Excellent Cosmetic Ingredient NOAEL Data

Denatonium Benzoate

Also known as: Benzyl diethyl ((2,6-xylylcarbamoyl)methyl) ammonium benzoate, Benzyldiethyl((2,6-xylylcarbamoyl)methyl)ammonium benzoate, Caswell No. 083BB, EINECS 223-095-2, EPA Pesticide Chemical Code 009106 (+7 more)

INCI: DENATONIUM BENZOATE

Denatonium Benzoate (CAS 3734-33-6) is a cosmetic cosmetic ingredient functioning as Denaturant — makes cosmetic products unpalatable to prevent accidental ingestion. NOAEL 15 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. 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 3734-33-6 →

Auto-generated CPSR Part A draft with source citations
Function
Denaturant — makes cosmetic products unpalatable to prevent accidental ingestion
Safety Rating
EXCELLENT

Chemistry & Identifiers

Formula
C28H34N2O3
MW
446.6 g/mol
EC Number
223-095-2
PubChem CID
19518
IUPAC Name
benzyl-[2-(2,6-dimethylanilino)-2-oxoethyl]-diethylazanium benzoate
InChIKey
VWTINHYPRWEBQY-UHFFFAOYSA-N

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Permitted — CIR Expert Panel reviewed and found safe as used (2008); TTB-approved denaturant

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Denatonium Benzoate.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for Denatonium Benzoate. 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 bw/day oral Rat reproduction developmental ToxValDB_ECHA_IUCLID
NOAEL =16 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =60 mg/kg bw/day oral Rat reproduction developmental ToxValDB_ECHA_IUCLID
NOAEL =535.896 mg/kg bw/day oral Mouse short-term ToxValDB_ECHA_IUCLID

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Denatonium Benzoate 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
100 - 1,000 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient Fragrance No specific technical function Viscosity modifier
Regulatory List Membership (5)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) Consumer Product Chemical

Expert Verdict

Expert safety assessment and concern-level summary for Denatonium Benzoate.

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Denatonium Benzoate by CAS number or substance name.

Studies
4
Lowest NOAEL
15 mg/kg bw/day
Highest NOAEL
535.896 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

Benzyl diethyl ((2,6-xylylcarbamoyl)methyl) ammonium benzoate Benzyldiethyl((2,6-xylylcarbamoyl)methyl)ammonium benzoate Caswell No. 083BB EINECS 223-095-2 EPA Pesticide Chemical Code 009106 Lidocaine benzyl benzoate Aversion Denatonii benzoas UNII-M5BA6GAF1O Bitterant-b Bitterant+Plus Bitrex

Chemical Function

Flavouring and nutrient

Regulatory Lists

inert_ingredient; non_food_use; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides pharmaceutical active_ingredient; Europe; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides children; Europe; Personal care children; Europe; Personal care

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Denatonium Benzoate safe in cosmetics?

Denatonium Benzoate has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database.

Is Denatonium Benzoate allowed in the EU?

Denatonium Benzoate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Denatonium Benzoate do in cosmetics?

Denatonium Benzoate functions as: Denaturant — makes cosmetic products unpalatable to prevent accidental ingestion. It is classified as a cosmetic ingredient in our database. CAS number: 3734-33-6.

What is the NOAEL for Denatonium Benzoate?

The NOAEL (No Observed Adverse Effect Level) for Denatonium Benzoate is =15 mg/kg bw/day based on a reproduction developmental study via oral route in Rat. A total of 4 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Denatonium Benzoate used outside cosmetics?

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

Does Denatonium Benzoate have different safety status in cosmetics vs industrial chemicals?

Denatonium Benzoate is classified GHS Danger (H302, H332, H318, H412) in the chemicals database but is allowed in EU cosmetics.

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