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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
BASF-Test, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no
Remarks:
study was performed prior to GLP implementation
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyloxirane
EC Number:
209-193-8
EC Name:
2,2-dimethyloxirane
Cas Number:
558-30-5
Molecular formula:
C4H8O
IUPAC Name:
2,2-dimethyloxirane
Details on test material:
Please refer to the section "confidential details on test material" below.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult (based on body weight)
- Weight at study initiation: 200 to 210 g (male), 180 - 200 g (female)
- Fasting period before study: 15 - 20 h before application
- Diet: H. EGGERSMANN KG, Germany

IN-LIFE DATES: From: 1979-07-17 To: 1979-07-31

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5 % aqueous solution)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 14.7, 21.5, 31.6, 46.4 and 50.0 % emulsion in aqueous 0.5 % carboxymethyl cellulose
Doses:
1470, 2150, 3160, 4640, 6810 mg/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopical examination

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 890 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 799 - <= 5 466
Mortality:
See details in the section "Any other information on results incl. tables".
Clinical signs:
other: Clinical signs were observed after a single dosage of 3160, 4640 and 6810 mg/kg bw: - dyspnoe - apathy - aberrant position - tumbling - ruffy fur - diarrhoea - exsiccosis - salivation - reduced general state
Gross pathology:
Animals died during the study: heart - right-sided acute dilatation, acute hyperaemia
Animals sacrificed: gluing of the rumen wall to the peritoneum

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw) Gender   1 h  24 h  48 h  7 days  14 days        
6810  male  0/5 2/5 2/5 2/5  2/5        
6810  female  0/5 5/5 5/5 5/5  5/5        
4640  male  2/5 2/5 2/5 2/5 2/5        
4640  female  0/5 5/5 5/5 5/5 5/5        
3160  male  0/5 2/5 2/5 2/5  2/5        
3160  female  0/5 3/5 4/5 4/5 4/5        
2150  male  0/5 0/5 0/5 0/5 0/5        
2150  female  0/5 0/5 0/5 0/5  0/5        
1470  male  0/5  0/5  0/5  0/5  0/5        
1470  female  0/5  0/5  0/5  0/5  0/5        

The test substance caused dose dependent toxicity after a single ingestion.

Applicant's summary and conclusion