NOAEL Data REACH Registered Cosmetic Ingredient

(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate

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)

CAS 54381-16-7

(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate (CAS 54381-16-7) is a chemical substance. Key regulatory status: REACH registered, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS, ECHA REACH.

View cosmetic safety profile for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE →

SOURCE NOAEL studies
NOAEL studies
25
SOURCE Chemical inventory jurisdictions
Regulatory lists
0
SOURCE EU CLP Annex VI
GHS signal
Not classified

Chemical Identity

CAS, identifiers, formula, and alternate names for the matched substance record.

SOURCE DSSTox identifiers 12 fields
Name
(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
CAS Number
54381-16-7
Molecular Formula
C10H16N2O2.H2O4S
InChI Key
KMCFMEHSEWDYKG-UHFFFAOYSA-N
Monoisotopic Mass
294.088557
Synonyms
2,2'-[(4-Aminophenyl)imino]bisethanol sulfateEthanol, 2,2'-[(4-aminophenyl)imino]bis-, sulfate (1:1) (salt)2,2'-((4-Aminophenyl)imino)bis(ethanol) sulfateN,N-Bis(beta-hydroxyethyl)-p-phenylenediamine sulfateEINECS 259-134-54-Amino-N,N-di(beta-hydroxyethyl)aniline sulfateUNII-3X5A8DP6HC

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 4 records
Dye

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 25 of 25 studies
ValueUnitEndpointRouteSpeciesSource
5mg/kg bw/day---Regulatory source
=0.176mg/m3DNEL systemicinhalationHumanToxValDB GESTIS DNEL
3X5A8DP6HCUNIIFDA UNII substance identifier--openFDA substances
20mg/kg bw/dayLOAELoralratCOSMOS DB
=0.003mg/kgNOAELoralratSCCS Opinion
5mg/kg bw/dayNOAELoralratCOSMOS DB
=5mg/kg bw/dayNOAELoralRatECHA
=5mg/kg bw/dayNOAEL--SCCS Opinion
=5mg/kg/dayNOAELoralhumanSCCS Opinion
=5mg/kgNOAELoralratSCCS Opinion
=20mg/kg bw/dayNOAELoralRatECHA
=20mg/kg bw/dayNOAEL--SCCS Opinion
=31mg/kg bwNOAELoral-SCCS Opinion
=40mg/kg bw/dayNOAELoralRatECHA
=48mg/kg bw/dayNOAELoralRatECHA
>=50mg/kg bw/dayNOAELoralRatECHA
=50mg/kg/dayNOAELoralhumanSCCS Opinion
>=121mg/kg bw/dayNOAELoralRatECHA
>=146mg/kg bw/dayNOAELoralRatECHA
20mg/kg bw/daycarcinogenicity--Regulatory source
=0.003mg/kgdermal absorptionoralratRegulatory source
=5mg/kgdermal absorptionoralratRegulatory source
5mg/kg/daydevelopmental toxicityoralhumanRegulatory source
31mg/kg bwdevelopmental toxicityoral-Regulatory source
50mg/kg/daydevelopmental toxicityoralhumanRegulatory source

Showing 25 of 25 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records
StatusNameEC NumberLink
Registered(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate259-134-5ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

SCCS Opinions

EU Scientific Committee opinions tied to the matched substance.

SOURCE SCCS Opinion 2 opinions
OpinionDateConclusionMax Conc.Concerns
SCCP/0949/0520 June 2006safe2.0%sensitisation not excluded
SCCP/0983/062006-06-20Based on the information provided, the SCCP is of the opinion that the use of N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate itself as an oxidative hair dye substance at a maximum concentration of 2.5% in the finished cosmetic product (after mixing with hydrogen peroxide) does not pose a risk to the health of the consumer, apart from its sensitising potential.2.5% (oxidative hair dye, after mixing with hydrogen peroxide)Apart from sensitising potential; tertiary amine prone to nitrosation, should not be used with nitrosating substances, nitrosamine content < 50 ppb; genotoxicity/mutagenicity studies in finished formulations required.

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
restricted
Max
III/198
Category
Hair Dyes
View full cosmetic safety profile →

Frequently Asked Questions

What is the NOAEL for (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate?

(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate has 25 NOAEL studies in the database. The lowest reported value is 0.176 mg/m3 via inhalation in Human. Source: ToxValDB GESTIS DNEL.

Is (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate used in cosmetics?

Yes, (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate is also indexed as a cosmetic ingredient under the name N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.

Where does the safety data for (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB. All data traces to primary regulatory sources and is updated from official government databases.

Does (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate have different safety status in cosmetics vs industrial chemicals?

(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate 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.

Is (p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate used outside industrial chemicals?

(p-Ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate also appears in cosmetics databases.