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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: From the Institute´s colony
- Age at study initiation: Young adult
- Weight at study initiation: Males: 196 to 298 g, females: 87 to 150 g
- Fasting period before study: Before dosing the rats fasted overnight
- Housing: Housed in groups of five in screen-bottomed stainless steel cages, in a well-ventilated room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: shellsol T
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 %

MAXIMUM DOSE VOLUME APPLIED: 6.22 mL/kg bw

Doses:
3.00, 3.60, 4.32, 5.18 or 6.22 mL/kg bw equivalent to 2670, 3204, 3844.8, 4610.2, 5535.8 mg/kg bw
No. of animals per sex per dose:
groups of 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examinations

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 575.3 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 424 - <= 1 735.5
Remarks on result:
other: Conversion of mg/kg bw based on density of 0.89
Mortality:
2670 mg/kg bw: 3/10
3204 mg/kg bw: 4/10
3844.8 mg/kg bw: 9/10
4610.2 mg/kg bw: 9/10
5535.8 mg/kg bw: 10/10
Clinical signs:
Within a few hours after dosing the rats showed sluggishness, sedation and ataxia. Later on coma was frequently observed.
Body weight:
not examined
Gross pathology:
Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral toxicity of the test item was examined in a study equivalent to OECD guideline 401. The LD50 value was determined to be 1575.3 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was examined in a study equivalent to OECD guideline 401. The test substance was applied in doses of 3.00, 3.60, 4.32, 5.18 or 6.22 mL/kg bw equivalent to 2670, 3204, 3844.8, 4610.2, 5535.8 mg/kg bw. The test material was given by gavage as 50 % dilution in shellsol T to groups of 5 male and 5 female albino rats. The LD50 value was determined to be 1575.3 mg/kg bw. Mortality occured between 2 hours and 3 days after treatment. Animals died from 3 mL/kg bw onwards. The rats showed sluggishness, sedation and ataxia. Later on come was frequently observed. The survivors recovered gradually and looked quite healthy again at the end of the observation period.