Bisisobutyryl peroxide

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:

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

Test material information

Constituent 1

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:

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.