Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute oral toxicity study. Limit test at dose level 15000 mg/kg bw in rats
GLP compliance:
not specified
Test type:
other: acute oral toxicity
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Not available

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: unspecified
Doses:
15000 mg/kg
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was determined to have an acute oral toxicity LD50 of >15000 mg/kg bw (in rats)