Good Cosmetic Ingredient NOAEL Data GHS Classified Dermal Penetration

Benzoyl Peroxide Regulatory &

INCI: BENZOYL PEROXIDE

CAS Number
94-36-0
Function
Insufficient Data
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status restricted
US Notes OTC drug classification; no specific concentration restrictions

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Benzoyl Peroxide Regulatory &. 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 dog Short Term Toxicity COSMOS_DB
NOAEL 280 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 280 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 1.4 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 4.2 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
LOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 30 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
dose_tested 280 mg/kg bw/day oral rat Chronic COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Benzoyl Peroxide Regulatory &, relevant to systemic exposure and MoS calculations.

Absorption %
10-20%
Penetration Level
epidermis
Penetration Depth
epidermis
Molecular Weight
242.2 Da
Log P
1.67
Systemic Absorption
minimal
Topical Bioavailability
6-16%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS Opinion, CIR

Expert Verdict

Benzoyl Peroxide is an OTC drug ingredient with restricted cosmetic use; generally considered safe at appropriate concentrations.

⚠️
Concern Level: Low

Regulatory Flags

EU Restricted fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Benzoyl Peroxide Regulatory & safe in cosmetics?

Benzoyl Peroxide is an OTC drug ingredient with restricted cosmetic use; generally considered safe at appropriate concentrations. The EU classifies Benzoyl Peroxide Regulatory & as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Benzoyl Peroxide Regulatory & allowed in the EU?

Benzoyl Peroxide Regulatory & EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Benzoyl Peroxide Regulatory & do in cosmetics?

Benzoyl Peroxide Regulatory & functions as: Insufficient Data. It is classified as a Cosmetic Ingredient in our database. CAS number: 94-36-0.

What is the Margin of Safety for Benzoyl Peroxide Regulatory &?

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 Benzoyl Peroxide Regulatory &?

The NOAEL (No Observed Adverse Effect Level) for Benzoyl Peroxide Regulatory & is 30 mg/kg bw/day based on a Short Term Toxicity study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Benzoyl Peroxide Regulatory & compliance across multiple jurisdictions:

🔬
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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