Is Stearic Acid safe in cosmetics?
Stearic Acid has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Stearic Acid
Also known as: 4-02-00-01206, BRN 0608585, Caswell No. 801D, Dar-chem 14, EINECS 200-313-4 (+14 more)
INCI: STEARIC ACID
Stearic Acid (CAS 57-11-4) is a cosmetic emulsifier functioning as emulsifier. Reported NOAEL =450 mg/kg bw/day in Rat (EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx); EU Regulation 1223/2009 status: permitted, max 20-40%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 57-11-4 →
Auto-generated CPSR Part A draft with source citations
Function
emulsifier
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
EU Max Conc.
20-40%
US US Status
permitted
US Notes
GRAS status (FDA); widely used at high concentrations in shaving soaps; low irritation potential
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Stearic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Stearic Acid. 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 | =450 mg/kg bw/day | oral: gavage | Rat | subchronic | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| NOAEL | =450 mg/kg bw/day | oral: gavage | Rat | subchronic | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Stearic Acid, relevant to systemic exposure and MoS calculations.
Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
284.5 Da
Log P
7.0
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Source: CIR
EPA ToxValDB — Toxicity Values
5 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >5000 mg/kg | Rabbit | dermal | - | ECHA IUCLID |
| LOEL | =0.9 mM | European Rabbit | environmental | short-term | ECOTOX |
| LOEL | =0.09 mM | European Rabbit | environmental | short-term | ECOTOX |
| LD50 | >5000 mg/kg | Rabbit | dermal | - | ChemIDplus |
| LD50 | =4600 mg/kg | Rat | oral | - | HPVIS |
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 | 4725 | - | - |
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: other
Receptor targets: PPARγ (limited)
LOEC: 10 µM
EU status: allowed
weak agonist (PPARγ)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | halal_prohibited | - | All cosmetics |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 2–8 | 20 | CIR/VCRP |
| Body Lotion | 2–8 | 20 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
anti_aging
{"anti_aging_claim": "barrier-repair", "mechanism_of_action": "Lipid barrier restoration, TEWL reduction, emollient", "target_skin_layer": "stratum corneum", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "4-8", "clinical_study_duration_weeks": "8", "sample_size": "30", "double_blind": "No", "placebo_controlled": "Yes", "published_journal": "Int J Cosmet Sci, PM…
anti_pollution
{"cas_number": "57-11-4", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
baby_pediatric
{"cas_number": "CAS-FUNC-13", "ingredient_class": "other", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Fatty acid - natural, safe", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Functional ingre…
comedogenicity_detail
{"comedogenicity_rating": "2", "irritancy_rating": "1", "skin_type_suitability": "dry,combination,normal", "acne_safe": "caution", "source": "Fatty acid - repeated"}
concentration
{"min_concentration_pct": "2.0", "max_concentration_pct": "10.0", "typical_concentration_pct": "6.0", "product_type": "Body Lotion", "function_at_concentration": "Emulsifier", "source": "CIR Safety Assessment"}
cost_pricing
{"cost_tier": "budget", "estimated_cost_per_kg_usd_low": "5", "estimated_cost_per_kg_usd_high": "10", "natural_premium_markup_pct": "15", "organic_certified_premium_pct": "35", "supply_chain_volatility": "medium", "primary_source_region": "Malaysia/Indonesia", "synthetic_vs_natural_cost_ratio": "1.5", "bulk_discount_threshold_kg": "1000", "seasonal_price_variation": "medium", "commodity_or_special…
deodorant
{"cas_number": "57-11-4", "ingredient_class": "other", "mechanism_of_action": "other", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "0", "odor_reduction_pct": "0", "bacteriostatic": "no", "bactericidal": "no", "microbiome_impact": "neutral", "axillary_microbiome_effect": "varies by ingredient", "MIC_value_if_antimicrobial": "varies", "astringency_level": "varies"…
dermal_absorption
{"molecular_weight_da": "284.5", "log_p_value": "7.0", "skin_penetration_level": "surface", "penetration_depth": "stratum corneum", "absorption_pct": "1-3", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "yes", "vehicle_dependent": "no", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "0.5-2", "safety_margin_factor": "low", "source": "CIR"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-adhesive/cohesive
Binder
Catalyst
Chemical reaction regulator
Cleaning agent
Deodorizer
Dispersing agent
Emulsifier
Filler
Flavouring and nutrient
Regulatory List Membership (6)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for Stearic Acid.
Regulatory Flags
peg-free
in-situ-soap-precursor
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Stearic Acid by CAS number or substance name.
Studies
8
Lowest NOAEL
450 mg/kg bw/day
Highest NOAEL
1500 mg/kg bw/day
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip
Known Synonyms
4-02-00-01206
BRN 0608585
Caswell No. 801D
Dar-chem 14
EINECS 200-313-4
Emersol 132
Emersol 150
EPA Pesticide Chemical Code 079082
FEMA No. 3035
Formula 300
Glycon S-70
Glycon S-80
Glycon S-90
Glycon DP
Glycon TP
Hy-phi 1199
Hy-phi 1205
Hy-phi 1303
Hy-phi 1401
Chemical Function
Emulsifier
Processing aids not otherwise specified
Surfactant (surface active agent)
Deodorizer
Cleaning agent
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
Arts and crafts/Office supplies - children's art and toys - modeling clay; detected; Europe
Cleaning products and household care - air freshener; Europe
detected; Europe; Toys and children's products
detected; Europe; Toys and children's products
Europe
pharmaceutical
drinking_water; Europe; manufacturing; plastic_additive
inert_ingredient; Pesticides
children; Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Road vehicles
Europe; Personal care - liniment
Europe; Other direct contact consumer goods
Europe; plastic_additive
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
STEARIC ACID
ChEMBL ID
CHEMBL46403
Max Phase
-1
Adverse Event Associations
694
Frequently Asked Questions
Is Stearic Acid allowed in the EU?
Stearic Acid EU regulatory status: permitted. Maximum allowed concentration: 20-40%. This is based on EU Regulation 1223/2009 and its amendments.
What does Stearic Acid do in cosmetics?
Stearic Acid functions as: emulsifier. It is classified as a Emulsifier in our database. CAS number: 57-11-4.
What is the NOAEL for Stearic Acid?
The NOAEL (No Observed Adverse Effect Level) for Stearic Acid is =450 mg/kg bw/day based on a subchronic study via oral: gavage route in Rat. A total of 2 study endpoints are available. Source: EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx.
Is Stearic Acid used outside cosmetics?
Stearic Acid also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Stearic Acid 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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