Moderate Cosmetic Ingredient NOAEL Data Sensitization Data

PROPYLIDENE PHTHALIDE

Also known as: Phthalide, 3-propylidene-, 3-Propylidene-1(3H)-isobenzofuranone, Propylidenephthalide, 1(3H)-Isobenzofuranone, 3-propylidene-, Celeriax (+6 more)

PROPYLIDENE PHTHALIDE (CAS 17369-59-4) is a cosmetic cosmetic ingredient functioning as Perfuming. NOAEL 5.42 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max III/175. 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
Function
Perfuming
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C11H10O2
MW
174.2 g/mol
PubChem CID
28500
IUPAC Name
3-propylidene-2-benzofuran-1-one
InChIKey
NGSZDVVHIGAMOJ-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. III/175
US US Status Not specifically regulated

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

Toxicological Studies

1 study endpoint found for PROPYLIDENE PHTHALIDE. 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 PROPYLIDENE PHTHALIDE across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
IFRA Restricted

Source: EU 2023/1545; SCCS/1459/11

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%

Additional Ingredient Properties

1 property record from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "patch_test_frequency_pct": "0.1", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "source": "EU 2023/1545; SCCS/1459/11"}

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 PROPYLIDENE PHTHALIDE.

Regulatory Flags

cosing-sourced eu-restricted fragrance needs-enrichment ifra_fragrance fda_food_additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to PROPYLIDENE PHTHALIDE 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- 3-Propylidene-1(3H)-isobenzofuranone Propylidenephthalide 1(3H)-Isobenzofuranone, 3-propylidene- Celeriax 3-propylidenephthalide 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 PROPYLIDENE PHTHALIDE safe in cosmetics?

PROPYLIDENE PHTHALIDE has a safety rating of "MODERATE" in our database. EU status: restricted. 1 toxicological study endpoint(s) are available in our database.

Is PROPYLIDENE PHTHALIDE allowed in the EU?

PROPYLIDENE PHTHALIDE EU regulatory status: restricted. Maximum allowed concentration: III/175. This is based on EU Regulation 1223/2009 and its amendments.

What does PROPYLIDENE PHTHALIDE do in cosmetics?

PROPYLIDENE PHTHALIDE functions as: Perfuming. It is classified as a cosmetic ingredient in our database. CAS number: 17369-59-4.

What is the NOAEL for PROPYLIDENE PHTHALIDE?

The NOAEL (No Observed Adverse Effect Level) for PROPYLIDENE PHTHALIDE is 6.55 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

Is PROPYLIDENE PHTHALIDE used outside cosmetics?

PROPYLIDENE PHTHALIDE also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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