Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
The rats were quarantined and acclimated to laboratry conditions for 14 days prior the initiation of the study. Animals were observed twice daily during the quarantine period. In the last day of the quarantine period, one group consisting of ten rats (5 males and 5 females) were selected and used for the study.
The animals were randomly placed in numbered cages. Each rat was sexed, weighted and ear punched. Body weights ranged from 212 to 268g. The rats were individually housed in wire-bottomed cages suspended above the droppings.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
corn oil
Details on oral exposure:
One solution of test material and vehicle was made using corn oil (33.3% w/v). The amount of test material vehicle solution was measured in a plastic disposable syringe and administered directly in the rat's stomach as a single dose using a rubber catheter and tubing adapter.
Individual dose amounts were calculated using fasted body weights, taken prior to dosing.
Doses:
5 g/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Water and food were offered ad libitum, except during the 4 hours period immediately prior to oral intubation, when food was withheld.
Approximately one hour after dosing, food was offered.
All animals selected for the study were weighted on days -1, 0, 6 and 13.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occurred
Clinical signs:
no abnoralities were observed
Body weight:
no abnoralities were observed
Gross pathology:
no abnoralities were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The test substance was evalueted for its acute oral toxicity potential in rats. The study was performed according to GLP following oral administration of a single dose to the rat.

No mortality occurred during the study and no abnormalities were observed.

There was no effect on body weight gain.

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

The acute oral LD50 was determined to be greater than 5000 mg/kg bw.