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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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