Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Maleic Anhydride

INCI: MALEIC ANHYDRIDE

CAS Number
108-31-6
Function
Chemical intermediate/monomer in cosmetic polymer synthesis; not typically used directly in finished cosmetics
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not specifically prohibited. Allowed as an indirect ingredient (polymer backbone component); direct use in finished cosmetics is essentially nonexistent due to reactivity and irritancy

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

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.

Signal Word
DANGER
Pictograms
corr; excl mark;warn; cancer;health haz
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
Short-term Exposure Effects
The substance and the vapour are corrosive to the eyes and skin. The substance is irritating to the respiratory tract. Inhalation may cause lung oedema, but only after initial corrosive effects on eyes and/or airways have become manifest. See Notes.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol, through the skin and by ingestion.

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...

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Concern Level: Moderate

Regulatory Flags

potential-allergen

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.

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