Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
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.
Regulatory Flags
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.
Compliance Tools
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Related Ingredients
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