Moderate Cosmetic Ingredient NOAEL Data

Methyl Undecylenate

INCI: METHYL UNDECYLENATE

CAS Number
111-81-9
Function
Skin conditioning, antimicrobial (undecylenic acid derivative — known antifungal)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA recognizes undecylenic acid derivatives as OTC antifungal actives (21 CFR 333); as a cosmetic ingredient, permitted without specific restriction

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Methyl Undecylenate. 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 60 mg/kg bw/day oral rat oral REACH

Expert Verdict

If marketed with antifungal claims, product may be reclassified as OTC drug (US) or borderline product (EU); keep claims cosmetic to avoid regulatory reclassification

⚠️
Concern Level: Moderate

Regulatory Flags

epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Methyl Undecylenate safe in cosmetics?

If marketed with antifungal claims, product may be reclassified as OTC drug (US) or borderline product (EU); keep claims cosmetic to avoid regulatory reclassification The EU classifies Methyl Undecylenate as "permitted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is Methyl Undecylenate allowed in the EU?

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

What does Methyl Undecylenate do in cosmetics?

Methyl Undecylenate functions as: Skin conditioning, antimicrobial (undecylenic acid derivative — known antifungal). It is classified as a cosmetic ingredient in our database. CAS number: 111-81-9.

What is the Margin of Safety for Methyl Undecylenate?

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 Methyl Undecylenate?

The NOAEL (No Observed Adverse Effect Level) for Methyl Undecylenate is 60 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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