Is Squalane safe in cosmetics?
Squalane has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Squalane
Also known as: 4-01-00-00593, BRN 0776019, Caswell No. 482A, EINECS 203-825-6, EPA Pesticide Chemical Code 045503 (+3 more)
INCI: SQUALANE
Squalane (CAS 111-01-3) is a cosmetic emollient functioning as emollient, skin-conditioning, spreading agent. NOAEL 10000 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 111-01-3 →
Auto-generated CPSR Part A draft with source citations
Function
emollient, skin-conditioning, spreading agent
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR Expert Panel confirmed safe; no FDA OTC drug concerns. VCRP 2019: 527 formulations listed for the Squalane/Squalene CIR review. No specific concentration limits imposed by FDA. Used up to 96.8% in US market formulations.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Squalane.
Calculate MoS for your specific formulation with the MoS Calculator.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Squalane across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Squalane, relevant to systemic exposure and MoS calculations.
Absorption %
1-4%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
422.8 Da
Log P
12.8
Systemic Absorption
minimal
Topical Bioavailability
0.5-3%
Safety Margin Factor
low
Source: Cosmetic Science
EPA ToxValDB — Toxicity Values
6 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOAEL | ~10000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOEL | ~1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
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
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_restricted | - | 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 | 2–10 | 30 | CIR/VCRP |
| Serum | 5–20 | 30 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "111-01-3", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "1", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction_a…
anti_aging
{"anti_aging_claim": "hydration-plumping, barrier-repair, antioxidant-protection", "mechanism_of_action": "Lipid emollient, prevents TEWL, antioxidant, mimics sebum", "target_skin_layer": "stratum corneum", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "5-10", "clinical_study_duration_weeks": "8", "sample_size": "30", "double_blind": "Yes", "placebo_controlled"…
anti_pollution
{"cas_number": "111-01-3", "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_inhibitio…
baby_pediatric
{"cas_number": "111-02-4/13986-24-8", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Biomimetic lipid, non-occlusive, stable, hypoallergenic", "transepidermal_absorption_risk_pediatric": "very_low", "dose_per_kg_body_weight_concern": "Biomimeti…
comedogenicity_detail
{"comedogenicity_rating": "1", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,mature,rosacea", "acne_safe": "yes", "source": "Dermatologic literature"}
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "5.0", "typical_concentration_pct": "3.0", "product_type": "Facial Oil", "function_at_concentration": "Emollient", "source": "CIR Safety Assessment"}
dermal_absorption
{"molecular_weight_da": "422.8", "log_p_value": "12.8", "skin_penetration_level": "stratum-corneum", "penetration_depth": "stratum corneum", "absorption_pct": "1-4", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "yes", "vehicle_dependent": "no", "skin_barrier_effect": "strengthens", "bioavailability_topical_pct": "0.5-3", "safety_margin_factor": "low", "source…
emulsion_hlb
{"hlb_required_as_emulsifier": "no", "hlb_required_of_oil_phase": "12", "co_emulsifier_pairs": "polysorbate_80,ceteth_20", "optimal_oil_phase_pct": "10-30", "optimal_water_phase_pct": "70-90", "droplet_size_range_um": "1-20", "creaming_resistance": "good", "coalescence_resistance": "excellent", "ostwald_ripening_resistance": "excellent", "freeze_thaw_stability": "excellent", "rheology_modifier_typ…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Humectant
Softener and conditioner
Regulatory List Membership (3)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
EPA Safer Chemical Ingredients List (SCIL)
Expert Verdict
Expert safety assessment and concern-level summary for Squalane.
Regulatory Flags
cir-reviewed
endogenous-compound
emollient
high-concentration-use
no-eu-restriction
hydrogenated-stable
eu_children_restricted
epa_safer_alternative
Known Synonyms
4-01-00-00593
BRN 0776019
Caswell No. 482A
EINECS 203-825-6
EPA Pesticide Chemical Code 045503
Hexamethyl tetracosane
Hexamethyltetracosane
UNII-GW89575KF9
Chemical Function
Softener and conditioner
Biocide
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Personal care
Europe; Personal care
Europe; Personal care
Europe; Personal care
Europe; Personal care
Europe; Personal care
SCIL (9/2019)
Canada; pharmaceutical
Australian Status
AICIS status: listed
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
SQUALANE
ChEMBL ID
CHEMBL1552157
Max Phase
-1
Frequently Asked Questions
Is Squalane allowed in the EU?
Squalane EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Squalane do in cosmetics?
Squalane functions as: emollient, skin-conditioning, spreading agent. It is classified as a Emollient in our database. CAS number: 111-01-3.
Is Squalane used outside cosmetics?
Squalane 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 Squalane 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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