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.
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.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Margin of Safety, dermal absorption, and sensitization profile summaries for Isoeugenol.
Calculate MoS for your specific formulation with the MoS Calculator.
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 NOAEL → SED → MoS audit trail for Isoeugenol across SCCS product categories, with measured dermal absorption where available.
Contact sensitization data for Isoeugenol based on clinical patch test studies and IFRA standards.
Source: ESSCA/IVDK
Skin absorption and penetration characteristics of Isoeugenol, relevant to systemic exposure and MoS calculations.
Source: SCCS Opinion
International Agency for Research on Cancer (WHO) monograph evaluation.
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
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| Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [57] Kligman AM (1971): Report to RIFM, 25 March, unpublished.
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) |
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
agonist (weak)
| 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) |
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | restricted | 0.001 | Leave-on products |
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Source: EPA Dryad Skin Absorption 2024
Source: Roberts Cheruvu Mendeley 2022
| 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) |
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% |
Preliminary editorial summary for Isoeugenol — not a computed safety verdict. See the sourced toxicological data above.
Public NOAEL study rows linked to Isoeugenol by CAS number or substance name.
| Absorption % | Method | Vehicle |
|---|---|---|
| 38.4 | In vitro human SABS (Bronaugh approach / RIFM protocol) | Typical cosmetic vehicle |
Same-CAS public records found in food safety data.
Same-CAS food additive or FDA GRAS records from the core public database.
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.
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.
Isoeugenol functions as: fragrance. It is classified as a Fragrance in our database. CAS number: 97-54-1.
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.
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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