Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Monoethanolamine (MEA)

INCI: ETHANOLAMINE

CAS Number
141-43-5
Function
alkalizer; pH adjuster; ammonia alternative; hair dye developer; buffering agent; emulsifier
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5% as leave-on cosmetic; higher concentrations permitted in rinse-off hair dye and bleach products
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel (2012) found ethanolamine and 12 of its salts safe in rinse-off products at concentrations formulated to be non-irritating. H2O2 + MEA synergistic cytotoxicity not fully addressed by CIR; implicated in hair-dye-induced hair loss at in-use concentrations.

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Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

9 study endpoints found for Monoethanolamine (MEA). 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 850 mg/kg bw/day oral mouse Reproductive COSMOS_DB
NOAEL 50 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 40 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 120 mg/kg bw/day oral rat Developmental COSMOS_DB
LOAEL 450 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat oral REACH
NOAEL 300 mg/kg bw/day oral - 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
corr; excl mark;warn
Hazard Statements
Harmful if swallowed, in contact with skin or if inhaled Causes severe skin burns and eye damage May cause respiratory irritation Harmful to aquatic life with long lasting effects
Short-term Exposure Effects
The substance is corrosive to the skin and eyes. Corrosive on ingestion. The vapour is irritating to the eyes, skin and respiratory tract. The substance may cause effects on the central nervous system. This may result in lowering of consciousness.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour, through the skin and by ingestion.

Expert Verdict

Monoethanolamine (MEA) is a restricted alkalizer in EU leave-on products (max 0.5%) and permitted in US rinse-off formulations, but research shows H2O2 + MEA synergistically induce oxidative stress and cytotoxicity in human keratinocytes and has been implicated as a causative agent in hair-dye-induced hair loss, a concern beyond standard sensitization profiles.

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Concern Level: Moderate

Regulatory Flags

alkalizer ammonia-alternative hair-dye-developer restricted keratinocyte-cytotoxic synergistic-h2o2-toxicity hair-loss-implicated eu-annex-iii epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Monoethanolamine (MEA) safe in cosmetics?

Monoethanolamine (MEA) is a restricted alkalizer in EU leave-on products (max 0.5%) and permitted in US rinse-off formulations, but research shows H2O2 + MEA synergistically induce oxidative stress and cytotoxicity in human keratinocytes and has been implicated as a causative agent in hair-dye-induced hair loss, a concern beyond standard sensitization profiles. The EU classifies Monoethanolamine (MEA) as "restricted". Safety rating: MODERATE. 9 toxicological study endpoint(s) are available in our database.

Is Monoethanolamine (MEA) allowed in the EU?

Monoethanolamine (MEA) EU regulatory status: restricted. Maximum allowed concentration: 0.5% as leave-on cosmetic; higher concentrations permitted in rinse-off hair dye and bleach products. This is based on EU Regulation 1223/2009 and its amendments.

What does Monoethanolamine (MEA) do in cosmetics?

Monoethanolamine (MEA) functions as: alkalizer; pH adjuster; ammonia alternative; hair dye developer; buffering agent; emulsifier. It is classified as a cosmetic ingredient in our database. CAS number: 141-43-5.

What is the Margin of Safety for Monoethanolamine (MEA)?

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 Monoethanolamine (MEA)?

The NOAEL (No Observed Adverse Effect Level) for Monoethanolamine (MEA) is 850 mg/kg bw/day based on a Reproductive study via oral route in mouse. A total of 9 study endpoints are available. Source: COSMOS_DB.

Is Monoethanolamine (MEA) classified as hazardous under GHS?

Monoethanolamine (MEA) carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed, in contact with skin or if inhaled Causes severe skin burns and eye damage May cause respiratory irritation Harmful to aquatic life with long lasting effects. 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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