Is Diethyl Malonate safe in cosmetics?
Diethyl Malonate has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Diethyl Malonate
Also known as: propanedioic acid, diethyl ester, EINECS 203-305-9, Ethyl malonate, Ethyl methanedicarboxylate, Ethyl propanedioate (+4 more)
Diethyl Malonate (CAS 105-53-3) is a cosmetic cosmetic ingredient functioning as Flavouring and nutrient; Fragrance; No specific technical function. 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 105-53-3 →
Auto-generated CPSR Part A draft with source citations
Function
Flavouring and nutrient; Fragrance; No specific technical function
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
diethyl propanedioate
InChIKey
IYXGSMUGOJNHAZ-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted, not restricted under 21 CFR
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Diethyl Malonate.
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Hazard Statements
Combustible liquid Causes eye irritation Harmful to aquatic life
Short-term Exposure Effects
The substance is mildly irritating to the eyes.
Long-term Exposure Effects
Health effects of the substance have been investigated but none have been found
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
NESIL
2700 µg/cm²
GHS: 1B
Human: positive
Source: HPPT: [147] Epstein WL (1975): Report to RIFM, 23 September, unpublished.
HRIPT Human Patch Test Studies
2 human repeat insult patch tests aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 2700 | - | - |
| HRIPT | - | 0 | 20000 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
ICSC Safety Card
1739
Source: WHO/JECFA
Skin Eye Respiratory Irritation
Eye irritation in rabbits: moderately irritating. | A skin irritant.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (6)
JECFA Number
614
Source: WHO/JECFA
JECFA Evaluation
DIETHYL MALONATE | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within 2 year
Source: WHO/JECFA
JECFA Evaluation
ETHYL PROPANEDIOATE | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within 2 y
Source: WHO/JECFA
JECFA Evaluation
MALONIC ESTER | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within 2 years (
Source: WHO/JECFA
JECFA Evaluation
ETHYL MALONATE | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within 2 years
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
No specific technical function
Regulatory List Membership (4)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for Diethyl Malonate.
Regulatory Flags
fragrance-component
epa_safer_alternative
ifra_fragrance
fda_food_additive
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Diethyl Malonate by CAS number or substance name.
Studies
6
Lowest NOAEL
300 mg/kg bw/day
Highest NOAEL
364 mg/kg bw/day
ECHA
Known Synonyms
propanedioic acid, diethyl ester
EINECS 203-305-9
Ethyl malonate
Ethyl methanedicarboxylate
Ethyl propanedioate
FEMA No. 2375
Malonic ester
Methanedicarboxylic acid, diethyl ester
UNII-53A58PA183
Chemical Function
Fragrance
No specific technical function
Flavouring and nutrient
Regulatory Lists
Australia; Food and drug - smoking-related products
IFRA Transparency
Europe
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
SCIL (9/2019)
consumer_product
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
MALONIC ACID DIETHYL ESTER
ChEMBL ID
CHEMBL177114
Frequently Asked Questions
Is Diethyl Malonate allowed in the EU?
Diethyl Malonate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Diethyl Malonate do in cosmetics?
Diethyl Malonate functions as: Flavouring and nutrient; Fragrance; No specific technical function. It is classified as a cosmetic ingredient in our database. CAS number: 105-53-3.
Is Diethyl Malonate classified as hazardous under GHS?
Diethyl Malonate carries a GHS signal word of "WARNING". Hazard statements: Combustible liquid 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 Diethyl Malonate used outside cosmetics?
Diethyl Malonate 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.
Compliance Tools
Check Diethyl Malonate 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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