Moderate Cosmetic Ingredient NOAEL Data

Carbamide Peroxide

INCI: CARBAMIDE PEROXIDE

CAS Number
124-43-6
Function
Bleaching/oxidizing agent and oral care agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel Safety Assessment of Hydrogen Peroxide as Used in Cosmetics - Draft Report, Cosmetic Ingredient Review

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Carbamide Peroxide. 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 100 ppm oral mouse oral REACH
NOAEL 216 mg/kg bw/day dermal rat dermal REACH
NOAEL 45000 ppm oral mouse oral REACH
NOAEL 338.4 mg/kg bw/day dermal - dermal REACH
NOAEL 45000 ppm oral rat oral REACH
NOAEL 100 ppm oral - oral REACH
NOAEL 45000 ppm oral - oral REACH
NOAEL 45000 ppm oral - oral REACH

Expert Verdict

Carbamide Peroxide is permitted in EU and US cosmetics, but insufficient safety data exists; further assessment is recommended, particularly for absorption and sensitization potential.

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Concern Level: Moderate

Frequently Asked Questions

Is Carbamide Peroxide safe in cosmetics?

Carbamide Peroxide is permitted in EU and US cosmetics, but insufficient safety data exists; further assessment is recommended, particularly for absorption and sensitization potential. The EU classifies Carbamide Peroxide as "permitted". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.

Is Carbamide Peroxide allowed in the EU?

Carbamide Peroxide EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Carbamide Peroxide do in cosmetics?

Carbamide Peroxide functions as: Bleaching/oxidizing agent and oral care agent. It is classified as a Cosmetic Ingredient in our database. CAS number: 124-43-6.

What is the Margin of Safety for Carbamide Peroxide?

not established 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 Carbamide Peroxide?

The NOAEL (No Observed Adverse Effect Level) for Carbamide Peroxide is 100 ppm based on a oral study via oral route in mouse. A total of 8 study endpoints are available. Source: REACH.

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