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
5 study endpoints found for Tonalide. 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 | oral | REACH |
| NOAEL | >=10 mg/kg bw/day | dermal | rat | dermal | REACH |
| NOEL | 10 mg/kg bw/day | oral | rat | oral | REACH |
| NOEL | 1.5 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 300 ppm | oral | rat | oral | REACH |
Expert Verdict
Second-largest volume polycyclic musk globally with documented environmental persistence and bioaccumulation. Detected in human blood and breast milk with combined environmental exposure studies showing toxicological effects at real-world concentrations. EU REACH and EPA have established usage guidelines. Avoid in clean-beauty formulations; consider macrocyclic replacements.
Regulatory Flags
Frequently Asked Questions
Is Tonalide safe in cosmetics?
Second-largest volume polycyclic musk globally with documented environmental persistence and bioaccumulation. Detected in human blood and breast milk with combined environmental exposure studies showing toxicological effects at real-world concentrations. EU REACH and EPA have established usage guidelines. Avoid in clean-beauty formulations; consider macrocyclic replacements. The EU classifies Tonalide as "restricted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.
Is Tonalide allowed in the EU?
Tonalide EU regulatory status: restricted. Maximum allowed concentration: 0.1% leave-on non-hydroalcoholic; 1.0% leave-on hydroalcoholic; 2.5% fine fragrance; 0.5% fragrance cream; 0.2% rinse-off. This is based on EU Regulation 1223/2009 and its amendments.
What does Tonalide do in cosmetics?
Tonalide functions as: Fragrance fixative (polycyclic synthetic musk, warm musky woody scent). It is classified as a Fragrance in our database. CAS number: 1506-02-1.
What is the Margin of Safety for Tonalide?
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 Tonalide?
The NOAEL (No Observed Adverse Effect Level) for Tonalide is 15 mg/kg bw/day based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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