Excellent Cosmetic Ingredient NOAEL Data

Denatonium Benzoate

INCI: DENATONIUM BENZOATE

CAS Number
3734-33-6
Function
Denaturant — makes cosmetic products unpalatable to prevent accidental ingestion
Safety Rating
EXCELLENT

Regulatory Status

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

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Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

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
LOAEL 8 mg/kg bw/day oral monkey oral REACH
NOAEL 535.896 mg/kg bw/day oral mouse oral REACH
NOAEL 15 mg/kg bw/day oral rat oral REACH
NOAEL 16 mg/kg bw/day oral rat oral REACH

Expert Verdict

Extremely bitter taste provides built-in safety against ingestion. Well-characterized with extensive use history in shampoos, soaps, and alcohol-containing products.

⚠️
Concern Level: Low

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance

Frequently Asked Questions

Is Denatonium Benzoate safe in cosmetics?

Extremely bitter taste provides built-in safety against ingestion. Well-characterized with extensive use history in shampoos, soaps, and alcohol-containing products. The EU classifies Denatonium Benzoate as "permitted". Safety rating: EXCELLENT. 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 Margin of Safety for Denatonium Benzoate?

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 Denatonium Benzoate?

The NOAEL (No Observed Adverse Effect Level) for Denatonium Benzoate is 8 mg/kg bw/day based on a oral study via oral route in monkey. A total of 4 study endpoints are available. Source: REACH.

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