Is 3-Propylidenephthalide safe in cosmetics?
3-Propylidenephthalide has a safety rating of "GOOD" in our database. EU status: prohibited. US status: permitted. 1 toxicological study endpoint(s) are available in our database.
3-Propylidenephthalide
Also known as: Phthalide, 3-propylidene-, Propylidene phthalide, 3-Propylidene-1(3H)-isobenzofuranone, Propylidenephthalide, 1(3H)-Isobenzofuranone, 3-propylidene- (+6 more)
INCI: 3-PROPYLIDENEPHTHALIDE
3-Propylidenephthalide (CAS 17369-59-4) is a cosmetic cosmetic ingredient functioning as Fragrance with celery and herbal character; used as flavor modifier. NOAEL 5.42 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 17369-59-4 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
3-Propylidenephthalide is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H317).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Fragrance with celery and herbal character; used as flavor modifier
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
3-propylidene-2-benzofuran-1-one
InChIKey
NGSZDVVHIGAMOJ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Permitted — FEMA GRAS #2952
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for 3-Propylidenephthalide.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for 3-Propylidenephthalide. 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 | 6.55 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for 3-Propylidenephthalide across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for 3-Propylidenephthalide based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
IFRA Restricted
Source: EU 2023/1545; SCCS
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
4.35%
DPRA Lys %
21.6%
KeratinoSens IC50
717.4 µM
hCLAT CV75
112.9 µg/mL
LLNA EC3
3.7%
NESIL
2700 µg/cm²
LLNA: Moderate (1B)
GHS: 1B
Human: positive
Source: LLNA: Gerberick et al. (2005); DPRA: Nukada et al. 2013 [DOI:10.1016/j.tiv.2012.11.006] | Natsch et al. 2013 [DOI:10.1002/jat.2868]; KS: Natsch et al. 2013 [DOI:10.1002/jat.2868]; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [6] Kligman AM (1975): Report to RIFM, 16 June, unpublished.
HRIPT Human Patch Test Studies
3 human repeat insult patch tests aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HRIPT | 109 | 0 | 945 | 945 | non-sensitizer |
| HMT | - | 0 | 2700 | - | - |
| OECD_DA_Human | - | 0 | - | - | 1B (Weak sensitizer) |
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.
SA Saudi SFDA (III - Restricted)
Product type: (a) Oral products (b) Other produts. Max: (b) 0.01%.
BRIN Brazil/India Cosmetics
India: Restricted · max (b) 0.01%
IFRA Concentration Limits (12 Product Categories)
International Fragrance Association standards per product category. Restriction: Restriction. Effective: 2024-01-01.
| Category | Max % | Category | Max % |
|---|---|---|---|
| 1 (Lip products) | – | 7a (Deodorant – not spray) | – |
| 2 (Body spray) | – | 7b (Deodorant spray) | – |
| 3 (Body cream) | – | 8 (Face cream) | – |
| 4 (Fine fragrance) | – | 9 (Soap) | – |
| 5a (Body lotion) | – | 10a (Household – non-spray) | – |
| 5b (Face cream leave-on) | – | 10b (Household – spray) | – |
| 5c (Hand cream) | – | 11a (Intimate – leave-on) | – |
| 5d (Baby cream) | – | 11b (Intimate – rinse) | – |
| 6 (Mouthwash) | – | 12 (Not for consumer exposure) | – |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "source": "EU 2023/1545; SCCS"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (2)
JECFA Number
1168
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
3-PROPYLIDENEPHTHALIDE | 2003 | No safety concern at current levels of intake when used as a flavouring agent | TRS 922-JECFA 61/49 | FAS 52-JECFA 61/175
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
Regulatory List Membership (3)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for 3-Propylidenephthalide.
Regulatory Flags
fragrance-component
ifra_fragrance
fda_food_additive
eu_cosing_listed
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to 3-Propylidenephthalide by CAS number or substance name.
Studies
1
Lowest NOAEL
6.55 mg/kg bw/day
Highest NOAEL
6.55 mg/kg bw/day
COSMOS_DB
Known Synonyms
Phthalide, 3-propylidene-
Propylidene phthalide
3-Propylidene-1(3H)-isobenzofuranone
Propylidenephthalide
1(3H)-Isobenzofuranone, 3-propylidene-
Celeriax
3-propylidenephthalimide
EC No.: 241-402-8
EINECS 241-402-8
FEMA No. 2952
UNII-WHD8YJ226P
Chemical Function
Fragrance
Flavouring and nutrient
Regulatory Lists
IFRA Transparency
Europe
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Europe; Personal care; restricted
Australian Status
AICIS status: listed
Frequently Asked Questions
Is 3-Propylidenephthalide allowed in the EU?
3-Propylidenephthalide EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does 3-Propylidenephthalide do in cosmetics?
3-Propylidenephthalide functions as: Fragrance with celery and herbal character; used as flavor modifier. It is classified as a cosmetic ingredient in our database. CAS number: 17369-59-4.
What is the NOAEL for 3-Propylidenephthalide?
The NOAEL (No Observed Adverse Effect Level) for 3-Propylidenephthalide is 6.55 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.
Is 3-Propylidenephthalide used outside cosmetics?
3-Propylidenephthalide also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does 3-Propylidenephthalide have different safety status in cosmetics vs industrial chemicals?
3-Propylidenephthalide is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H317).
Compliance Tools
Check 3-Propylidenephthalide compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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