Is Itaconic Acid safe in cosmetics?
Itaconic Acid has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Itaconic Acid
Also known as: 2-Methylidenebutanedioic acid (Methylenebutanedioic acid) (Itaconic acid), EINECS 202-599-6, UNII-Q4516562YH, 2-methylidenebutanedioic acid
INCI: ITACONIC ACID
Itaconic Acid (CAS 97-65-4) is a cosmetic cosmetic ingredient functioning as Antimicrobial; Buffering (pH control); Skin Conditioning; Emollient. NOAEL 500 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. 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 97-65-4 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Itaconic Acid is classified GHS Danger (H315, H318, H319, H335, H402) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antimicrobial; Buffering (pH control); Skin Conditioning; Emollient
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
2-methylidenebutanedioic acid
InChIKey
LVHBHZANLOWSRM-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Allowed - no specific prohibition; widely used industrially and in personal care
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Itaconic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Itaconic 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 bw/day | oral | Rat | short-term | ToxValDB_ECHA_IUCLID |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Itaconic Acid across SCCS product categories, with measured dermal absorption where available.
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
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Softener and conditioner
pH regulating agent
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Itaconic Acid.
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Itaconic Acid by CAS number or substance name.
Studies
2
Lowest NOAEL
500 mg/kg bw/day
Highest NOAEL
1000 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
2-Methylidenebutanedioic acid (Methylenebutanedioic acid) (Itaconic acid)
EINECS 202-599-6
UNII-Q4516562YH
2-methylidenebutanedioic acid
Chemical Function
Softener and conditioner
Biocide
pH regulating agent
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
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
ITACONATE
ChEMBL ID
CHEMBL359159
Frequently Asked Questions
Is Itaconic Acid allowed in the EU?
Itaconic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Itaconic Acid do in cosmetics?
Itaconic Acid functions as: Antimicrobial; Buffering (pH control); Skin Conditioning; Emollient. It is classified as a cosmetic ingredient in our database. CAS number: 97-65-4.
What is the NOAEL for Itaconic Acid?
The NOAEL (No Observed Adverse Effect Level) for Itaconic Acid is =500 mg/kg bw/day based on a short-term study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Itaconic Acid used outside cosmetics?
Itaconic Acid 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 Itaconic Acid have different safety status in cosmetics vs industrial chemicals?
Itaconic Acid is classified GHS Danger (H315, H318, H319, H335, H402) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Itaconic Acid compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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