tert-butyl perbenzoate

Acute Toxicity: oral

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl perbenzoate

EC Number:

210-382-2

EC Name:

tert-butyl perbenzoate

Cas Number:

614-45-9

Molecular formula:

C11H14O3

IUPAC Name:

tert-butyl benzenecarboperoxoate

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 or test system 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:

other: 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.

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 acute oral toxicity study according to the Acute Toxic Class method (OECD 423) resulted to no mortality and only minor clinical signs in one animal on one day after dosing with 2000 mg/kg. The LD50 cut-off has therefore been established to be greater than 5000 mg/kg bw.

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 LD50 cut-off for tert-Butyl peroxybenzoate (CAS# 641-45-9) after single oral administration observed over a period of 14 days, therefore has been established to be greater than 5000 mg/kg body weight.