Dioctanoyl peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP guideline type study, limited details but sufficient, no COA but test article is identified withing text of report.

Data source

Reference

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dioctanoyl peroxide

EC Number:

212-094-2

EC Name:

Dioctanoyl peroxide

Cas Number:

762-16-3

Molecular formula:

C16H30O4

IUPAC Name:

octanoyl octaneperoxoate

Test material form:

solid: crystalline

Details on test material:

A 500 g sample of the test material was received from the
principal on May 5, 1976. It was a white crystalline
powder, designated: Perkadox SE-8, di-octanoyl peroxide.
The material was stored at -20 C until use.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult albino rats from the Institute's colony (Wistar
derived; males 192 to 255 g and females 157 to 225 g body
weight) were used. They were housed in groups of five in
screen-bottomed stainless steel cages, ln a well-ventilated
room maintained at 25 C. Before dosing the rats were
fasted overnight.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Shellsol T

Details on oral exposure:

After some preliminary observations the test material was
given by gavage as a 50% (w/v) suspension in Shellsol T,
to groups of ten males and ten females in one single dose
of 10 ml per kg body weight, which is equivalent to 5 g
test material per kg body weight.
Since the LD50 of Shellsol T was stated to be about 8 ml/kg
body weight, no higher dose of the suspension was considered
to be tolerated. After treatment the rats received stock
diet and tap water ad libitum. They were observed for signs
of intoxication during a 14-days period, after which
autopsies were carried out on the survivors.

Doses:

5g/kg

No. of animals per sex per dose:

Ten

Control animals:

no

Details on study design:

After some preliminary observations the test material was
given by gavage as a 50% (w/v) suspension in Shellsol T,
to groups of ten males and ten females in one single dose
of 10 ml per kg body weight, which is equivalent to 5 g
test material per kg body weight.
Since the LD50 of Shellsol T was stated to be about 8 ml/kg
body weight, no higher dose of the suspension was considered
to be tolerated. After treatment the rats received stock
diet and tap water ad libitum. They were observed for signs
of intoxication during a 14-days period, after which
autopsies were carried out on the survivors.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities

Mortality:

None

Clinical signs:

other: None observed

Gross pathology:

Macroscopic examination revealed no treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of dioctanoyl peroxide to rats was greater than 5 g/kg.

Executive summary:

The test article was evaluated for acute oral toxicity to rats at a limit dose of 5 g/kg. No moralities, clinical signs of toxicity or macroscopic findings were reported.

The acute oral LD50 to rats was greater than 5 g/kg.