Moderate Cosmetic Ingredient NOAEL Data Sensitization Data

m-Aminophenol

INCI: M-AMINOPHENOL

CAS Number
591-27-5
Function
Oxidative hair dye (coupler)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 1.2%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted under coal-tar hair dye exemption (21 CFR 73); requires caution labeling per FD&C Act ยง601(a)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

7 study endpoints found for m-Aminophenol. 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 20 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 70 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 0.59 other dermal rat dermal REACH
NOAEL 70 mg/kg bw/day oral rat oral REACH
NOAEL 70 mg/kg bw/day oral rat oral REACH
NOAEL 9.7 other dermal code:3543 dermal REACH
NOAEL 240 mg/kg bw/day oral rat oral REACH

Sensitization Profile

Contact sensitization data for m-Aminophenol based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

Expert Verdict

Must not exceed 1.0% in-use concentration after mixing with Hโ‚‚Oโ‚‚. Mandatory patch testing labeling in EU. Potential N-nitrosamine formation if combined with nitrosating agents.

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Concern Level: Moderate

Frequently Asked Questions

Is m-Aminophenol safe in cosmetics?

Must not exceed 1.0% in-use concentration after mixing with Hโ‚‚Oโ‚‚. Mandatory patch testing labeling in EU. Potential N-nitrosamine formation if combined with nitrosating agents. The EU classifies m-Aminophenol as "restricted". Safety rating: MODERATE. 7 toxicological study endpoint(s) are available in our database.

Is m-Aminophenol allowed in the EU?

m-Aminophenol EU regulatory status: restricted. Maximum allowed concentration: 1.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does m-Aminophenol do in cosmetics?

m-Aminophenol functions as: Oxidative hair dye (coupler). It is classified as a cosmetic ingredient in our database. CAS number: 591-27-5.

What is the Margin of Safety for m-Aminophenol?

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 m-Aminophenol?

The NOAEL (No Observed Adverse Effect Level) for m-Aminophenol is 20 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.

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