Moderate Cosmetic Ingredient GHS Classified

Ammonium Hydroxide

INCI: AMMONIUM HYDROXIDE

CAS Number
1336-21-6
Function
pH adjuster, buffering agent, denaturant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 6% as NH3
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA GRAS as direct food ingredient per 21 CFR 184.1139. Classified as skin protectant under OTC drug framework but FDA determined inadequate data to establish GRASE for that indication. Not a UV filter; no sunscreen relevance. VCRP 2017 data: 1,354 cosmetic products; highest concentration 12.5% in rinse-off hair dyes, 1.5% in leave-on face/neck products. CIR 2018 final conclusion: safe as used in hair dyes/colors and safe in cosmetics applied directly to skin at present practices of use and concentration when formulated to be non-irritating.

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Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

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; enviro;aqua
Hazard Statements
May be osive to metals Harmful if swallowed Causes severe skin burns and eye damage May cause respiratory irritation Very toxic to aquatic life
Short-term Exposure Effects
The substance is corrosive to the eyes, skin and respiratory tract. Corrosive on ingestion. Inhalation of high concentrations of the vapour may cause laryngeal oedema, inflammation of the respiratory tract and pneumonia. Exposure could cause asphyxiation due to swelling in the throat. The effects may be delayed.
Long-term Exposure Effects
Repeated or prolonged inhalation may cause effects on the lungs.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol or vapour and by ingestion.

Expert Verdict

EU Annex III restricted ingredient under Regulation (EC) No 1223/2009 with maximum 6% as NH3 in finished product and mandatory label declaration of Contains Ammonia above 2% as NH3. CIR (2018): safe as used in hair dyes/colors and safe in cosmetics applied to skin when formulated to be non-irritating. FDA GRAS as direct food ingredient per 21 CFR 184.1139 but inadequate data for OTC skin protectant GRASE. Primary function is pH adjustment and denaturant. Used in 1,354 products per 2017 VCRP data with 81.5% in hair coloring. Safety is conditional on finished-product pH and free ammonia concentration control.

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Concern Level: Moderate

Regulatory Flags

eu-annex-iii restricted ph-adjuster denaturant irritant-potential hair-dye labeling-required cir-reviewed endogenous-metabolite concentration-dependent-safety epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Ammonium Hydroxide safe in cosmetics?

EU Annex III restricted ingredient under Regulation (EC) No 1223/2009 with maximum 6% as NH3 in finished product and mandatory label declaration of Contains Ammonia above 2% as NH3. CIR (2018): safe as used in hair dyes/colors and safe in cosmetics applied to skin when formulated to be non-irritating. FDA GRAS as direct food ingredient per 21 CFR 184.1139 but inadequate data for OTC skin protectant GRASE. Primary function is pH adjustment and denaturant. Used in 1,354 products per 2017 VCRP data with 81.5% in hair coloring. Safety is conditional on finished-product pH and free ammonia concentration control. The EU classifies Ammonium Hydroxide as "restricted". Safety rating: MODERATE.

Is Ammonium Hydroxide allowed in the EU?

Ammonium Hydroxide EU regulatory status: restricted. Maximum allowed concentration: 6% as NH3. This is based on EU Regulation 1223/2009 and its amendments.

What does Ammonium Hydroxide do in cosmetics?

Ammonium Hydroxide functions as: pH adjuster, buffering agent, denaturant. It is classified as a cosmetic ingredient in our database. CAS number: 1336-21-6.

What is the Margin of Safety for Ammonium Hydroxide?

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.

Is Ammonium Hydroxide classified as hazardous under GHS?

Ammonium Hydroxide carries a GHS signal word of "DANGER". Hazard statements: May be osive to metals Harmful if swallowed Causes severe skin burns and eye damage May cause respiratory irritation Very toxic 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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