Moderate Fragrance NOAEL Data Sensitization Data Dermal Penetration

Eugenol

INCI: EUGENOL

CAS Number
97-53-0
Function
fragrance; antimicrobial; anesthetic
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 10 ppm in leave-on products, 100 ppm in rinse-off products
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No US federal individual fragrance ingredient disclosure requirement; listed as fragrance only under FDA rules

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Eugenol. 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 638 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 1200 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 410.5 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 100 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 25 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB

Sensitization Profile

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

Sensitization Rate
moderate
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
1.5%
Cross-reactivity Group
balsam-of-peru-group
Reaction Type
contact-dermatitis
IFRA Restricted โ€” max 0.5% in finished products

Source: ESSCA/IVDK

Dermal Penetration Profile

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

Absorption %
22-35%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
164.2 Da
Log P
2.27
Systemic Absorption
yes
Topical Bioavailability
15-30%
Safety Margin Factor
very-high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1459/11, IFRA

Expert Verdict

EU 26 declared allergen with moderate sensitization rates. Occurs naturally in clove and cinnamon oils; EU regulations and IFRA standards apply equally to natural and synthetic origin. Must be individually declared on EU labels above threshold concentrations.

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Concern Level: Moderate

Regulatory Flags

eu-26-allergen label-declaration-required contact-allergen natural-origin eu_children_restricted ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Eugenol safe in cosmetics?

EU 26 declared allergen with moderate sensitization rates. Occurs naturally in clove and cinnamon oils; EU regulations and IFRA standards apply equally to natural and synthetic origin. Must be individually declared on EU labels above threshold concentrations. The EU classifies Eugenol as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Eugenol allowed in the EU?

Eugenol EU regulatory status: restricted. Maximum allowed concentration: 10 ppm in leave-on products, 100 ppm in rinse-off products. This is based on EU Regulation 1223/2009 and its amendments.

What does Eugenol do in cosmetics?

Eugenol functions as: fragrance; antimicrobial; anesthetic. It is classified as a Fragrance in our database. CAS number: 97-53-0.

What is the Margin of Safety for Eugenol?

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 Eugenol?

The NOAEL (No Observed Adverse Effect Level) for Eugenol is 638 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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