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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
Study period:
1995-08-24 until 1995-09-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl peroxyisobutyrate
EC Number:
203-650-5
EC Name:
tert-butyl peroxyisobutyrate
Cas Number:
109-13-7
Molecular formula:
C8H16O3
IUPAC Name:
tert-butyl 2-methylpropaneperoxoate
additive 1
Chemical structure
Reference substance name:
2,2,4,6,6-pentamethylheptane
EC Number:
236-757-0
EC Name:
2,2,4,6,6-pentamethylheptane
Cas Number:
13475-82-6
Molecular formula:
C12H26
IUPAC Name:
isododecane
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks old
- Weight at study initiation: mean body weight of 184 ± 5 g for the males and 136 ± 4 g for the females
- Fasting period before study: 1 day
- Housing: The animals were housed individually in polystyrene cages
- Diet: A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water: drinking water filtered by a F.G. Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 30 to 70 %
- Air changes: about 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h/12 h

IN-LIFE DATES: 1995-08-24 to 1995-09-07

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- The test substance was administered in its original form taking into consideration that its density was 0.86. The volume administered to each animal was adjusted according to body weight determined on the day of treatment.
Doses:
2000 mg/kg in active material (i.e. corresponding to 2642 mg/kg in finished product)
No. of animals per sex per dose:
5 rats per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of the animals was made at least once a day. The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
No

Results and discussion

Preliminary study:
No
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
Two out of five females were found dead on day 2 or 3.
Clinical signs:
In the males, sedation was observed one hour after treatment, and then piloerection and hypoactivity which persisted for four hours. Thereafter, no clinical signs were noted. In the females, sedation was noted one hour after treatment, in addition to piloerection and dyspnea two hours after; then, hypoactivity and piloerection were noted after four hours. Thereafter, no clinical signs were noted, except coma in one out of five females on day 2 prior to death on day 3.
Body weight:
The body weight gain of the animals was not influenced by treatment.
Gross pathology:
Macroscopic examination of the main organs of the animals demonstrated no apparent abnormalities.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study LD50 of > 2000 mg/kg was determined.
Executive summary:

The test substance, tert-butyl peroxyiisobutyrate (TBPIB) 75.7 % in hydrocarbon was administered by oral route to one group of ten fasted Sprague-Dawley rats (five males and five females). according to OECD 401 and EU method B1 guidelines. The test substance was administered in its original form, by gavage, at a dose of 2000 mg/kg in active material. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single administration of the test substance. All animals were subjected to necropsy.

The body weight gain of the animals was not affected by treatment with the test substance. Two out of five females were found dead on day 2 or 3. In the males, sedation was observed one hour after treatment, and then piloerection and hypoactivity which persisted for four hours. Thereafter, no clinical signs were noted. In the females, sedation was noted one hour after treatment, in addition to piloerection and dyspnea two hours after; then, hypoactivity and piloerection were noted after four hours. Thereafter, no clinical signs were noted, except coma in one out of five females on day 2 prior to death on day 3. No abnormalities were observed at necropsy.

Under the study experimental conditions, the oral LD50 of the test substance was higher than 2000 mg/kg in rats.