Good Preservative NOAEL Data GHS Classified Sensitization Data Dermal Penetration

Sorbic Acid

INCI: SORBIC ACID

CAS Number
110-44-1
Function
Preservative; antifungal; antimicrobial (primarily active against fungi and yeasts)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.6%
🇺🇸 US Status permitted
US Notes Permitted; GRAS for food use (21 CFR 182.3089). No US-specific cosmetic concentration cap.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Sorbic 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 1200 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 5100 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 80 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 40 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral gerbil Short Term Toxicity COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol.

Sensitization Profile

Contact sensitization data for Sorbic Acid based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Dermal Penetration Profile

Skin absorption and penetration characteristics of Sorbic Acid, relevant to systemic exposure and MoS calculations.

Absorption %
8-15%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
112.1 Da
Log P
1.33
Systemic Absorption
minimal
Topical Bioavailability
5-12%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

Expert Verdict

Good organic acid preservative and hurdle component with pH-dependent antimicrobial activity optimal below pH 5.5. EU Annex V listed at 0.6% max as acid, GRAS for food use, and low sensitization potential at permitted concentrations.

⚠️
Concern Level: Low

Regulatory Flags

preservative eu-annex-v organic-acid ph-dependent hurdle-technology epa_safer_alternative fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Sorbic Acid safe in cosmetics?

Good organic acid preservative and hurdle component with pH-dependent antimicrobial activity optimal below pH 5.5. EU Annex V listed at 0.6% max as acid, GRAS for food use, and low sensitization potential at permitted concentrations. The EU classifies Sorbic Acid as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Sorbic Acid allowed in the EU?

Sorbic Acid EU regulatory status: restricted. Maximum allowed concentration: 0.6%. This is based on EU Regulation 1223/2009 and its amendments.

What does Sorbic Acid do in cosmetics?

Sorbic Acid functions as: Preservative; antifungal; antimicrobial (primarily active against fungi and yeasts). It is classified as a Preservative in our database. CAS number: 110-44-1.

What is the Margin of Safety for Sorbic 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 Sorbic Acid?

The NOAEL (No Observed Adverse Effect Level) for Sorbic Acid is 1200 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Sorbic Acid compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
 🌸
82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

Sodium Borate
Moderate
METHYLISOTHIAZOLINONE (MIT)
Good
Silver Chloride
Good
Benzisothiazolinone
Moderate
Triclocarban
Good
Browse all 30,000+ ingredients →
📱

Is Sorbic Acid in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Sorbic Acid in your formulation.

Ingredient Decoder MoS Calculator