Excellent Humectant NOAEL Data Dermal Penetration

Sodium PCA

Also known as: EINECS 249-277-1, L-5-Oxoproline monosodium salt, 5-Oxo-L-proline monosodium salt, UNII-1V74VH163T

INCI: SODIUM PCA

Sodium PCA (CAS 28874-51-3) is a cosmetic humectant functioning as Humectant, NMF component (pyrrolidone carboxylic acid fraction). Reported NOAEL =7200 mg/kg bw/day in Rat (ECHA); 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 data.

View industrial chemical safety profile for CAS 28874-51-3 →

Auto-generated CPSR Part A draft with source citations
Function
Humectant, NMF component (pyrrolidone carboxylic acid fraction)
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
249-277-1

Regulatory Status

EU EU Status permitted
US 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 multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Sodium PCA.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Sodium PCA. 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 =7200 mg/kg bw/day oral Rat subchronic ECHA
NOAEL =8200 mg/kg bw/day oral Rat subchronic ECHA

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

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Serum 0.5–2 5 CIR Safety Assessment
Body Lotion 0.5–2 5 CIR Safety Assessment

Additional Ingredient Properties

10 property records from structured ingredient metadata.

acne
{"cas_number": "28874-51-3", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "0-1", "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_restricti…
amino_acid
{"cas_number": "28874-51-3", "ingredient_class": "amino_acid", "source_origin": "fermentation", "molecular_weight_range_Da": "151", "amino_acid_composition_key": "pyrrolidone_carboxylic_acid", "charge_at_pH_5_5": "anionic", "water_solubility": "soluble", "oil_solubility": "insoluble", "film_forming_ability": "good", "moisture_binding_capacity": "excellent", "NMF_component": "yes", "skin_penetratio…
anti_aging
{"anti_aging_claim": "hydration-plumping, barrier-repair", "mechanism_of_action": "Building block for proteins, NMF component", "target_skin_layer": "epidermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "8-15", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "Yes", "placebo_controlled": "Yes", "published_journal": "Int J Cosm…
baby_pediatric
{"cas_number": "28874-51-3", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Natural moisturizing factor", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Humec…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,sensitive,combination,normal,acne-prone,mature,rosacea", "acne_safe": "yes", "source": "Natural moisturizing factor"}
concentration
{"min_concentration_pct": "0.5", "max_concentration_pct": "2.0", "typical_concentration_pct": "1.0", "product_type": "Toner", "function_at_concentration": "Hydration", "source": "Supplier TDS"}
cost_pricing
{"cost_tier": "mid-range", "estimated_cost_per_kg_usd_low": "18", "estimated_cost_per_kg_usd_high": "32", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "Global", "bulk_discount_threshold_kg": "100", "seasonal_price_variation": "low", "commodity_or_specialty": "specialty", "substitute_ingredients": "PCA, Sodium La…
dermal_absorption
{"molecular_weight_da": "139.1", "log_p_value": "-3.8", "skin_penetration_level": "surface", "penetration_depth": "stratum corneum", "absorption_pct": "2-5", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "no", "skin_barrier_effect": "strengthens", "bioavailability_topical_pct": "1-3", "safety_margin_factor": "low", "source": "Int J C…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Anti-static agent Humectant Softener and conditioner
Regulatory List Membership (1)
EU Regulated in Personal Care

Expert Verdict

Expert safety assessment and concern-level summary for Sodium PCA.

Regulatory Flags

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

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Sodium PCA by CAS number or substance name.

Studies
2
Lowest NOAEL
7200 mg/kg bw/day
Highest NOAEL
8200 mg/kg bw/day
ECHA

Known Synonyms

EINECS 249-277-1 L-5-Oxoproline monosodium salt 5-Oxo-L-proline monosodium salt UNII-1V74VH163T

Chemical Function

Humectant Anti-static agent Softener and conditioner

Regulatory Lists

Europe; Personal care Europe; Personal care Europe; Personal care

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Sodium PCA safe in cosmetics?

Sodium PCA has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.

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 NOAEL for Sodium PCA?

The NOAEL (No Observed Adverse Effect Level) for Sodium PCA is =7200 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 2 study endpoints are available. Source: ECHA.

Is Sodium PCA used outside cosmetics?

Sodium PCA also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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