Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-07-04 to 1967-07-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP but equivalent to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: "US" rats
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2, 8, 10 and 16% (w/v)
Doses:
200, 800, 1250 and 1600 mg/kg
No. of animals per sex per dose:
10 per dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 400 mg/kg bw
Based on:
test mat.
Mortality:
200 and 800 mg/kg: no deaths; 1250 mg/kg: 3/10 after 7 days; 1600 mg/kg: 8/10 after 7 days
Clinical signs:
Dyspnea, apathy, abdominal and lateral position
Gross pathology:
Animals that died: all animals with bloody-serous snouts and blurred anus; 1 x diarrhea, 1 x severe distended ectatic stomach, 1 x suspicion of necrosis and hemorrhages of the liver (with putrescence)
Sacrificed animals: nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria