Di-tert-butyl sec-butylidene diperoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Date: 14 June 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

fixed dose procedure

GLP compliance:

not specified

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Di-tert-butyl sec-butylidene diperoxide

EC Number:

218-507-2

EC Name:

Di-tert-butyl sec-butylidene diperoxide

Cas Number:

2167-23-9

Molecular formula:

C12H26O4

IUPAC Name:

2,2-bis(tert-butylperoxy)butane

additive 1

Reference substance name:

White mineral oil (petroleum)

EC Number:

232-455-8

EC Name:

White mineral oil (petroleum)

Cas Number:

8042-47-5

Molecular formula:

C15H32 - C50H102

IUPAC Name:

White mineral oil (petroleum)

Test material form:

liquid

Specific details on test material used for the study:

A 1kg sample of the test material was received from the principal on April 9, 1979. It was a clear colourless liquid, designated Trigonox D-E50, and coded nr. 5478090039. The material was stated to be a 50% solution of 2,2 di-tert-butyl-peroxybutane in mineral oil.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult albino rats (Wistar derived) from the Institute's colony were used. The body weights of males varied from 185 to 263 g, those of females from 103 to 142 g. The rats were housed in groups of five screen-bottomed stainless steel cages, in a well-ventilated room, maintained at 23±1°C. Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Remarks:

mineral oil

Details on oral exposure:

After some preliminary observations, the test material was given undiluted by gavage to groups of ten males and ten females in one single dose of 30.0 ml per kg body weight. This dose is considered to be the highest tolerable amount to be given in a single dose.

Doses:

30.0 ml per kg body weight

No. of animals per sex per dose:

10 males and 10 females per dose.

Control animals:

no

Details on study design:

After treatment, the rats received stock diet and water ad libitum. The were observed for signs of intoxication during a 14-day 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:

> 30 mL/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

Within a few hours after treatment the rats showed sluggishness humpback behaviour and severe diarrhoea. Later on the rats recovered gradually and looked quite healthy again at the end of the observation period.

Gross pathology:

Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

From the results, it appears that the LD50 of Trigonox D-E50 exceeds 30 ml per kg bodyweight. Therefore, the material can be classified as relatively harmless.

Executive summary:

From the results, it appears that the LD₅₀ of Trigonox D-E50 exceeds 30 ml per kg bodyweight (24.34 g/kg bw, based on density, 0.8114).

Therefore, the material can be classified as relatively harmless.