What is the NOAEL for Methylenebutanedioic acid?
Methylenebutanedioic acid has 10 NOAEL studies in the database. The lowest reported value is 22.05 mg/m3 via inhalation in Human. Source: ToxValDB_GESTIS_DNEL.
NOAEL Data
REACH Registered
Cosmetic Ingredient
Methylenebutanedioic acid
Also known as: 2-Methylidenebutanedioic acid (Methylenebutanedioic acid) (Itaconic acid), EINECS 202-599-6, UNII-Q4516562YH, 2-methylidenebutanedioic acid
CAS 97-65-4
Methylenebutanedioic acid (CAS 97-65-4) is a chemical substance. Key regulatory status: REACH registered, 2 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, ECHA REACH.
Cross-Vertical Regulatory Divergence
Methylenebutanedioic acid is classified GHS Danger (H315, H318, H319, H335, H402) in the chemicals database but is allowed in EU cosmetics.
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
SOURCE
noael studies public
NOAEL studies
10
SOURCE
chemical inventory jurisdictions
Regulatory lists
2
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
10 fields
Name
Methylenebutanedioic acid
CAS Number
97-65-4
DTXSID
DTXSID2026608
Molecular Formula
C5H6O4
InChI Key
LVHBHZANLOWSRM-UHFFFAOYSA-N
Monoisotopic Mass
130.026609
Synonyms
2-Methylidenebutanedioic acid (Methylenebutanedioic acid) (Itaconic acid)EINECS 202-599-6UNII-Q4516562YH2-methylidenebutanedioic acid
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
4 records
Softener and conditionerBiocidepH regulating agent
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
2 records
| List | Keyword | Source |
|---|---|---|
| drinking_water; Europe; manufacturing; plastic_additive | Belgaqua | CPCat |
| Indirect additives food contact (10/2018) | FDA | United States Food and Drug Administration (FDA) |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 10 of 10 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| =22.05 | mg/m3 | DNEL systemic | inhalation | Human | ToxValDB_GESTIS_DNEL |
| Q4516562YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| Q4516562YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| Q4516562YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| Q4516562YH | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| ~300 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =500 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =1000 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =1000 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =1001 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB_ECHA_IUCLID |
Showing 10 of 10 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Itaconic acid | 202-599-6 | ECHA overview → |
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
SOURCE
AICIS inventory
1 records
Inventory Status
listed
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Emollient
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
ITACONATE
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
2
Frequently Asked Questions
What regulatory lists include Methylenebutanedioic acid?
Methylenebutanedioic acid appears on 2 regulatory/inventory lists including drinking_water; Europe; manufacturing; plastic_additive, Indirect additives food contact (10/2018). Source: EPA CPDat.
Is Methylenebutanedioic acid used in cosmetics?
Yes, Methylenebutanedioic acid is also indexed as a cosmetic ingredient under the name Itaconic Acid. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Methylenebutanedioic acid come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does Methylenebutanedioic acid have different safety status in cosmetics vs industrial chemicals?
Methylenebutanedioic acid is classified GHS Danger (H315, H318, H319, H335, H402) in the chemicals database but is allowed in EU cosmetics.
Is Methylenebutanedioic acid used outside industrial chemicals?
Methylenebutanedioic acid also appears in cosmetics, pharmaceutical databases.