Is Diethyl Phthalate (DEP) safe in cosmetics?
Diethyl Phthalate (DEP) has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Diethyl Phthalate (DEP)
Also known as: 1,2-Benzenedicarboxylic acid, diethyl ester, 4-09-00-03172, BRN 1912500, Diethyl o-phenylenediacetate, Di-n-ethyl phthalate (+12 more)
INCI: DIETHYL PHTHALATE
Diethyl Phthalate (DEP) (CAS 84-66-2) is a cosmetic cosmetic ingredient functioning as Solvent, denaturant, fragrance fixative. NOAEL 900 mg/kg bw/day (PDF-verified 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 84-66-2 →
Auto-generated CPSR Part A draft with source citations
Function
Solvent, denaturant, fragrance fixative
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
diethyl benzene-1,2-dicarboxylate
InChIKey
FLKPEMZONWLCSK-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted — no specific CFR restriction; FDA has not banned DEP in cosmetics
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 Phthalate (DEP).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Diethyl Phthalate (DEP). 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 | =1600 mg/kg bw/day | - | - | Developmental toxicity | WHO/JECFA |
| NOAEL | =1900 mg/kg bw/day | oral | - | Toxicology study | WHO/JECFA |
| NOAEL | =1900 mg/kg bw | - | Rat | Toxicology study | WHO/JECFA |
| NOAEL | =350 mg/kg | - | rat | carcinogenicity | SCCNFP Opinion |
| NOAEL | =350 mg/kg | - | rat | carcinogenicity | SCCNFP Opinion |
| NOAEL | =350 mg/kg | - | rat | carcinogenicity | SCCNFP Opinion |
| NOAEL | =350 mg/kg | - | rat | carcinogenicity | SCCNFP Opinion |
| NOAEL | =514 mg/kg | - | mouse | carcinogenicity | SCCNFP Opinion |
| NOAEL | =514 mg/kg | - | mouse | carcinogenicity | SCCNFP Opinion |
| NOAEL | =514 mg/kg | - | mouse | carcinogenicity | SCCNFP Opinion |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Diethyl Phthalate (DEP) 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 |
|---|---|---|---|---|---|
| LEL | =63627.3 mg/m3 | Human | inhalation | - | DOE Protective Action Criteria |
| RfD | =0.8 mg/kg-day | Human | oral | - | OW Drinking Water Standards |
| LEL | =1297 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =197 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =1375 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =222 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =267 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =1375 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =1150 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
| LEL | =1375 mg/kg-day | Rat | oral | chronic (developmental) | EPA ToxRefDB |
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
0.5%
DPRA Lys %
0.9%
KeratinoSens IC50
2000 µM
hCLAT CV75
600 µg/mL
LLNA EC3
100%
NESIL
6207 µg/cm²
LLNA: NC (non-sensitizer)
GHS: not classified
Human: positive
Source: LLNA: Gerberick et al. (2005); DPRA: Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064] | Nukada et al. 2013 [DOI:10.1016/j.tiv.2012.11.006]; KS: Joint Research Centre of the European Union 2014 | Natsch et al. 2011 [DOI:10.1021/tx2003678]; hCLAT: Nukada et al. 2011 [DOI:10.1111/j.1600-0536.2011.01952.x]; HPPT: [103] Greif N (1967): Cutaneous safety of fragrance material as measured by the maximization test.
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 6206.9 | - | - |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: phthalate
Receptor targets: ERα, AR, PPARγ
LOEC: 1 µM
EU status: allowed (no specific limit in cosmetics)
agonist (ER, PPARγ); antagonist (AR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| sperm_DNA_damage | reproductive | 443 ng/mL urine (MEP) ng/mL | - |
| AED | systemic | >1 µg/kg/day (4 cosmetics co-used) µg/kg/day | - |
| AR luciferase activity (antagonist) | AR | EC50/IC50: IC50 >100 uM (very weak); LOEC: 10 uM; NOEC: 1 uM mixed | weak antagonist |
SIN List ED: Suspected ED
Cosmetic relevance: direct
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| AU | restricted | 15.0 | fragrances |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Roberts Skin Permeation (Mendeley 2022)
MW: 222.2
Log Kow: 2.47
Log Kp: -1.7050930893948075
Log Jmax: -7.043188034891143
Source: Roberts Cheruvu Mendeley 2022
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (6)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Diethyl Phthalate | TR-429: Toxicology and Carcinogenesis Studies of Diethylphthalate (CASRN 84-66-2) in F344/N Rats and B6C3F1 Mice (Dermal Studies) with Dermal Initiation/Promotion Study of Diethylphthalate and Dimethylphthalate (CASRN 131-11-3) in Male Swiss (CD-1) Mice (1995 ) | 11/17/93 | No Evidence | No Evidence | Equivocal Evidence | Equivocal Evidence | Under the conditions of th
Source: NTP Technical Reports
Evidence for Carcinogenicity
Cancer Classification: Group D Not Classifiable as to Human Carcinogenicity | CLASSIFICATION: D; not classifiable as to human carcinogenicity. BASIS FOR CLASSIFICATION: Pertinent data regarding carcinogenicity were not located in the available literature. HUMAN CARCINOGENICITY DATA: None. ANIMAL CARCINOGENICITY DATA:Inadequate. /Classification based on former EPA guidelines/ | A4; Not classifiable
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0258
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Film former
Fragrance
Lubricating agent
Plasticizer
Processing aids not otherwise specified
Softener and conditioner
Solvent
Viscosity modifier
Regulatory List Membership (3)
IFRA Fragrance Transparency List
FDA Indirect Food Contact Additives
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for Diethyl Phthalate (DEP).
Regulatory Flags
fragrance-component
ifra_fragrance
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Diethyl Phthalate (DEP) by CAS number or substance name.
Studies
33
Lowest NOAEL
11.7
Highest NOAEL
2500
Units vary across source rows: mg/kg bw/day, mg/kg, mg/kg bw
ECHA
SCCNFP Opinion
WHO/JECFA
Known Synonyms
1,2-Benzenedicarboxylic acid, diethyl ester
4-09-00-03172
BRN 1912500
Diethyl o-phenylenediacetate
Di-n-ethyl phthalate
EINECS 201-550-6
NCI-C60048
RCRA waste number U088
Diethylester kyseliny ftalove
Phthalsaeurediaethylester
UNII-UF064M00AF
1,2-Diethyl phthalate
DEP
Diethyl o-phthalate
Phthalic acid diethyl ester
benzene-1,2-dicarboxylic acid diethyl ester
diethyl benzene-1,2-dicarboxylate
Chemical Function
Fragrance
Regulatory Lists
detected; Europe; Toys and children's products
detected; Europe; Other direct contact consumer goods
detected; Europe; Toys and children's products
air; detected; emissions; Europe; Vehicle - car interior
artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods
inert_ingredient; non_food_use; Pesticides
Indirect additives food contact (10/2018)
active_ingredient; animal_products; Europe; pharmaceutical; residue
detected; Europe; Toys and children's products
air; detected; emissions; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior
detected; Europe; Vehicle - car interior
detected; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior
air; detected; emissions; Europe; Vehicle - car interior - auto air freshener
Australian Status
AICIS status: listed_with_terms
Specific information requirements: Obligations to provide information apply. These obligations are: 1. A person introducing this chemical must tell us in writing within 28 calendar days if any of the following circumstances have occurred in relation to their introduction (importation or manufacture): a. Additional information becoming available on the...
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
DIETHYL PHTHALATE
ChEMBL ID
CHEMBL388558
Max Phase
-1
Frequently Asked Questions
Is Diethyl Phthalate (DEP) allowed in the EU?
Diethyl Phthalate (DEP) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Diethyl Phthalate (DEP) do in cosmetics?
Diethyl Phthalate (DEP) functions as: Solvent, denaturant, fragrance fixative. It is classified as a cosmetic ingredient in our database. CAS number: 84-66-2.
What is the NOAEL for Diethyl Phthalate (DEP)?
The NOAEL (No Observed Adverse Effect Level) for Diethyl Phthalate (DEP) is =1600 mg/kg bw/day based on a Developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: WHO/JECFA.
Is Diethyl Phthalate (DEP) used outside cosmetics?
Diethyl Phthalate (DEP) 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 Phthalate (DEP) 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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