Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
doses applied exceed the limit dose
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
Temperature:24-25°C
Humidity: 60-75 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5860, 7620, and 9900 mg/kg bw

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 9 900 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
no clinical signs have been reported
Body weight:
no effects have been reported
Gross pathology:
no abnormalities have been reported
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 oral (rat) exceeds 9900 mg/kg bw.