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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

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

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:
- Name of test material (as cited in study report): N-Butylenoxid-2.3
- Substance-No.: 81-356

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, Biberach
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: mean 280 g (males), 230 g (females)
- Fasting period before study: 16 hours prior to dosing, but water ad libitum
- Housing: 5 per cage in V-II-A-STAHL-wire mesh cages, type DK-III (Becker & C., Castrop-Rauxel)
- Diet (e.g. ad libitum): SSNIFF R; SSNIFF, Versuchstierdiaeten, Soest
- Water (e.g. ad libitum): VE-water on working days; tap water on weekends; ad libitum
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10.0, 14.7, 21.5, 31.6%
- Amount of vehicle (if gavage):10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
1000, 1470, 2150, 3160 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: <15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after dosing. Then daily on weekdays. Twice daily on weekdays and once daily on weekends check for mortality. Weighing on days prior to dosing and on days 4, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 150 mg/kg bw
Mortality:
3160 mg/kg bw: 5/5 males and 2/5 females within 24 hours
2150 mg/kg bw: 3/5 males and 3/5 females within 24 hours
1470, 1000 mg/kg bw: no mortality
Clinical signs:
other: Clinical signs included dyspnoe, apathy, staggering, skin redness and reduced state in males and females at all doses. At highest dose excicossis, abnormal position and atonia was also observed.
Gross pathology:
- Sacrified animals: nothing abnormal detected
- Moribund animals:
2150 mg/kg bw: congestion, pronounced hydrothorax, pronounced hyperemia with edema in lungs, brownish liver, brighten kidneys
3160 mg/kg bw: pronounced hydrothorax, pronounced hyperemia with edema in lungs, partial degeneration

Applicant's summary and conclusion

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