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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 ā 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of benzoyl peroxide is low: LD50 in mice >2,000 mg/kg, and in rats 5,000 mg/kg. No deaths occurred in male rats following inhalation of 24.3 mg/l.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted according to OECD guideline and according to GLP. The report is in korean but the summary tables and the individual data are reported in English. It is to be noted that the study was used as key study in the SIDS report (2002) and was quoted Kilimish 1.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age of animals: 5 weeks
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 percent methylcellulose sol.
- Details on oral exposure:
- Volume administered : 10 ml/kg
- Doses:
- 2 000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsyof all dosed animals - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality
- Clinical signs:
- other: The only clinical symptom observed in 2000 mg/kg dose groupe was piloerection. This symptom was reversible after one day.
- Gross pathology:
- No abnormal finding was observed in all dosed animals at necropsy.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions, the oral LD0 of dibenzoyl peroxide is higher than 2000mg/kg in ICR mouse.
- Executive summary:
The Acute oral toxicity of dibenzoyl peroxide was evaluated in rats according to OECD NĀ°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female ICR mouse were given a single oral dose of 2000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).
During exposure, the only clinical sign observed was piloerection. This symptom was reversible after one day. No animal died following exposure. At necropsy, no abnormal finding was observed in all dosed animals.
Under these experimental conditions, the oral LD0 of dibenzoyl peroxide is expected to be more than 2000 mg/kg in ICR mouse.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance with a recognized scientific procedure for analyzing the acute inhalation toxicity of a test material in experimental animals. However, only males were tested and no gross pathology results were reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- only one sex used (males), few data are provided on exposure conditions.
- Principles of method if other than guideline:
- Federal Hazardous Substances Act, Chapter II, Title 16 CFR
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Spartan albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 232-248 g
- Housing: by groups of 5 animals, in metal cages
- Food and water were available ad libitum pre- and post-exposure
ENVIRONMENTAL CONDITIONS
- Temperature and humidity were controlled quarters throughout the pre-exposure and post-exposure periods - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- A single group of 10 male rats were placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere of test material.
- Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- Concentrations were calculated
- Duration of exposure:
- 4 h
- Concentrations:
- 24.3 mg/l (the physical properties of the test material prohibited exposure of the test rats to highest atmospheric concentrations).
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (then the rats were sacrified)
- Frequency of observations and weighing: during the expsoure period, the rats were observed continuously for changes in behavior and/or appearance
- Necropsy of rats who died during or after the exposure: yes
- Necropsy of survivors performed: no - Statistics:
- not applicable
- Preliminary study:
- not applicable
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- 24.3 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality was observed at a single dose of 24.3 mg/L.
- Clinical signs:
- other:
- Body weight:
- Body weight gain was determined to be normal throughout study.
- Gross pathology:
- not performed (none of the animals died during and after the exposure)
- Other findings:
- No more data
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- No mortality occured at a concentration of 24.3 mg/L of dibenzoyl peroxid (no highest concentration could be tested, limitations from the physical properties of the substance).
- Executive summary:
The acute inhalation toxicity of dibenzoyl peroxide was evaluated in a 4-hour, single-exposure study in rats according to a method similar to the OECD Guideline 403 (May 12th1981). A limit test was performed: dibenzoyl peroxide was administered to a single group of ten male rats (Spartan strain) via whole-body vapor exposure at concentrations of 24.3 mg/L during 4 hours.
Mortality, clinical observations for clinical signs and body weight changes were evaluated over a 14-day observation period. Detailed clinical observations were conducted immediately following each exposure at 1 day, 2 days, and 5 days post-exposure.
No mortality occured during the exposure and during the post-exposure period.
During the exposure period, eye squint, dyspnea, salivation, lacrimation, erythema, increased and decreased respiratory rates, and increased and decreased motor activity were observed. After 24 hours post-exposure, all rats appeared normal. Observable signs after 48 hours post-exposure were soft stools. All animals appeared normal from day 5 until the end of the study. A few of the rats showed signs of ocular irritation (corneal opacity, ulceration of corneal surface)
Based on the results of this results, LD50 is expected to be more than 24.3 mg/L in rats, Spartan strain following a whole-body exposure to dust during 4 hours.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 24 300 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
The acute oral toxicity of benzoyl peroxide is likely to be low. In a key acute oral toxicity test with ICR mice, a limit test at dose level of 2,000 mg/kg benzoyl peroxide was carried out in a group of 5 males and 5 females using OECD TG 401 (NIER Korea, 2001). There were no deaths in treated animals. No significant findings were observed at necropsy. The only clinical symptom observed in the highest dose group was piloerection. Similar results were obtained in another acute oral study in rats. No mortality, toxic symptoms or signs were reported at the single dose of 5,000 mg/kg (Wazeter and Goldenthal, 1973).
Acute inhalation toxicity:
In an acute inhalation study, a single group of 10 male rats were placed in a sealed 59.1 liter glass chamber and exposed to a dynamic atmosphere containing the dust of benzoyl peroxide for 4 hrs. All the rats exposed to 24.3 mg/l of 78 % benzoyl peroxide, survived during the 14 days observation period. Observable signs during the 4 hr exposure period were eye squint, dyspnea, salivation, lacrimation, erythema, increased and decreased respiratory rates, and increased and decreased motor activity. A few of the rats showed ocular irritation at 5 days after exposure (Wazeter and Goldenthal, 1973).
Justification for selection of acute toxicity ā oral endpoint
Key study
Justification for selection of acute toxicity ā inhalation endpoint
Key study
Justification for classification or non-classification
According to EU Regulation (EC) N0. 1272/2008 (CLP), dibenzoyl peroxide is not classified for acute oral toxicity (LD50>2000 mg/kg bw) and for acute inhalation toxicity (LC50 >24.3 mg/L).
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