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: OECD method, GLP compliance

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD GUIDELINE 401 (84/449/EEC B.1)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Vehicle:
other: 0.5% /w/w) CMC in0.1% aqueous polysorbate 80

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals:5; Number of death:0
Female: 2000 mg/kg bw; Number of animals:5; Number of death:0
Clinical signs:
Signs of toxicity related to dose levels:
COMMON SYMPTOMS IN ACUTE TESTS, (PILOERECTION, HUNCHED, POSTURE, EXOPHTALMOS, DYSPNEA). THE ANIMALS RECOVERED WITHIN 6-7 DAYS. ADDITIONALLY, REDUCED LOCOMOTOR ACTIVITY WAS OBSERVED IN ALL ANIMALS.
Gross pathology:
Effects on organs:
NONE

Applicant's summary and conclusion

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