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
6 study endpoints found for Drometrizole. 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 | 30 mg/kg bw/day | oral | rat | oral | REACH |
| NOEL | 1000 ppm | oral | dog | oral | REACH |
| NOEL | 1000 ppm | oral | rat | oral | REACH |
| NOEL | 0.2 other | oral | rat | oral | REACH |
| NOEL | 1000 ppm | oral | dog | oral | REACH |
| NOEL | 2500 mg/kg bw/day | oral | rat | oral | REACH |
Expert Verdict
Korea revised maximum from 7% to 1% after risk assessment; Japan permits up to 7% in leave-on products; MoS only 16.7 at the legacy 7% level โ formulate at โค1% for adequate MoS
Regulatory Flags
Frequently Asked Questions
Is Drometrizole safe in cosmetics?
Korea revised maximum from 7% to 1% after risk assessment; Japan permits up to 7% in leave-on products; MoS only 16.7 at the legacy 7% level โ formulate at โค1% for adequate MoS The EU classifies Drometrizole as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database.
Is Drometrizole allowed in the EU?
Drometrizole EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Drometrizole do in cosmetics?
Drometrizole functions as: UV absorber; fragrance functional. It is classified as a cosmetic ingredient in our database. CAS number: 2440-22-4.
What is the Margin of Safety for Drometrizole?
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 Drometrizole?
The NOAEL (No Observed Adverse Effect Level) for Drometrizole is 30 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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