NOAEL Data Cosmetic Ingredient

Hydroxyethyl-p-phenylenediamine sulphate

CAS 93841-25-9

Hydroxyethyl-p-phenylenediamine sulphate (CAS 93841-25-9) is a chemical substance. Key regulatory status: 3 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS.

View cosmetic safety profile for Hydroxyethyl-p-Phenylenediamine Sulfate →

Cross-Vertical Regulatory Divergence

Hydroxyethyl-p-phenylenediamine sulphate is prohibited in EU cosmetics at max 2.0% but has active industrial GHS classifications (H301, H317, H373, H411, H319).

SOURCE Cross-vertical comparison Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code

SOURCE NOAEL studies

NOAEL studies

SOURCE Chemical inventory jurisdictions

Regulatory lists

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 5 fields

Name

Hydroxyethyl-p-phenylenediamine sulphate

CAS Number

93841-25-9

Molecular Formula

C8H12N2O.H2O4S

InChI Key

VBSLNFWECRRALP-UHFFFAOYSA-N

Monoisotopic Mass

250.062343

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 2 records

Dye

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 3 records

List	Keyword	Source
Europe; Personal care; restricted	European Commission	CosIng
Canada; Personal care; Substances in PCP - Canada (4/2014)	Government of Canada	CPCat
Europe; Personal care - hair coloring	Danish Environmental Protection Agency	Danish EPA

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 30 of 30 studies

Value	Unit	Endpoint	Route	Species	Source
25	mg/kg bw	-	oral	rat	Regulatory source
2000	mg/kg bw	-	dermal	rat	Regulatory source
2000	mg/kg bw	-	dermal	-	Regulatory source
=2.12	mg/m3	DNEL systemic	inhalation	Human	ToxValDB GESTIS DNEL
L8W90PN89R	UNII	FDA UNII substance identifier	-	-	openFDA substances
=0.035	mg/kg bw	NOAEL	oral	rat	SCCS Opinion
=25	mg/kg bw	NOAEL	oral	rat	SCCS Opinion
=25	mg/kg bw/day	NOAEL	-	rat	SCCS Opinion
=30	mg/kg bw/day	NOAEL	oral	Rat	ECHA
=30	mg/kg/day	NOAEL	-	-	SCCS Opinion
=30	mg/kg	NOAEL	oral	rat	SCCS Opinion
=30	mg/kg/day	NOAEL	-	human	SCCS Opinion
=30	mg/kg bw/d	NOAEL	oral	rat	SCCS Opinion
=35	mg/kg bw/day	NOAEL	oral	Rat	ECHA
=35	mg/kg bw	NOAEL	oral	rat	SCCS Opinion
=55	mg/kg bw/day	NOAEL	-	rat	SCCS Opinion
=250	mg/kg bw/day	NOAEL	oral	rat	SCCS Opinion
=2000	mg/kg bw	NOAEL	dermal	rat	SCCS Opinion
=2000	mg/kg bw	NOAEL	dermal	-	SCCS Opinion
=0.035	mg/kg bw	dermal absorption	oral	rat	Regulatory source
=30	mg/kg	dermal absorption	oral	rat	Regulatory source
=30	mg/kg bw/d	dermal absorption	oral	rat	Regulatory source
30	mg/kg/day	developmental toxicity	-	-	Regulatory source
30	mg/kg/day	developmental toxicity	oral	rat	Regulatory source
30	mg/kg/day	developmental toxicity	-	human	Regulatory source
35	mg/kg bw	developmental toxicity	oral	rat	Regulatory source
250	mg/kg bw/day	developmental toxicity	oral	rat	Regulatory source
55	mg/kg bw/day	genotoxicity	-	rat	Regulatory source
25	mg/kg bw/day	repeated dose toxicity	-	rat	Regulatory source
250	mg/kg bw/day	repeated dose toxicity	oral	rat	Regulatory source

Showing 30 of 30 studies

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 3 opinions

Opinion	Date	Conclusion	Max Conc.	Concerns
SCCP/0666/03	2004-12-07	The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: complete physico-chemical characterisation of the test substances used, including data on stability; data on percutaneous absorption following the SCCNFP Notes of Guidance; data on the genotoxicity/mutagenicity following the relevant SCCNFP-opinions and in accordance with the Notes of Guidance.	-	Inadequate dossier: missing physico-chemical characterisation/stability data, percutaneous absorption data, and genotoxicity/mutagenicity data. COLIPA No A80 (hair dye ingredient).
SCCP/1124/07	30 September 2008	Based on the information provided, a margin of safety of 74 has been calculated suggesting that the use of hydroxyethyl-p-phenylenediamine sulphate as an oxidative hair dye at a maximum concentration of 1.5% in the finished cosmetic product (after mixing with hydrogen peroxide) poses a risk to the health of the consumer.	1.5%	Margin of safety of only 74 — poses a risk to consumer health at 1.5%. Strong skin sensitiser (LLNA EC3 = 0.57%). Positive in vitro micronucleus (clastogenic) findings. Conclusion may be re-evaluated if an adequately performed in vitro dermal absorption study is provided.
SCCS/1310/10	2010-03-23	The SCCS is of the opinion that the use of hydroxyethyl-p-phenylenediamine sulfate itself as an ingredient in oxidative hair dyes at a maximum concentration on-head of 2% does not pose a risk to the health of the consumer, apart from its strong sensitising potential.	2% on-head	Strong sensitiser. No in vivo mutagenic potential, but genotoxicity/mutagenicity studies in finished hair dye formulations should be undertaken. Definitive genotoxicity conclusion requires tests in combination with hydrogen peroxide.

Cosmetic Safety Profile

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

SOURCE CosIng / Ingredients DB

EU Status

prohibited

Max

2.0%

Frequently Asked Questions

What is the NOAEL for Hydroxyethyl-p-phenylenediamine sulphate?

Hydroxyethyl-p-phenylenediamine sulphate has 30 NOAEL studies in the database. The lowest reported value is 0.035 mg/kg bw via oral in rat. Source: SCCS Opinion.

What regulatory lists include Hydroxyethyl-p-phenylenediamine sulphate?

Hydroxyethyl-p-phenylenediamine sulphate appears on 3 regulatory/inventory lists including Europe; Personal care; restricted, Canada; Personal care; Substances in PCP - Canada (4/2014), Europe; Personal care - hair coloring. Source: EPA CPDat.

Is Hydroxyethyl-p-phenylenediamine sulphate used in cosmetics?

Yes, Hydroxyethyl-p-phenylenediamine sulphate is also indexed as a cosmetic ingredient under the name 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 Hydroxyethyl-p-phenylenediamine sulphate come from?

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

Does Hydroxyethyl-p-phenylenediamine sulphate have different safety status in cosmetics vs industrial chemicals?

Hydroxyethyl-p-phenylenediamine sulphate is prohibited in EU cosmetics at max 2.0% but has active industrial GHS classifications (H301, H317, H373, H411, H319).

Is Hydroxyethyl-p-phenylenediamine sulphate used outside industrial chemicals?

Hydroxyethyl-p-phenylenediamine sulphate also appears in cosmetics databases.