Good Active Ingredient Sensitization Data

Undecylenic Acid

INCI: UNDECYLENIC ACID

CAS Number
112-38-9
Function
Antifungal; scalp care active
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA OTC Monograph M016 (antifungal): 10-25% for superficial skin fungal infections. Not listed in OTC Dandruff Monograph M032. Cosmetic use at lower concentrations does not trigger OTC drug requirements.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Expert Verdict

Broad-spectrum antifungal with activity against dermatophytes and Candida that disrupts fungal cell morphogenesis and biofilm formation. FDA M016 covers 10-25% for OTC skin infections but is absent from the dandruff monograph. At lower cosmetic concentrations it functions as a scalp care active in both EU and US, with zinc undecylenate derivative preferred for formulation stability and skin compatibility.

โš ๏ธ
Concern Level: Low

Regulatory Flags

antifungal otc-drug-us-m016 cosmetic-low-concentration epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Undecylenic Acid safe in cosmetics?

Broad-spectrum antifungal with activity against dermatophytes and Candida that disrupts fungal cell morphogenesis and biofilm formation. FDA M016 covers 10-25% for OTC skin infections but is absent from the dandruff monograph. At lower cosmetic concentrations it functions as a scalp care active in both EU and US, with zinc undecylenate derivative preferred for formulation stability and skin compatibility. The EU classifies Undecylenic Acid as "permitted". Safety rating: GOOD.

Is Undecylenic Acid allowed in the EU?

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

What does Undecylenic Acid do in cosmetics?

Undecylenic Acid functions as: Antifungal; scalp care active. It is classified as a Active Ingredient in our database. CAS number: 112-38-9.

What is the Margin of Safety for Undecylenic Acid?

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.

Compliance Tools

Check Undecylenic Acid compliance across multiple jurisdictions:

๐Ÿ”ฌ
Ingredient Decoder
Paste a full ingredient list for instant analysis
 ๐ŸŒธ
82 Allergen Checker
Check for EU declarable fragrance allergens
 ๐Ÿงช
Substance Compliance
Check compliance across 55 jurisdictions
 ๐Ÿงฎ
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 โš—๏ธ
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

Lactobacillus Paracasei
Good
L-Lysine
Excellent
Transforming Growth Factor Beta (TGF-ฮฒ)
Moderate
Cubosomes
Moderate
Retinyl Palmitate
Good
Browse all 30,000+ ingredients โ†’
๐Ÿ“ฑ

Is Undecylenic Acid in Your Products?

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

Try Piro Free โ†’

Analyze Your Full Ingredient List

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

Ingredient Decoder MoS Calculator