Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05. Sept. 1986 - 19. Sept. 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report, which meets basic scientific priniciples

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrabutan (dest.)
- Physical state: liquid
- Isomers composition: C16-(branched), C20-(branched) and C24-(branched)-alkanes

Test animals

Species:
rat
Strain:
other: WISW (SPF TNO)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann, Borchen, Germany
- Weight at study initiation: 115.4 g
- Housing: 1-5 animals per macrolon cage type III
- Diet (e.g. ad libitum): R10 Alleindiät, Ssniff Spezialfutter GmbH, Soest Germany; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimatisation: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 12.5 cm3/kg
Doses:
10000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
1-2 hours after dosing bristled coat and diuresis were recorded in all animals. After 4-6 hours all animals showed oily wet coat in the anal region and on the hind legs.24 hours after administration all animals were free of symptoms.
Body weight:
no effect on body weight
Gross pathology:
Necropsy revealed no macroscopic changes.
Other findings:
None

Any other information on results incl. tables

 

 

 

 

 

 

 

 

6 hours

24 hours

7 days

14 days

Mortality

female

0/5

0/5

0/5

0/5

 

male

0/5

0/5

0/5

0/5

 

 

 

 

 

 

0/5 = animals dead/animals treated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the described test conditions, mortality did not occur up to the highest dose tested of 10000 mg/kg/bw. Thus, the LD50 is above 10000 mg/kg/bw, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Executive summary:

Tetrabutan (dest.) was tested in an Acute Oral Toxicity Test, performed in consideration of the guideline OECD 401. The test was conducted as a limit test. 5 female and 5 male rats were administered Tetrabutan (dest.) at a dose of 10000 mg/kg bw by gavage. Besides transient clinical symptoms attributable to an overload with test substance, no mortality or irreversible clinical signs were recorded. Tetrabutan (dest.) is practically non toxic by the oral route. The LD50 > 10000 mg/kg bw.