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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
T25
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
LOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
500
Dose descriptor:
T25
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
500
Dose descriptor starting point:
LOAEC

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The most critical effect is tumorigenicity as demonstrated by a study with the structural homologue 1,2-epoxybutane (CAS 106 -88 -7; Butylene oxide-1.2). Moreover, 2.3-epoxybutane may contain up to 20 % of 1.2-epoxybutane. Therefore, the legal classification for this material is also employed for the 2.3 -isomer.

In a long-term inhalation study in rats 1.2-epoxybutane has caused nasal and lung tumors in rats. The following tumor incidences were obtained in the males:

 Dose  Nasal adenoma  Lung adenoma plus carcinoma
 0 ppm  0  0
 200 ppm  0  8.9%
 400 ppm  24.2%  17.6%

At 400 ppm there was a markedly decreased survival in male rats. In females, a low tumor response was seen only at 400 ppm. For the nasal tumors in males a T25 of 413 ppm is obtained. For lung tumors in males a T25 of 568 ppm (calculated from the top dose) or 562 ppm (calculated from the lower dose ) is obtained. A linear extrapolation from a T25 of 500 ppm would indicate a numerical risk of 1:2000 at 1 ppm. However, the real risk is assumed to be lower due to a likelyhood for non-linear elements in the dose response relation at lower doses (as it has been shown for propylene oxide). 1 ppm (= 3 mg/m3) can therefore serve as a preliminary DMEL for epoxybutane ( - both isomers). This value should also be protective from local effects including nasal tumors.

No dermal DNELs/DMELs are derived, because there is no dermal exposure unless in accidental cases.

Due to the structural similarities, the same conclusions can be drawn for 2,3 -epoxybutane.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
3 000
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
3 000
Dose descriptor:
T25
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Dose descriptor starting point:
LOAEC

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

For the general population, the chronic worker DMEL is devided by 6. No dermal or oral exposure is expected.

Due to the structural similarities, the same conclusions can be drawn for 2,3 -epoxybutane.