Poor Cosmetic Ingredient NOAEL Data GHS Classified

Ethylenediamine ⚠️

INCI: ETHYLENEDIAMINE

CAS Number
107-15-3
Function
Chelating agent, pH adjuster, intermediate (rarely used standalone in finished cosmetics)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status permitted
US Notes Permitted — not prohibited under 21 CFR; however, FDA expects safety substantiation for sensitizers

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Ethylenediamine ⚠️. 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 250 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral mouse Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 150 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 310 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 80 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 200 mg/kg bw/day oral rat Subchronic COSMOS_DB

GHS Hazard Classification

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

Signal Word
DANGER
Pictograms
flam;flame; excl mark;warn; corr; cancer;health haz
Hazard Statements
Flammable liquid and vapour Harmful if swallowed or in contact with skin Causes severe skin burns and eye damage May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled
Short-term Exposure Effects
The substance is corrosive to the eyes, skin and respiratory tract. Corrosive on ingestion.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin and by ingestion.

Expert Verdict

Strong sensitizer (Skin Sens. 1A) included in dermatological patch test baseline series with corrosive effects to eyes (H318) and acute toxicity concerns; if present as residual monomer in ethylenediamine-based copolymers, must be controlled below 10 ppm or NESIL-derived safe threshold and is not recommended for leave-on cosmetics unless present only as trace impurity.

⚠️
Concern Level: High

Regulatory Flags

potential-allergen fda_food_additive

Frequently Asked Questions

Is Ethylenediamine ⚠️ safe in cosmetics?

Strong sensitizer (Skin Sens. 1A) included in dermatological patch test baseline series with corrosive effects to eyes (H318) and acute toxicity concerns; if present as residual monomer in ethylenediamine-based copolymers, must be controlled below 10 ppm or NESIL-derived safe threshold and is not recommended for leave-on cosmetics unless present only as trace impurity. The EU classifies Ethylenediamine ⚠️ as "prohibited". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.

Is Ethylenediamine ⚠️ allowed in the EU?

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

What does Ethylenediamine ⚠️ do in cosmetics?

Ethylenediamine ⚠️ functions as: Chelating agent, pH adjuster, intermediate (rarely used standalone in finished cosmetics). It is classified as a cosmetic ingredient in our database. CAS number: 107-15-3.

What is the Margin of Safety for Ethylenediamine ⚠️?

adequate 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 Ethylenediamine ⚠️?

The NOAEL (No Observed Adverse Effect Level) for Ethylenediamine ⚠️ is 250 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Ethylenediamine ⚠️ classified as hazardous under GHS?

Ethylenediamine ⚠️ carries a GHS signal word of "DANGER". Hazard statements: Flammable liquid and vapour Harmful if swallowed or in contact with skin Causes severe skin burns and eye damage May cause an allergic skin reaction May cause allergy or asthma symptoms or breathing difficulties if inhaled. 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.

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