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Diss Factsheets
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EC number: 202-327-6 | CAS number: 94-36-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact sensitization to benzoyl peroxide
- Author:
- Leyden JJ and Kligman AM
- Year:
- 1 977
- Bibliographic source:
- Contact Dermatitis, 3:273-275
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Maximization test according to Kligman & Epstein procedure, 1975
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibenzoyl peroxide
- EC Number:
- 202-327-6
- EC Name:
- Dibenzoyl peroxide
- Cas Number:
- 94-36-0
- Molecular formula:
- C14H10O4
- IUPAC Name:
- diphenylperoxyanhydride
- Details on test material:
- Benzoyl peroxide (topical preparations for acne)
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- white, young
- Route of administration:
- dermal
- Details on study design:
- - A 1.0 cm² of non-wvoven cloth was liberally saturated with 0.3 grams or ml of the test material and applied occlusively for five 48-hour periods.
- First test: use of 5 and 10 % Benzoyl peroxide gels (Desquamex) (evaluation in 25 students)
- Second test: use of 5 (Johnson & Johnson) and 10 % (Panoxyl 10) Benzoyl peroxide gels (evaluation in 25 students),
- Since the substance is irritant, no sodium lauryl sulfate was required
- Challenge: 10 -14 days later by a 48 hours patch test
- Evaluation at 48, 72 and 96 hours
- Grading system: 0 : no reaction, 1 : mild sensitization (erythema with mild edema); 2 : moderate sensitization (erythema with infiltration, raised sepreading beyond the borders with or without vesiculation), 3: strong sensitization (large vesiculo-bullous, vividly red, infiltrated plaques)
Results and discussion
- Results of examinations:
- 38 of 50 subjects developed a ++ or greater reaction. Sensitized subjects reacted equally to the 5 and 10% concentration.
Applicant's summary and conclusion
- Conclusions:
- Sensitising in humans
- Executive summary:
Four formulation of benzoyl peroxide, two 5 % and two 10 % gel, were evaluated in a group of 50 white college students (human maximisation pacth test). The subjects were challenged 10 - 14 days later by a 48 hours patch test and the responses compared to pretesting with the same materials. The challenge site was evaluated at 48, 72, and 96 hours on a four point scale. The results showed that in human, dibenzoyl peroxide is clearly a sensitiser.
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