Also known as: (2E)-2-Butenedioic acid, trans-Butenedioic acid, 4-02-00-02202, Allomalenic acid, BRN 0605763 (+15 more)
INCI: FUMARIC ACID
Fumaric Acid (CAS 110-17-8) is a cosmetic cosmetic ingredient functioning as Buffering agent, pH adjuster, fragrance ingredient. NOAEL 600 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
US NotesGRAS under 21 CFR 172.350 and FEMA GRAS as flavoring. No FDA cosmetic restrictions. CIR 2009 final safety assessment on file.
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Fumaric Acid.
Calculate MoS for your specific formulation with the
MoS Calculator.
Toxicological Studies
10 study endpoints found for Fumaric Acid. 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
intravenous
rabbit
kidney and liver function
CIR_vision_codex
NOAEL
=500 mg/kg
intravenous
rabbit
kidney and liver function
CIR_vision_codex
NOAEL
=500 mg/kg
intravenous
rabbit
kidney and liver function
CIR_vision_codex
NOAEL
=500 mg/kg
intravenous
rabbit
kidney and liver function
CIR_vision_codex
NOAEL
=2080 mg/kg bw/day
oral
rabbit
general toxicity
CIR_vision_codex
NOAEL
=2080 mg/kg bw/day
oral
rabbit
general toxicity
CIR_vision_codex
NOAEL
=2080 mg/kg bw/day
oral
rabbit
general toxicity
CIR_vision_codex
NOAEL
=2080 mg/kg bw/day
oral
rabbit
general toxicity
CIR_vision_codex
NOAEL
400 mg/kg bw/day
oral
guinea pig
Chronic
COSMOS_DB
NOAEL
500 mg/kg bw/day
oral
rat
Chronic
COSMOS_DB
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Hazard Statements
Causes eye irritation Harmful to aquatic life
Short-term Exposure Effects
The substance is irritating to the eyes.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cirMarch 23, 2009
Verdict: unknown
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Fumaric Acid across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
Endpoint
Value
Species
Route
Duration
Source
LD50
>=10600 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
<=11000 mg/kg
Rat
oral
-
ECHA IUCLID
LC50
>1306 mg/m3
Rat
inhalation
-
ECHA IUCLID
LD50
=20000 mg/kg
Rabbit
dermal
acute
ECHA IUCLID
LD50
=10700 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
=9300 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
=10700 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
=9300 mg/kg
Rat
oral
-
ECHA IUCLID
NOAEL
~600 mg/kg-day
Rat
oral
chronic
ECHA IUCLID
NOAEL
~600 mg/kg-day
Rat
oral
chronic
ECHA IUCLID
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Harmful / Irritant
Hazard Class and Category
Eye Irrit. 2
Hazard Statements
H319Causes serious eye irritation
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 %
10.8%
DPRA Lys %
4.6%
KeratinoSens IC50
2000 µM
hCLAT CV75
1250 µg/mL
GHS: inconclusive
Source: DPRA: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]; KS: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Joint Research Centre of the European Union 2014; hCLAT: 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
10,000 - 100,000 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)
Carcinogen Classification
Not listed by IARC. Has been implicated in oncogenesis (A15088, A15092).
Source: Toxin and Toxin Target Database (T3DB)
ICSC Safety Card
1173
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
It is a mild irritant of skin and mucous membranes ... | Dust: Irritating to eyes, nose and throat. If inhaled will cause coughing or difficult breathing. Solid: Irritating to skin and eyes. | May cause respiratory tract irritation. May cause skin irritation. Causes eye irritation.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (3)
JECFA Number
618
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
(E)-BUTENEDIOIC ACID | 1999 | NOT SPECIFIED (1989) | No safety concern at current levels of intake when used as a flavouring agent. The 1989 group ADI of "not specified" for fumaric acid and its salts was maintained at the fifty-third meeting (1999). | TRS 896-JECFA 53/67 | FAS 44-JECFA 53/229
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
BiocideChemical reaction regulatorDispersing agentFixing agent (mordant)Flavouring and nutrientFood preservativeFragranceLeavening agentPharmaceuticalProcessing aids not otherwise specified
Regulatory List Membership (3)
EPA Safer Chemical Ingredients List (SCIL)FDA Substances Added to Food (EAFUS)FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Fumaric Acid.
Fumaric Acid has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Fumaric Acid allowed in the EU?
Fumaric Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Fumaric Acid do in cosmetics?
Fumaric Acid functions as: Buffering agent, pH adjuster, fragrance ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 110-17-8.
What is the NOAEL for Fumaric Acid?
The NOAEL (No Observed Adverse Effect Level) for Fumaric Acid is =500 mg/kg based on a kidney and liver function study via intravenous route in rabbit. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Is Fumaric Acid classified as hazardous under GHS?
Fumaric Acid carries a GHS signal word of "WARNING". Hazard statements: Causes eye irritation 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 Fumaric Acid used outside cosmetics?
Fumaric Acid also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
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