Excellent Emollient NOAEL Data Dermal Penetration

Phytosqualane

INCI: SQUALANE

CAS Number
111-01-3
Function
Emollient; plant-derived hydrogenated squalene
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Phytosqualane. 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 ca.10000 mg/kg bw/day oral rat oral REACH

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

Expert Verdict

CAS 111-01-3 (INCI: Squalane). EU: Not restricted under Regulation 1223/2009; freely permitted, listed in CosIng inventory with no concentration limits. US: CIR affirmed safe (1982, reaffirmed 2001, 2019). EWG Score: 1 (Low Hazard). Phytosqualane is plant-derived squalane -- same molecule, same CAS, same regulatory standing.

⚠️
Concern Level: None

Regulatory Flags

plant-derived source-dependent eco-preferred low-absorption non-sensitizing cir-affirmed eu_children_restricted epa_safer_alternative

Frequently Asked Questions

Is Phytosqualane safe in cosmetics?

CAS 111-01-3 (INCI: Squalane). EU: Not restricted under Regulation 1223/2009; freely permitted, listed in CosIng inventory with no concentration limits. US: CIR affirmed safe (1982, reaffirmed 2001, 2019). EWG Score: 1 (Low Hazard). Phytosqualane is plant-derived squalane -- same molecule, same CAS, same regulatory standing. The EU classifies Phytosqualane as "permitted". Safety rating: EXCELLENT. 1 toxicological study endpoint(s) are available in our database.

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.

What is the Margin of Safety for Phytosqualane?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Phytosqualane?

The NOAEL (No Observed Adverse Effect Level) for Phytosqualane is ca.10000 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

Colloidal Oatmeal (Avena Sativa Kernel Flour)
Good
Methicone
Excellent
Isocetyl Stearate
Good
Elemi Oil (Canarium Luzonicum)
Good
Castor Oil
Excellent
Browse all 30,000+ ingredients →
📱

Is Phytosqualane in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Phytosqualane in your formulation.

Ingredient Decoder MoS Calculator