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.
View industrial chemical safety profile for CAS 54381-16-7 →
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
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_vision_codex |
| NOAEL | =0.003 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.003 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.003 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =5 mg/kg bw/day | - | - | NOAEL study | SCCS_vision_codex |
| NOAEL | =5 mg/kg/day | oral | human | developmental toxicity | SCCS_vision_codex |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =5 mg/kg bw/day | - | - | NOAEL study | SCCS_vision_codex |
| NOAEL | =5 mg/kg/day | oral | human | developmental toxicity | SCCS_vision_codex |
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.
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
Source: LLNA: CosmEur database; DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_hair_dye | 3 | Oxidative hair dye products |
| BR | permitted_hair_dye | - | Oxidative hair dye |
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 0.014% | - | - | SCCP/0983/06 |
1 property record from structured ingredient metadata.
Expert safety assessment and concern-level summary for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE.
Public NOAEL study rows linked to N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE by CAS number or substance name.
Units vary across source rows: mg/kg bw/day, mg/kg/day, mg/kg
| Absorption % | Method | Vehicle |
|---|---|---|
| 0.014% | SCCS PDF direct extraction | - |
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.
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.
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.
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.
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