | NOAEL | oral: feed | Mouse | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| 5000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS_DB |
| =1000 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB_HESS |
Showing 22 of 22 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Sorbitan stearate | 215-664-9 | 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
-
Category
emulsifier
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
SORBITAN MONOSTEARATE
ChEMBL Phase
2
Adverse Events
0
Bioactivity
1
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA / FDA GRAS
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 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.