Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Isopropanolamine

INCI: ISOPROPANOLAMINE

CAS Number
78-96-6
Function
pH adjuster, buffering agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” CIR concluded safe as used; must not be used in products containing N-nitrosating agents (CIR 1987, reaffirmed 2006)

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

Safety Data

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

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.

Signal Word
DANGER
Pictograms
excl mark;warn; corr; cancer;health haz
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
Short-term Exposure Effects
The substance is corrosive to the eyes, skin and respiratory tract. Corrosive on ingestion. Inhalation may cause lung oedema, but only after initial corrosive effects on eyes and/or airways have become manifest. Medical observation is indicated. If swallowed the substance may cause vomiting and could result in aspiration pneumonitis.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
Serious local effects by all routes of exposure.

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)

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Concern Level: High

Regulatory Flags

fda_food_additive

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.

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