Is Phthalic Anhydride safe in cosmetics?
Phthalic Anhydride has a safety rating of "POOR" in our database. EU status: permitted. US status: restricted. 3 toxicological study endpoint(s) are available in our database.
Phthalic Anhydride
Also known as: 1,3-Isobenzofurandione, EINECS 201-607-5, Isobenzofuran, 1,3-dihydro-1,3-dioxo-, NCI-C03601, RCRA waste number U190 (+15 more)
INCI: PHTHALIC ANHYDRIDE
Phthalic Anhydride (CAS 85-44-9) is a cosmetic cosmetic ingredient functioning as Monomer/intermediate used in copolymer synthesis; not typically a finished. NOAEL 500 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 85-44-9 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Phthalic Anhydride is classified GHS Danger (H302, H315, H317, H318, H334, H335, H319, H371) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Monomer/intermediate used in copolymer synthesis; not typically a finished cosmetic ingredient
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
2-benzofuran-1,3-dione
InChIKey
LGRFSURHDFAFJT-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
restricted
US Notes
Not specifically FDA-restricted for cosmetics; OECD SIDS flags it as a candidate for further work
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Phthalic Anhydride.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Phthalic Anhydride. 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 | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1785 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =3570 mg/kg bw/day | oral | Mouse | reproduction developmental | ToxValDB_ECHA_IUCLID |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
CorrExcl markWarnCancerHealth haz
Hazard Statements
Harmful if swallowed Causes skin irritation May cause respiratory irritation Causes serious eye damage May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled
Short-term Exposure Effects
The substance is severely irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Phthalic Anhydride across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantCorrosiveHealth Hazard
Hazard Class and Category
Acute Tox. 4 *; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Hazard Statements
- H302 Harmful if swallowed
- H335 May cause respiratory irritation
- H315 Causes skin irritation
- H318 Causes serious eye damage
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
- H317 May cause an allergic skin reaction
Inserted via ATP: CLP00
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
0.95%
DPRA Lys %
56%
KeratinoSens IC50
2000 µM
hCLAT CV75
408.35 µg/mL
LLNA EC3
0.16%
NESIL
40 µg/cm²
LLNA: Strong (1A)
GHS: 1A
Source: LLNA: Dearman et al. (2000); DPRA: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064]; KS: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Joint Research Centre of the European Union 2014; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403] | Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (4)
Carcinogen Classification
Phthalic anhydride | TR-159: Bioassay of Phthalic Anhydride for Possible Carcinogenicity (CASRN 85-44-9) (1979 ) | 12/13/78 | No Evidence | No Evidence | No Evidence | No Evidence | It is concluded that under the conditions of this bioassay, phthalic anhydride was not carcinogenic for F344 rats or B6C3F1 mice of either sex.
Source: NTP Technical Reports
Evidence for Carcinogenicity
A4; Not classifiable as a human carcinogen.
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
0315
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
Dust vapor or fumes ... are irritating to eyes ... . | The substance is severely irritating to the eyes, the skin and the respiratory tract ... Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation exposure may cause asthma.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Chemical reaction regulator
Flame retardant
No specific technical function
Plasticizer
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Phthalic Anhydride.
Regulatory Flags
potential-allergen
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Phthalic Anhydride by CAS number or substance name.
Studies
21
Lowest NOAEL
500 mg/kg bw/day
Highest NOAEL
7140 mg/kg bw/day
ToxValDB_ECHA_IUCLID
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip
Known Synonyms
1,3-Isobenzofurandione
EINECS 201-607-5
Isobenzofuran, 1,3-dihydro-1,3-dioxo-
NCI-C03601
RCRA waste number U190
Vulkalent B
Wiltrol P
Anhydrid kyseliny ftalove
Anidride ftalica
Ftaalzuuranhydride
Ftalanhydrid
Ftalowy bezwodnik
UNII-UVL263I5BJ
1,3-dioxophthalan
o-phthalic acid anhydride
ortho-phthalic acid anhydride
ADP 1200
ESEN
OP 392
Rikacid PA
Chemical Function
Regulatory Lists
artificial_saliva; detected; emissions; Europe; Furniture and Furnishings
artificial_saliva; detected; emissions; Europe; Furniture and Furnishings
air; Arts and crafts/Office supplies - children's art and toys - modeling clay; detected; emissions; Europe
detected; Europe; Other direct contact consumer goods
detected; Europe; Other direct contact consumer goods
air; Cons electronics mech appliances and machinery; detected; emissions; Europe
detected; Europe; Other direct contact consumer goods
drinking_water; Europe; manufacturing; plastic_additive
inert_ingredient; non_food_use; Pesticides
Cons electronics mech appliances and machinery; Europe
CEDI
Indirect additives food contact (10/2018)
children
artificial_saliva; detected; emissions; Europe; Toys and children's products
artificial_saliva; detected; emissions; Europe; Furniture and Furnishings
artificial_saliva; detected; emissions; Europe; Furniture and Furnishings
air; Arts and crafts/Office supplies - children's art and toys - modeling clay; detected; emissions; Europe
detected; Europe; Other direct contact consumer goods
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
PHTHALIC ANHYDRIDE
ChEMBL ID
CHEMBL1371297
Frequently Asked Questions
Is Phthalic Anhydride allowed in the EU?
Phthalic Anhydride EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Phthalic Anhydride do in cosmetics?
Phthalic Anhydride functions as: Monomer/intermediate used in copolymer synthesis; not typically a finished cosmetic ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 85-44-9.
What is the NOAEL for Phthalic Anhydride?
The NOAEL (No Observed Adverse Effect Level) for Phthalic Anhydride is =1000 mg/kg bw/day based on a reproduction developmental study via oral route in Rat. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Phthalic Anhydride classified as hazardous under GHS?
Phthalic Anhydride carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes skin irritation May cause respiratory irritation Causes serious eye damage May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is Phthalic Anhydride used outside cosmetics?
Phthalic Anhydride also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Phthalic Anhydride have different safety status in cosmetics vs industrial chemicals?
Phthalic Anhydride is classified GHS Danger (H302, H315, H317, H318, H334, H335, H319, H371) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Phthalic Anhydride compliance across multiple jurisdictions:
Ingredient Decoder
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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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