Moderate Cosmetic Ingredient NOAEL Data

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE

CAS Number
54381-16-7
Function
Hair Dyeing
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status Restricted
EU Max Conc. III/198
๐Ÿ‡บ๐Ÿ‡ธ US Status allowed
US Notes Allowed โ€” under coal tar hair dye exemption with required caution labeling

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

Toxicological Studies

2 study endpoints found for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE. 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 5 mg/kg bw/day oral rat Developmental COSMOS_DB
LOAEL 20 mg/kg bw/day oral rat Developmental COSMOS_DB

Expert Verdict

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/198.

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Concern Level: Medium

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment

Frequently Asked Questions

Is N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE safe in cosmetics?

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/198. The EU classifies N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE as "Restricted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE allowed in the EU?

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE EU regulatory status: Restricted. Maximum allowed concentration: III/198. This is based on EU Regulation 1223/2009 and its amendments.

What does N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE do in cosmetics?

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE functions as: Hair Dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 54381-16-7.

What is the NOAEL for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE?

The NOAEL (No Observed Adverse Effect Level) for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is 5 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

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