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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD guideline 423 with full conformance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
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:
Identification: tert-butyl perbenzoate
Other Test Item Name: tert-Butyl peroxybenzoate
Description: Liquid; colorless
CAS#: 614-45-9
Batch Number: 0903225181
Purity: 99.2%
Stability of Test Item: Stable under storage conditions.
Expiry Date: 01-Apr-2010
Stability of Test Item Dilution: Not known; will be excluded from Statement of Compliance.
Storage Conditions: In a refrigerator (2-8°C) away from direct sunlight.

Test animals

Species:
rat
Strain:
other: RccHan:WIST(SPF)
Sex:
female
Details on test animals and environmental conditions:
Test System
Animals: Rat, RccHan: WIST(SPF)
Rationale: Recognized by international guidelines as a
recommended test system.
Breeder: Harlan Laboratories B.V.
Kreuzelweg 53
5961 NM Horst / The Netherlands
Number of Animals per Group: 3 females
Total Number of Animals: 6 females
Age (when treated): 11 weeks
Body Weight Range (when treated): 201.8 g - 217.2 g
Identification: Unique cage number and corresponding color-coded
spots on the tail. The animals were marked at
acclimatization start.
Randomization: Selected by hand at time of delivery.
Acclimatization: Under laboratory conditions, after health
examination. Only animals without any visible signs
of illness were used for the study.

Room Numbers: 136, Harlan Laboratories Ltd., Itingen
Conditions: Standard Laboratory Conditions. Air-conditioned
with 10 - 15 air changes per hour, and continuously
monitored environment with ranges for room
temperature 22 ± 3 °C and for relative humidity
between 30 - 70% (values above 70% during
cleaning process possible), automatically controlled
light cycle of 12 hours light and 12 hours dark,
music during the daytime light period.
Accommodation: In groups of three in Makrolon type-4 cages with
wire mesh tops and standard softwood bedding
(J. Rettenmaier & Söhne GmbH & Co. KG, 73494
Rosenberg / Germany, imported by Provimi Kliba
AG, 4303 Kaiseraugst / Switzerland) including paper
enrichment (Enviro-dri from Lillico, Biotechnology,
Surrey / UK).
Diet: Pelleted standard Harlan Teklad 2914C rodent
maintenance diet (Provimi Kliba AG,
4303 Kaiseraugst / Switzerland), batch no. 82/09,
was available ad libitum. Results of respective
analyses for contaminants are included.
Water: Community tap-water from Itingen was available ad
libitum in water bottles. Results of bacteriological
assay, chemical and contaminant analyses of
respective samples are included.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Oral administration was considered to be an appropriate application method as it is a possible
route of human exposure during manufacture, handling and use of the test item.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirrer.
The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg
body weight after being fasted for approximately 17 hours (access to water was permitted). Food
was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg body weight.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6F
Control animals:
no
Details on study design:
Oral administration was considered to be an appropriate application method as it is a possible
route of human exposure during manufacture, handling and use of the test item.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirrer.
The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg
body weight after being fasted for approximately 17 hours (access to water was permitted). Food
was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg body weight.
Statistics:
none

Results and discussion

Preliminary study:

5 CONCLUSION
Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
One female (no. 2) showed slight somnolence and slightly ruffled fur 5 hours post treatment.
Otherwise, no clinical signs were observed during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of tert-Butyl peroxybenzoate (CAS# 641-45-9) after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight
Executive summary:

Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with tert-Butyl peroxybenzoate (CAS# 641-45-9) by single oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was formulated in corn oil at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2 - 15. Mortality/viability was recorded within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 - 15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. Slight clinical signs including somnolence and ruffled fur were noted in one female at the 5-hour observation. Otherwise, no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of tert-Butyl peroxybenzoate (CAS# 641-45-9) after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight.