tert-butyl α,α-dimethylbenzyl peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

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:

1977

Report date:

1977

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl α,α-dimethylbenzyl peroxide

EC Number:

222-389-8

EC Name:

tert-butyl α,α-dimethylbenzyl peroxide

Cas Number:

3457-61-2

Molecular formula:

C13H20O2

IUPAC Name:

[2-(tert-butylperoxy)propan-2-yl]benzene

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Albino White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Prior to the study, The body weights of males varied from 235 to 354 g, those of females from 150 to 199 g.
The rats were housed in groups of five in screen-bottomed stainless steel cages in a well-ventilated room, maintained at 23-25°C.
Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

3.0, 3.6, 4.32, 5.18, 6.22 ml/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observation post-exposure: 14 days.
Autopsy was carried out on all survivors.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5.18 mL/kg bw

Based on:

test mat.

95% CL:

3.2 - 8.4

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 870 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on a density of 0.94

Mortality:

Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period.

Clinical signs:

other: Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors. After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea.

Gross pathology:

At autopsy pale kidneys were seen in some of the males.

Other findings:

Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats.

Any other information on results incl. tables

Dose(ml/kg)	males	females	Mortality (%)
3.00	2	1	30
3.60	2	2	40
4.32	1	3	40
5.18	2	3	50
6.22	2	4	60

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral LD 50 of tert buty cumyl peroxide is 5.18 ml/kg (4870 mg/kg) in rats.

Executive summary:

Trigonox T (90 -92% tert-butyl cumyl peroxide) was administered by oral route (gavage at 3, 3.6, 4.32, 5.18, 6.22 ml/kg bw) to groups of 10 White Albino rats (5 males, 5 females). Animals were then observed for 14 days. 3/10 animals died at the lowest dose exposure. 4/10 animals died at 3.6 and at 4.32 ml/kg doses. 5/10 animals died at 5.18 ml/kg and 6/10 animals died at the highest dose. Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors. After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea. Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats.At autopsy pale kidneys were seen in some of the males. Under these experimental conditions, the oral LD50 of the test item in rat is 5.18 ml/kg, equivalent to 4870 mg/kg.