Moderate Cosmetic Ingredient NOAEL Data

Bishydroxyethyl Biscetyl Malonamide

INCI: BISHYDROXYETHYL BISCETYL MALONAMIDE

Bishydroxyethyl Biscetyl Malonamide (CAS 149591-38-8) is a cosmetic cosmetic ingredient functioning as Skin conditioning agent (ceramide mimic / pseudo-ceramide); used in skin. Reported NOAEL =15 mg/kg/day (SCCS Opinion); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 149591-38-8 →

Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning agent (ceramide mimic / pseudo-ceramide); used in skin creams, shampoos, conditioners, makeup, sun care
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C39H78N2O4
MW
639 g/mol
EC Number
422-560-9
PubChem CID
9809545
IUPAC Name
N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide
InChIKey
RHIIHYCQYFKTHL-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
US US Status restricted
US Notes No specific CIR monograph; not FDA-restricted; used commercially since 1993

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Bishydroxyethyl Biscetyl Malonamide.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for Bishydroxyethyl Biscetyl Malonamide. 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 =15 mg/kg/day oral - repeated dose toxicity SCCS Opinion
NOAEL =15 mg/kg/day oral - repeated dose toxicity SCCS Opinion
NOAEL =15 mg/kg/day oral - repeated dose toxicity SCCS Opinion
NOAEL =15 mg/kg/day oral - repeated dose toxicity SCCS Opinion

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Health HazardHarmful / Irritant
Hazard Class and Category
Repr. 2; Eye Irrit. 2; Aquatic Chronic 4
Hazard Statements
  • H361f ***
  • H319 Causes serious eye irritation
  • H413 May cause long lasting harmful effects to aquatic life

Inserted via ATP: CLP00

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
No longer valid
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1243
(EC) 2009/1223
CMR: Reprotoxic Cat. 2()

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 (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1243
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
KR prohibited - -

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_sccs_opinion 0.1% - - SCCP/0852/04

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Humectant Softener and conditioner
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Bishydroxyethyl Biscetyl Malonamide.

Regulatory Flags

eu_banned_cosmetics eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Bishydroxyethyl Biscetyl Malonamide by CAS number or substance name.

Studies
4
Lowest NOAEL
15 mg/kg/day
Highest NOAEL
15 mg/kg/day
SCCS Opinion

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.1% SCCS PDF direct extraction -

Chemical Function

Humectant Softener and conditioner

Regulatory Lists

banned; Europe; Personal care

Australian Status

AICIS status: listed_with_terms

Specific information requirements: Obligations to provide information apply. You must tell us within 28 days if the circumstances of your importation or manufacture (introduction) are different to those in our assessment.

Frequently Asked Questions

Is Bishydroxyethyl Biscetyl Malonamide safe in cosmetics?

Bishydroxyethyl Biscetyl Malonamide has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: restricted. 4 toxicological study endpoint(s) are available in our database.

Is Bishydroxyethyl Biscetyl Malonamide allowed in the EU?

Bishydroxyethyl Biscetyl Malonamide EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Bishydroxyethyl Biscetyl Malonamide do in cosmetics?

Bishydroxyethyl Biscetyl Malonamide functions as: Skin conditioning agent (ceramide mimic / pseudo-ceramide); used in skin creams, shampoos, conditioners, makeup, sun care. It is classified as a cosmetic ingredient in our database. CAS number: 149591-38-8.

What is the NOAEL for Bishydroxyethyl Biscetyl Malonamide?

The NOAEL (No Observed Adverse Effect Level) for Bishydroxyethyl Biscetyl Malonamide is =15 mg/kg/day based on a repeated dose toxicity study via oral route in rat. A total of 4 study endpoints are available. Source: SCCS Opinion.

Is Bishydroxyethyl Biscetyl Malonamide used outside cosmetics?

Bishydroxyethyl Biscetyl Malonamide also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Bishydroxyethyl Biscetyl Malonamide have different safety status in cosmetics vs industrial chemicals?

Bishydroxyethyl Biscetyl Malonamide is prohibited in EU cosmetics but has active industrial GHS classifications (H319, H361f, H413).

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