Poor Fragrance NOAEL Data Sensitization Data Dermal Penetration

Isoeugenol

INCI: ISOEUGENOL

CAS Number
97-54-1
Function
fragrance
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. >10 ppm leave-on / >100 ppm rinse-off
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; classified as strong sensitizer; restrict in leave-on products

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

7 study endpoints found for Isoeugenol. 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 Subchronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 528 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 800 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 70 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 528 mg/kg bw/day oral rat Reproductive COSMOS_DB

Sensitization Profile

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

Sensitization Rate
moderate
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
2.0%
Cross-reactivity Group
fragrance-mix-I
Reaction Type
contact-dermatitis
IFRA Restricted โ€” max 0.02% in finished products

Source: ESSCA/IVDK

Dermal Penetration Profile

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

Absorption %
20-32%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
164.2 Da
Log P
2.91
Systemic Absorption
yes
Topical Bioavailability
15-28%
Safety Margin Factor
very-high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1459/11, IFRA

Expert Verdict

One of the most potent sensitizers among the EU 26 fragrance allergens with mandatory allergen labelling; very low use levels permissible and avoidance recommended in products for sensitized or compromised skin.

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Concern Level: High

Regulatory Flags

allergen-eu strong-sensitizer ifra-restricted annex-iii-restricted eu-labelling-required original-26-allergen endocrine_disruptor eu_children_restricted ifra_fragrance fda_food_additive eu_cosing_listed jecfa_safe

Frequently Asked Questions

Is Isoeugenol safe in cosmetics?

One of the most potent sensitizers among the EU 26 fragrance allergens with mandatory allergen labelling; very low use levels permissible and avoidance recommended in products for sensitized or compromised skin. The EU classifies Isoeugenol as "restricted". Safety rating: POOR. 7 toxicological study endpoint(s) are available in our database.

Is Isoeugenol allowed in the EU?

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

What does Isoeugenol do in cosmetics?

Isoeugenol functions as: fragrance. It is classified as a Fragrance in our database. CAS number: 97-54-1.

What is the Margin of Safety for Isoeugenol?

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 Isoeugenol?

The NOAEL (No Observed Adverse Effect Level) for Isoeugenol is 1000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.

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