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
10 study endpoints found for Maleic 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 | 40 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| LOAEL | 60 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 40 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| LOAEL | 100 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| LOAEL | 250 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOEL | 10 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | 250 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 60 mg/kg bw/day | oral | dog | oral | REACH |
| LOAEL | 100 mg/kg bw/day | oral | rat | oral | REACH |
| NOEL | 40 mg/kg bw/day | 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
Strong skin and mucous membrane irritant. Maleic acid (hydrolysis product) caused acute vascular dermatitis in 17 of 50 test subjects after 6 weeks of topical application and inflammatory skin responses at 24- and 48-hour marks. Corrosive in neat form. Respiratory sensitizer upon inhalation. Highly reactive cyclic acid anhydride. Hydrolyzes rapidly to maleic acid in the presence of water. Its primary cosmetic relevance is as a building block for maleated derivatives (maleated soybean oil, mal...
Regulatory Flags
Frequently Asked Questions
Is Maleic Anhydride safe in cosmetics?
Strong skin and mucous membrane irritant. Maleic acid (hydrolysis product) caused acute vascular dermatitis in 17 of 50 test subjects after 6 weeks of topical application and inflammatory skin responses at 24- and 48-hour marks. Corrosive in neat form. Respiratory sensitizer upon inhalation. Highly reactive cyclic acid anhydride. Hydrolyzes rapidly to maleic acid in the presence of water. Its primary cosmetic relevance is as a building block for maleated derivatives (maleated soybean oil, mal... The EU classifies Maleic Anhydride as "prohibited". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.
Is Maleic Anhydride allowed in the EU?
Maleic Anhydride EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Maleic Anhydride do in cosmetics?
Maleic Anhydride functions as: Chemical intermediate/monomer in cosmetic polymer synthesis; not typically used directly in finished cosmetics. It is classified as a cosmetic ingredient in our database. CAS number: 108-31-6.
What is the Margin of Safety for Maleic Anhydride?
not established 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 Maleic Anhydride?
The NOAEL (No Observed Adverse Effect Level) for Maleic Anhydride is 40 mg/kg bw/day based on a Subchronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is Maleic Anhydride classified as hazardous under GHS?
Maleic Anhydride carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed May be harmful in contact with skin Causes severe skin burns and eye damage May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled May cause damage to lungs if inhaled Harmful to aquatic life. 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 โ at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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