Is Diethanolamine (restrictions) safe in cosmetics?
Diethanolamine (restrictions) has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Diethanolamine (restrictions)
Also known as: Ethanol, 2,2'-iminobis-, 2,2'-Iminobisethanol, 2-(2-Hydroxy-ethylamino)-ethanol, 4-04-00-01514, BRN 0605315 (+14 more)
INCI: DIETHANOLAMINE
Diethanolamine (restrictions) (CAS 111-42-2) is a cosmetic cosmetic ingredient functioning as pH adjuster, emulsifier. Reported NOAEL =10 mg/kg/d in mouse (CIR_vision_codex); EU Regulation 1223/2009 status: permitted, max 10%. 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 111-42-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Diethanolamine (restrictions) is classified GHS Danger (H302, H315, H318, H373) in the chemicals database but is allowed in EU cosmetics at max 10%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
pH adjuster, emulsifier
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
EU Max Conc.
10%
US US Status
permitted
US Notes
CIR Expert Panel assessed diethanolamine and its salts in 2017 and concluded that diethanolamine and its salts are safe for use when formulated to be nonirritating.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Diethanolamine (restrictions).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Diethanolamine (restrictions). 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 | =10 mg/kg/d | dermal | mouse | NOAEL study | CIR_vision_codex |
| NOAEL | =10 mg/kg/d | dermal | mouse | NOAEL study | CIR_vision_codex |
| NOAEL | =10 mg/kg/d | dermal | mouse | NOAEL study | CIR_vision_codex |
| NOAEL | =10 mg/kg/d | dermal | mouse | NOAEL study | CIR_vision_codex |
| NOAEL | =35 mg/kg/d | oral | mouse | developmental toxicity | CIR_vision_codex |
| NOAEL | =35 mg/kg/d | oral | mouse | developmental toxicity | CIR_vision_codex |
| NOAEL | =35 mg/kg/d | oral | mouse | developmental toxicity | CIR_vision_codex |
| NOAEL | =35 mg/kg/d | oral | mouse | developmental toxicity | CIR_vision_codex |
| NOAEL | =50 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
| NOAEL | =50 mg/kg/d | oral | rat | developmental toxicity | CIR_vision_codex |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is corrosive to the eyes.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. The substance may have effects on the liver and kidneys.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour and by ingestion.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
2B
Volume
77, 101
Evaluation Year
2011
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantHealth HazardCorrosive
Hazard Class and Category
Acute Tox. 4 *; STOT RE 2 *; Skin Irrit. 2; Eye Dam. 1
Hazard Statements
- H302 Harmful if swallowed
- H373 **
- H315 Causes skin irritation
- H318 Causes serious eye damage
Inserted via ATP: CLP00
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
5.9%
DPRA Lys %
2.2%
KeratinoSens IC50
2000 µM
hCLAT CV75
2277 µg/mL
GHS: inconclusive
Source: DPRA: Hoffmann et al., 2018; KS: Hoffmann et al., 2018 | Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009]; hCLAT: No reference provided in NICEATM database
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: surfactant
Receptor targets: TR, choline uptake inhibition (indirect neurological)
LOEC: 1 mM
EU status: restricted (CMR 2; banned in leave-on; restricted in rinse-off)
modulator
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
Hazard classification: Restricted (Annex XVII)
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 0.08-10 | In vitro; [14C]-DEA; flow-through diffusion cells; viable and non-viable | Excised human skin (viable and non-viable) | Kraeling et al. 2004 (Food Chem Toxicol) (2004) |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Catalyst
Chelating agent
Chemical reaction regulator
Corrosion inhibitor
Degradant/impurity
Emulsifier
Fragrance
Humectant
Surface modifier
Surfactant (surface active agent)
Regulatory List Membership (5)
California Proposition 65 (OEHHA)
EU Banned in Cosmetics
FDA Indirect Food Contact Additives
Consumer Product Chemical
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Diethanolamine (restrictions).
Regulatory Flags
prop65
eu_banned_cosmetics
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Diethanolamine (restrictions) by CAS number or substance name.
Studies
32
Lowest NOAEL
10
Highest NOAEL
380
Units vary across source rows: mg/kg, mg/kg d, mg/kg/d
CIR_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.08-10 | In vitro; [14C]-DEA; flow-through diffusion cells; viable and non-viable | Shampoo, hair dye, body lotion |
Known Synonyms
Ethanol, 2,2'-iminobis-
2,2'-Iminobisethanol
2-(2-Hydroxy-ethylamino)-ethanol
4-04-00-01514
BRN 0605315
Diethylamine, 2,2'-dihydroxy-
N,N-Di(hydroxyethyl)amine
EINECS 203-868-0
NCI-C55174
Di(beta-hydroxyethyl)amine
UNII-AZE05TDV2V
2,2'-Iminobis
2,2'Iminobisethanol
2-(2-hydroxyethylamino)ethanol
2-[(2-hydroxyethyl)amino]ethan-1-ol
Aliphatic amine
Bis(2-hydroxyethyl)tallow amine oxide
Bis-2-hydroxyethylamine
DEA
Chemical Function
pH regulating agent
Corrosion inhibitor
Regulatory Lists
pharmaceutical
banned; Europe; Personal care
agricultural; detected; Pesticides; surface_water
detected; Europe; Other direct contact consumer goods
active_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
pharmaceutical
Indirect additives food contact (10/2018)
OEHHA Proposition 65 (3/2019)
Europe; Specialty occupational products
consumer_product
OEHHA Proposition 65 (1/2023)
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
DIETHANOLAMINE
ChEMBL ID
CHEMBL119604
Max Phase
3
Frequently Asked Questions
Is Diethanolamine (restrictions) allowed in the EU?
Diethanolamine (restrictions) EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.
What does Diethanolamine (restrictions) do in cosmetics?
Diethanolamine (restrictions) functions as: pH adjuster, emulsifier. It is classified as a cosmetic ingredient in our database. CAS number: 111-42-2.
What is the NOAEL for Diethanolamine (restrictions)?
The NOAEL (No Observed Adverse Effect Level) for Diethanolamine (restrictions) is =10 mg/kg/d based on a NOAEL study study via dermal route in mouse. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Is Diethanolamine (restrictions) used outside cosmetics?
Diethanolamine (restrictions) 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 Diethanolamine (restrictions) have different safety status in cosmetics vs industrial chemicals?
Diethanolamine (restrictions) is classified GHS Danger (H302, H315, H318, H373) in the chemicals database but is allowed in EU cosmetics at max 10%.
Compliance Tools
Check Diethanolamine (restrictions) compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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