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
3 study endpoints found for Climbazole. 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 | 5 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 45 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | 50 mg/kg bw/day | oral | rat | oral | REACH |
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Climbazole.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 20 mg/kg/day | 200 mg/kg/day | Oral | Rat | Subchronic (90-day) (90 days) | 100 | SCCS/1506/13 (2013) |
Sensitization Profile
Contact sensitization data for Climbazole based on clinical patch test studies and IFRA standards.
Source: ESSCA; IVDK; NACDG
Expert Verdict
EU-restricted imidazole antifungal with same ergosterol-inhibition mechanism as ketoconazole. SCCS/1600/18 confirmed safety at 2% rinse-off with adequate margin of safety accounting for 0.01 rinse-off retention factor. CoRAP evaluation for endocrine-disrupting potential is ongoing and could trigger future reclassification; monitor regulatory updates.
Regulatory Flags
Frequently Asked Questions
Is Climbazole safe in cosmetics?
EU-restricted imidazole antifungal with same ergosterol-inhibition mechanism as ketoconazole. SCCS/1600/18 confirmed safety at 2% rinse-off with adequate margin of safety accounting for 0.01 rinse-off retention factor. CoRAP evaluation for endocrine-disrupting potential is ongoing and could trigger future reclassification; monitor regulatory updates. The EU classifies Climbazole as "restricted". Safety rating: GOOD. 3 toxicological study endpoint(s) are available in our database.
Is Climbazole allowed in the EU?
Climbazole EU regulatory status: restricted. Maximum allowed concentration: 2.0% rinse-off (anti-dandruff) / 0.5% rinse-off (preservative) / 0.2% leave-on (preservative). This is based on EU Regulation 1223/2009 and its amendments.
What does Climbazole do in cosmetics?
Climbazole functions as: Antifungal; anti-dandruff active; preservative. It is classified as a Active Ingredient in our database. CAS number: 38083-17-9.
What is the Margin of Safety for Climbazole?
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 Climbazole?
The NOAEL (No Observed Adverse Effect Level) for Climbazole is 5 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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