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.
US NotesNo specific CIR monograph; not FDA-restricted; used commercially since 1993
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Bishydroxyethyl Biscetyl Malonamide.
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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 ***
H319Causes serious eye irritation
H413May 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No longer valid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
HumectantSoftener and conditioner
Regulatory List Membership (2)
EU Banned in CosmeticsEU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Bishydroxyethyl Biscetyl Malonamide.
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).
Compliance Tools
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