Registration Dossier

Toxicological information

Acute Toxicity: oral

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Groups of 5 male Sherman rats were administered doses of 126, 252, 500, 1000, and 2000 mg/kg bw by gavage. The animals were observed for lethality, changes in general appearance and demeanor and body weight gain during a 14-day post-exposure period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sherman
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: yes

ENVIRONMENTAL CONDITIONS
no details

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
Doses:
126, 252, 500, 1000, and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight
Statistics:
Weil CS (1952). Biometrics 8: 249-263

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
540 mg/kg bw
95% CL:
>= 390 - <= 750
Mortality:
At the highest dose of 2000 mg/kg bw 5/5 rats died within 2-24 hrs after dosing. At the doses of 1000 and 500 mg/kg bw 2/5 rats died within 24 hrs after administration. At the two lower doses of 252 and 126 mg/kg bw, no mortality occurred.
Clinical signs:
No changes in general appearance and demeanor were observed among any of the surviving animals.
Body weight:
Except for one animal dosed with 126 mg/kg and one with 252 mg/kg bw all animals surviving until the termination of the study displayed body weight gains.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria