Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
NA
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Harlan Industries, Inc. Indianapolis, Indiana
Housing: rats were housed by sex in 5 rats per cage, in temperature and humidity controlled quarters
Conditioning period: 8 days prior to study initiation
Fasting period: about 18 h over night prior to oral administration
Body weights prior to administration: males 210 - 250 g; females 210 - 250 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
NA
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Rats were observed for mortality during the first four hours after administration and daily for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days.
Statistics:
NA

Results and discussion

Preliminary study:
No preliminary study
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 10 000 mg/kg bw
Mortality:
None of the ten rats died during the 14 day study period. The minimum lethal dose by the oral route of administration was found to be greater than
10000 mg/kg bw.
Clinical signs:
NA
Body weight:
No adverse effects on body weight observed.
Gross pathology:
NA
Other findings:
NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
None of the test animals died during the 14 day study period. Thus the LD50 > 10000 mg/kg bw.
Executive summary:

Tert.-Butylperoxy- 2-ethylhexanoat was administered to 5 male and 5 female Sprague-Dawley rats at a dose of 10000 mg/kg bw. The test material was administered orally by gavage as a solution in corn oil. The rats were observed for mortality during the first four hours after administration and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.

None of the animals died during the 14 day study period. Thus, the minimum lethal dose as well as the LD50 are > 10000 mg/kg bw. No adverse effects related to the body weights were observed. The LD0 was >= 10000 mg/kg bw.