Also known as: 2,2'-[(4-Aminophenyl)imino]bisethanol sulfate, Ethanol, 2,2'-[(4-aminophenyl)imino]bis-, sulfate (1:1) (salt), 2,2'-((4-Aminophenyl)imino)bis(ethanol) sulfate, N,N-Bis(beta-hydroxyethyl)-p-phenylenediamine sulfate, EINECS 259-134-5 (+2 more)
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE (CAS 54381-16-7) is a cosmetic cosmetic ingredient functioning as Hair Dyeing. NOAEL 5 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max III/198. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is classified GHS Danger (H301, H311, H315, H317, H319, H331, H400, H410) in the chemicals database but is restricted in EU cosmetics at max III/198.
US NotesAllowed — under coal tar hair dye exemption with required caution labeling
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Toxicological Studies
10 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
NOAEL
=0.003 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.003 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.003 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.003 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=5 mg/kg bw/day
-
-
NOAEL study
SCCS Opinion
NOAEL
=5 mg/kg/day
oral
human
developmental toxicity
SCCS Opinion
NOAEL
=5 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=5 mg/kg bw/day
-
-
NOAEL study
SCCS Opinion
NOAEL
=5 mg/kg/day
oral
human
developmental toxicity
SCCS Opinion
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE across SCCS product categories, with measured dermal absorption where available.
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: Restricted. Max: 산화염모제에 2.5%. 기타 제품에는 사용금지
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 2.5%
Additional Jurisdictional Restrictions (2)
Jurisdiction
Status
Max %
Product Type
CN
permitted_hair_dye
3
Oxidative hair dye products
BR
permitted_hair_dye
-
Oxidative hair dye
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured_sccs_opinion
0.014%
-
-
SCCP/0983/06
Additional Ingredient Properties
1 property record from structured ingredient metadata.
Is N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE safe in cosmetics?
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE has a safety rating of "MODERATE" in our database. EU status: restricted. US status: allowed. 10 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 10 study endpoints are available. Source: COSMOS DB.
Is N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE used outside cosmetics?
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE have different safety status in cosmetics vs industrial chemicals?
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is classified GHS Danger (H301, H311, H315, H317, H319, H331, H400, H410) in the chemicals database but is restricted in EU cosmetics at max III/198.
Compliance Tools
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