Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods 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:
not specified
Test type:
standard acute method

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6% to 35% suspension in 0.5% CMC
- Justification for choice of vehicle: test substance is not soluble in water or oranic solvents
Doses:
8000 mg/kg bw
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 d

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 8 000 mg/kg bw
Based on:
test mat.
Clinical signs:
Dyspnea, slight apathy; slight diarrhea, faeces stained blue
Body weight:
slight decrease in bw at study end
Gross pathology:
dilated heart, congestive hyperemia, dilated stomach with liquid content; intestines: diarrhetic content

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (acute, oral) for rats was determined to be ca. 8000 mg/kg bw. test material (3200 mg/kg bw active ingredient)
Executive summary:

The LD50 (acute, oral) for rats was determined to be ca. 8000 mg/kg bw.