Moderate Cosmetic Ingredient NOAEL Data

Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl

INCI: HYDROXYPROPYL BIS(N-HYDROXYETHYL-P-PHENYLENEDIAMINE) HCL

CAS Number
128729-28-2
Function
Hair Dyeing - oxidative hair dye coupler
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 3.0%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Allowed - the CIR Expert Panel concluded it is safe for use in oxidative hair dye formulations at described concentrations. Coal-tar hair dyes carry a statutory exemption under FD\&C Act ยง601(a) with mandatory caution labeling

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Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl. 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 25 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 30 mg/kg bw/day oral rat Developmental COSMOS_DB
LOAEL 70 mg/kg bw/day oral rat Developmental COSMOS_DB

Expert Verdict

Reviewed by both the EU SCCP and the CIR Expert Panel. Potential for skin sensitization typical of phenylenediamine-class dyes; patch testing required. CIR concluded safe as used. Functions as a coupler in oxidative hair dye systems - reacts with primary intermediates (e.g., p-phenylenediamine, p-aminophenol) in the presence of hydrogen peroxide to form final dye chromophores; the hydroxypropyl and hydroxyethyl substituents improve solubility and reduce irritation potential relative to unsubs...

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Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl safe in cosmetics?

Reviewed by both the EU SCCP and the CIR Expert Panel. Potential for skin sensitization typical of phenylenediamine-class dyes; patch testing required. CIR concluded safe as used. Functions as a coupler in oxidative hair dye systems - reacts with primary intermediates (e.g., p-phenylenediamine, p-aminophenol) in the presence of hydrogen peroxide to form final dye chromophores; the hydroxypropyl and hydroxyethyl substituents improve solubility and reduce irritation potential relative to unsubs... The EU classifies Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl as "restricted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.

Is Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl allowed in the EU?

Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl EU regulatory status: restricted. Maximum allowed concentration: 3.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl do in cosmetics?

Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl functions as: Hair Dyeing - oxidative hair dye coupler. It is classified as a cosmetic ingredient in our database. CAS number: 128729-28-2.

What is the Margin of Safety for Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl?

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.

What is the NOAEL for Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl?

The NOAEL (No Observed Adverse Effect Level) for Hydroxypropyl Bis(N-Hydroxyethyl-P-Phenylenediamine) HCl is 25 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

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