Poor Cosmetic Ingredient NOAEL Data GHS Classified

Diethyl Ethanolamine

INCI: DIETHYL ETHANOLAMINE

CAS Number
100-37-8
Function
pH adjuster, buffering agent
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status permitted
US Notes Permitted under 21 CFR; FDA guidance advises against nitrosamine contamination

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Diethyl Ethanolamine. 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 125 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 10 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 440 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

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. The substance is severely irritating to the skin and respiratory tract. The substance may cause effects on the nervous system.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin and by ingestion.

Expert Verdict

Primary concern: Nitrosamine formation potential—must test finished product for N-nitrosodiethanolamine (NDELA) or related nitrosamines. Skin and eye irritant, corrosive at high concentrations. Classified GHS: H302, H312, H332, H311, H314. Requires strict use-level control.

⚠️
Concern Level: High

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Diethyl Ethanolamine safe in cosmetics?

Primary concern: Nitrosamine formation potential—must test finished product for N-nitrosodiethanolamine (NDELA) or related nitrosamines. Skin and eye irritant, corrosive at high concentrations. Classified GHS: H302, H312, H332, H311, H314. Requires strict use-level control. The EU classifies Diethyl Ethanolamine as "prohibited". Safety rating: POOR. 5 toxicological study endpoint(s) are available in our database.

Is Diethyl Ethanolamine allowed in the EU?

Diethyl Ethanolamine EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Diethyl Ethanolamine do in cosmetics?

Diethyl Ethanolamine functions as: pH adjuster, buffering agent. It is classified as a cosmetic ingredient in our database. CAS number: 100-37-8.

What is the Margin of Safety for Diethyl Ethanolamine?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Diethyl Ethanolamine?

The NOAEL (No Observed Adverse Effect Level) for Diethyl Ethanolamine is 125 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 5 study endpoints are available. Source: COSMOS_DB.

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