Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Albino White
Sex:
male/female
Details on test animals 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5.18 mL/kg bw
Based on:
test mat.
95% CL:
3.2 - 8.4
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:
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.