Good Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

Hydroxyethyl-3,4-Methylenedioxyaniline HCl

INCI: HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL

CAS Number
94158-14-2
Function
Oxidative hair dye precursor (coupler)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 1.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted under coal tar hair dye exemption; CIR concluded safe in present practices of use (2022)

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 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 bw/day oral rat Subchronic COSMOS_DB
LOAEL 100 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 20 mg/kg bw/day oral rat oral REACH

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)

Expert Verdict

Restricted in EU with mandatory warnings per Annex III conditions; contains/may release methylene dioxyphenyl moiety; sensitization potential requires patch-test instruction on consumer products; must not exceed maximum on-head concentration.

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Concern Level: Moderate

Regulatory Flags

potential-allergen eu_cosing_listed

Frequently Asked Questions

Is Hydroxyethyl-3,4-Methylenedioxyaniline HCl safe in cosmetics?

Restricted in EU with mandatory warnings per Annex III conditions; contains/may release methylene dioxyphenyl moiety; sensitization potential requires patch-test instruction on consumer products; must not exceed maximum on-head concentration. The EU classifies Hydroxyethyl-3,4-Methylenedioxyaniline HCl as "restricted". Safety rating: GOOD. 3 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 Margin of Safety for Hydroxyethyl-3,4-Methylenedioxyaniline HCl?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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 bw/day based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

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