Good Cosmetic Ingredient NOAEL Data

Drometrizole

INCI: DROMETRIZOLE

CAS Number
2440-22-4
Function
UV absorber; fragrance functional
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” not restricted; CIR Amended Final Report concluded safe as used in cosmetics

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

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 โ‰ค1% for adequate MoS

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Concern Level: Low

Regulatory Flags

fragrance-component ifra_fragrance

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 โ‰ค1% 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.

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