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Toxicological information

Acute Toxicity: oral

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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:
2001
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

Constituent 1
Chemical structure
Reference substance name:
Dibenzoyl peroxide
EC Number:
202-327-6
EC Name:
Dibenzoyl peroxide
Cas Number:
94-36-0
Molecular formula:
C14H10O4
IUPAC Name:
benzoyl benzenecarboperoxoate
Details on test material:
Purity = 79 percent, in water

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:
The only clinical symptom observed in 2000 mg/kg dose groupe was piloerection. This symptom was reversible after one day.
Body weight:
No data
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.