Poor Fragrance NOAEL Data Sensitization Data Dermal Penetration

Isoeugenol

Also known as: 3-06-00-04993, BRN 1909602, EINECS 202-590-7, FEMA No. 2468, 1-Hydroxy-2-methoxy-4-propen-1-ylbenzene (+8 more)

INCI: ISOEUGENOL

Isoeugenol (CAS 97-54-1) is a cosmetic fragrance functioning as fragrance. NOAEL 25 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max >10 ppm leave-on / >100 ppm rinse-off. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.

View industrial chemical safety profile for CAS 97-54-1 →

Auto-generated CPSR Part A draft with source citations
Function
fragrance
Safety Rating
POOR

Regulatory Status

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

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Isoeugenol.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 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 70 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 528 mg/kg bw/day oral rat Reproductive COSMOS_DB

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Isoeugenol across SCCS product categories, with measured dermal absorption where available.

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 — 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 — absorption varies by formulation

Source: SCCS/1459/11, IFRA

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
2B
Volume
134
Evaluation Year
2023

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
89.3%
DPRA Lys %
12.6%
KeratinoSens IC50
723.015 µM
hCLAT CV75
80.4 µg/mL
LLNA EC3
1.3%
NESIL
5039 µg/cm²
LLNA: Strong (1A) GHS: 1A Human: positive

Source: LLNA: Basketter & Cadby (2004) | Ashby et al. (1995); DPRA: Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030] | Jaworska 2011 [DOI:10.1002/jat.2869]; KS: Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009] | Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030]; hCLAT: Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030] | Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [57] Kligman AM (1971): Report to RIFM, 25 March, unpublished.

HRIPT Human Patch Test Studies

5 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 250 250 moderate
HMT - 0 5184 - -
HRIPT - 0 250 - -
HRIPT - 0 5039.37 - -
OECD_DA_Human - 0 - - 1B (Weak sensitizer)

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: fragrance
Receptor targets: ERα
LOEC: 50 µM
EU status: restricted (allergen; max 0.02% leave-on)

agonist (weak)

Dose-Response Data Points
Endpoint Target Value Direction
Cell proliferation, ER-mediated transcription ERa EC50/IC50: EC50 ~10-100 uM; LOEC: 10 uM; NOEC: 1 uM mixed agonist (weak)

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

BRIN Brazil/India Cosmetics
Brazil: Restricted (Fragrance Allergen) · max >0.001% leave-on / >0.01% rinse-off requires labeling
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
GCC restricted 0.001 Leave-on products

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

EPA Dryad Skin Absorption (physics-based)
MW: 164.204
LogP: 3.03542
Kp epidermis: 0.03864 cm/h
% dose epidermis: 0.96%
% dose stratum corneum: 0.91%
% dose dermis: 0.94%

Source: EPA_Dryad_Skin_Absorption_2024

Roberts Skin Permeation (Mendeley 2022)
MW: 164.2
Log Kow: 2.354
Log Kp: -1.4130090971130056
Log Jmax: -6.660094607516842

Source: Roberts_Cheruvu_Mendeley_2022

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_in_vitro 38.4 In vitro human SABS (Bronaugh approach / RIFM protocol) Human skin (RIFM SABS) RIFM monograph 2016 (2016)

IFRA Concentration Limits (12 Product Categories)

International Fragrance Association standards per product category. Restriction: Restriction. Effective: 2021-02-10.

Category Max % Category Max %
1 (Lip products) 0.0013% 7a (Deodorant – not spray) 0.0027%
2 (Body spray) 0.0004% 7b (Deodorant spray) 0.0027%
3 (Body cream) 0.0013% 8 (Face cream) 0.00044%
4 (Fine fragrance) 0.0053% 9 (Soap) 0.0066%
5a (Body lotion) 0.0013% 10a (Household – non-spray) 0.0066%
5b (Face cream leave-on) 0.0013% 10b (Household – spray) No Restriction%
5c (Hand cream) 0.0013% 11a (Intimate – leave-on) 0.00044%
5d (Baby cream) 0.00044% 11b (Intimate – rinse) 0.00044%
6 (Mouthwash) 0.0013% 12 (Not for consumer exposure) No Restriction%

Additional Ingredient Properties

7 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "cross_reactivity_group": "fragrance-mix-I", "patch_test_frequency_pct": "2.0", "sensitization_rate": "moderate", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "ifra_max_level_pct": "0.02", "source": "ESSCA/IVDK"}
dermal_absorption
{"molecular_weight_da": "164.2", "log_p_value": "2.91", "skin_penetration_level": "dermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "20-32", "systemic_absorption": "yes", "penetration_enhancer": "yes", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "15-28", "safety_margin_factor": "very-high", "source": "SCC…
fragrance
{"cas_number": "97-54-1", "ingredient_class": "aroma_chemical", "chemical_class": "phenol", "odor_family": "spicy", "odor_description": "Sweet, spicy carnation, clove-like", "odor_strength": "very_strong", "odor_tenacity_hours": "72.0", "top_note": "no", "heart_note": "yes", "base_note": "yes", "blending_factor_1_10": "9.0", "threshold_of_detection_ppb": "3.0", "molecular_weight_Da": "164.2", "boi…
fragrance_ifra
{"cas_number": "97-54-1", "ifra_amendment_number": "49", "ifra_restriction_type": "Restricted", "ifra_max_use_level_category_1_pct": "0.012", "ifra_max_use_level_category_4_pct": "0.06", "ifra_max_use_level_category_7_pct": "0.04", "ifra_max_use_level_category_11_pct": "0.012", "eu_allergen_declaration_required": "Yes", "eu_26_allergens_list": "Yes", "sccs_opinion_available": "Yes", "sensitization…
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.05", "adult_max_concentration_pct": "unlimited", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "low", "eye_irritation_risk…
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Potent sensitizer; related to eugenol", "alternative_ingredient": "Linalool", "source": "dermatology literature"}
regulatory
{"eu_status": "restricted", "us_status": "allowed", "eu_max_concentration": "0.001", "restricted_in": "rinse-off: >0.01%, leave-on: >0.001%", "regulation_reference": "Annex III/205"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient Fragrance Processing aids not otherwise specified
Regulatory List Membership (5)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS) Consumer Product Chemical EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Isoeugenol.

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

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Isoeugenol by CAS number or substance name.

Studies
3
Lowest NOAEL
70 mg/kg bw/day
Highest NOAEL
528 mg/kg bw/day
COSMOS_DB

Dermal Absorption

View details ->
Absorption % Method Vehicle
38.4 In vitro human SABS (Bronaugh approach / RIFM protocol) Typical cosmetic vehicle

Known Synonyms

3-06-00-04993 BRN 1909602 EINECS 202-590-7 FEMA No. 2468 1-Hydroxy-2-methoxy-4-propen-1-ylbenzene 4-Hydroxy-3-methoxy-1-propen-1-ylbenzene 3-Methoxy-4-hydroxy-1-propen-1-ylbenzene NCI-C60979 UNII-5M0MWY797U 1-Hydroxy-2-methoxy-4-propenylbenzene 3-Methoxy-4-hydroxypropenylbenzene 4-Hydroxy-3-methoxypropenylbenzene Propenylguaiacol

Chemical Function

Fragrance Flavouring and nutrient

Regulatory Lists

Europe Cleaning products and household care - air freshener; Europe Cleaning products and household care - air freshener; Europe active_ingredient; Australia Cleaning products and household care - air freshener; detected; Europe children; Europe; Personal care children; Europe; Personal care - general moisturizing - hand/body lotion children; Europe; Personal care children; Europe; Personal care children; Europe; nondetect; Personal care detected; Europe; Personal care - make-up and related detected; Europe; Personal care - make-up and related Cleaning products and household care - general household cleaning - surface cleaner; Cleaning products and household care - laundry and fabric treatment; detected; Europe consumer_product; detected; Europe detected; Europe; Personal care - sexual wellness detected; Europe; Personal care - sexual wellness detected; Europe; Personal care - sexual wellness Europe; Personal care - sexual wellness

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
ISOEUGENOL
ADI
No safety concern at current levels of intake when used as a flavouring agent mg/kg bw
Food Category
flavoring
View full food safety profile →

Frequently Asked Questions

Is Isoeugenol safe in cosmetics?

Isoeugenol has a safety rating of "POOR" in our database. EU status: restricted. US status: permitted. 3 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 NOAEL for Isoeugenol?

The NOAEL (No Observed Adverse Effect Level) for Isoeugenol is 70 mg/kg bw/day based on a Multigeneration Reproductive study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

Is Isoeugenol used outside cosmetics?

Isoeugenol also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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