Hydroxyethyl-3,4-Methylenedioxyaniline HCl (CAS 94158-14-2) is a cosmetic cosmetic ingredient functioning as Oxidative hair dye precursor (coupler). NOAEL 20 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 1.5%; 3 safety opinions reviewed (cir). Industrial safety data is also available in the chemical safety database.
US NotesPermitted under coal tar hair dye exemption; CIR concluded safe in present practices of use (2022)
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Hydroxyethyl-3,4-Methylenedioxyaniline HCl.
Calculate MoS for your specific formulation with the
MoS Calculator.
Toxicological Studies
10 study endpoints found for Hydroxyethyl-3,4-Methylenedioxyaniline 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
NOAEL
=20 mg/kg/d
oral
rat
developmental toxicity
CIR_vision_codex
NOAEL
=20 mg/kg/d
oral
rat
developmental toxicity
CIR_vision_codex
NOAEL
=20 mg/kg/d
oral
rat
developmental toxicity
CIR_vision_codex
NOAEL
=20 mg/kg/d
oral
rat
developmental toxicity
CIR_vision_codex
NOAEL
=26 mg/kg/d
-
mouse
developmental toxicity
CIR_vision_codex
NOAEL
=26 mg/kg/d
-
mouse
developmental toxicity
CIR_vision_codex
NOAEL
=26 mg/kg/d
-
mouse
developmental toxicity
CIR_vision_codex
NOAEL
=26 mg/kg/d
-
mouse
developmental toxicity
CIR_vision_codex
NOAEL
20 mg/kg bw/day
oral
rat
Subchronic
COSMOS_DB
NOAEL
=20 mg/kg bw/day
-
rat
genotoxicity
SCCS_vision_codex
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cir
Verdict: unknown
NOAEL: 20 mg/kg/d (not specified)
cir
Verdict: unknown
NOAEL: 26 mg/kg/d (not specified)
cir
Verdict: unknown
NOAEL: 20 mg/kg/d (oral)
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Hydroxyethyl-3,4-Methylenedioxyaniline HCl across SCCS product categories, with measured dermal absorption where available.
ECHA REACH Registration
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.
SA Saudi SFDA (III - Restricted)
Product type: Hair dye substance in oxidative hair dye products.
BRIN Brazil/India Cosmetics
India: Restricted
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (5 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured
2.0%
-
-
SCCP/0044
measured
1.5%
-
-
SCCP/0044
measured
97.0%
-
-
SCCP/0044
measured
1.4%
-
-
SCCP/0044
measured
2.1%
-
-
SCCP/0044
Additional Ingredient Properties
1 property record from structured ingredient metadata.
Europe; Personal care; restrictedCanada; Personal care; Substances in PCP - Canada (4/2014)Europe; Personal care - hair coloring
Australian Status
AICIS status:listed
Frequently Asked Questions
Is Hydroxyethyl-3,4-Methylenedioxyaniline HCl safe in cosmetics?
Hydroxyethyl-3,4-Methylenedioxyaniline HCl has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Hydroxyethyl-3,4-Methylenedioxyaniline HCl allowed in the EU?
Hydroxyethyl-3,4-Methylenedioxyaniline HCl EU regulatory status: restricted. Maximum allowed concentration: 1.5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Hydroxyethyl-3,4-Methylenedioxyaniline HCl do in cosmetics?
Hydroxyethyl-3,4-Methylenedioxyaniline HCl functions as: Oxidative hair dye precursor (coupler). It is classified as a cosmetic ingredient in our database. CAS number: 94158-14-2.
What is the NOAEL for Hydroxyethyl-3,4-Methylenedioxyaniline HCl?
The NOAEL (No Observed Adverse Effect Level) for Hydroxyethyl-3,4-Methylenedioxyaniline HCl is =20 mg/kg/d based on a developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Compliance Tools
Check Hydroxyethyl-3,4-Methylenedioxyaniline HCl compliance across multiple jurisdictions:
Is Hydroxyethyl-3,4-Methylenedioxyaniline HCl in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Hydroxyethyl-3,4-Methylenedioxyaniline HCl in your formulation.