Also known as: Akneroxid 5, Asidopan, Aztec BPO, Benoxyl (5&10) Lotion, Benzoic acid, peroxide (+15 more)
INCI: BENZOYL PEROXIDE
Benzoyl Peroxide Regulatory & (CAS 94-36-0) is a cosmetic cosmetic ingredient functioning as Insufficient Data. NOAEL 500 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Benzoyl Peroxide Regulatory & is classified GHS Danger (H241, H317, H319, H400, H410, H335, H316) in the chemicals database but is restricted in EU cosmetics.
US NotesOTC drug classification; no specific concentration restrictions
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Benzoyl Peroxide Regulatory &.
Calculate MoS for your specific formulation with the
MoS Calculator.
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.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Benzoyl Peroxide Regulatory & across SCCS product categories, with measured dermal absorption where available.
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
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
36, Sup 7, 71
Evaluation Year
1998
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
H410Very toxic to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
M = 10; M = 10
Inserted via ATP: ATP22
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
100%
DPRA Lys %
81.3%
KeratinoSens IC50
567.615 µM
hCLAT CV75
41 µg/mL
LLNA EC3
0.043%
NESIL
14177 µg/cm²
LLNA: Strong (1A)GHS: 1AHuman: positive
Source: LLNA: Kimber et al. (1998); DPRA: Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064]; KS: Natsch et al. 2013 [DOI:10.1002/jat.2868] | Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009]; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [791] Poole RL et al. (1970): https://jamanetwork.com/journals/jamadermatology/article-abstract/531
HRIPT Human Patch Test Studies
2 human repeat insult patch tests aggregated from dermatological literature.
Test Type
N
Sensitized
Dose µg/cm²
NESIL µg/cm²
Potency
HRIPT
-
0
14177.16
-
-
OECD_DA_Human
-
0
-
-
1B (Weak sensitizer)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification:Restricted (Annex XVII)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (III - Restricted)
Product type: Artificial nail systems. Max: 0.7% (after mixing for use).
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Restricted · max 0.7% (after mixing for use)
Additional Jurisdictional Restrictions (6)
Jurisdiction
Status
Max %
Product Type
CN
banned
-
-
AU
therapeutic_good
5.0
acne treatment
CA
restricted
10%
Nail products (catalyst); hair dyes only
CA
drug_classification
-
-
ASEAN
restricted
0.7% after mixing
Artificial nail systems
KR
prohibited
-
-
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (4)
Carcinogen Classification
Benzoyl peroxide | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 36: (1985) Allyl Compounds, Aldehydes, Epoxides and Peroxides | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 71: (1999) Re-evaluation of Some Organic Chemicals, Hydrazine and Hydrogen Peroxide…
Source: International Agency for Research on Cancer (IARC)
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of benzoyl peroxide. There is limited evidence in experimental animals for the carcinogenicity of benzoyl peroxide. Overall evaluation: Benzoyl peroxide is not classifiable as to its carcinogenicity to humans (Group 3). | A4: Not classifiable as a human carcinogen.
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
0225
Source: WHO/JECFA
Skin Eye Respiratory Irritation
An allergen and eye irritant. | Benzoyl peroxide dust irritates the eyes of albino rabbits ... . | Potential symptoms of overexposure are irritation of skin, eyes and mucous membranes ... . | In an investigation made in a plant located in New York state where benzoyl peroxide formulations were being processed ... no objectionable subjective symptoms /were experienced/ when exposed to dust…
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (1)
JECFA Evaluation
BENZOYL PEROXIDE | 2004 | NOT SPECIFIED | Treatment of whey with benzoyl peroxide at a maximum concentration of 100 mg/kg does not pose a safety concern. | TRS 928-JECFA 63/13 | FAS 54-JECFA 63/17
Is Benzoyl Peroxide Regulatory & safe in cosmetics?
Benzoyl Peroxide Regulatory & has a safety rating of "GOOD" in our database. EU status: restricted. US status: restricted.
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.
Is Benzoyl Peroxide Regulatory & used outside cosmetics?
Benzoyl Peroxide Regulatory & also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Benzoyl Peroxide Regulatory & have different safety status in cosmetics vs industrial chemicals?
Benzoyl Peroxide Regulatory & is classified GHS Danger (H241, H317, H319, H400, H410, H335, H316) in the chemicals database but is restricted in EU cosmetics.
Compliance Tools
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