Registration Dossier

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:
1989
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

Constituent 1
Chemical structure
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

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:
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.
Body weight:
All animals gained weight after 3 days and thereafter however in most females a growth delay was observed.
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.