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:
other: Body responsible for the test
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Vehicle:
other: Tylose + Tween 20

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
3 440 mg/kg bw
Remarks on result:
other: Slope of the mortality curve: 1.26
Clinical signs:
Signs of toxicity related to does levels:
At all doses apathy, sedation, trembling, incidences of lack of coordination, stomach pains, sanguineous nasal secretion and changed reflexive responsiveness up to four days or excitus after coma. Animals from the high-dose group died within 24 h. After 4-5 days there was reduced weight gain and 3 late mortalities in dose group III.
Gross pathology:
Animals which died within the first 24 h did not reveal any post-mortem findings, the late mortalities in group III revealed hyperaemia of the digestive tract. Similar findings were found in the surviving animals in group III after 14 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU