Excellent Humectant Dermal Penetration

Sodium PCA

INCI: SODIUM PCA

CAS Number
28874-51-3
Function
Humectant, NMF component (pyrrolidone carboxylic acid fraction)
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Listed in FDA Voluntary Cosmetic Registration Program (VCRP); used in 1,289 formulations as of the 2019 CIR assessment. Not subject to specific FDA restrictions for cosmetic use under 21 CFR general cosmetic ingredient provisions. CIR Expert Panel concluded safe in 2019.

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.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Sodium PCA, relevant to systemic exposure and MoS calculations.

Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
139.1 Da
Log P
-3.8
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low

Source: Int J Cosmet Sci 1993

Expert Verdict

Sodium PCA is a naturally occurring component of human skin's Natural Moisturizing Factor and is permitted in EU cosmetics without concentration limits. The CIR Expert Panel (2019) concluded it is safe at present practices of use (0.2-4%), with no sensitization, irritation, genotoxicity, or reproductive toxicity findings. Avoid combination with N-nitrosating agents due to potential nitrosamine formation.

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Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion humectant non-sensitizing

Frequently Asked Questions

Is Sodium PCA safe in cosmetics?

Sodium PCA is a naturally occurring component of human skin's Natural Moisturizing Factor and is permitted in EU cosmetics without concentration limits. The CIR Expert Panel (2019) concluded it is safe at present practices of use (0.2-4%), with no sensitization, irritation, genotoxicity, or reproductive toxicity findings. Avoid combination with N-nitrosating agents due to potential nitrosamine formation. The EU classifies Sodium PCA as "permitted". Safety rating: EXCELLENT.

Is Sodium PCA allowed in the EU?

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

What does Sodium PCA do in cosmetics?

Sodium PCA functions as: Humectant, NMF component (pyrrolidone carboxylic acid fraction). It is classified as a Humectant in our database. CAS number: 28874-51-3.

What is the Margin of Safety for Sodium PCA?

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.

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