Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
5 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 | 500 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 1250 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 7140 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | ca.1717 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | 3800 ppm | oral | rat | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Known skin and respiratory sensitizer causing serious eye damage and irritation; if present as residual monomer in copolymers, must be controlled to trace levels; occupational exposure limits apply
Regulatory Flags
Frequently Asked Questions
Is Phthalic Anhydride safe in cosmetics?
Known skin and respiratory sensitizer causing serious eye damage and irritation; if present as residual monomer in copolymers, must be controlled to trace levels; occupational exposure limits apply The EU classifies Phthalic Anhydride as "permitted". Safety rating: POOR. 5 toxicological study endpoint(s) are available in our database.
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 Margin of Safety for Phthalic Anhydride?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Phthalic Anhydride?
The NOAEL (No Observed Adverse Effect Level) for Phthalic Anhydride is 500 mg/kg bw/day based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.
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.
Compliance Tools
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Related Ingredients
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