Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
male: 200 and 500 mg/kg body weight (bw)
female: 200, 500 and 2000 mg/kg body weight (bw)
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 - < 1 000 mg/kg bw

Any other information on results incl. tables

At 200 mg/kg in both genders diarrhea was observed. At 500 mg/kg in both genders decreased motility, uncoordinated gait, labored breathing and temporary tachypnea occurred. Additionally, in the females of this group the skin showed a good blood supply and one male (no. 11) lay in abdominal position. At 2,000 mg/kg females showed dazed condition, poor reflexes, temporary increased motility, uncoordinated gait, abdominal position, laboured breathing and temporary tachypnea, and the skin showed a good blood supply. The signs observed started 25 minutes after administration and lasted up to day 2 of the study.

There were no toxicological effects on body weights or on body weight development in males and females.

In animals that died during the observation period the following changes were detected:

Liver pale discolorations;

Lungs: slightly collapsed;

Spleen: dark-red discolorations;

Kidneys: pale discolorations

Animals killed at the end of the study period showed the following changes:

Thyroid glands: enlarged

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU