tert-butyl 2-ethylperoxyhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

NA

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl 2-ethylperoxyhexanoate

EC Number:

221-110-7

EC Name:

tert-butyl 2-ethylperoxyhexanoate

Cas Number:

3006-82-4

Molecular formula:

C12H24O3

IUPAC Name:

tert-butyl 2-ethylhexaneperoxoate

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: Harlan Industries, Inc. Indianapolis, Indiana
Housing: rats were housed by sex in 5 rats per cage, in temperature and humidity controlled quarters
Conditioning period: 8 days prior to study initiation
Fasting period: about 18 h over night prior to oral administration
Body weights prior to administration: males 210 - 250 g; females 210 - 250 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

NA

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Rats were observed for mortality during the first four hours after administration and daily for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days.

Statistics:

NA

Results and discussion

Preliminary study:

No preliminary study

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 10 000 mg/kg bw

Mortality:

None of the ten rats died during the 14 day study period. The minimum lethal dose by the oral route of administration was found to be greater than
10000 mg/kg bw.

Clinical signs:

other: NA

Gross pathology:

NA

Other findings:

NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

None of the test animals died during the 14 day study period. Thus the LD50 > 10000 mg/kg bw.

Executive summary:

Tert.-Butylperoxy- 2-ethylhexanoat was administered to 5 male and 5 female Sprague-Dawley rats at a dose of 10000 mg/kg bw. The test material was administered orally by gavage as a solution in corn oil. The rats were observed for mortality during the first four hours after administration and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.

None of the animals died during the 14 day study period. Thus, the minimum lethal dose as well as the LD50 are > 10000 mg/kg bw. No adverse effects related to the body weights were observed. The LD0 was >= 10000 mg/kg bw.