Is Phytosqualane safe in cosmetics?
Phytosqualane has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Phytosqualane
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
Phytosqualane (CAS 111-01-3) is a cosmetic emollient functioning as Emollient; plant-derived hydrogenated squalene. 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; plant-derived hydrogenated squalene
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No FDA restriction. CIR Expert Panel reaffirmed safe in 2019 across all cosmetic product types and reported concentrations. Historically derived from shark liver; phytosqualane variant preferred for vegan/sustainability claims -- identical regulatory status.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Phytosqualane.
Calculate MoS for your specific formulation with the MoS Calculator.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Phytosqualane across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Phytosqualane, 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 Phytosqualane.
Regulatory Flags
plant-derived
source-dependent
eco-preferred
low-absorption
non-sensitizing
cir-affirmed
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 Phytosqualane allowed in the EU?
Phytosqualane EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Phytosqualane do in cosmetics?
Phytosqualane functions as: Emollient; plant-derived hydrogenated squalene. It is classified as a Emollient in our database. CAS number: 111-01-3.
Is Phytosqualane used outside cosmetics?
Phytosqualane 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 Phytosqualane 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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