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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 generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
EC Number:
236-050-7
EC Name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
Cas Number:
13122-18-4
Molecular formula:
C13H26O3
IUPAC Name:
tert-butyl 3,5,5-tris(methylperoxy)hexanoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Institute's colony
- Weight at study initiation: Males: 219 to 348 g; females: 137 to 200 g
- Fasting period before study: Before dosing the rats were fasted overnight
- Housing: In groups of five in screen-bottomed stainless steel cages in a well-ventilated room, maintained at 23 - 25°C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
NA
Doses:
12.1, 14.5, 17.4, 20.1, 25 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after which autopsies were carried out on the survivors. The LD50 was calculated according to the method of Weil (Biometrics 6 (1952) 249-263).
Statistics:
Not performed

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 14.5 - < 17.4 mL/kg bw
Remarks on result:
other: Calculated based on relative density of 0.89g/mL
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 12 905 - < 15 486 mg/kg bw
Mortality:
Deaths occurred between 9 hours and 6 days after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period.
Clinical signs:
Within a few hours after treatment the rats showed sluggishness and decreased activity. Thereafter slight diarrhoea, humpback behaviour, rough coats and loss of consciousness were frequently observed.
Body weight:
Not stated
Gross pathology:
Macroscopic examination of the survivors revealed no treatment-related gross alterations.

Any other information on results incl. tables

The doses applied and the mortality-figures are shown in the table below:

dose (ml/kg)

mortality

number

%

males

females

12.1

0/5

3/5

30

14.5

1/5

3/5

40

17.4

5/5

3/5

80

20.8

4/5

5/5

80

25

5/5

5/5

100

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
From the mortality-figures the LD50 of tert-Butylperoxy-3,5,5-trimethylhexanoat was between 14.5 and 17.4 mL/kg bw, corresponding to 12905 - 15486 mg/kg bw. Therefore, the material can be classified as relatively harmless.
Executive summary:

Young adult albino rats (Wistar derived) from the Institute's colony were used to determine the acute oral toxicity of tert-Butylperoxy-3,5,5-trimethylhexanoat. After some preliminary observations, the test material was given undiluted by gavage to groups of five males and five females in single doses of 12.1, 14.5, 17.4, 20.1 or 25 mL/kg bw. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after which autopsies were carried out on the survivors.

Within a few hours after treatment the rats showed sluggishness and decreased activity. Thereafter slight diarrhoea, humpback behaviour, rough coats and loss of consciousness were frequently observed. Deaths occurred between 9 hours and 6 days 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 no treatment-related gross alterations.

From the mortality-figures the LD50 of tert-Butylperoxy-3,5,5-trimethylhexanoat was between 14.5 and 17.4 mL/kg bw, corresponding to 12905 - 15486 mg/kg bw. Therefore, the material can be classified as relatively harmless.