Poor Cosmetic Ingredient NOAEL Data GHS Classified

Diethylene Glycol

Also known as: Ethanol, 2,2'-oxybis-, 2-Hydroxyethyl ether, 2,2'-0xydiethanol, 4-01-00-02390, Bis(beta-hydroxyethyl) ether (+10 more)

INCI: DIETHYLENE GLYCOL

Diethylene Glycol (CAS 111-46-6) is a cosmetic cosmetic ingredient functioning as Solvent, Viscosity Controlling. Reported NOAEL =1.6 mg/kg bw/day (SCCS_vision_codex); EU Regulation 1223/2009 status: restricted, max Subject to Annex III concentration and purity conditions; GHS signal word DANGER. 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 111-46-6 →

Auto-generated CPSR Part A draft with source citations
Function
Solvent, Viscosity Controlling
Safety Rating
POOR

Chemistry & Identifiers

Formula
C4H10O3
MW
106.12 g/mol
EC Number
203-872-2
PubChem CID
8117
IUPAC Name
2-(2-hydroxyethoxy)ethanol
InChIKey
MTHSVFCYNBDYFN-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. Subject to Annex III concentration and purity conditions
US US Status restricted
US Notes FDA issued Import Alert IA6674 to block DEG-containing toothpaste and developed GC-MS screening method for DEG at >=0.1% w/w. Primarily regulated as a contaminant and adulterant risk in glycerin and PEG-based raw materials.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Diethylene Glycol.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Diethylene Glycol. 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 =1.6 mg/kg bw/day dermal - NOAEL study SCCS_vision_codex
NOAEL =1.6 mg/kg bw/day dermal - NOAEL study SCCS_vision_codex
NOAEL =1.6 mg/kg bw/day dermal - NOAEL study SCCS_vision_codex
NOAEL =1.6 mg/kg bw/day dermal - NOAEL study SCCS_vision_codex
NOAEL =50 mg/kg bw/day oral rat NOAEL study SCCS_vision_codex
NOAEL =50 mg/kg bw/day oral rat NOAEL study SCCS_vision_codex
NOAEL =50 mg/kg bw/day oral rat NOAEL study SCCS_vision_codex
NOAEL =50 mg/kg bw/day oral rat NOAEL study SCCS_vision_codex
NOAEL =200 mg/kg/day - rat NOAEL study SCCS_vision_codex
NOAEL =200 mg/kg bw/day - rat genotoxicity SCCS_vision_codex

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
Excl markWarnCancerHealth haz
Hazard Statements
Harmful if swallowed Causes damage to kidneys if swallowed May cause drowsiness and dizziness
Short-term Exposure Effects
The substance may cause effects on the kidneys. This may result in kidney impairment. Ingestion could cause effects on the central nervous system and liver. Ingestion could cause death.
Routes of Exposure
The substance can be absorbed into the body by ingestion.

EPA ToxValDB — Toxicity Values

6 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LEL =69445.6 mg/m3 Human inhalation - DOE Protective Action Criteria
LD50 =7800 mg/kg Guinea Pig oral - ChemIDplus
LD50 =23700 mg/kg Mouse oral - ChemIDplus
LD50 =4400 mg/kg Rabbit oral - ChemIDplus
LD50 =11890 mg/kg Rabbit dermal - ChemIDplus
LD50 =12565 mg/kg Rat oral - ChemIDplus

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
Acute Tox. 4 *
Hazard Statements
  • H302 Harmful if swallowed

Inserted via ATP: CLP00

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1370
(EC) 2013/344

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.

SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: A1140
JPKR Japan/Korea Cosmetics
Japan (Restricted): ; Category: General
BRIN Brazil/India Cosmetics
Brazil: Prohibited
Brazil: Restricted
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (5)
Jurisdiction Status Max % Product Type
JP restricted - Prohibited in toothpaste
CN banned - -
BR restricted 0.1 As impurity trace only in other cosmetic ingredients; 0.1% max
ASEAN banned - All cosmetic products prohibited
ASEAN restricted ≤0.1% as unavoidable trace All cosmetic products

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (2 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 10.0% - - SCCP/0139
measured 100.0% in_vitro - SCCP/0139

Additional Ingredient Properties

1 property record from structured ingredient metadata.

humectant
{"cas_number": "111-46-6", "ingredient_class": "humectant/polyol", "molecular_weight_Da": "106.12", "chemical_type": "polyol", "water_binding_mechanism": "hydrogen_bonding/hygroscopic", "water_holding_capacity_g_per_g": "0.4-0.6", "hygroscopicity_at_50_RH": "good", "hygroscopicity_at_80_RH": "excellent", "NMF_component": "no", "NMF_percentage_natural": "0", "TEWL_reduction_pct": "12-20", "skin_hyd…

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (2)
ICSC Safety Card
0619
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
... It is not appreciably irritating to the eyes or skin ... | An eye and human skin irritant.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (1)
JECFA Evaluation
DIETHYLENE GLYCOL | 1979 | NOT TO BE USED | TRS 648-JECFA 23/16 | NOT PREPARED
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Binder Catalyst Deodorizer Emulsifier Fragrance Lubricating agent Monomers No specific technical function Plasticizer Processing aids not otherwise specified
Regulatory List Membership (4)
EU Banned in Cosmetics IFRA Fragrance Transparency List FDA Indirect Food Contact Additives EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Diethylene Glycol.

Regulatory Flags

restricted-eu prohibited-china prohibited-canada contaminant-risk renal-toxicant never-formulate annex-iii poisoning-incidents endocrine_disruptor eu_banned_cosmetics ifra_fragrance eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Diethylene Glycol by CAS number or substance name.

Studies
28
Lowest NOAEL
1.6
Highest NOAEL
1118

Units vary across source rows: mg/kg bw/day, mg/kg/day

SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
10.0% - -
100.0% in_vitro -

Known Synonyms

Ethanol, 2,2'-oxybis- 2-Hydroxyethyl ether 2,2'-0xydiethanol 4-01-00-02390 Bis(beta-hydroxyethyl) ether BRN 0969209 Caswell No. 338A EINECS 203-872-2 EPA Pesticide Chemical Code 338200 Ethanol, 2,2'-oxydi- Glycol ether Glycol ethyl ether UNII-61BR964293 Diethylenglykol beta,beta'-dihydroxydiethyl ether

Chemical Function

Emulsifier Solvent Deodorizer Fragrance Viscosity modifier Binder

Regulatory Lists

Europe; Personal care; restricted detected; Europe; Toys and children's products artificial_saliva; detected; emissions; Europe; Toys and children's products Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe drinking_water; Europe; manufacturing; plastic_additive active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides

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
DI(HYDROXYETHYL)ETHER
ChEMBL ID
CHEMBL1235226
View full pharmaceutical profile →

Frequently Asked Questions

Is Diethylene Glycol safe in cosmetics?

Diethylene Glycol has a safety rating of "POOR" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is Diethylene Glycol allowed in the EU?

Diethylene Glycol EU regulatory status: restricted. Maximum allowed concentration: Subject to Annex III concentration and purity conditions. This is based on EU Regulation 1223/2009 and its amendments.

What does Diethylene Glycol do in cosmetics?

Diethylene Glycol functions as: Solvent, Viscosity Controlling. It is classified as a cosmetic ingredient in our database. CAS number: 111-46-6.

What is the NOAEL for Diethylene Glycol?

The NOAEL (No Observed Adverse Effect Level) for Diethylene Glycol is =1.6 mg/kg bw/day based on a NOAEL study study via dermal route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Diethylene Glycol classified as hazardous under GHS?

Diethylene Glycol carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes damage to kidneys if swallowed May cause drowsiness and dizziness. 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 Diethylene Glycol used outside cosmetics?

Diethylene Glycol 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 Diethylene Glycol have different safety status in cosmetics vs industrial chemicals?

Diethylene Glycol is classified GHS Danger (H302, H361, H372) in the chemicals database but is restricted in EU cosmetics at max Subject to Annex III concentration and purity conditions.

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