Moderate Cosmetic Ingredient NOAEL Data GHS Classified

ANILINE

CAS Number
62-53-3
Function
Not Reported
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status Restricted
EU Max Conc. II/22 CMR2
🇺🇸 US Status Not specifically regulated

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Safety Data

Margin of Safety (MoS)
NOAEL: No single cosmetic‑use NOAEL; multiple repeated‑dose studies show haematological effects at low doses. Canadian assessment reports haematological changes at 10–30 mg/kg bw/day in animals and identifies critical effects, but does not clearly state a numeric NOAEL in the summary text retrieved . Some rabbit dermal lethality studies report non‑lethal doses around 838–2200 mg/kg on abraded/i...
Dermal Absorption
Human in vivo dermal absorption from aqueous solutions 1–2%: reported absorption rates 0.20–1.22 mg/cm²/h; studies in volunteers indicate considerable percutaneous uptake but not expressed as a sim...

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for ANILINE. 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
LOAEL 4 other oral rat oral REACH
LOAEL 7 other oral rat oral REACH
LOAEL 4 other oral rat oral REACH
NOAEL 174.4 other oral rat oral REACH
NOAEL 23.3 mg/kg bw/day oral rat oral REACH
NOAEL 10 ppm 1991 rat inhalation REACH
NOAEL 0.6 other oral mouse oral REACH
NOAEL ca.43 other oral rat oral REACH
NOAEL ca.65 mg/kg bw/day oral rat oral REACH
LOAEL 30 other 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
skull;toxic; cancer;health haz; enviro;aqua
Hazard Statements
Toxic if swallowed, in contact with skin or if inhaled Causes damage to red blood cells Causes damage to the blood through prolonged or repeated exposure Causes serious eye irritation May cause an allergic skin reaction Very toxic to aquatic life
Short-term Exposure Effects
The substance is severely irritating to the eyes. The substance may cause effects on the blood. This may result in the formation of methaemoglobin. See Notes. Exposure could cause haemolysis. This may result in haemolytic anaemia. The effects may be delayed. Medical observation is indicated.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. The substance may have effects on the blood. This may result in haemolytic anaemia.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin also as a vapour and by ingestion.

Expert Verdict

ANILINE is listed in the EU CosIng database with functions: Not Reported It is restricted under EU Cosmetics Regulation. Restriction: II/22 CMR2.

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Concern Level: Medium

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment prop65 eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is ANILINE safe in cosmetics?

ANILINE is listed in the EU CosIng database with functions: Not Reported It is restricted under EU Cosmetics Regulation. Restriction: II/22 CMR2. The EU classifies ANILINE as "Restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is ANILINE allowed in the EU?

ANILINE EU regulatory status: Restricted. Maximum allowed concentration: II/22 CMR2. This is based on EU Regulation 1223/2009 and its amendments.

What does ANILINE do in cosmetics?

ANILINE functions as: Not Reported. It is classified as a cosmetic ingredient in our database. CAS number: 62-53-3.

What is the Margin of Safety for ANILINE?

NOAEL: No single cosmetic‑use NOAEL; multiple repeated‑dose studies show haematological effects at low doses. Canadian assessment reports haematological changes at 10–30 mg/kg bw/day in animals and identifies critical effects, but does not clearly state a numeric NOAEL in the summary text retrieved . Some rabbit dermal lethality studies report non‑lethal doses around 838–2200 mg/kg on abraded/i... 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 ANILINE?

The NOAEL (No Observed Adverse Effect Level) for ANILINE is 4 other based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

Is ANILINE classified as hazardous under GHS?

ANILINE carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed, in contact with skin or if inhaled Causes damage to red blood cells Causes damage to the blood through prolonged or repeated exposure Causes serious eye irritation May cause an allergic skin reaction 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 — at cosmetic use concentrations, hazard thresholds may not be met.

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