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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals used
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: mortality and toxicity

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Diarrhea was observed on day 1 and 2. Lethargy was observed on day 4.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met