Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
88 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible

Workers - Hazard for the eyes

Additional information - workers

This DMEL derivation is only valid if the substance contains > 0.1 % 1,3 -butadiene:

The DMEL for "Reaction mass of butane and butene" is based on the DMEL of 1,3 -butadiene which is present in the "Reaction mass of butane and butene" at concentrations above 0.1% and therefore triggers classification and labeling as carcinogen and mutagen. Limit values - eight hours for 1,3 -butadiene are as high as 10 ppm (= 22 mg/m3) in member states of the European Union. In the Reach dossier of 1,3 -butadiene a DMEL, inhalation (long-term exposure, systemic effects) of 1 ppm (=2.2 mg/m3) is suggested. This DMEL was modified due to the lower content of 1,3 -butadiene in "Reaction mass of butane and butene" and set at 40 ppm (= 88 mg/m3). This DMEL should sufficiently protect up to and including a maximum concentration of 2.5 % 1,3- butadien in "Reaction mass of butane and butene".

DNEL for Reaction mass of butane and butene with < 0.1 % 1,3-butadiene.

DNELs for the other substances in "Reaction mass of butane and butene" (Butene, 2 -methylpropene, butane and isobutane) are much higher than 40 ppm as indicated by EU limit values and the Reach dossiers of these substances. The lowest DNEL was 335 ppm (ca. 800 mg/m3) for butene and 2 -methylpropene. The eight hour limit values for butane and isobutane are set at 1000 ppm in Germany (2400 mg/m3).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
2.64 mg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

This DMEL derivation is only valid if the substance contains > 0.1 % 1,3 -butadiene:

See also discussion section of the worker.

The consumer DMEL is based on the consumer DMEL of 1,3 -butadiene which was set at 30 ppb (= 0.0664 mg/m3).

This DMEL was modified due to the lower content of 1,3 -butadiene in "Reaction mass of butane and butene" and set at 1.2 ppm (= 2.64 mg/m3). This DMEL should sufficiently protect up to and including a maximum concentration of 2.5 % 1,3- butadien in "Reaction mass of butane and butene".

DNEL for Reaction mass of butane and butene with < 0.1 % 1,3-butadiene.

Consumer DNELs for Butene, 2 -methylpropene, butane and isobutane were at 71 ppm (ca. 170 mg/m3) or higher as indicated by the respective Reach dossiers.