Excellent Emollient NOAEL Data GHS Classified Dermal Penetration

Palmitic Acid

INCI: PALMITIC ACID

CAS Number

57-10-3

Function

Saturated long-chain fatty acid (C16:0). One of the two predominant free fatty acids in the stratum corneum lipid matrix alongside stearic acid (C18:0). Contributes to the crystalline lamellar structure underpinning barrier function at the equimolar ceramide:cholesterol:FFA (1:1:1) molar ratio. Functions as emollient, consistency agent, co-emulsifier, and skin-conditioning agent. Predominantly palm-derived in cosmetic supply chains; also present in tallow and some plant oils.

Safety Rating

EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes Endogenous SC lipid component. No FDA or CIR restrictions. Palm-derived supply chain: EU Deforestation Regulation (EUDR) mandates plot-level traceability for palm oil and derivatives. RSPO Mass Balance or Segregated certification required for EU market compliance. Fully saturated — no oxidative stability concerns.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

low

Sensitization

none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Palmitic 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	7500 mg/kg bw/day	oral	mouse	Special Toxicology Study	COSMOS_DB

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 Palmitic Acid, relevant to systemic exposure and MoS calculations.

Absorption %

1-4%

Penetration Level

surface

Penetration Depth

stratum corneum

Molecular Weight

256.4 Da

Log P

6.4

Systemic Absorption

minimal

Topical Bioavailability

0.5-2%

Safety Margin Factor

low

Source: CIR

Expert Verdict

Endogenous stratum corneum free fatty acid (C16:0) contributing directly to the crystalline lamellar structure that underpins skin barrier function alongside stearic acid and ceramides. Formulation rationale: including palmitic and stearic acid in barrier-repair formulations helps replicate the approximately 1:1:1 molar ceramide:cholesterol:FFA ratio of healthy SC. Excellent safety and tolerability profile; fully saturated with no oxidative stability concern. Palm-derived supply chain note: EUDR traceability and RSPO certification are now market-mandatory for EU-facing products. Tallow or high-palmitic plant oil alternatives exist for non-palm supply chains.

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Concern Level: None

Regulatory Flags

sc-lipid-component barrier-active palm-derivative eudr-compliance rspo-required oxidatively-stable eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Palmitic Acid safe in cosmetics?

Is Palmitic Acid allowed in the EU?

Palmitic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Palmitic Acid do in cosmetics?

Palmitic Acid functions as: Saturated long-chain fatty acid (C16:0). One of the two predominant free fatty acids in the stratum corneum lipid matrix alongside stearic acid (C18:0). Contributes to the crystalline lamellar structure underpinning barrier function at the equimolar ceramide:cholesterol:FFA (1:1:1) molar ratio. Functions as emollient, consistency agent, co-emulsifier, and skin-conditioning agent. Predominantly palm-derived in cosmetic supply chains; also present in tallow and some plant oils.. It is classified as a Emollient in our database. CAS number: 57-10-3.

What is the Margin of Safety for Palmitic Acid?

adequate 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 Palmitic Acid?

The NOAEL (No Observed Adverse Effect Level) for Palmitic Acid is 7500 mg/kg bw/day based on a Special Toxicology Study study via oral route in mouse. Source: COSMOS_DB.

Compliance Tools

Check Palmitic Acid compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

Calculate Margin of Safety using SCCS methodology

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Heavy Metal Limits

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