Excellent Emollient NOAEL Data Dermal Penetration

Squalane

INCI: SQUALANE

CAS Number
111-01-3
Function
emollient, skin-conditioning, spreading agent
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Squalane. 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 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

Expert Verdict

CIR confirmed Squalane safe in current practices of use up to 96.8%. Hydrogenated form of Squalene (CAS 111-01-3) is fully saturated and non-oxidizable with no peroxide formation risk. No EU source restriction. No genotoxicity or carcinogenicity concerns. Ideal leave-on emollient.

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Concern Level: None

Regulatory Flags

cir-reviewed endogenous-compound emollient high-concentration-use no-eu-restriction hydrogenated-stable eu_children_restricted epa_safer_alternative

Frequently Asked Questions

Is Squalane safe in cosmetics?

CIR confirmed Squalane safe in current practices of use up to 96.8%. Hydrogenated form of Squalene (CAS 111-01-3) is fully saturated and non-oxidizable with no peroxide formation risk. No EU source restriction. No genotoxicity or carcinogenicity concerns. Ideal leave-on emollient. The EU classifies Squalane as "permitted". Safety rating: EXCELLENT. 1 toxicological study endpoint(s) are available in our database.

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.

What is the Margin of Safety for Squalane?

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 Squalane?

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

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