Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: limited test
Mortality:
no death
Clinical signs:
No signs of systemic toxicty were observed during the observation period.
Body weight:
All animals showed expected gain in bodyweight.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Nothing to add in this field.

Any other information on results incl. tables

The test chemical was of very low acute oral toxicity in rats.

Mortality: No deaths were recorded.

Clinical observations: No clinical signs of toxicity were noted.

Morphological findings: No abnormalities were noted at necropsy.

Comment: All animals showed expected gain in bodyweight.

LD50: >2 000 mg/kg

Result: The test chemical was of very low acute oral toxicity in rats.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material was considered as a nontoxic substance via acute oral toxicity study in rats.
Executive summary:

According to OECD TG 401, the acute oral toxicity was well investigated and the results indicated the test material has very low toxicity in rats. OECD TG 401 was deleted in 2002 due to animal welfare reasons, however, the validity of the results which accomplished under TG 401 should be confirmed.