Excellent Preservative NOAEL Data Sensitization Data Dermal Penetration

Potassium Sorbate

INCI: POTASSIUM SORBATE

CAS Number
590-00-1
Function
preservative
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.6% as sorbic acid equivalent
🇺🇸 US Status permitted
US Notes Permitted; GRAS for food use (21 CFR 182.3640). No US-specific cosmetic concentration cap. Very low sensitization rate — preferred preservative for sensitive-skin and baby formulations. pH-dependent efficacy: most active below pH 5.5 as undissociated sorbic acid.

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

10 study endpoints found for Potassium Sorbate. 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 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 460 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 340 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 7500 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 500 mg/kg bw/day oral dog Subchronic COSMOS_DB
dose_tested 460 mg/kg bw/day oral mouse Developmental COSMOS_DB

Sensitization Profile

Contact sensitization data for Potassium Sorbate based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Dermal Penetration Profile

Skin absorption and penetration characteristics of Potassium Sorbate, relevant to systemic exposure and MoS calculations.

Absorption %
1-4%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
150.2 Da
Log P
-1.6
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

Expert Verdict

Excellent safe preservative for sensitive-skin applications when formulated at pH <5.5. Potassium sorbate delivers very low sensitization rates — substantially lower than phenoxyethanol (0.3–1%) and vastly lower than MI (6–12%) — confirming suitability for leave-on sensitive and baby formulations. Antimicrobial spectrum is narrower than broad-spectrum systems (limited against yeasts and molds; moderate vs bacteria), making it best suited for combination use with sodium benzoate in pH-optimized formulations (pH <5.5). Formulating at pH 5.5 (acid mantle preservation for syndet cleansers and leave-on moisturizers) aligns perfectly with optimal pH for organic acid preservative activity. EU Annex V listed at ≤0.6% as sorbic acid equivalent. Not restricted in US. Supports clean-label positioning.

⚠️
Concern Level: None

Regulatory Flags

preservative eu-annex-v organic-acid very-low-sensitization ph-dependent sensitive-skin-suitable baby-safe clean-label gras synergistic-with-sodium-benzoate ph-5.5-optimal eu_children_restricted epa_safer_alternative

Frequently Asked Questions

Is Potassium Sorbate safe in cosmetics?

Excellent safe preservative for sensitive-skin applications when formulated at pH <5.5. Potassium sorbate delivers very low sensitization rates — substantially lower than phenoxyethanol (0.3–1%) and vastly lower than MI (6–12%) — confirming suitability for leave-on sensitive and baby formulations. Antimicrobial spectrum is narrower than broad-spectrum systems (limited against yeasts and molds; moderate vs bacteria), making it best suited for combination use with sodium benzoate in pH-optimized formulations (pH <5.5). Formulating at pH 5.5 (acid mantle preservation for syndet cleansers and leave-on moisturizers) aligns perfectly with optimal pH for organic acid preservative activity. EU Annex V listed at ≤0.6% as sorbic acid equivalent. Not restricted in US. Supports clean-label positioning. The EU classifies Potassium Sorbate as "restricted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Potassium Sorbate allowed in the EU?

Potassium Sorbate EU regulatory status: restricted. Maximum allowed concentration: 0.6% as sorbic acid equivalent. This is based on EU Regulation 1223/2009 and its amendments.

What does Potassium Sorbate do in cosmetics?

Potassium Sorbate functions as: preservative. It is classified as a Preservative in our database. CAS number: 590-00-1.

What is the Margin of Safety for Potassium Sorbate?

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 Potassium Sorbate?

The NOAEL (No Observed Adverse Effect Level) for Potassium Sorbate is 1000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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