Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Isopropanolamine. 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 | 100 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 300 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 100 mg/kg bw/day | oral | rat | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Nitrosamine formation risk is the primary concern โ must not co-formulate with nitrosating agents; secondary amine impurities must be controlled; reproductive toxicity NOAEL 300 mg/kg bw/d (F0 reproductive)
Regulatory Flags
Frequently Asked Questions
Is Isopropanolamine safe in cosmetics?
Nitrosamine formation risk is the primary concern โ must not co-formulate with nitrosating agents; secondary amine impurities must be controlled; reproductive toxicity NOAEL 300 mg/kg bw/d (F0 reproductive) The EU classifies Isopropanolamine as "restricted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.
Is Isopropanolamine allowed in the EU?
Isopropanolamine EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Isopropanolamine do in cosmetics?
Isopropanolamine functions as: pH adjuster, buffering agent. It is classified as a cosmetic ingredient in our database. CAS number: 78-96-6.
What is the Margin of Safety for Isopropanolamine?
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 Isopropanolamine?
The NOAEL (No Observed Adverse Effect Level) for Isopropanolamine is 100 mg/kg bw/day based on a oral study via oral route in rat. A total of 3 study endpoints are available. Source: REACH.
Is Isopropanolamine classified as hazardous under GHS?
Isopropanolamine carries a GHS signal word of "DANGER". Hazard statements: Combustible liquid Harmful if swallowed or in contact with skin Causes severe skin burns and eye damage Causes damage to respiratory tract May be harmful if swallowed and enters airways Harmful to aquatic life. 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 โ at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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Related Ingredients
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