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EC number: 222-340-0 | CAS number: 3437-84-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 20, 1989 - November 3, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performe according to OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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:
- Bisisobutyryl peroxide
- EC Number:
- 222-340-0
- EC Name:
- Bisisobutyryl peroxide
- Cas Number:
- 3437-84-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 2-methylpropanoyl 2-methylpropaneperoxoate
- Details on test material:
- name of the compound DIISOBUTRYLPEROXIDE
- trade name or code Trigonox 187-C30
- batch no. 060789
- content of active ingredient 30%
- carrier, solvent or diluting agent : isododecane
- CAS. Reg. no. 3437-84-1
- general appearance: clear liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River wiga GmbH, Sulzfeld, F .R. Germany.
- Age at study initiation: ± 5 weeks
- Weight at study initiation: 209 to 230 g for males and from 143 to 159 g for females.
- Fasting period before study: overnight
- Housing: The rats were housed in groups of five animals, males and females separated. They were kept under conventional conditions in stainless cages with wire-screen bottom.
- Diet (e.g. ad libitum): ad libitum, cereal-based, open-formula basal diet
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: October 20, 1989 - November 3, 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10.0 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalityoccurred.
- Clinical signs:
- other: At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Sign
- Gross pathology:
- In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 exceeds 2000 mg per kg body weight, both in male and female rats.
- Executive summary:
The acute oral toxicity of diisobutyryl peroxide, 30% in phlegmatizer, was determined in rats. The test substance was given to groups of 5 males and 5 females in one single dose of 2000 mg per kg body weight. At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Signs of diarrhoea were not observed 24 hours after treatment. All animals gained weight after 3 days and thereafter, and no mortality occurred, however in most females a growth delay was observed. In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration. The oral LD50 of the test substance was found to exceed 2000 mg per kg body weight, both in male and female rats.
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