Is Maleic Anhydride safe in cosmetics?
Maleic Anhydride has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
Maleic Anhydride
Also known as: cis-Butenedioic anhydride, Toxilic anhydride, 2,5-Dihydrofuran-2,5-dione, Crystal Man, Crystal Man AB (+14 more)
INCI: MALEIC ANHYDRIDE
Maleic Anhydride (CAS 108-31-6) is a cosmetic cosmetic ingredient functioning as Chemical intermediate/monomer in cosmetic polymer synthesis; not typically used. NOAEL 40 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited; 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 108-31-6 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Maleic Anhydride is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H314, H317, H318, H334, H372, H370, H373).
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Chemical intermediate/monomer in cosmetic polymer synthesis; not typically used directly in finished cosmetics
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
furan-2,5-dione
InChIKey
FPYJFEHAWHCUMM-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Maleic Anhydride.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 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 |
| NOAEL | =55 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
| NOAEL | =60 mg/kg bw/day | oral | Dog | subchronic | ECHA |
| NOAEL | =250 mg/kg bw/day | oral | Rat | subchronic | ECHA |
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 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.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Maleic 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 / IrritantHealth HazardCorrosive
Hazard Class and Category
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
Hazard Statements
- H302 Harmful if swallowed
- H372 (inhalation) (respiratory system)
- H314 Causes severe skin burns and eye damage
- H318 Causes serious eye damage
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
- H317 May cause an allergic skin reaction
Specific Concentration Limits / M-factors
Skin Sens. 1A; H317: C ≥ 0.001%
Inserted via ATP: ATP13
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
100%
DPRA Lys %
43.45%
KeratinoSens IC50
2000 µM
hCLAT CV75
658 µg/mL
LLNA EC3
0.16%
NESIL
40 µg/cm²
LLNA: Strong (1A)
GHS: 1A
Source: LLNA: Dearman et al. (2000); DPRA: Nukada personal communication (undated) | 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]
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 (3)
Evidence for Carcinogenicity
A4; Not classifiable as a human carcinogen.
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
0799
Source: WHO/JECFA
Skin Eye Respiratory Irritation
A corrosive irritant to eyes, skin, and mucous membranes. | Inhalation causes coughing, sneezing, throat irritation. Skin contact causes irritation and redness. Vapors cause severe eye irritation; photophobia and double vision may occur.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Film former
Hardener
Solvent
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Maleic Anhydride.
Regulatory Flags
potential-allergen
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Maleic Anhydride by CAS number or substance name.
Studies
4
Lowest NOAEL
40 mg/kg bw/day
Highest NOAEL
250 mg/kg bw/day
COSMOS DB
ECHA
Known Synonyms
cis-Butenedioic anhydride
Toxilic anhydride
2,5-Dihydrofuran-2,5-dione
Crystal Man
Crystal Man AB
HG 3-993-76
Nourymix MA 901
NSC 137651
NSC 137652
NSC 137653
NSC 9568
UN 2215
5-17-11-00055
BRN 0106909
EINECS 203-571-6
RCRA waste number U147
Anhydrid kyseliny maleinove
Maleinanhydrid
UNII-V5877ZJZ25
Chemical Function
Film former
Solvent
Hardener
Biocide
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
Cleaning products and household care - oven - oven cleaner; Europe
inert_ingredient; non_food_use; Pesticides
CEDI
Indirect additives food contact (10/2018)
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
MALEIC ANHYDRIDE
ChEMBL ID
CHEMBL374159
Frequently Asked Questions
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 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 4 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 — at cosmetic use concentrations, hazard thresholds may not be met.
Is Maleic Anhydride used outside cosmetics?
Maleic 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 Maleic Anhydride have different safety status in cosmetics vs industrial chemicals?
Maleic Anhydride is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H314, H317, H318, H334, H372, H370, H373).
Compliance Tools
Check Maleic 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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