Registration Dossier
Registration Dossier
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EC number: 202-327-6 | CAS number: 94-36-0
Acute Toxicity: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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:
- Purity = 79 percent, in water
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age of animals: 5 weeks
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- 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 N°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.
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