Dioctanoyl peroxide

Endpoint summary

Description of key information

The oral LD50 is > 5000 mg/kg bw. no further information available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

One study is availble, K2. It was performed pre-GLP.

Justification for classification or non-classification

Based on the available information the subsatnce is not classified for acute toxicity.