Moderate Cosmetic Ingredient NOAEL Data

4-Amino-M-Cresol

INCI: 4-AMINO-M-CRESOL

CAS Number
2835-99-6
Function
Oxidative hair dyeing
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
EU Max Conc. 1.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Panel concluded safe as used in oxidative hair dyes (reassessed 2024). Coal-tar hair dye exemption under FD&C Act applies

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for 4-Amino-M-Cresol. 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 60 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 120 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Prohibited in EU. Permitted in US as oxidative hair dye ingredient. Must carry mandatory warning: Can cause allergic reaction. Not to be used for dyeing eyelashes or eyebrows unless specifically permitted. Must not exceed 1.5% on-head concentration.

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Concern Level: Moderate

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is 4-Amino-M-Cresol safe in cosmetics?

Prohibited in EU. Permitted in US as oxidative hair dye ingredient. Must carry mandatory warning: Can cause allergic reaction. Not to be used for dyeing eyelashes or eyebrows unless specifically permitted. Must not exceed 1.5% on-head concentration. The EU classifies 4-Amino-M-Cresol as "prohibited". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is 4-Amino-M-Cresol allowed in the EU?

4-Amino-M-Cresol EU regulatory status: prohibited. Maximum allowed concentration: 1.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does 4-Amino-M-Cresol do in cosmetics?

4-Amino-M-Cresol functions as: Oxidative hair dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 2835-99-6.

What is the Margin of Safety for 4-Amino-M-Cresol?

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 4-Amino-M-Cresol?

The NOAEL (No Observed Adverse Effect Level) for 4-Amino-M-Cresol is 60 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

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