Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1960
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:
1960
Report date:
1960

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Five groups of ten albino rats of the Sherman Wistar strain were dosed by gavage with a 25% suspension of the test substance in corn oil. Highest dose level was 16 mg/kg and observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Etocrilene
EC Number:
226-029-0
EC Name:
Etocrilene
Cas Number:
5232-99-5
Molecular formula:
C18H15NO2
IUPAC Name:
etocrilene
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 +/- 5 °C), light protected

Test animals

Species:
rat
Strain:
other: Sherman Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 4 - 64 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 64 ml/kg
Doses:
1, 2, 4, 8 and 16 g/kg
No. of animals per sex per dose:
10 animals per dose (no details on sex given)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
16 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal of the highest dose died, no other mortalities.
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test article exceeds 16000 mg/kg
Executive summary:

In an oral toxicity study five groups of ten albino rats of the Sherman Wistar strain were treated with the test substance to assess its acute oral toxicity. The animals were starved for a period of twenty-four hours prior to dosing and then treated by oral gavage at dose levels of 1, 2, 4, 8 and 16 g/kg. One animal treated with 16000 mg/kg died during the course of the study, no other mortalities were reported. The LD50 of the test article was therefore set at 16000 mg/kg.