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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:
from 06 November 2009 to
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3(4)-bis(tert-butylperoxyisopropyl)benzene
- Physical state: yellowish solid
- Peroxide content: 97.6%
- Purity test date: 28 July 2009
- Lot/batch No.: 307090713
- Expiration date of the lot/batch: July 2010
- Storage conditions of test material: at room temperature (below 30°C) and protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 204 +/- 5 g
- Fasting period before study: approximately 18 hours
- Housing: polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet (e.g. ad libitum): conventional laboratory diet (SSNIFF R/M-H pelleted maintenance diet)
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron), provided ad libitum
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)

IN-LIFE DATES: From 13 November 2009 to 01 December 2009.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: standard vehicle used for specific routes of administration (the test item was not soluble in purified water)
- Lot/batch no. (if required): 066K0129

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: at the request of the Sponsor, the starting dose-level was 2000 mg/kg.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day. The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: no.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
None.
Body weight:
When compared to CIT historical control data, a lower body weight gain was noted in 2/6 animals (6 and 8 g vs. 17 ± 8 g in historical data base) between day 8 and day 15.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The oral LD0 of the test item 1,3(4) bis(tert butylperoxyisopropyl)benzene (batch No. 307090713) was higher than 2000 mg/kg in rats.
Executive summary:

The acute oral toxicity of the test item, 1,3(4)‑bis(tert-butylperoxyisopropyl)benzene (batch No. 307090713), was evaluated in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was prepared in 0.5% methylcellulose and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats. The study design was as follows:

 

Dose-level

(mg/kg)

Volume

(mL/kg)

Female

2000

10

3

2000

10

3

Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item.

 

All animals were subjected to necropsy.

Neither mortality nor clinical signs were observed during the study. When compared to CIT historical control data, a lower body weigh gain was noted in 2/6 animals (6 and 8 g vs. 17 ± 8 g in historical data base) between day 8 and day 15. 

At necropsy, no apparent abnormalities were observed in any animals. Under the experimental conditions of this study, the oral LD0of the test item 1,3(4)‑bis(tert‑butylperoxyisopropyl)benzene (batch No. 307090713) was higher than 2000 mg/kg in rats.