Is Sorbitan Stearate safe in cosmetics?
Sorbitan Stearate has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 3 toxicological study endpoint(s) are available in our database.
Sorbitan Stearate
Also known as: Sorbitan, monostearate, Stearic acid, monoester with sorbitan, Arlacel 60, Span 60, Sorbitan, monooctadecanoate (+8 more)
INCI: SORBITAN STEARATE
Sorbitan Stearate (CAS 1338-41-6) is a cosmetic emulsifier functioning as Emulsifier; W/O co-emulsifier; stabilizer. NOAEL 161.667 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 1338-41-6 →
Auto-generated CPSR Part A draft with source citations
Function
Emulsifier; W/O co-emulsifier; stabilizer
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR assessed sorbitan esters as safe as used. Non-ethoxylated sorbitan stearate (C18). HLB 4.7 — W/O emulsification range. COSMOS-eligible. Often paired with Polysorbate 60 for HLB-balanced O/W systems.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Sorbitan Stearate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Sorbitan Stearate. 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 | 1250 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Sorbitan Stearate 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 |
|---|---|---|---|---|---|
| ADI | <=25 mg/kg | Human | oral | - | WHO JECFA ADI |
| NOAEL | =2600 mg/kg-day | Mouse | oral | chronic | EFSA |
| NOEL | =1000 mg/kg-day | Rat | oral | subchronic | HESS |
| LD50 | >15900 mg/kg | Rat | oral | - | HPVIS |
| NOAEL | >=1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | >=1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | >638 mg/kg-day | Dog | oral | chronic | ECHA IUCLID |
| LD50 | =31000 mg/kg | Rat | oral | - | ChemIDplus |
| LD50 | >15900 mg/kg | Rat | oral | - | HPVIS |
| LOAEL | =485 mg/kg-day | Dog | oral | chronic | HPVIS |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
9 property records from structured ingredient metadata.
baby_pediatric
{"cas_number": "CAS-FUNC-22", "ingredient_class": "other", "pediatric_safety_rating": "good", "minimum_age_months": "3", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Functional ingredient - generally safe", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern…
comedogenicity_detail
{"comedogenicity_rating": "1", "irritancy_rating": "1", "skin_type_suitability": "dry,combination,normal", "acne_safe": "yes", "source": "Emulsifier"}
emulsion_hlb
{"hlb_value": "4.7", "hlb_required_as_emulsifier": "yes", "emulsifier_type": "w_o", "critical_packing_parameter": "0.60-0.80", "emulsion_stabilization_mechanism": "steric_stabilization", "co_emulsifier_pairs": "polysorbate_60,cetyl_alcohol", "optimal_oil_phase_pct": "50-80", "optimal_water_phase_pct": "20-50", "electrolyte_tolerance": "high", "pH_emulsion_stability_range": "5.0-10.0", "viscosity_b…
hair_care
{"hair_function": "conditioning", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "kera…
pediatric_safety
{"safe_for_newborn_0_6m": "yes", "safe_for_infant_6_12m": "yes", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "5.0", "adult_max_concentration_pct": "5.0", "pediatric_dermal_absorption_factor": "minimal", "diaper_area_safe": "yes", "pediatric_allergy_prevalence": "low", "banned_in_children_products_eu": "no", "banne…
ph_stability
{"optimal_ph_min": "3.0", "optimal_ph_max": "9.0", "stable_ph_min": "3.0", "stable_ph_max": "10.0", "ph_dependent_function": "Non-ionic W/O emulsifier", "formulation_note": "Low HLB ~4.7", "source": "Formulation literature"}
self_tanning
{"cas_number": "1338-41-6", "ingredient_class": "other", "tanning_mechanism": "other", "color_development_onset_hours": "0.0", "full_color_development_hours": "0", "color_duration_days": "0", "DHA_concentration_if_applicable_pct": "0", "erythrulose_concentration_pct": "0", "pH_dependent_color": "no", "formaldehyde_release_concern": "no", "formaldehyde_release_ppm": "0", "AGE_formation_concern": "n…
sensory
{"silky": "waxy", "smooth, glides easily": "creamy, emulsifies", "dry-touch, non-greasy": "soft, smooth", "instant": "moderate", "low": "high", "w/o": "w/o", "very-high": "moderate", "no": "yes", "yes": "no", "light-diffusing": "matte", "1.40": "1.46", "transparent": "opaque", "colorless": "white", "excellent": "fair", "light": "medium", "synthetic": "botanical"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dispersing agent
Emulsifier
Flavouring and nutrient
Humectant
Processing aids not otherwise specified
Solvent
Surface modifier
Surfactant (surface active agent)
Thickening agent
Regulatory List Membership (4)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Sorbitan Stearate.
Regulatory Flags
non-ethoxylated
peg-free
cosmos
w-o-emulsifier
hlb-blending
solid-texture
eu_children_restricted
epa_safer_alternative
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Sorbitan Stearate by CAS number or substance name.
Studies
3
Lowest NOAEL
1250 mg/kg bw/day
Highest NOAEL
5000 mg/kg bw/day
COSMOS_DB
Known Synonyms
Sorbitan, monostearate
Stearic acid, monoester with sorbitan
Arlacel 60
Span 60
Sorbitan, monooctadecanoate
EINECS 215-664-9
FEMA No. 3028
D-Glucitol, anhydro-, monooctadecanoate
Glycomul S
Liposorb S-20
Sorbitan monooctadecanoate
Sorbitani stearas
UNII-NVZ4I0H58X
Chemical Function
Emulsifier
Surfactant (surface active agent)
Dispersing agent
Humectant
Regulatory Lists
Canada; Personal care; Substances in PCP - Canada (4/2014)
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
SCIL (9/2019)
pharmaceutical
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; plastic_additive
Europe; Personal care
Europe; Personal care
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
SORBITAN MONOSTEARATE
ChEMBL ID
CHEMBL3186117
Max Phase
2
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Sorbitan monostearate
E Number
E491
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Sorbitan Stearate allowed in the EU?
Sorbitan Stearate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Sorbitan Stearate do in cosmetics?
Sorbitan Stearate functions as: Emulsifier; W/O co-emulsifier; stabilizer. It is classified as a Emulsifier in our database. CAS number: 1338-41-6.
What is the NOAEL for Sorbitan Stearate?
The NOAEL (No Observed Adverse Effect Level) for Sorbitan Stearate is 1250 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 3 study endpoints are available. Source: COSMOS_DB.
Is Sorbitan Stearate used outside cosmetics?
Sorbitan Stearate 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 Sorbitan Stearate 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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