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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxybutane
EC Number:
221-877-8
EC Name:
2,3-epoxybutane
Cas Number:
3266-23-7
Molecular formula:
C4H8O
IUPAC Name:
2,3-dimethyloxirane
Details on test material:
- Substance-No.: 81/356
- Physical state: liquid, colorless
- Analytical purity: 99%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: mean 239 + 20 g (males), 176 + 6 g (females)
- Housing: 5 per cage in wiremesh cages (Typ D III, Becker)
- Diet (e.g. ad libitum): SSNIFF R Alleindiät für Ratten und Mäuse (SSNIFF-Versuchstierdiäten GmbH); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system made out of glass and steel
- Exposure chamber volume: ca. 200 l
- Method of holding animals in test chamber: individually in wiremesh cages
- Source and rate of air: fresh air
System of generating particulates/aerosols: substance was led to a preheated vaporizer at constant doses by a dosing pump
- Treatment of exhaust air: exhausting by air pressure system, 7% lower than fresh air system


TEST ATMOSPHERE
- Brief description of analytical method used: two connected absorption container collected air at a rate of 1.25 m/s. Analysis was done by gas chromatography
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by gas chromatography
Duration of exposure:
4 h
Concentrations:
5.2 mg/l air
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation; weighing prior to exposure and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
Binominal test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.2 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
No mortality
Clinical signs:
other: Nothing abnormal detected
Body weight:
Mean body weights (g) prior to exposure and on days 7 and 14:
- Males: 239, 284, 319
- Females: 176, 193, 210
Gross pathology:
Nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU