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Toxicological information

Acute Toxicity: oral

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Administrative data

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
After some preliminary observations the test material was given undiluted by gavage to groups of five males and five females in single doses. They were observed for signs of intoxication during a 14 days period, after which autopsies were carried out on the survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute`s colony
- Age at study initiation: young adults
- Weight at study initiation: males 243 to 321 g; females 140 to 220 g
- Fasting period before study: overnight
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet: stock diet ad libitum (after treatment)
- Water: tap water ad libitum (after treatment)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 °C


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Maximum dose volume applied: 20 mL /kg bw
Doses:
11.6, 13.9, 16.7 or 20.0 mL /kg bw
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952) 249-263).

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 mL/kg bw
Based on:
test mat.
95% CL:
>= 10.2 - <= 14.4
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 776 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 mg/kg bw
Based on:
act. ingr.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 082 mg/kg bw
Based on:
act. ingr.
Mortality:
Most of the deaths occurred between 21 hours and 8 hours after treatment. One female rat died after 13 days. After 8 days the animals who survived recovered gradually.
Clinical signs:
Within a few hours after treatment all rats showed sluggisness, humpback behavior and severe diarrhoea. Within a few days after treatment several rats showed irritation of the skin in the area arround anus and tailroot; encrustations around eyes and nostrils were frequently observed.
Gross pathology:
At the end of the observation period some of the rats still showed necrosis of the skin around anus and tailroot. No other treatment-related gross alterations were seen at autopsy.

Any other information on results incl. tables

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

Dose mL/kg

Mortality

Males (number)

Females (number)

%

11.6

3/5

1/5

40

13.9

3/5

3/5

60

16.7

5/5

4/5

90

20.0

5/5

3/5

80

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A LD50 value of 12.0 mL /kg bw (10776 mg/kg bw) for tert-butyl peroxyneodecanoate (75 % solution) was determined in this study and a LD50 value of 9 mL/kg bw (8082 mg/kg bw) was calculated for the pure t-butyl peroxyneodecanoate (actual ingredient). Therefore, the test substance was considered as practically non-toxic.

Executive summary:

Tert-butyl peroxyneodecanoate (75 % solution) was given undiluted by gavage to groups of five males and five females in single doses of 11.6, 13.9, 16.7 or 20.0 mL/kg bw. They were observed for signs of intoxication during a 14 days period, after which autopsies were carried out on the survivors.

The LD50 of the test item was calculated in study to be 12.0 mL/kg bw (10776 mg/kg bw) with 10.2 and 14.4 as the 95 % confidence limits. a LD50 value of 9 mL/kg bw (8082 mg/kg bw) was calculated for the pure t-butyl peroxyneodecanoate (actual ingredient). Therefore, the material was considered practically non-toxic.